Room 440-D, Hubert Humphrey Building
200
Independence Avenue, SW
Washington, DC 20201
MR. LUMPKIN: Let's get started. We've got the agenda on the board. Any additions to the agenda? The agenda, let me read it, is the NPRM options. This is for the organizations that will be acceptable to do the updating. The second is the attachments issues that we have to deal with, and we either may come to a resolution or decide how we're going to come to a resolution. The third are some follow-up issues on the CPR Work Group charge and scope issues. The fourth is next steps, hearings that we need to schedule. Jeff.
MR. BLAIR: Could I make just a very brief announcement because when I introduce the inventory, I think there was somebody who was wondering about its availability to folks that are not on the committee. I realize there's a lot of sensitivity towards documents or standards or code sets and folks charging for them. The ANSIHSP(?) will be meeting two weeks from now. They're going to discuss how they can make it available to folks as inexpensively as possible and with the support that Michael Fitzmorris and Jim Scanlon have given ANSIHSP it enables us to try to make it available at little or no cost if possible.
So, please understand for those folks who might be interested in getting copies of this, it's just that we haven't addressed the issue yet at the ANSIHSP but we will do our best to make it available as inexpensively as possible to the rest of the world.
MR. MCDONALD: The last one I thought was free, wasn't it? The first version.
MR. BLAIR: We did it on diskettes.
MR. MCDONALD: I bring it because many people submitted stuff to it. I think no one maybe knew ahead of time that this was going to be a charged product.
MR. BLAIR: The reason I'm deferring on making a statement that it could be distributed for free is that when we produced it in hard copy it was a fairly substantial amount of money. Then the diskettes will be distributed free to everyone attending the ANSIHSP meeting two weeks from now. Then there will be a discussion as to how it could be provided beyond that. There are even some publishers that have inquired as to whether they could publish this for wider distribution and we don't know how to handle that. So it's a --
MR. MCDONALD: Is the web on the table?
MR. BLAIR: It's going to be up on the web page for ANSIHSP as well, so ostensibly it's free.
MS. BALL: I also have a revision to the subcommittee's charge if you would like to see these.
MS. GREENBERG: Does anyone have the MPR(?)? We sent it to you.
MR LUMPKIN: Just that section that we're going to talk about so we can read so everyone knows what option one is.
MS. GREENBERG: Just from the document they did yesterday.
MR. BRAITHWAITE: Option one and two are listed in the document from yesterday.
MR. LUMPKIN: Well, we already adopted this so, this is our committee charge that was just passed out. The addition was that we said uniform data standards for patient medical record information [words lost] such information, including computer based medical record systems. We just took the language from the law to enhance that one item.
MS. GREENBERG: This should be presented tomorrow, right, as part of your report?
MR. LUMPKIN: Yes, it will be presented tomorrow as part of the report.
Do we have that language? I think it would be useful. Not for ANSI.
MS. GREENBERG: I have it hear from yesterday's discussion. Do you want me to read it?
MR. LUMPKIN: There are two approaches, so we're all on the same page. Approach two you know, which is --
MS. GREENBERG: You really need to read it. There seems to be some question as to whether we're talking about accreditation or just due process.
MR. LUMPKIN: Okay, approach number one, that they would meet the following criteria.
First, have biannual meetings that the public is welcome to attend and participate without payment.
Two, meetings are announced to the broadest possible audience at minimum by means of a web site. Announcements of the meetings may also be available by widely read publications such as Commerce Business Daily or the Federal Register.
MS. GREENBERG: Or the New York Post.
MR. LUMPKIN: Number three, annual public meeting schedules are posted on a web site not later than 90 days after the effective date of the final rule and annually thereafter.
Four, the data maintenance body establishes a central contact to which the public can submit correspondence.
Five, during the two open meetings, the public has the opportunity to voice concerns and suggest changes.
Six, each data maintenance body drafts procedures for the public to follow in regard to its meeting protocols. Seven, each data maintenance body drafts procedures for the public to submit requests for data or for revisions to the standard. These draft procedures are easy to use and are adequately communicated to the public.
Eight, each designated data maintenance body is also responsible for communicating actions taken on the request to the requester and the public in addition to communicating any changes made to a standard. This may be done via mail, e-mail, publications or newsletter, but at a minimum are published on a web site.
Nine, each data maintenance body responds definitively to each request it receives no later than three months after the request was received.
That's option one.
Option two, require an organization as the official data content maintenance body for a particular transaction to meet the ANSI criteria for due process, which we had before.
So we have nine requirements. The first is the ANSI document.
MR. BRAITHWAITE: Should we read the ANSI requirements for due process?
MR. LUMPKIN: Due process, which is this entire document?
PARTICIPANT: No, it's just this paragraph.
MR. BRAITHWAITE: Unfortunately, the way they've written this, the section is due process and criteria for approval and withdrawal of national standards, so we have to figure out what is the due process part and it's paragraphs 1.2 through 1.2.7.
MR. COHN: Where is 1.2.7?
MR. BRAITHWAITE: Page 3 has 1.2.7 on it and page 3 got left out of some of the copies. That's why it's worth reading.
MR. LUMPKIN: Do you have the full thing?
MR. BRAITHWAITE: I have the whole thing, yes. Due process means that any person, organization, company, government agency, individual, et cetera with a direct and material interest has a right to participate by A, expressing a position and its basis; B, having that position considered; and C, appealing if adversely affected. Due process allows for equity and fair play.
The following constitute the minimal acceptable due process requirements for the development of consensus. Openness, participation shall be open to all persons who are directly and materially affected by the activity in question. There shall be no undue financial barriers to participation. Participation shall not be conditional upon membership in any organization nor unreasonably restricted on the basis of technical qualifications or other such requirements.
Timely and adequate notice of any action to create, revise, affirm or withdraw the standard and the establishment of new consensus developing group or canvas list(?) should be provided to all known directly and materially affected interests. Notice should include a clear and meaningful description of the purpose of the proposed activity, which will identify a readily available source for further information.
The second principle, balance. The standards development process should have a balance of interests and it should not be dominated by any single interest category. Dominance means a position or exercise of dominant authority, leadership or influence by reason of superior leverage, strength or representation to the exclusion of fair and equitable consideration of other viewpoints.
The requirement implicit in the phrase shall not be dominated by any single interest category. Normally(?) it will it be satisfied by the historical criteria for balance that is A, no single interest category constitutes more than one-third of the membership of a committee; or B, no single interest category constitutes a majority of the membership of a committee.
It has some peculiar categories to ANSI here, which is safety committees and product standards, but that's not relevant here.
Unless it is claimed by a directly and materially affected person that a single interest category dominated the standards development process, no test for dominance is required.
The third paragraph is interest categories. The interest categories appropriate to the development of consensus and integrating standards activity are a function of the nature of the standards being developed. In defining interest categories appropriate to a standards activity, consideration shall be given to at least the following, producer interest, user and general interest, in this case producer and user of data. In the standards world, this was originally written for producers and users of products.
Where appropriate, more detailed subdivisions should be considered. Appropriate representative user views shall be actively sought and fully considered in standards activities. Whenever possible, user participants shall be those with the requisite technical knowledge but other users may also participate. User participation should come from both individuals and representatives of organized groups. There are several user categories discussed, most of which don't have anything to do with the kind of thing we deal with in information standards.
There's also a requirement for written procedures. Written procedures shall govern the methods used for standards development and shall be available to any interested person. There's a requirement for an appeals process. Written procedures shall contain an identifiable, realistic and readily available appeals mechanism for the impartial handling of substantive and procedural complaints regarding any action or inaction.
Then the paragraph on notification. Notification of standards activities shall be announced in suitable media as appropriate to demonstrate provision of opportunity for participation by all directly and materially affected persons. The rest of that paragraph is probably not relevant to this group.
Then there is a paragraph, the final paragraph, on consideration of views and objections. Prompt consideration shall be given to the written views and objections of all the participants including those commenting on the listing(?) of standards action, which is their publication for announcing things like the Federal Register.
An effort to resolve all comments shall be made and each objector shall be advised of the disposition of the objection and the reasons therefor. In addition, each objector shall be informed an appeals process exists within the procedures used by the developer. When this procedure is completed in accordance with the written procedures of the standards developer, the standards developer may consider any comments received subsequent to the closing of public review and comment period or shall consider them at the next review. Unresolved objections or any substantive change made in a proposed standard shall be reported to the consensus developing group, a canvas list in order to afford all members or canvassees an opportunity to respond, reform or change their vote.
The rest of the stuff has to do with international standards and particular mechanisms in ANSI for adopting and changing standards.
There's no mention at all about specific time frames in this due process, just that it be timely.
MS. GREENBERG: What about the time frames, 1.2.6?
MR. COHN: A minimum of 60 days, the comment period shall be a minimum of 60 days.
MR. MCDONALD: Bill, are you proposing that we should encourage that method or just saying it's one that's there?
MR. BRAITHWAITE: I'm just explaining that this is what is the content of option two to have the content committees follow the due process requirements of ANSI, not the whole ANSI process, not become ANSI accredited or anything else, just the due process requirements.
MR. MCDONALD: How are you defining now the content committee? How do we, is X12N a content committee?
MR. BRAITHWAITE: X12N is responsible for some of the content at the moment.
MR. MCDONALD: What I'm really worried about is the definition of content committee is pretty vague.
MR. BRAITHWAITE: NACC is a content committee.
MR. MCDONALD: Wouldn't it be helpful -- I propose [word lost] to split these categories up a little bit into the existing standards which are ANSI approved and by the law. Then as I said, we've got the code set committees, which have some other processes. We've got these -- the Ns(?) are really starting to come in.
MR. BRAITHWAITE: I think we should consider that, but first I would like to hear what would be the difference in the process as the reason for splitting.
MR. MCDONALD: I think the ANSI process is ideal for the kind of things it does. I don't think it's, as I said before, I don't think there's any example of success in code sets for an ANSI-like process. Keeping up with 3,000 vocabulary terms or 10,000 or 100,000, it just is not something that's easily subject to a technical review. It's like an encyclopedia or a dictionary.
The process is slow. It's the right speed for the things it's doing, and it can't be faster for those things because there's an awful lot of analysis needed in terms of working through status structures and messages and transactions.
MR. LUMPKIN: Let me try to focus the discussion, because I think we need to -- if we all agree, if we agree with ANSI accredited as an SDO, then we don't need to talk about it. They meet some standard. So we're really talking about applying test one or test two to a non-accredited organization. So maybe the first thing we could say is, our response is there are -- the first test is is ANSI accredited. If it is, end of story. Can we agree on that?
MR. MCDONALD: No. I worry about making that the first because what that's going to really encourage is the SDOs maybe going after some of this other content which may not be appropriate.
MR. LUMPKIN: Well, we're not saying that it's the preferred. We're saying that if you have a potential content committee for approval, and we want to make sure they have an acceptable process, the first question you ask is are they ANSI accredited, a flow chart. If the answer is yes, then you make your decision based upon the other criteria, which is are they the right people, do they make the data content, are they ones who develop it, whatever we used.
If the answer is no, NUCC, NUBC, CPT-4, editorial committee, all of these things, do we want to hold them to some other way to approve their process? We have option one, which were the nine elements listed in the NPRM, option two, which is meeting the standard that Bill just read, or do we want to have a third option that we can't quite define as yet.
MR. BLAIR: As I tried to follow along, this phrase content committee, and I'm thinking of it both with respect to YCTs(?), CPT, snowmed(?), a variety of things, in some cases they have committees that they call editorial boards, in some cases they have advisory committees. I don't know whether the data council might be a phrase. Are all of these different names what we would consider to be a content committee? Am I heading down the right track?
AUDIENCE: Yes, actually I have a question about that because even in the legislation code sets are separate. Domain value, groups that deal with domain values are separated from the standards group. I don't really see what -- when I think of content committee I think more of like the NUCC, and BC, more than CPT or ICD-9. That whole process, in fact the Secretary -- changes to a standard can only be made once a year. Changes to code sets can be made as necessary.
MS. GREENBERG: But a code set is not just a medical code set, it can also be the code set say within the transaction, like the NUBC does, or the NUCC does.
