[This Transcript is Unedited]
Hubert H. Humphrey Building
Room 705A
200 Independence Avenue, S.W.
Washington, D.C. 20201
TABLE OF CONTENTS
SUBJECT: PMRI, HIPAA and NEXT STEPS
DR. COHN: Yesterday we spent most of the day talking about HIPAA administrative simplification. Today, the focus of these meetings will be to address next steps for patient medical record information and discuss the report to Congress and HHS.
I am Dr. Simon Cohn. I am chairman of this subcommittee and a member of the National Committee on Vital and Health Statistics.
MR. BLAIR: Jeff Blair, Medical Records Institute and member of the committee.
MR. SCANLON: I am Jim Scanlon from the Office of the Assistant Secretary for Planning and Evaluation in HHS and I am the executive staff director for the committee.
DR. MC DONALD: Clem McDonald.
MR. BLAIR: For those on the Internet that couldn't hear that, it is Dr. Clem McDonald from Regenstrief and he is a member of the committee.
DR. FITZMAURICE: Michael Fitzmaurice from the Agency for Health Care Research and Quality. I am liaison to the National Committee and staff to the Subcommittee on Standards and Security.
DR. KOLODNER: Dr. Rob Kolodner from the Department of Veterans Affairs and staff to the Subcommittee on Computer-Based Patient Records.
MS. HUMPHREYS: Betsy Humphreys, National Library of Medicine and staff to the subcommittee.
MS. GREENBERG: Marjorie Greenberg from the National Center for Health Statistics, CDC and executive secretary to the committee.
MS. FYFFE: Kathleen Fyffe. I work for the Health Insurance Association of America and I am a member of the committee.
DR. SHORTLIFFE: This is Ted Shortliffe. I am a member of the committee. I am from Columbia University, where I am chair of the Department of Medical Informatics.
MS. TRUDEL: Karen Trudel, Health Care Financing Administration, staff to the subcommittee.
MS. WILLIAMSON: Michelle Williamson, National Center for Health Statistics.
MR. WAEGEMANN: Peter Waegemann, Medical Records Institute and NCHISB.
MR. MONDA: -- government relations manager of the American Health Information Management Association.
MS. TESEA: Claudia Tesea, American Association of Medical Transcription and ASTM.
MR. LANG: Doug Lang, Social Security Administration.
DR. ZUBELDIA: Kepa Zubeldia with Claredi Corporation, member of the committee.
DR. COHN: With that, we would like to start up our first item of business, which is PMRI, the next steps discussion.
I just want to take a second just first of all to acknowledge Suzie Burke-Bebee for her work in terms of helping us set up the session yesterday. I really want to thank her for her help.
I am going to turn over this session to the vice chair, Jeff Blair.
Jeff.
MR. BLAIR: Thank you, Simon.
This is a working session and I am going to just put things a little bit in perspective here. All of the members of the committee received on January 22nd, two documents. One of them was the document that we reviewed on November the 29th, at our last meeting, which was the beginning of our considerations for how do we wind up developing criteria for the selection of PMRI standards and also help us with defining our areas of focus for the selection of PMRI standards.
That meeting was shorter than we had hoped it would be. So, we only had about 20 minutes to go through that session. There did appear to be some general agreement. But we weren't really sure whether there were concerns or questions. So, that is the reason that we distributed the document to you again a couple of weeks and asked you to review that prior to this meeting because in this meeting we really want to focus on the shorter document that sort of builds on that.
However, for the benefit of some of our new members and for, you know, just in case there might be some confusion or maybe even because of some of the attendees that we have at our meeting today, I would like to just take about five minutes and just review very briefly what we did back in the November session and then we will move on to our new document.
You will recall that this last summer we released our report to the Secretary on PMRI information and in a lot of ways that was a framework. It had a basic set of recommendations. It also had a basic set of guiding principles for the selection of PMRI standards in a very general format. Okay?
One of the recommendations was that we would start to select specific PMRI standards 18 months after the release of that document. That is about one year from now that we would be selecting our first series, our first iteration of PMRI standards.
In the meeting in November, we had some discussions and we pretty much, I think, came to an agreement and, you know, obviously, I am sitting next to Simon. He is going to help me on this because I can't see the expressions on your faces. So, please indicate if anything that I say you don't concur with or if you want to correct me as I go through.