AUDIENCE: That's right, but that's saying that within this data element this is the domain values that you will be accepting, but that's not actually -- there's a difference between saying we shall use ICD-9 versus here are all the accepted values within ICD-9. The NUCC is the one who says we should use ICD-9, but WHO says here are the acceptable values.
MR. LUMPKIN: Would we be then comfortable, following up on Jeff's question, to exclude those organizations that only deal with a specific code set? So CPT-4 editorial committee, Snowmed, whatever, from this definition of a data content committee.
MS. GREENBERG: Well, I question if you really want to exclude them entirely. I guess my reading is, although I think you would have to hold hearings as you suggested to really get the reading of the groups themselves, but that you could basically go along with option one and these groups could continue. They might have to open up a little more, they might have to do a little more with their web site, but I personally don't think this is necessarily a bad thing and I think it's in keeping with the testimony has heard, et cetera.
You go to option two and I do think you open up -- and you may want to do this -- but you open up particularly the people who maybe strongly object to the way content is currently being defined, to really follow up the situation, particularly with the appeals process. Although I defer to Bill in the sense that I know he is much more knowledgeable about this than I am, but I think what it says in option two, not only will these criteria meet the intent of HIPA(?) to advocate an open balanced consensus process, once an organization met these criteria it would be able to apply for ANSI accreditation if it so desired. We really are tying the ability to apply for ANSI accreditation and meeting these criteria pretty closely. So it may not be that you would have to meet all of the criteria, but this certainly indicates that you would be close.
My sense is if you want to be able to continue with the current groups, with perhaps some improvement at least in the short term, you could go with option one. I think to the extent that it would require those groups to maybe be a little more open, provide information more, have maybe more open meetings, I don't think that's a bad thing myself, though some people may think so. But you go to option two, and I think you potentially really change the dynamics.
MR. COHN: I actually was generally going to support what Marjorie was saying, which I also think was sort of what you were saying, which is an either or option. You can do option one or option two. I would disagree with Bob Mays, I think it should be included, the code set developer should be included. I think there's a need for a more open process in relationship to the development of code sets. But I think it's one or the other and I think that that's really the type of comment that we ought to make.
AUDIENCE: What do you do about zip codes? Zip codes is a code set. Zip codes and addresses is a code set. The Postal Service is not -- I mean see, you're differentiating organizations that have certain authority over the domains --
MS. GREENBERG: It isn't a health code set though.
AUDIENCE: The point is, I'm just saying -- the Postal Service is not going to open up their decision to add or subtract zip codes. It's the same thing as an ICD-9 code.
MR. LUMPKIN: Hold on, we're breaking down the process here.
MR. BLAIR: I would like to support the thinking that Marjorie has expressed from this standpoint. I think we have an opportunity to move many of the data set and code set developers. I think we have an opportunity to begin to move many of the data set and code set developers towards a -- it's not entirely being accredited, but at least towards standardization if we do this.
As I start to -- and I can't remember all of the ones that were in the inventory, over 60 code set and data set developers are represented there. But the only ones that I think would not be able to take this step towards at least sanctioning, maybe I will use that word, to sanctioning or recognition by HIPA, if not accreditation, is those who are the drug knowledge base vendors as vendors, in which case they would have to set up some type of a content committee. I don't know whether they can or not. They would have to move into some form that provided that function or service.
But I think that this is really needed. I've had a number of these code set developers that have wound up being very interested in the idea of somehow becoming accredited. I think it is broad enough that even though ICD-CM and PCS are done within the Department of Health and Human Services, I suspect that the councils that you have to be able to solicit input from a diversity of users would be able to meet these criteria so you have government agencies that are developing code sets that I think could meet it. You have professional associations that I believe could meet it. You probably have consortiums that could probably meet it. So the only other piece in my mind that's a maybe would be like a multima(?) or first data bank whereby maybe they would have to do something significant to be able to move to the point where they are a recognized standard.
MS. GREENBERG: Are you talking about option one, they could meet that?
MS. COLTIN: I was going to actually support what Simon said. I agree with option one being a reasonable choice. And I agree with having it apply to code sets. I'm wondering if there might not be some value to making a distinction between code sets that are maintained in the public domain versus those that are proprietary because I think the biggest issues that we heard about in terms of openness and balance have really applied to those that are proprietary. So we might consider excluding those that are in the public domain from having to comply.
MR. MCDONALD: I'm not one of the day(?), but I think we're doing a social experiment we don't know the consequence of. The zip code, [word lost] or the VCRI, there are a lot of things that are effectively making codes out there. ICD-9, that are not fully qualifying and all this kind of stuff. I just worry that we're blindly making a big plan.
Now, I'm in favor of something one-ish for lots of things, including whoever wants to -- I would comply with it, except we've got some onerous requirements here that are not applied to the standards organizations like it must be free. The meetings must be free. What if 5,000 people come, where in the heck do you put them?
MS. GREENBERG: I think the reasonable cost thing makes more sense.
MR. BLAIR: Reasonable cost I think is more appropriate.
MR. MCDONALD: There are a number of things. I think you have to publish all the changes. The standards don't publish all the changes to the general public, you have to belong to the committee, or you have to pay. So I think there are some problems with the specifics in here that may break down too.
MR. BLAIR: Would you want to streamline it or simplify it a little bit and that would be acceptable?
MR. MCDONALD: From someone who has tried to build code sets on the cheap, we basically pick interested parties who come. No one who has ever wanted to come have we ever turned out, but we only had room for about 20 people in this room that we had at our institute. We do feed them lunch for free, but we couldn't do loaves and fishes and feed the whole --
[Laughter.]
We're not exactly always -- we're probably less than three months to all responses, but by golly, I don't know if I want to go to jail if I miss that three month thing.
AUDIENCE: I don't want to make it sound like I'm opposed to having an open process. This is a real area that I have real concern about is this content area. I would go back to I think what was your initial issue, Clem, which was there's the process of setting up the structure of the code sets and basically setting the classification or changing the classification system. There's been a day-to-day process of assigning specific codes to particular things that come up.
So I think in fact there probably is input into how zip codes are arranged in the world, in the country, but the post office doesn't go to everybody every time they want to assign a new zip code. That's -- the problem, this one process I think, this open process is perfectly legitimate for discussing how you structure the classification, how you make a revision for instance, a new addition or something of an entire set, but it's not going to be very workable when something new comes on the horizon and you need to get a new code out there to meet it because they've suddenly decided -- there's a new drug for instance. I mean they aren't going to wait for 90 days or 120 days to put a code out for a drug that's already on the market. Somebody, they ought to capture it somehow, somebody is going to pay for it.
MS. GREENBERG: Does option one say you have to wait that long?
PARTICIPANT: There's no waiting time for option one, or public comment.
AUDIENCE: Well, but I mean you have a new drug, they put out a new drug, they're going to have to have a whole series of meetings and public comment before they make a code to cover a drug that's commercially available or FDA approved?
MR. MCDONALD: It just says you have a meeting.
MR. COHN: I think, Bob, you're describing option two, which is really the ANSI process. I think what we're looking at is whether even option one fits in, which is this -- you have biannual public meetings. I didn't see anything in here that said you had to cover everything that you ever did.
AUDIENCE: Okay, that's my big issue is would you have to wait. If you wanted to make changes to a code set, i.e. there's a new drug out, do you have to wait for one of these biannual meetings? I don't think that we're trying to be unreasonable, but I just think it's a little unclear as to where the line draws in terms of the content change.
MR. LUMPKIN: Let me perhaps suggest looking at those nine principles, I kind of boiled it down to four principles rather than specific provisions, because I just wonder if we're going to get all bogged down in a particular -- those four principles are that there are public meetings at reasonable cost, that the meetings and actions are announced, that the product is available at a reasonable cost, and that there's evidence that we're responsive to public input.
PARTICIPANT: There you go, that's a good phrase.
MR. MCDONALD: This does not say the product is available at reduced cost. It says the meetings are free.
MR. BLAIR: That last one I think is a beautiful way of summarizing a lot of difficult issues to say reasonable -- there's evidence of reasonable responses. Maybe you could say diverse input or something like that.
MR. LUMPKIN: Okay, let me rephrase this. One, public meetings at reasonable cost at reasonable intervals. Meetings are announced. Changes in the product are announced and that there's evidence of responsiveness to public input. We would recommend these be the four principles that would be reflected in the changes to the NPRM.
AUDIENCE: I would just like to make an observation. There's a distinction between the development of vocabularies and code sets and the adoption of code sets. A lot of what ANSI and related types of due process considerations have to do with are the adoption of a code set. I think what you want to encourage is a group, even if they're meeting in a black hole somewhere, if they produce the world's best code set, then the issue is adoption should be consensus process. Then your concern is for the maintenance of that and upgrading of it.
MR. LUMPKIN: But the issue is the maintenance, that's really what we're talking about, not the adoption.
AUDIENCE: The point is I don't think that the way that you expressed things, it seemed to be the onus of an organization in all their development process rather than how they handle changes and extensions. I think there's a distinction there.
MR. LUMPKIN: Right, but the issue before us is the maintenance of the code sets.
AUDIENCE: The principles, I like how they're evolving, I'm just wondering especially if one is particularly vague, what difference does it make? You've stated the principle and that would be nice. Now can we adopt a particular code set, maintenance of a particular code set, what's the enforcement? What happens if somebody doesn't do it? How do you judge that it's not responsive enough?
If an organization wanted to jump in and say oh yes, we will do it, and then basically was not responsive, so what? Nice principles, but --
MS. GREENBERG: I think the next time you issue NPRM you could --
MR. LUMPKIN: I really wasn't suggesting that we tell HHS to just adopt these principles. We're saying that the specifics of the final rule should reflect these principles.
MR. MCDONALD: Remember on the other side of this that there are codes that don't exist yet and there are some that we probably need mightily and Lord knows how they're going to make it happen. The other side is how would you ever get a catalog of attachment questions? What are the legal questions to ask?
One of the proposals made when I wasn't there by somebody was that UUNC would do it and I, the [word lost], would set up a web site which would provide new codes for any question they sent me on a daily basis. That is not a job I don't think anyone on earth wants without some process to filter and kind of boil down and analyze these. The challenge really is finding the workers or the volunteers or the funding or whatever. I like what we're doing now on a volunteer basis, but that could [word lost] any system. So you've got these yings and yangs. I just think we're really in the early days of figuring out how to do some of these things. I just hate to have it too constricting because some company comes up and says for free, like UCRI(?) as a foundation, they basically give away their codes. They just do it and everybody seems to be happy with it, they get input but there's no formality to it.
MR. LUMPKIN: As I read this section, we're not talking about somebody comes up with this brand new code and HHS says yes, we like it. The question becomes now that everybody has got to follow this new code, is it going to be maintained. My specialty, emergency medicine, was new on the scene. I can tell you we had battles royal with the CPT committee so we could charge for an EKG. The premise was if I read an EKG when a patient was in front of me, that was an appropriate use of an EKG code. The cardiologist who billed for it two days later when the patient was already gone, buried or in the ICU really was not value added. How do we adjudicate those kinds of issues?
So it doesn't become the initial adoption, it becomes the maintenance where many of these issues of evolution of care get raised and there has to be a process for people to have some way to have a voice in it.
MR. MCDONALD: It only gets hot in those areas that have to do with payment. I'm going to stay real clear of those.
MR. BLAIR: Joan, I know that that was the number one hot item that we listed within the work plan for the CPR. Do you want to move that issue forward into this NPRM? Are we ready to go through that at this point? The issue of maintenance of code sets and the infrastructure.
AUDIENCE: This is a broader question. The content issue is -- we've sort of gotten off on a tangent, but fundamentally there's a really big sociopolitical issue of who is it that determines what's in an attachment, what's in a claim, not just the code sets, but actually what fields are [word lost], not just code sets.
MR. LUMPKIN: Again, it's not what's in them at the point of adoption. It's what's going to be in them when it changes.
MR. MCDONALD: Both those are hard.
MR. LUMPKIN: The initial adoption issue, that's hard too, but fortunately that's not covered in this section.
Let me suggest that I hear another issue coming up and we still haven't gotten resolution on the issue of code sets. I'm hearing some difference of opinion. So the question I'm posing is should we treat code sets differently than other data content committees.
MS. FRAWLEY: I'm just going back to the actual language that's in the notice, which is I think that we have to just stay focused, because I was getting confused. I was like we're switching from apples to oranges. It lays out all these criteria and then it says we welcome any comments regarding the approach outlined above, which is option one or option two and recommendations for data maintenance committees for each X12N transaction standard identified in this rule.
PARTICIPANT: Why didn't you say that earlier?
MS. FRAWLEY: I just looked because I said to Marjorie I'm confused. Except it doesn't say code set up there either.
MS. GREENBERG: It does refer to data element content.
MS. FRAWLEY: Except, the NPRM is electronic transactions and code sets. What this section is relating to is the data maintenance committees for each X12N transaction standard. That's what we're being asked to comment on. I was getting confused. I'm just bringing us back to reality, what we were asked to comment on.
MR. COHN: I'm not sure if that solves the problem. The only thing it removes is the NCPDP standards and the data elements because the code sets that are within the X12 standards include the types of code sets --
MR. LUMPKIN: Actually it does scratch an itch.
PARTICIPANT: Mention data maintenance, the data maintenance committees are the ones that handle the code set changes within X12 for immediate response.
MR. LUMPKIN: What I would suggest that we do for procedure, if we've gotten to some conclusion about the transaction and maintenance committees, that we take the issue of whether or not code sets are in, because we're not asked that in here, and the other issues and put those into a hearing, which is what we had intended to do before. So, since we are not in the position of being forced to make a decision, let's find out more about the patient and then try to make a decision. Does that work?
MR. MCDONALD: Well, we need one more hearing? Is this a hearing we would have had under the normal kind of course of events or is --
MR. LUMPKIN: Yes, this a hearing that we had planned to have when we got to this section of NPRM.
MS. GREENBERG: I think maybe actually this whole discussion may mix apples and oranges, but actually the people who wrote it should probably be here to defend themselves. But as I say, we intend that the private sector, with public sector involvement, continue to have responsibility for defining the data element content of the administrative transactions. The data element content does include some code sets. I'm not sure this applies to the medical code sets, but certainly say the code set for discharge status. That's a data element, and the NUBC or the NUCC defines that content. So it seems to include some code sets.
AUDIENCE: I don't think that that's, if I remember -- I was involved in some of these discussions on the infrastructure. When they say the data element content, I don't think they were meaning the content of specific data elements, but rather what data elements constitute this transaction. In that case, it would not really be that somebody is going to say yes, the code set for sex should be M, F or -- I don't think they were thinking that it was going to be public discussion of that.
MR. BLAIR: Those are the segments and fields within a transaction as opposed to saying that they're data elements.
AUDIENCE: The content of the message versus the content of the data element.
MR. MCDONALD: The other challenge here is that the two ends really ran the show with the 1500 and UB92 correct? They did all right, except there wasn't enough discipline so people cheated, [word lost] variance. So the challenge is how do we move into this next rule and whip away this connectedness to the providers and payers and maintain it in this new world. I think that's another reason to support the two Ns in this, some role in this process. I'm not on any of those committees, so I don't know really.
AUDIENCE: Well, one of the issues is, for instance the public health people have a real concern because they have historically not had as much participation in the uniform billing, uniform claim committee, and yet they relied on the claims and such to get a lot of their information. The concern is what they're hearing -- I think Marjorie you can address this because this is what we heard at [word lost] -- is gee, you know, if you start stripping back some of this non-payment type of information off the claims, where is it going to go? Who do we turn to to make sure that we get this data or that data that currently we're now getting on the claim, but we may not in the future. Does the NUCC or the NUBC truly represent us or do we have a voice on that? I think that fundamentally those are the kinds of concerns.
MR. LUMPKIN: Let's maybe not get into specific data content of each of the transactions. What I would like, if it's okay with the committee, to try to focus on what our task is today. That task is to make recommendations regarding the approach outlined above and recommendation for data maintenance committees for each of the X12N transaction standards identified in this rule.
MR. COHN: I was actually going to agree with you, but I reread this and I was originally confused myself. As I looked through this again, they make reference to the code sets, but the code sets are clearly not the -- it's a little confusing but I just wanted to reaffirm the --
MS. FRAWLEY: It's very clear what we're supposed to be doing.
MR. LUMPKIN: So in reference to data maintenance committees, I mean we were all looking at it in a much broader sense than maybe we need to at this moment, recognizing that we have wanted to do hearings on this specific issue, particularly related to code sets and non-code sets.
Do we want to comment on the data maintenance organizations for the transactions? I assume that we're still comfortable with saying those organizations if they're ANSI accredited, they're okay. If they're not ANSI accredited, then do we want to apply the four principles or do we want to take it to the other --
MR. MCDONALD: I think I would still go in the same order, four principles and ANSI accredited. It changes the --
MR. LUMPKIN: Four principles for ANSI accredited, okay.
MR. COHN: The point that I was going to make though is that this is actually square on the topic that we had no need(?) to talk about in this area, it actually gets murkier as we get into it, because the key pieces, there are some data maintenance committees for some areas, not for others, how are they going to get handled, the relationships between these data maintenance committees and the standards organizations are mostly informal and somewhat unclear. Probably if we're writing a letter, we maybe need to make a comment that says we are intending to look at these issues and make some further recommendations, after we've had hearings on some of these areas.
MS. COLTIN: One thing that I think is not clear in your principles that was in what was laid out is this notion of balance. You can be responsive to public input all from one side and not across. So I think there needs to be something in the report, the principle that speaks to the issue of balance or balanced input.
MR. LUMPKIN: Responses to balanced public input.
MR. MCDONALD: That can be a problem. I think we have to decide what are we fixing. What's broken that we're trying to fix? Because if you basically just open it up to a public brouhaha, that doesn't make it a more efficient process. So the question is what ANSI has to say is interested parties. They don't say everyone, who have a significant interest or something like that in the process.
So if you get the payers and the providers battling about the billing, if there's someone else who should be there, they should be there, but it isn't everybody.
MR. LUMPKIN: Because ANSI talks about the balance of the committee, not the balance of the public comments.
MS. COLTIN: Right, but there's nothing in those principles that speaks to balance at either of those.
MR. MCDONALD: But see, the balance you can fix --
MR. LUMPKIN: So we could add a principle zero, because I already used one, and sort of put it up. Anyway, that would be balance and reference the ANSI definition, which was no more than -- no?
MS. FRAWLEY: My problem is there's nine criteria laid out in the NPRM. The nine criteria kind of collapse three or four principles, but now all of a sudden we're adding something on. So I just felt a little uncomfortable because I think that the balance, if you read the definition, doesn't really fit. Basically what this criteria says is that the public needs to be informed that there's meetings, that they're open, that they can voice concerns and suggest changes, there's communication via the Internet, web sites, da, da, da, da, da. But it doesn't necessarily say there has to be any balance.
MS. GREENBERG: I must say it's a comment I've thought about.
MS. COLTIN: That's I think one of the biggest criticisms that has come up around the data content is that --
MS. GREENBERG: Major users are not represented on the committee, which is different than balance actually.
MS. COLTIN: Well, one of the issues that comes up I think is it's not just the providers and the users. I think there's a distinction among the users of primary users and secondary users. That's where I think a lot of the contention comes up is whether these secondary users, who are kind of outside the process than the primary users, providers and payers, whatever have hammered out, want to come in and say gee, you came up with a kind of neat thing that we could use, but now we would like to change it. And that's what happens sometimes. This is part of the tension I think that we've seen in these committees.
MR. BLAIR: I would suggest that we try to accommodate the desire for balance within the principle that you have there on announcing, that it's announced maybe to as wide a group as possible, that it's announced with sufficient notice. The reason I'm switching it to that is because I think there's many times in these voluntary standards organizations where, even in the inventory standards, you reach out to an awful lot of people and there's only a small group that's interested enough strongly enough to come and participate to work on the standard.
So you wind up doing that and in short, you can't really ensure that the people that are going to attend and be part of the process is balanced. All you can ensure is that you've reached out and announced and invited people to participate. So that would be where I would put the emphasis.
MS. FRAWLEY: I concur with that point, because our concern seems to be with NUBC or NUCC and the ability of secondary users of data to be able to express concerns and be open, our four principles actually cover that. Basically the NUBC and NUCC would have to have open meetings. People would be able to come forward and express concerns. I think that's really what we're looking for. We're not saying that the composition of those committees has to change as much as there has to be a process for input.
MS. GREENBERG: I think that is an issue the composition of the committees too, but it isn't addressed in these principles. It could be addressed in a comment, it wouldn't have to be. There are ways that this is being addressed now I think other ways. It may be a little premature without hearings. There's going to be some processes like I'm reporting on tomorrow which might offer some new options. So --
MR. BLAIR: I changed principle two to read the meetings are announced in a balanced fashion. Why don't we say meetings are announced to all interested parties or a wide -- broadly announced with sufficient advance notice or something like that.
MS. FYFFE: Actually I have a suggestion. The principle of balance is in the ANSI due process. Let me repeat this because I think there's some [word lost]. The standards development process should have a balance of interests and should not be dominated by any single interest category. I can tell you as a minority member of the NUCC, which is -- I don't want to get into it -- the NUCC and NUBC do not have a balanced composition. So I think it would be prudent for us to consider adding that as well to the criteria.
MR. MCDONALD: But the problem is -- ANSI, everybody who wants to be on they let them on it, and it's over balanced. The only reason why that works is because no one bitches about it, because you can divide this, you can find 15 categories and you're going to find imbalance, I guarantee it in any statistical distribution of whatever categories you make up. It's always someone is going to be unbalanced.
MS. FYFFE: Well, no, but what I'm talking about here is domination by any single interest. The permanent chair of the National Uniform Claim Committee is an employee of the American Medical Association. The permanent chair of the National Uniform Billing Committee is an employee of the American Hospital Association. The chairmanships do not rotate. To me that is domination by a single interest category.
MR. BLAIR: That's a different point. It's a valid point. I think that's a slightly different thing, that is a lack of open --
MS. FYFFE: It's composition.
MR. COHN: We need to come to a conclusion on what it is we need to say about the NPRM. It's very obvious to me that we need to structure a hearing of some sort to investigate these issues, because there is some knowledge in the room here about them, but I think we need to investigate all these further and then make some further recommendations.
MR. BLAIR: Are you saying we're not a balanced committee?
[Laughter.]
We're balanced but ignorant.
MR. LUMPKIN: It's clear that many of us, myself included, are unbalanced.
So what I hear us saying, if I could summarize this, that a committee, that a data maintenance committee for each of the X12N standards identified in this rule should have public meetings at a reasonable cost, the meetings are announced in a broad group to involved parties --
PARTICIPANT: Interested parties.
MR. LUMPKIN: Involved parties means you tell the pediatricians that you're having a meeting, because you're talking about pediatric codes. Interested party means that if they didn't come to the last meeting, they don't know about the next meeting.
MS. GREENBERG: Involved could sound like the people are already involved in the process.
MR. LUMPKIN: Yes, that's what I interpret it as. It would be affected parties. Okay, meetings announced in a broad way to affected parties.
MR. BRAITHWAITE: Directly and materially affected.
MR. LUMPKIN: The changes in products are announced to affected parties and there's evidence of a response to public input, or ANSI accredited.
MR. COHN: We're saying not all the meetings have to be public meetings, is that right?
MS. GREENBERG: At reasonable intervals.
MR. LUMPKIN: And that we would, in our response, comment that there is still a number of issues that need to be resolved in reference to maintenance of data content and that it is our intention to hold a hearing and make further recommendations to the department for future rules in this area.
MR. BLAIR: I move that the principles be accepted.
[The motion was duly seconded.]
MR. LUMPKIN: It's been moved and seconded. Discussion?
MS. GREENBERG: You still want to retain something about the need to coordinate all this. Wasn't there a paragraph about that? That there not be separate data maintenance committees for each transaction. For administration simplification, linkages and relationships need to be acknowledged. When changes to the content of one, blah, blah -- it is recognized that a coordinated approach to data maintenance is necessary and the number of bodies that can effectively manage such coordination should be limited. Whether this coordinating function should remain the responsibility of X12 or whether a super structure for data maintenance committees is necessary should be evaluated with an eye toward achieving a careful balance between costs and benefits. Are you still interested in that?
MR. LUMPKIN: Hold that off and we're going to have that as a separate issue.
MS. GREENBERG: Okay, so we're not necessarily replacing that.
MR. LUMPKIN: We're not, as of this point, replacing that. Everybody clear on what we're voting on?
All in favor say "aye".
[Chorus of "ayes".]
Opposed?
[No response.]
Okay.
MR. MCDONALD: Can I make a proposal on that one? Just leave it because it said it doesn't really tie to anything and it sounds reasonable. Leave that paragraph in.
MR. LUMPKIN(?): I thought that was part of the issue that we wanted hearings on. Am I wrong about that?
MS. GREENBERG: The coordinating function? Well you might, I guess.
MR. LUMPKIN: We can say that and then put our sentence in there about holding hearings on that.
MS. BALL: There's another paragraph that relates to this that follows the one that you just said leave in.
MS. FYFFE: What page are you on?
MS. GREENBERG: Page 7 of yesterday's document.
MS. BALL: The rules said we also solicit comments on the appropriateness of ongoing federal oversight, monitoring and maintenance processes and procedures.
MR. LUMPKIN: We might have to change that paragraph a little bit.
MS. GREENBERG: That one will have to be changed. It refers to the ANSI due process requirement.
MR. LUMPKIN: Well, I think we cab just change it to say minimize the requirements suggested above which would apply the --
MS. GREENBERG: You could just stop there.
MR. LUMPKIN: Okay, do you want to vote?
PARTICIPANT: I move that we do that.
MR. LUMPKIN: Okay. All those in favor?
[Chorus of "ayes".]
Opposed?
[No response.]
Okay. Simon, if you would do -- I've got to do a call, back to the office -- if you could do your stuff. It will probably be about 15, 20 minutes.
MR. COHN: Sure we will do my stuff.
We were actually going to talk about the charge and scope document for the work group as well as try to identify what next steps we need to do with both of these.
MS. GREENBERG: I have to go to the other subcommittee, but on your last topic, I would just suggest that thinking in terms of a second hearing in conjunction with the September meeting, because at least we have those dates, and that's in Washington?
MR. COHN: The next hearing would be around whatever issues we decide around --
MS. GREENBERG: Unique identifier.
MR. COHN: Oh, you're talking about unique identifier?
MS. GREENBERG: Hearings, yes.
MR. COHN: That was not what we were talking about.
MS. GREENBERG: That was a variety of hearings that you were talking about under four, okay.
MR. COHN: I understand what you meant to talk about the data maintenance committees.
First of all, does everybody have copies of the revised charge and scope document?
PARTICIPANT: For the work group on computer based patient records.
MR. COHN: We're going to talk about that for a couple minutes.
Now, first of all, I was going to go very briefly through the charge document which we revised, hopefully is -- and I don't think there's really much problem with it -- the changes that we made had to, from yesterday, had to do with bullet three where we added and other interested parties. We did some more significant wordsmithing on bullet four, which I just want to read over, which is specifically the work group role. We say, based upon public hearings, consultation and analysis, develop recommendations for the department and legislative proposals for subcommittee and full committee consideration on issues related to the adoption of uniform data standards for patient medical record information and related information and the electronic exchange of such information.
So that's what we came up with. Any comments or does that meet everyone's needs?
MS. FYFFE: Do you have an extra copy? I want to take one here.
MR. COHN: Yes.
MS. FYFFE: Okay, so this is no longer draft, this is final?
MR. COHN: Unless I hear otherwise, this becomes final upon I think approval of -- I guess we submit it tomorrow to the committee. I think we present this as part of the work group report tomorrow. As we said, we have a charge and this is our charge and get the approval from the full committee is I think what we do.
Now, I did want to spend a little time talking about the revised draft of the focus, scope and deliverable document. Kathleen, did you not get the other piece? I thought I had given you -- I may have given away too many of these.
As I said, this is what I consider to be a second draft. The real questions that we need to talk about have to do with does this sort of passing -- are these appropriate scope and deliverables. Are they the right ones, are they all where they need to go? Are they going to be something that we're going to want to send out and are they okay? We just say fine. Are they something that we want to recommend that we send out to a wider audience for validation and for other comment before we develop a full work plan around them?
So, this is really meant to be the scope and the targets of what the work group is talking about for the year 2000.
So once again, quoting the section of the law, which we keep going back to, because it's good to be pretty focused in on what it is we're supposed to be doing. Obviously it's around the adoption of uniform data standards for patient medical record information and reporting back to the subcommittee and committee.
Now, I just read what the objective of this document is to provide -- I'm reading this also for Jeff, I know you have received this before. You can muse about it as we go sort of paragraph by paragraph.
The objective of this document is to provide a basis for the development of a work plan by the work group to meet these legislative requirements.
Now, the next paragraph I've actually already made a change to, so that means we need to pay some attention. It is understood that the first activity of the work group is to develop and articulate a common vision of the CPR, and then I've added here, and the value and use of uniform data standards for patient medical record information --
MS. FYFFE: Could you repeat that again?
MR. COHN: Okay. After the word CPR. Really as I looked at this I wasn't sure that we, really developing a vision for the CPR is really what we needed to do.
MS. FYFFE: So it starts with the sentence it is understood that the first activity.
MR. COHN: Yes, of the work group is to develop and articulate a common vision for the CPR, and now what I'm proposing we put here is, and the value and use of uniform data standards for patient medical record information to be used as a basis for the development of a work plan and to bound the activity.
I bring this up, I mean this is, once again it's still in draft, the question I'm really bringing up to you is is a vision of the CPR a value to this work group to meet further objectives, or is it really a vision around really what we're talking about about uniform data standards for patient medical record information or do we need to do both.
MR. BLAIR: My thinking is that the first task, the task that is directed most at fulfilling our responsibilities to the HIPA law is addressing the issues related to uniform data standards for patient medical record information, that piece, that it is a value to us and helpful to us because we added and computer based patient record systems, because we added that, that the first task related to that is for us to understand or come to a consensus on the vision and usage of computer based patient record systems. But I would put that as the second task, not the first.
MR. COHN: Just change the order.
MR. MCDONALD: It's actually parenthetical in my mind. We can't do the whole IOM thing all over again, number one. Number two is that there's a lot of value for patient data to be floating without knowing where it's going. I don't mean that to mean that we send it all around, but I mean there should be transmission between pharmacy and labs and labs to pharmacies for drug interactions. So it isn't only in some host system and who knows what else, back to patient homes, to their own registry of their lab tests.
I think if we can feed on the business about -- we need scenarios to help remember the other things that we may forget about, but if we focus on how we can really deal with clinical data in any context.
MR. COHN: Okay, so you're agreeing with the first.
MR. MCDONALD: I'm agreeing with Jeff.
MR. COHN: With Jeff, good, okay.
AUDIENCE: What I heard you say was develop an articulated vision of the electronic exchange of patient medical record information, not just of the CPR, but the electronic exchange of patient medical record information.
MR. BLAIR: Michael, yesterday we added a phrase at the end of this, which added and computer based patient record systems at the end of that phrase.
AUDIENCE: But the vision word wasn't in there yesterday was it?
MR. COHN: John Lumpkin had brought up this issue of creating a vision.
MR. BLAIR: My understanding wasn't that we should create a vision, but that we should understand the vision articulated by the Institute of Medicine.
MS. FRAWLEY: Yes, exactly, my understanding was that --
PARTICIPANT: How about adopt a vision?
MR. MCDONALD: I thought that was something we just have to do to get our work done, that wasn't going to be our work.
MS. FRAWLEY: That wasn't going to be our work. My understanding was that we were just going to take the IOM report and just kind of bless it and just move on in our work. So the way this is reading makes it all sound like we're going to start from ground zero.
MR. COHN: If we say adopt would that help?
PARTICIPANT: I don't know why we need the word vision in there.
MS. FRAWLEY: I don't even know why we need to mention vision. To me it's just something that we just kind of --
MR. MCDONALD: It would be good to have a common vision so we work on that and then we do our report.
AUDIENCE: We need to see where this is all going because we can't just do it for today. What does the documentation need to be to make a decision right now for this patient, but where's it going.
MR. BLAIR: If I recall the discussion yesterday, your point was made and everybody agreed that we did, everyone needed to have the same vision of what a computer based patient record system is. And I thought that our discussion said that the way we would do that is we would distribute a copy of the executive summary of the Institute of Medicine book, the Computer Based Patient Record Essential Technology for Health Care as the way we would accomplish that task.
MS. FRAWLEY: That was my understanding. To me, it's kind of like you don't need that sentence.
MR. COHN: You don't need that whole thing at all? MS. FRAWLEY: No, my understanding was we just said, for people that weren't up to speed that we were just going to give them the executive summary and that we agreed that the primary focus of what we were going to start on was the next series of things.
MR. COHN: Okay, I guess what I realized -- let me make a couple comments. You are sort of right, except if you remember, I started out with a comment when I talked about the wide spectrum of really what it is we're trying to do. It's unclear whether we're exchanging HL7 transactions and really that's what we're focused on or whether we're moving patients around and off-loading and downloading information.
[Laughter.]
The point that I was making that really what we do on all the things down further -- maybe the CPR isn't really the focus of where we need to come to common agreement, but the implications of well gee, we're talking about uniform data standards and really we're talking about connections between CPRs and lab systems to send lab data versus sending the whole medical record from Kaiser Permanente to the VA when the patient moves to Florida or whatever. Those are things that we probably need to all agree on and share a common vision on and I think have implications for what we do below that.
AUDIENCE: Maybe an easy way is just to take out to develop -- just say articulate a common vision. We can hand out the executive summary and say here, here's our common vision we've articulated. I think it's useful to say this is where we're starting from because there was in fact that discussion yesterday. You brought up the fact that you guys in what you're calling the GCPR is actually looking only at the interfaces between organization systems and not internally. I think it's important to describe --
AUDIENCE: I think this discussion also is when we were starting with the five or six things before we scoped down. We said what was going to help us scope down in terms of what we were going to do as a committee. What's the goal, what are we trying to achieve.
MR. COHN: Exactly, I guess that was really what I was -- the level of the goals. So we're using the term articulate, develop, adopt --
MS. FRAWLEY: Not develop, articulate is fine, but we're not developing.
MR. COHN: Okay. So this is the first activity of the work group or are we just articulating -- the committee will articulate --
MR. BLAIR: I think it's a task. I guess I don't think it's a major piece. It's almost a level set to make sure everybody is informed.
MR. COHN: An early task of the work group, does that sound a little better, will be to articulate. We talk about the value and use of uniform data standards for patient medical record information and the CPR to be used as the basis for development of the work plan and to bound the activity. So we're okay with that?
Okay, now let's get down to the real work. The primary focus of the work group will be to develop recommendations and legislative proposals for the NCVHS on these high priority issues. One, guidelines and standards for administrative and clinical messages and their formats -- Clem, I'm looking at you, hopefully I've said that right.
MR. MCDONALD: That's okay.
MR. COHN: Two, is guidelines and standards for patient clinical information, and in parentheses we have data definitions, data elements, data models and code sets, including their specification which is number one, and number two is recommendations to enhance the coordination and maintenance of both administrative and clinically specific code sets so that they can support the demands of a computer environment that requires continuous availability, greater interoperability, more timely updates and greater clinical specificity. These are core data dictionary issues.
AUDIENCE: Just to go back to guidelines and standards for patient --
MR. COHN: Which one are you talking about?
AUDIENCE: Number two, the first sentence. I'm not sure I would include data elements in there. Data definitions, data models and code sets probably. The only reason I say that, I mean it depends on what you mean by data elements. I don't really think we want to get into the level of specifying representational attributes of data and things like that.
MR. MCDONALD: Plus they're really part of the model.
AUDIENCE: Right.
AUDIENCE: But do we think the standards are needed for them?
PARTICIPANT: When you do definitions, then you've encompassed the elements --
MR. BLAIR: Could I suggest that we leave it in at this point, not to guarantee that we necessarily might be explicit in identifying particular data elements, but just to give us a little bit of room, because I think ideally it would be more helpful if we could focus on data models or a data model or an approach for a data model, whatever. But I'm just afraid that we may fall short and we may need to make recommendations that have to bridge the gap. Is that all right?
MR. MCDONALD: I want to dissent because whenever you have redundant statements in a sentence, you end up with crazy stuff coming out of it as people evolve it. Data elements says nothing, not a zip, nothing on top of these other words. It doesn't offer anything and it creates great confusion I think because people think it does. What's the data definition of -- if it's not of a data element. What the heck is in a data model if it doesn't have data elements? What's in a data set if it's not a set of data elements?
AUDIENCE: Could I propose saying data element definitions and strike data elements. Put elements in between data and definitions on the first term.
AUDIENCE: That would work, because the first bullet is there's specification. I just feel very strongly we don't want to get into specifying at the representational level data elements. You know what this goes into, this is data sets.
AUDIENCE: We might recommend that somebody does do that.
MR. COHN: So what are we --
MR. BLAIR: Could I make one more appeal to Clem on this? The principle data model that I'm aware of is the RIM, the reference information model in HL7. It's being worked on and I am just afraid to put all of our eggs in one basket so to speak. It's not --
MR. MCDONALD: I'm not trying to put it in one basket. It has nothing to do with the RIM or whether it's a SEM(?) model or anyone else's model.
AUDIENCE: And the X12 model. Let me try to give you an example, Jeff, that supports what Bob is talking about. In the X12 -- Bob Maye's point -- in the X12 model, we model the attributes of the X12 transactions. Now let's take one of those and it's called identifier. That identifier is cross referenced to any number of data elements in the transactions that are specific to the transactions. It exists as a single data definition but it exists in multiple places as data elements specific to the transaction. I think that's the key we're trying to get rid of here. We don't want to be message specific here, we want to be in the generality of modeling the environment, the process, the enterprise.
MR. BLAIR: Let me make my last concern -- maybe if you address this concern then I will feel a lot more comfortable. I may not be right in the way I'm looking at this, because transparently this subject of patient clinical information in my mind in part I translate that to the work effort that goes into defining the content and structure of computer based patient record systems. It's evolving over time and I felt as if it needed to be broad enough to accommodate the fact that we're in transition. I felt that if you go all the way to the data model you're really assuming that we're much closer to coming to consensus on what's in a computer based patient record system or what should be than we may be two years from now when we're making this recommendation. Am I wrong? Tell me where I'm wrong.
AUDIENCE: No, you're right. I think part of it has to do with perspective. One of the things that you see now in the ISO work(?) on data representation, one of the fundamental things they've done is separate out the concept of data element, data concept and data representation, because it's very useful to be able to talk about those things separately.
I think what you're interested in and what we're all talking about is the concept part of the data element. We're all sort of saying well no, we're not going to get into saying whether it's five bytes or whatever. The problem is though that some people come at it from a very different perspective. If you talk to the people who are DDAs or system builders or system specifiers, they often when you start talking data element they think you're talking about the representational attributes of the specific implementation of a particular -- that has to go about the message -- so I don't have a problem with talking about data elements. I just want to make sure that we don't get ourselves sucked into some level of --
MR. COHN: I guess we had heard earlier data element definition.
AUDIENCE: Because in point of fact the reverse is true, when you go into the transaction it cross references you back to the data element definition in the model.
MR. COHN: Be aware, the problem of all this area, which is an area that I know well, is the fact that everybody means something slightly different about the terms they're using. That's the danger, there's an opportunity and danger here. I think Jeff speaks of the fact he's afraid we were missing something. The question is do other people understand what we're talking about. Hopefully they will.
MR. MCDONALD: Where we really get into trouble with this, there's different levels of abstraction. So you look at a lab system or pharmacy system and they have a record for things, and you look at some of these databases that have each record as a field. Then that's a data element. So we end up --
MR. BLAIR: I yield.
AUDIENCE: I have a question with one. If somebody is reading from the outside and looking at one, they're going to say well HIPA already does this administrative stuff, what are we mucking around with this. I would propose adding guidelines and standards for administrative and clinical messages that use patient medical record information to distinguish it from administrative data which may also contain the same information.
AUDIENCE: Is there any reason why you couldn't remove the reference to administrative? Because you say there's a point, administrative data is predefined in the first round of HIPA.
MR. BLAIR: It's hard to make a definitive line between the two so we covered ourselves a little by --
AUDIENCE: I wouldn't preclude us from recommending standards for clinical, patient medical record information, clinical information that finds its way into the administrative set.
MR. MCDONALD: How about we use the word management, because the administrative -- the set of administrative as it's defined is a pretty narrow set.
MR. BLAIR: Even when you have an order, an order in some ways has characteristics of being an administrative procedure as well as a clinical procedure.
AUDIENCE: What I'm proposing adding is the patient medical record information, to say that yes we do have that charge.
AUDIENCE: Just a point of reference here, there is stuff in the first phase of HIPA that is totally clinically related. I would suggest that if you're going to redefine it or if you're going to discuss it in this work group that it be done so that it was congruent with the stuff that is out there in phase one. My concern, from someone who has got to implement HIPA, is that I don't know where I'm going to get this information from, because we don't have it currently in our systems. It is clinical information that does not interface with billing. I don't know if there are vendors who are going to write(?) us the ability to take that clinical information over. So if you go up and redefine stuff that we're just starting to collect within phase one, and redefine it in a subsequent project, then --
MR. MCDONALD: Could you be specific?
AUDIENCE: Sure, activities permitted is in phase one, it's in 837. It is not currently collected in UB92. It is, I can tell you what it is, these are real clinical bits of information, bed rest with bathroom privileges, required complete bed rest. These are things that are rarely(?) stored in a clinical data set.
MR. COHN: Just to try to bound that conversation, remember we are a work group of the subcommittee that is responsible for the administrative. So one would expect that this would be --
MR. MCDONALD: What I mean is you've got fields for creatinine, you've got fields for CKMB, you don't have fields for triponin(?).
AUDIENCE: There are fields for the type of monitor patients wear.
AUDIENCE: Well, but that goes to this ongoing discussion about -- there are some proponents saying that we should actually strip back --
AUDIENCE: I'm not saying strip it back. All I'm pointing out is, I'm not saying strip it back. I'm simply saying if you're going to use it, make sure it's [word lost].
MS. FRAWLEY: My concern is that we're starting to get -- all we're trying to do is lay out a scope for the work. We're not going to solve the problems of the world, but otherwise we could sit here and be wordsmithing and I think that yesterday we felt pretty comfortable with the document. We want to just prioritize some activities. Now it seems like we're getting down to a lot of -- we could be here all night. I don't intend to stay all night.
MS. FYFFE: Two of the items which I sent you all an e-mail about I would like to just go over them briefly because I'm not sure that they've been included.
MR. COHN: They may not be. Can we make it through one and two? Let's just finish off with this last bit of wordsmithing and then we will add -- if we wade through this, the question is what else. This is not final, this is the second draft.
So just to try to deal with Mike's issue, do we want to add --
AUDIENCE: My concern is it looks too much like the other part of HIPA, and to give it under our charge I would put after messages, that contain this medical record information.
MR. COHN: Are we okay with that? Okay, sounds good.
Is it okay if we go through and then we will go to your issues? This is really the point of the discussion.
Okay, basically at a lower priority, time and resources permitting, the work group will also develop recommendations and legislative proposals on model legislation to promote consistent state laws and regulations for the acceptance, authentication, sharing, ownership and retention of patient medical record information in electronic form across state boundaries.
I may not have wordsmithed this quite right, but I thought we thought this was a side issue.
MR. MCDONALD: I think it sounds good. I would worry a little bit about whether -- I'm worried about whether one of our board members should have a say.
PARTICIPANT: Kathleen you mean?
MS. FYFFE: Oh, the state law thing, yes.
MR. MCDONALD: Is that going to be a hot potato?
MR. BLAIR: Right now it's only a matter of the scope that we're really talking about right now, right? This is not our recommendations.
MS. FRAWLEY: I don't understand what the problem is.
MR. COHN: Kathleen, do you have a comment about this?
MS. FRAWLEY: I don't remember the word sharing being there yesterday.
MR. COHN: Sharing, where is it?
MS. FYFFE: Consistent state laws for the acceptance, authentication, sharing, ownership and retention.
MR. COHN: Do you want to get rid of sharing?
MS. FRAWLEY: I don't remember sharing yesterday. I don't have all of my documents with me, but I don't remember the word sharing. I remember we talked about acceptance, authentication, ownership, retention. I don't remember the word sharing.
PARTICIPANT: I remember Bob had some objections to ownership.
MS. FRAWLEY: He just has an objection just because it's a personal opinion. I don't think that should stalemate an entire committee process. He's a member of the Subcommittee on Privacy and Confidentiality. He is one person out of 18. So I mean I have a differing opinion on ownership, so we could debate that. That's a [word lost] activity.
MR. COHN: I guess the question is I will check with the previous version on this. It doesn't seem to be in my pile here. If it was in there before, do we leave it in or do we take it out?
MR. BLAIR: If it was in there originally, I might have put it in there from the standpoint of integrated delivery networks that might be across state boundaries and having to share information and having difficulty being -- or telemedicine where you're sharing information and you have inconsistent state laws. So that, if it was in there before, that would have been my thought as to what it would mean.
MR. COHN: Are we uncomfortable with that as an additional --
MR. MCDONALD: I think I would make disclosing --
MR. BRAITHWAITE: I'm worried that we're sort of putting our tentacles up beyond where we ought to be here in terms of scope. Acceptance and authentication is pretty much covered by security issues.
MS. FRAWLEY: Right, which was my point yesterday.
MR. BRAITHWAITE: Sharing and ownership is a privacy committee issue.
MS. FRAWLEY: Is very clear is going to be addressed by either legislation or regulation. Retention is already addressed by federal and state law. My point yesterday was I thought we didn't need to be focusing on this.
MR. BLAIR: What if we just simply -- and you just tell me whether you think this is right or not, Kathleen. You've already basically created model legislation or worked with people that have. It's been adopted by what, one or two or three or four states?
MS. FRAWLEY: It's been adopted by several states.
MR. BLAIR: Several states. Would it be within our scope if at the end of these two years there's been stalemating or difficulty with nationwide acceptance by all the states for us to say we would consider without our scope efforts to promote the acceptance of model legislation?
MS. FRAWLEY: My point yesterday was I didn't think we needed to focus our efforts on this issue because my perspective was that between the security standards that will be adopted under HIPA and the either federal legislation or regulation on confidentiality and the standards for electronic signatures, we have essentially solved those particular issues.
MR. BLAIR: Including ownership?
MR. LUMPKIN: Given that our plate is very full now, why not just take this out, revisit these a year from now and --
MR. COHN: All right, let's move on. Take it out and let's move on.
Okay, the last two paragraphs. The work group will also -- and this is badly written -- but will also further investigate the data issues related to CPR processes, functions and services including decision support and enabling technologies that lead to improved data exchange and interoperability.
MR. MCDONALD: Does that lead modify all these things or just enabling technology and decision support? I'm looking for the condition on that -- that lead to -- all these things, issues related that lead to exchange or just decision support that lead to --
MR. BLAIR: To be honest with you, at least in my mind, Clem, this is a very ambiguous area. My suggestion was that this is an example of an area where we should learn more, we should -- this is where we should send this out for, or get testimony from different organizations to determine whether or not this should be within our scope.
MR. COHN: You're worried about the colon.
MR. BLAIR: I'm sorry, I misunderstood what your --
MR. COHN: Okay, we got rid of the colon. Are we okay with that one? Does it make sense to people?
MS. FRAWLEY: Yes, I have my notes from yesterday, I just found them, so I will keep you honest.
MR. COHN: Okay. There were critical fact(?) issues related to data security, access control, authentication, dependability, reliability, non-repudiation(?), auditability(?) of patient medical record information for caregivers and institutions and track recommendations, guidelines and standards for EMR storage.
MS. FYFFE: We're tracking and not analyze.
MR. BRAITHWAITE: It gives us the opportunity to bring them and do something about it later because we will keep tracking.
MS. FRAWLEY: The only thing under permanence of media, i.e. permanence of media, yesterday I have a note that what we were talking about there was the principles regarding permanence of media.
MR. COHN: Okay, so get rid of guidelines and standards and call it principles?
MS. FRAWLEY: No, but we left that. But then I have a note, we inserted the word principles.
MR. COHN: Okay, principles, guidelines.
MS. FRAWLEY: No, no, you're not listening to me, i.e. --
MR. COHN: You want to add one?
MS. FRAWLEY: What we amended yesterday was we said that recommendations promote the development of guidelines and standards for EMR storage. Then in parentheses, i.e. principles regarding permanence of media, end of parens and EMR processing. Then in parens, standards for decision support rules, medical knowledge couplers, et cetera. Because what we were concerned about there was just the fact that it was the underlying principle that when you're storing patient medical record information we were talking yesterday, Clem's example was 200 years from now -- I mean you could still have it, but the point is you can't read it.
I think that's a problem we're going to face now where a lot of hospitals went to microfilm. Now walk around a hospital and try to find a microfilm reader, that's a real problem these days. They all ran and they all put their patient medical records and patient account records on microfilm and a lot of people had microfilm readers at the nursing units and now that's not a common practice. You've got tons and tons of medical records stored on microfilm with people not being able to read them any more.
MR. BLAIR: I think that's a good clarification.
MS. FRAWLEY: I think that was the point we were trying to get to yesterday was that it was some of the principles regarding the permanence of the media.
MR. COHN: Okay, so what you're adding is i.e. principles regarding the permanence of the media. That's fine with me if that's okay with everyone else.
Okay now, the question is I think we've honed things down pretty well what we have, what we started with. Now, is it sufficient, what are we missing? What do we want to do beyond this with this particular piece? Go, Kathleen.
MS. FYFFE: Okay. Let's say I'm a hospital administrator and the government has said to me okay, if you want to conduct business electronically you have to do certain things according to administrative simplification, the 837, the 844, et cetera, et cetera. Now, you're coming along and you're telling me I need to modify my systems for something called electronic or computerized patient record. How do those two coordinate? Is there anything that was done in terms of administrative simplification on the business side that overlaps into the computerized patient record so that I don't have to --
MR. BLAIR: Attachments.
MS. FYFFE: Okay, attachments is one thing. What my concern is is that is there any administrative message, formats, data sets, code sets which are already part of the administrative simplification law? If yes, we should add an explicit work step called use of existing administrative simplification standards.
MR. BLAIR: Can I paraphrase what you're saying and see if I've caught your idea correctly because I think it's an excellent one? What you're saying is that it should be within the scope of this work group that we need to also look at the evolution and transition towards electronic medical records in addition to saying what it should, what the standards are and all these other things. Is that what you're saying?
MS. FYFFE: Well, that wasn't quite what I was saying. That's another good point.
AUDIENCE: Let me make a comment, because I think I understand what you're saying. You don't want to do a lot of work and have to throw it out.
MS. FYFFE: No, no, okay, I will say one other thing. I am a hospital administrator and guess what, federal government, you enacted laws that take money away from me with the Medicare program. How can you do that to me and also say I have to spend money on admin simp and then spend money on computerized patient records? That's very simple mindedness and I agree, but it's still --
AUDIENCE: Well, that's what the Congress -- that point was brought up earlier. Congress enacts the law, we're just mandated to develop the implementation.
The other point is that ultimately I don't think we should let the administrative simplification drive the medical record because all the information in the administrative simplification is from the medical record.
MR. COHN: Okay, now, let me just ask Kathleen, what you're talking about is the relationship between administrative data and clinical data and you're talking about the things like interlocking?
MS. FYFFE: I think we have some overlap. And are we going to -- okay, we have overlap, what happens to that stuff that is part of the administrative set?
MR. COHN: So are you talking about another bullet under two where we talk about the relationship between clinical and administrative data? Is that what you're --
MR. LUMPKIN: I would suggest that that's more of a fundamental issue than just a work step and it ought to be in the vision statement that we talked about developing.
PARTICIPANT: We eliminated that.
PARTICIPANT: No we didn't.
MR. COHN: Where in the beginning we say this is what we see doing, this is how we're going to get to it, that the data dictionary that's developed under administrative simplification has to be a fundamental foundation in which the computerized patient record is built on.
MR. MCDONALD: No, wait a minute. Currently in hospitals, where there's overlap, the pull is for administrative simplification to say put this crap(?) in this most stupid place on earth in the administrative record where they're always sending the damn stuff around and another message. So I don't think the administrative simplification specs should not drive what's ended up being a --
PARTICIPANT: I'm not saying that. I'm just a simple hospital administrator and I have a limited amount of money.
PARTICIPANT: The medical record isn't mandated.
MR. COHN: Okay, I think we need to articulate this in a way that we can do something with, because I hear sort of the issue sort of. I don't know whether this is a bullet or a focus or a piece of scope.
MS. FRAWLEY: I just think what John just said. It came up to this discussion yesterday and we will go back to it again today. We don't want to be reinventing the wheel, so we've already got security standards that are coming forward that address some of these issues. So the point is we don't want to be reworking those issues. Industry knows they have to comply with it, then we should move that into whatever our work plans, confidentiality and privacy issues, that gets moved into our work plan.
So wherever there are existing standards that have been adopted in compliance with HIPA that becomes -- the whole idea is you would make everyone nuts if we turned around and said okay, forget about the security standards that you were doing for administrative financial transactions, now for the CPR we want you to do X, Y and Z. I mean you would have people crazy.
AUDIENCE: There is something there to keep in mind, and that is that the standards can be changed from year to year, under the law, the administrative standards. Ultimately, if you look at IOM's vision, administrative data is ultimately driven from the clinical record. So we don't want to -- we want to be sure that if we see in the development of these other proposals the fact that there's a more efficient way once we get an electronic medical record in place of deriving that administrative data, we should in fact encourage the administrative side to begin to look at their standards.
MS. FRAWLEY: That's when we can make our report to Congress and say oh by the way, we figured out --
MR. COHN: I see two options here, the gentleman --
MR. LUMPKIN: I think we're talking apples and oranges. What the principle is that let's not develop the CPR as if we never did administrative simplification. If you're going to have an administrative field that's generated, let's recognize that somewhere down the line this CPR is going to have to generate something that's going to populate this administrative field. So let's make it compatible. I think that's the principle.
MR. COHN: Okay, so I'm hearing two things. Let me see if I can put this like John did so well. I'm hearing one that there needs to be a sentence after we talk about this issue of vision where it says that where there are existing standards under HIPA we will leverage these in our work plan. That's number one.
Then number two, we have another bullet under guidelines and standards for patient clinical information where we talk about these guidelines and standards for the relationship between clinical and administrative data because the idea is at the end of the day they're all supposed to work together. So if you need to do an administrative transaction, you should be able to derive it from the clinical data and it's in our province to try to make sure this all fits together.
MR. BLAIR: In my mind, both of those two statements, while I would agree with them as things we might do as we operate, I think they're probably getting down to a deeper level than a scope statement of what our work group is going to be engaged in.
MS. FRAWLEY: It's just some guiding principles is what I see it as.
MR. BLAIR: As opposed to scope.
MS. FRAWLEY: Right, or a work plan.
MR. COHN: This isn't a work plan, this is focus and scope. So the first sentence then, which is sort of the overall principles, which is where there are existing standards under HIPA, they will be leveraged -- the leveraging is in our work plan.
MR. BLAIR: I see. You're saying now that we've finished the scope, we're talking about guiding principles and that's what this would be.
MR. COHN: No, no, I'm saying this is a sentence where we talk about vision. We need to do a vision and this is just sort of a statement of something that's understood. This sort of goes in there. I don't think it's going to be a problem.
My question though is there another bullet under guidelines and standards for patient care and clinical information that talks about this issue that we need to be concerned to make sure that the data connects. This is what Betsy was talking about yesterday, this issue of interlockingness.
MR. MCDONALD: What's going on, there's an underlying discussion of HIPA, the players(?), the idea there is a strong interest in getting what looks like attachments out of the principal claim over some comfortable period of time because it isn't evolvable(?). Then we don't have this two step process.
MS. FRAWLEY: Chuck wanted to say something.
AUDIENCE: I'm hearing expressed here even a lower level. She's saying if I have a transaction that has patient identification information in it, why can't I use that same patient identification information to start my clinical transaction. I'm concerned because we're operating in two different domains here. The information comes from the same place, and I agree with Bob. Here's a patient database where you pull information that is administrative or demographic in nature, as well as where you pull information that's clinical. Who you're communicating to determines that format. Administratively, "externally" to a payer or other management organization versus clinicians sharing information across the network or whatever it is, those are inherently two different formats that have two different intents. If we try to mix and match those --
MS. FYFFE: -- one and the same. So if you said that you're going to do one thing here and one thing there and one for administrative and one for clinical, I can't completely accept that statement.
MR. COHN: I think meanwhile we don't have to get this completely done now.
MS. FRAWLEY: I think we've addressed all the issues.
MR. FYFFE: Have we finished with my e-mail to you guys?
PARTICIPANT: No, I don't know whether we are.
MS. FYFFE: I've got another issue. I was asking if it would make sense to add a work plan step called financial and cost issues under something called related issues, because now let me step ahead here. I could be completely wrong and Judy and Bill and you all here, if the national committee is going to make recommendations and legislative proposals to Congress, should we not be concerned about the cost of this?
MR. COHN(?): The cost of implementing it or evolving toward it?
MS. FYFFE: Yes, the cost of implementing it.
MR. COHN: Implementation costs.
PARTICIPANT: That's something that CBO does. Are we going to anticipate what CBO is going to say before we come up with what we think is necessary?
MS. FYFFE: Again, I'm really a neophyte in this but can you say make a recommendation, from the executive branch, make a recommendation to Congress that's going to say okay, health care industry, you guys have got to spend a lot of money. Where is the money going to come from? See, I'm very uncomfortable with all that.
MR. COHN(?): Kathleen, at any rate we're talking about whether or not there's a bullet there.
PARTICIPANT: I think the difference is when you talk about the computerized patient record, it's not the same kind of thing as administrative simplification. Administrative simplification says when you do business electronically, you have to adhere to this. The computerized patient record says there are a lot of folks out there who believe that there's some utility in developing the computerized patient record but there's no standards, there's no framework. So go out and spend your money on a product that's never going to work with anybody else's. Instead, we're going to create a framework for you to build your own system, for a vendor to build a system, and when you decide you're going to spend your money, we're going to help you spend it a little bit wiser because there will be something, Consumers Report or something you can measure it to. So it's a different kind of standard. I think the cost issues become so much different.
PARTICIPANT: This is enabling rather than prescribed.
PARTICIPANT: The easiest way to look at it.
PARTICIPANT: I actually wouldn't take it off the plate so fast. I think the question is whether we develop a cost model related to implementation. That may be a nothing or it may be a big deal.
PARTICIPANT: I've just got to think that's better left to industry and better left to CBO than for us --
PARTICIPANT: We had to do, of course, the cost impact analysis for the HIPA administrative transactions --
PARTICIPANT: Yes, and I helped with that.
PARTICIPANT: -- and that was a major, major undertaking. Frankly, I think a lot of us would say that it was just smoke and mirrors in the end anyway, because there are simply no good models out there for costing and other things. So it would be extremely interesting information and probably very valuable but it could be a whole thing in and of itself, and I think worthwhile making that one of the recommendations was that work be done on developing a good model for costing these type of things.
MS. FYFFE: Now, let me just have one more word here. Louis Lorton(?) [word lost], testified in front of this committee and he said somewhat quietly, we have all this stuff here, but there's this one word, it's called budget. Do you remember when he said that? That's why none of this has happened because of budget.
PARTICIPANT: That's not why it hasn't happened.
MS. FYFFE: Oh, it's not? Okay.
PARTICIPANT: No, it's not happening because there are no viable systems out there that can do this.
PARTICIPANT: Actually, that's not true, it's budget.
[Laughter.]
PARTICIPANT: It really depends on the organization.
PARTICIPANT: Right now, cost is prohibitive for the perceived benefit.
PARTICIPANT: There's a lot of companies selling these systems.
[Laughter.]
PARTICIPANT: We're not solving your problem yet. I want to refocus the discussion. What we're trying to do is create really what I consider to be sort of the deliverables of what we think we're trying to do with the idea that then we can develop a work plan around them to make them happen. So we're not solving problems, we're trying to decide gee, are these the things that we want to focus on trying to do and are these all the right things. We've got some things out of scope, we've talked about cost and I think we've identified what that is, everybody is running away from that real quick.
MS. FYFFE: Well, the other part of my e-mail was I would be happy to lead and coordinate the cost issue.
PARTICIPANT: Oh, well --
[Laughter.]
MS. FYFFE: But I don't want to spin my wheels on something that's --
PARTICIPANT: No, if you're willing to lead that, that's --
PARTICIPANT: I almost feel this is one of those things where you get what you ask for.
MS. FYFFE: I mean I just want to hear some people testify about what this is going to cost.
PARTICIPANT: That presumes, that biases that we're enforcing -- I mean that starts out saying that this law is going to require [word lost] to do this, and I haven't heard anyone suggesting that's what we're going to try to do.
PARTICIPANT: Actually, I think you're onto something, because we just talked about -- people were saying well why aren't we doing this. Some people said budget, other people said it doesn't work, Don said well it's cost/benefit. I think that's actually one of the problems that all of us have who have to try to put in a systems of a whole variety of sorts is trying to justify for the business case what [word lost] they are. We would have loved to see a model, a costing model when we did --
PARTICIPANT: Okay --
PARTICIPANT: The recommendation would be that that would be of great utility.
PARTICIPANT: My concern here is that we're going to wind up reinventing the work that other organizations are working on. The CPRI has been working on this for a long time. We have the Davy(?) Symposium on July 10. My recommendation is that we incorporate by reference wherever we can -- this is a work group, this is not a full committee. I agree with you that cost is important, and I think if you're willing to lead that, but I'm just saying there's work being done out there already. We don't need to --
MR. COHN(?): Okay, and I want to redirect this for just a minute because I think that there's a -- maybe it's become almost a business case. The business case related to the CPR, which I do not want to replicate here. There is a business case, however, about uniform data standards for patient medical information that is a different case. I think that actually might be a very powerful piece as this work. I think if we can specify it to that, I think it would be a great thing to state. Jeff.
MR. BLAIR: I feel as if we have veered off of our target a little bit. The target, as I understand it, and I'm going back to the same words that were in the law, is to study issues related to uniform data standards for patient medical record information and electronic exchange of such information. Now, it stuck with information and the exchange of such information and it was saying issues related to uniform data standards, and what we did in order to set a backdrop, just sort of so we could understand that target. If that's the target, we added and computer based patient record systems to me not as a new target, but as the environment within which, that will help us understand that target and that goal. I feel like we're going to get misdirected if we start saying we're developing standards for computer based patient record systems. We're developing standards as it was said in the law which facilitates interoperability. It just so happens to do that job, we need to understand computer based patient record systems. Is this correct?
PARTICIPANT: You're right, yes.
PARTICIPANT: So you agree with me about the business case I was just describing?
PARTICIPANT: Restate that please.
PARTICIPANT: Okay, I was saying that I think I was basically agreeing with you that the business case, if we need to have one developed or evaluated, it has to do with uniform data standards for patient medical record information as opposed to the CPRI.
PARTICIPANT: Yes, very good, excellent.
PARTICIPANT: That was really what I was hoping that we could add --
PARTICIPANT: That's a variation.
PARTICIPANT: Is that okay?
PARTICIPANT: Yes, it's fine.
PARTICIPANT: Is that going to be reflected in the statement or is that just --
PARTICIPANT: No, no, that becomes a focus as number three.
Now, let me ask again the question -- there's two pieces here and I know people are getting a little tired on this topic. But number one is are we sort of close enough to begin to show this around?
PARTICIPANT: No.
PARTICIPANT: No?
PARTICIPANT: Well, what do you mean by show it around?
PARTICIPANT: I think that before we can show it around, that it would be prudent to get this revised and let the subcommittee, or I guess whoever belongs to this work group now, since we're not quite sure who volunteered to be on the work group. Remember, there are people who expressed interest in the work group who couldn't be here this afternoon. So I think that at a minimum, this revised document should go out to the new work group members and I'm not quite sure then after that whether it needs to go anywhere else.
My concern about showing it around means you could be shopping this for the next year or two with everybody putting their two cents in and I think at some point we just have to say okay, here's our scope, here's our guiding principles, here's our work plan and here we go. If we manage to do all of this and are looking for other things to do, then we can go back to some of the issues that we've kind of taken off the plate.
PARTICIPANT: So, okay, let's look at everyone else here. The question is do we want additional comments from people, either from us or from other experts in the field, about whether this is sufficient, whether we're missing something.
PARTICIPANT: Who would you go to? What organizations would you solicit from? What organizations or individuals would you solicit -- where you would want them to give an opinion on what our scope of our work group is?
PARTICIPANT: I imagine that probably there are some experts in the GCPR that might want to comment, that there are maybe some individuals in the public.
PARTICIPANT: Well, then this is the issue in terms of our charter and our guidelines. Since I'm not toting that around, and Marjorie is --
PARTICIPANT: Guidelines are sent out for public comment?
PARTICIPANT: I don't think we should spend more work on this. I think we should print it and maybe you could circulate it again with the committee and let's get started on the work.
PARTICIPANT: I mean Rob is the liaison to this work group, so he gets to --
PARTICIPANT: If an issue comes up --
PARTICIPANT: I think that the people that are serving as lead staff would tell us if we were like way off.
PARTICIPANT: Actually, Simon, that does not preclude us running this scope by the GCPR folks and asking for a comment, but I do think like Clem that this is the scope of our work group and within the subcommittee I think basically we have enough to start on and run on. So this is the scope as of June 1998 and we can always send it around to other folks. If they critique it and say our scope should be different, then we could consider that and modify it, but let's start working on what we have. There's enough to start working on it.
PARTICIPANT: You can't send any documents around without making sure that you're following the committee's charter and rules.
PARTICIPANT: We talked to some of our support staff about those issues. The question is whether we want to recommend and think it would be a good idea, not whether or not legally it's possible, what rules we have to follow. I was asking the work group whether or not people felt comfortable enough about what we've done so far to start moving on it and developing a work plan to begin to support it, or whether we felt we needed to get more input from others.
PARTICIPANT: No more input.
PARTICIPANT: No more input.
PARTICIPANT: The request for input could be here is our scope we've agreed upon, do you have any issues you would like us to consider. So you just nail down the scope right now and get on with the work.
PARTICIPANT: Okay.
PARTICIPANT: In this room, we have vendors, we have standard setting organizations, we have providers, the federal government.
PARTICIPANT: A plethora of prejudice and biases are right here.
PARTICIPANT: What I will do is to take these revisions, put them into a final document, have you all review it. We will need approval tomorrow with the charge document, which I think is done. This I think we will say that we are mostly done with this, we are developing a work plan. I guess we will meet again in September to begin to approve the work plan, hopefully with the idea that we can start work after September. There may be some other things we can do before that.
PARTICIPANT: You did an excellent job of leading us through this stuff.
PARTICIPANT: There's a third page that's attached to this.
PARTICIPANT: Yes, I'm sorry.
PARTICIPANT: There's a sentence there that I don't agree with, that I think is a problem.
PARTICIPANT: I forgot we had that.
PARTICIPANT: Oh, we thought you had missed that.
PARTICIPANT: We can even leave that alone.
PARTICIPANT: I don't have any problem with the above list does not include issues related to privacy and confidentiality because it assumes Congress will pass. It's the second sentence, these laws and regulations will probably set forth policies and practices to ensure confidentiality but not specific guidelines and standards of data security. That's not necessarily true. There are a number of bills in Congress right now that do talk about data security. So I would delete that sentence.
PARTICIPANT: Okay, so get rid of the sentence.
PARTICIPANT: Then the rest of it is fine. It's just if you look at the Shay's(?) bill, the Shay's bill is very specific, as is the Lahey(?) bill on issues regarding security.
PARTICIPANT: Is one of the bills going to shut this all down?
PARTICIPANT: Why do we need that paragraph?
PARTICIPANT: Initially I had forgotten it was on the disk, that's why we got it. It's up to you about whether we stick that in or not.
PARTICIPANT: You could eliminate the whole thing I think.
MR. COHN: Strike, okay.
Now, one final question just to make sure, one area I had a question mark about which had to do with my attempt to try to answer one of your issues and whether it's within or without the scope of this work. This has to do with the issues of the relationship between clinical uniform patient medical record information and administrative information. Does that relationship need to be referenced somehow as part of the focus or activities of this work group?
PARTICIPANT: Would you repeat the statement please?
MR. COHN: Okay.
PARTICIPANT: We already talked about that. It was out.
PARTICIPANT: But Simon wants to clarify what we said.
MR. COHN: I guess if I had understood, I would not be bringing it back up. Have we decided that it's out of -- no, what we said was is whenever there are existing standards under HIPA, we will leverage these in our work plan.
PARTICIPANT: We struck that.
MR. COHN: There was an area that I was unclear about whether it was in our out having to do with the relationship between uniform patient medical record information and administrative information.
PARTICIPANT: I actually view that as a principle rather than an area of focus.
PARTICIPANT: Okay, so we just say that there's a principle. Okay.
PARTICIPANT: As we choose to move forward, resolving those, bringing those together is something that we're -- we're also not letting one absolutely limit it, although it's a starting point.
MR. COHN: See, the problem is that that's not a principle because it doesn't exist right now. It takes some effort to put them together.
PARTICIPANT: It's still complicated but I think that conceptually the function of the computerized patient record is to treat people and lead them to the process of staying healthy, getting better, living with illness. Abstracted from that would be all this administrative data. So if it doesn't meet that primary purpose, it doesn't matter whether or not it integrates with the administrative systems.
PARTICIPANT: Very good.
PARTICIPANT: So I think we need to sort of --
PARTICIPANT: I think you're agreeing with what I just said.
MR. COHN: Well, there are some ironies here because you the clinical aim(?) is to keep the patient alive, the administrative aim is to keep the hospital alive. [Laughter.]
PARTICIPANT: But the business of medicine is taking care of patients. So if we conceive of them, they may not necessarily mean that it is one system intertwined with the other, as much as it's two systems cooperating and sharing information.
PARTICIPANT: Is that issue that you're describing, and the issues around that, is that a concern for this particular work group or is this [word lost]?
PARTICIPANT: I think we can't deal with it tonight. This is a long, long discussion and I think --
PARTICIPANT: I think that issue that you just described is within the scope of the work group to define and clarify.
PARTICIPANT: It's a good thing we like each other.
PARTICIPANT: We have two issues. The first I don't know if we want to deal with it, it has to do with the claims attachment based upon the discussion that we had yesterday. That is whether or not we want to carry forward a recommendation to HHS that they delay the development of an NPRM on claims attachments until those standards have been tested, which is similar to the recommendation that we made about the 834, no.
PARTICIPANT: First report of injury.
PARTICIPANT: It had to be developed first.
[Laughter.]
PARTICIPANT: We're just saying we think it ought to be tested before it's required.
PARTICIPANT: It's interesting because I had expected today that you would have brought up the recommendation that we would urge HHS to find funding for the testing. I guess you're taking the sort of inverse, which is delaying until it's been tested.
PARTICIPANT: Clem, what would you like to see us do?
MR. MCDONALD: Well, I don't know that it's practical to put all those kinds of conditions on. It's not how any of the other standards, they don't get tested before they get released, except for Internet. That actually is the right way to do it, but it isn't they get released and then there's feedback as the thing is put into use. Just like the HEDIS one.
PARTICIPANT: The difference is, Clem, that in the past the standards were voluntary. You did that and if people applied them they evolved to the correct form. Now, it's mandated.
MR. MCDONALD: But we haven't done that criteria on some of the --
PARTICIPANT: Can I make a suggestion that there's going to be time for NCVHS to make that recommendation if an NPRM gets published for attachments. See what it looks like, let industry make its voice known and NCVHS then will have information saying you know, this ought to be tested before it goes ahead.
PARTICIPANT: We actually had discussions previously around this kind of issue. That's actually the approach I think that the infrastructure team sort of drifted towards, because there is that opportunity to delay -- ultimately the Secretary has the authority to decide when they're going to require this adoption, but it's ready for prime time so to speak.
PARTICIPANT: Let me ask a more fundamental question. Has the work on NPRM for claims attachment begun? PARTICIPANT: Just in the very beginning stages.
PARTICIPANT: Okay, we can talk about this in September.
PARTICIPANT: Okay, that's done.
PARTICIPANT: You send the same message to the Secretary by saying you can't do this until you've tested it, say find more money, because either way --
PARTICIPANT: Well, but September, we have a meeting in mid-September, FY99 budget goes into effect October 1. We will know where we are. I can guarantee it, knowing how the process has gone, that if they don't have a final draft of an NPRM I mean ready to go through the approval process, there is no way these things -- ye of long experience.
PARTICIPANT: There's two issues. One of them is if industry doesn't understand this is how it's being put together until two years from now, they're going in trouble. So the longer lead time they have to fuss on it and tune it and tweak it and bitch back or whatever, the better off there.
The second thing is, the part that's kind of hidden, is this catalog of questions that doesn't exist. It doesn't have anything to do with the message standards, it doesn't have to do with the combination of these two, and in fact both sides haven't agreed -- some of the players say no way we're going to agree to any sort of cataloguing questions.
PARTICIPANT: But the question I'm posing, is there anything that we need to do with this before our September meeting.
PARTICIPANT: John, I think it's your choice about whether or not -- it's a statement that we urge them to put more money into testing or delay until it's been tested. One way or another something like that needs to come out of the subcommittee. I think we would be very silly not to make a recommendation like that at this point.
PARTICIPANT: We're not being consistent.
PARTICIPANT: I don't care.
PARTICIPANT: Well, what about the provider number? Are we testing it before we let it be released?
PARTICIPANT: I think we've had some experience with the UPINS(?).
PARTICIPANT: This is not a UPINS.
PARTICIPANT: I agree with that, but what I'm saying is we've --
PARTICIPANT: I know, but across the board, this is the only one you're picking out to say this has got to be tested first. We just released a whole pile of them, including the one for first accident, which barely was written.
PARTICIPANT: But it isn't in the transaction standard.
PARTICIPANT: It is.
PARTICIPANT: No, it's not. We're not recommending adopting anything right now.
PARTICIPANT: Yes, but eventually the Secretary has to do something because it's in the law.
PARTICIPANT: Okay, I've given my opinion.
PARTICIPANT: What do you think we should do? What position do you think we should take?
PARTICIPANT: I think it would be good to say get some more money in, this is in general because there should be more money on this HIPA [word lost] across the board.
PARTICIPANT: Let me be chairish. The issue is not what position should we take, the issue is whether or not this should be postponed until the September meeting. Simon believes that there are issues that we need to discuss. The question before us is should we talk about it and try to reach some resolution today or should we postpone it until September.
PARTICIPANT: It's an easy answer.
PARTICIPANT: The whole process needs funding from Congress for HCFA to be able to do what it's being requested to do by HIPA. How that message gets across, I'm not sure it's a problem that I can make a good recommendation. I don't know if NCVHS is in the business of making a recommendation that Congress fund what it told HHS to do related to HIPA. Does NCVHS recognize a shortfall of resources to do what Congress told us to do? I would separate that from the attachments.
Then secondly, I would go with Clem, it wouldn't be bad to have a recommendation that somebody compile a list of questions to answered by attachments.
PARTICIPANT: The only thing that I'm concerned about here is that --
PARTICIPANT: Now, we're --
PARTICIPANT: The question is, this is like a motion to postpone definitely. Debate is only allowed on the motion of whether or not to postpone definitely.
PARTICIPANT: Postponing the discussion.
PARTICIPANT: Postponing discussion of attachments until September.
PARTICIPANT: This is a binary question.
PARTICIPANT: Yes or no.
PARTICIPANT: Do we need a second on that motion?
PARTICIPANT: No, I'm --
PARTICIPANT: He's moving.
PARTICIPANT: I would vote against that motion but I would vote for one very close to that.
PARTICIPANT: Which would be?
PARTICIPANT: I think Mike's thing about recommending funding to HIPA --
PARTICIPANT: Let's take care of this motion and then let's see -- those are two separate issues.
PARTICIPANT: Okay, do I hear a desire to recommend to HCFA that they continue to fund testing of the 725 --
PARTICIPANT: Question related to that motion --
PARTICIPANT: No, it's that they should provide funding to facilitate implementation of HIPA legislation.
PARTICIPANT: I have a question related to that. Not being part of the political spectrum here, I'm not sure whether I clearly understand the political landscape here, but I have a sense that there is a little bit of a war going on between the Department of Health and Human Services and Congress and the pawn, the hostage here is the funding for HIPA. So if we wind up making this statement, do we have to be careful to make the statement of the nature that the NCVHS cannot go forward to make its recommendation until funding, and not specify whether the funding is from HCFA or because it hasn't been funded from Congress, just avoid the phrasing as to who is holding you back, but just say until funding is available for that prototype.
PARTICIPANT: Well, first you need to get that information, you need to make that recommendation, you need to pull that out of HCFA and from the Department. You need to ask the Department representatives is this true, do you have sufficient funds for this. And if you think the answer is no, then you can make the recommendation that research is being devoted to it.
PARTICIPANT: But I mean at our level here, do we need to wind up saying we need money from HCFA or do we need money from Congress, can't we just simply say we need funding.
PARTICIPANT: Let's slow down, because one of the problems about meetings is that after you get after 5:00 they become more diffuse. So I'm going to ask everyone to raise their hand and be recognized and then we're going to try to proceed to answer this question.
PARTICIPANT: I personally would feel uncomfortable about making a recommendation to the Department or to HCFA about funding that project. I personally felt uncomfortable yesterday when those people came forward. I felt, this is just my personal feeling, that there was an effort to try to get us to buy into whatever their agenda was.
My concern is that I don't have all the information available, I know Karen clarified that there would be appropriations through FY99 and FY2000, and my feeling was that our committee could become a forum for every Tom, Dick and Harry within the federal government to come in and say I want dollars for this, I want dollars for that. I just felt there was a different agenda yesterday afternoon. It wasn't quite within the scope of what the committee needs to be focusing on.
PARTICIPANT: I don't think we should recommend specific funds for specific projects, but it is clear that HCFA is being asked to do extra things to make HIPA work. HIPA won't work as well if there isn't money released. So I would argue that we should at least encourage the appropriate funding to make the legislation work.
Secondly, I frankly don't think testing is going to make any difference because it's too small a test. I hate to say that but I really --
PARTICIPANT: At this point we do not know that we don't have funding. It's a little bit premature to be concerned. So I would suggest if you want to make a recommendation now, perhaps it would just be to highlight the importance of continuing to pursue these activities.
PARTICIPANT: If I can weigh in on this and then I'm leaving. I operate an organization with a budget of about $200 million which is peanuts to HCFA. If there's a project for a quarter of a million dollars that I want to find money for, I can find a way. I don't just sit around and say oh gee, the legislature didn't give me the money because it's not important. I do tell you that if someone asks me to do something and I don't want to do it, I say I don't have the money because the legislature didn't give it to me.
I'm not sure we want to step into a situation until we fully understand it. I would encourage us not to take action. I sometimes, it can get us into more trouble and our legitimacy as a committee --
PARTICIPANT: Our credibility --
PARTICIPANT: -- our credibility is always our best card and we have to be careful we don't play it when we don't have to.
PARTICIPANT: So you're suggesting that we revisit this in September.
PARTICIPANT: That's correct.
PARTICIPANT: Let's just do that. I will second that motion.
PARTICIPANT: We all agree to September.
PARTICIPANT: Okay.
PARTICIPANT: Don't confuse HCFA's budget with the trust fund, very, very separate items.
PARTICIPANT: How big is HCFA?
PARTICIPANT: Three hundred and fifty million.
PARTICIPANT: Operational budget.
PARTICIPANT: Illinois?
PARTICIPANT: Probably about 200, but that's not all operational.
PARTICIPANT: I'm sure they can find a quarter of a million for anything.
PARTICIPANT: Once a year.
PARTICIPANT: Two hundred million, three hundred million, so what's the difference?
PARTICIPANT: Next hearings. If we're going to have hearings in the fall we need to decide what they're going to be on and roughly a time frame so we can begin working on it. My guess is that like any other new work group, that probably Simon, you're going to want to do some hearings, and Jeff.
MR. COHN: You probably are right.
PARTICIPANT: We need to schedule two more hearings, well actually one more hearing for unique identifier. We've got one, did we decide yes in July?
PARTICIPANT: Yes.
PARTICIPANT: Okay, one in July, one scheduled with our meeting in September.
PARTICIPANT: Another one in July, not the one we have?
PARTICIPANT: No, the one we have in July and we will need to schedule one there. We also need to schedule some time to have hearings about implementation issues related to content committees. Are there other issues that we need?
PARTICIPANT: When you say in conjunction, we mean as you have a subcommittee meeting Monday, you do a Monday hearing?
PARTICIPANT: That's right, that Monday was originally scheduled to be a hearing.
PARTICIPANT: You're talking about September 15, 16, which are a Tuesday and a Wednesday.
PARTICIPANT: It overlaps the HL7 meeting.
PARTICIPANT: It does?
PARTICIPANT: It will only be a day before or a day after, one day of hearing.
PARTICIPANT: [Inaudible question.]
PARTICIPANT: No, that's for unique identifier in September, the second unique identifier hearing.
PARTICIPANT: Now, are we talking about one day for the implementation issues? Do we want to maybe look at a one day for implementation, one day to get started on CPR?
PARTICIPANT: That may be a useful way of feedback(?).
PARTICIPANT: Well, could we notice the comment that Chuck just made about an overlapping HL7? We are a work group on computer based patient record systems. A lot of our expertise is going to be torn between that and HL7. Could we, if it's going to be Tuesday and Wednesday, could we do the CPR work group on the Monday so it minimizes the overlap with HL7?
PARTICIPANT: We're talking about a different hearing -- we're talking about a separate set of hearings that would be different than the committee meeting in September.
PARTICIPANT: Oh, I'm sorry.
PARTICIPANT: Probably looking at a date in October or November, somewhere around that range. Okay, so we will try to schedule a date then. The next meeting is in September so we can then figure out hearing dates after that.
PARTICIPANT: Why do I have November 2 and 3, question mark NCVHS?
PARTICIPANT: That's the full committee.
PARTICIPANT: It's the full committee? Are those firm now?
PARTICIPANT: Two and three.
PARTICIPANT: No, it's the 12 and 13.
PARTICIPANT: The 12 and 13 is what's on the Internet site.
PARTICIPANT: Okay, I've got the 12 and 13, but I also have question mark two and three.
PARTICIPANT: We were probably holding dates.
PARTICIPANT: Let me just point out that that date of the 12 and 13 is at the [word lost], which is in Orlando. PARTICIPANT: That's fine, everything is.
PARTICIPANT: I'm just looking around the room at how many people will be AIME(?).
PARTICIPANT: No, AIME is not the 12 and 13.
PARTICIPANT: AIME is the 11.
PARTICIPANT: That's why I was surprised when somebody said we had another life.
PARTICIPANT: Okay, do we have anything else to discuss?
PARTICIPANT: I think we're done.
PARTICIPANT: The individual identifier?
PARTICIPANT: Yes, we will need to schedule probably two days for that.
PARTICIPANT: We've also had a request not to have it in the D.C. area.
PARTICIPANT: It's going to be out west somewhere. PARTICIPANT: Denver in February.
[Laughter.]
PARTICIPANT: We will schedule that also, start picking some tentative dates and move on from there.
PARTICIPANT: Yes, and we will coordinate about CPR and I think we will have at least one day probably in the fall.
[Whereupon the meeting was adjourned.]