But we pretty much agreed that the way we would begin to address this first iteration was to basically select low hanging -- the standards that might be the least controversial, the most easy to implement and so the 16 page document that we reviewed back then -- and you have a copy of it, you know, that was distributed to you before this meeting and another copy that was just distributed to you now.
I am going to just very briefly in the next five minutes step through that as a review and just make sure that we all feel comfortable with that as our foundation. Okay? We wound up having a work plan for the 18 months and the work plan basically called for the fact that we would establish the criteria or at least our first cut at the criteria and the areas of focus between now and the end of March.
We would then move into a phase where we would in March and in April begin to get outside comments on our initial conclusions with hearings and we would wind up -- then based on the outside comments, we should by then feel comfortable that we could begin to send out questionnaires to SDOs that would be able to respond to a questionnaire that was built on the criteria, that would give us the information that we needed.
Then in the summer, we would wind up compiling that information and in the fall we would wind up determining what our decisions are based on that information and then make our report to the Secretary on the first iteration as of February of this next year. We don't have the same limitations that we did on the other standards because there is nothing in the law that says it has to be an NPRM. We might recommend that it be an NPRM or we might recommend that it is some other mechanism based on how we feel is the best way to go forward.
So, that is in a sense the work plan, which was the first piece that we went through. Actually, we had also reviewed that in September. So, we have gone through that very quickly on two separate occasions in the past. So, that is our general framework. It is not locked in concrete, but that is, you know, basically what we are working with.
The next piece that is in there is that Clem had offered some areas that we might focus on and I expanded that a little bit, but basically those were the initial areas of focus that we were going to look at and we are going to talk about that more today. Okay?
But that was sort of our, you know, first cut at looking at what might be areas of focus. We then wound up beginning with the criteria for selection and the criteria for selection that we had from the report to the Secretary was rather comprehensive and -- I shouldn't say "comprehensive." I should say I think we had 15 different criterias that we had in our report to the Secretary this last summer.
However, when we began to examine those, it is clear that not all of them are measurable, not all of them will be useful to us as we actually select specific standards. Some of them might be more appropriate for message format standards, some for terminologies, some are good for screening, some are actually measurable and can be discriminators.
So, what we did in the 16 page document is we said, well, what progress can we make with those criteria to try to get us down to some things that are more measurable. So, what you see in the pages there is the first thing we went through, the 15 different criteria. We wound up breaking them down into which were screening, which were discriminators, which were completely -- you know, that we really didn't feel like we could do very much with.
We then went on to some matrices there and we boiled it down to eight, okay, that we felt were measurable and then when we got down to the eight criteria that we felt we could do some kind of measure, we wound up giving a stab at maybe what a measure might be and we would up saying, well, here is like four different levels of measuring each one. We are not stuck with those. Those are just a cut, just an example of what we might be able to do.
We then wound up theoretically saying, okay, if we had that, then how do we step forward from there? We wound up saying, well, let's put weighting factors on the criterias and having them add up to a hundred. That might be a way for us to be able to compare different standards on a fair, equitable, meaningful and documented basis.
We then went from there and what I did was I actually pulled a questionnaire that we had used two years ago as part of the ANSI HISB inventory of standards. It was clear that we didn't want to go through something as detailed as that or as comprehensive as that, but it was there just for reference so that you all could wind up seeing, you know, what that looked like and if there is anyone on the committee that hasn't had a chance to see that document, any committee members that are new or not familiar, I brought a copy of just the message format, results from that.
It is 170 pages of results. We had 16 different
SDOs that responded to that, to the questionnaire. And you could wind up at least getting a feeling for what that was like. We are not looking at doing anything as detailed as that this time. It is just that you could wind up seeing that was done two years ago.
Okay. So, that was what we went through on November the 29th. Let me just pause for a second and just ask if there are any questions or concerns about what we did at that time before we go into the new concise six page document that builds on that.
DR. MC DONALD: Jeff, could I just restate something that I think you didn't emphasize and I thought we agreed on, but maybe not, was that we were talking -- the first thing is that we are talking about two stages, possibly more stages. We don't have to do it all at once. We discussed that at length. We tried to get the real hanging fruit.
MR. BLAIR: Clem, that is correct.
DR. MC DONALD: The second one was that -- and you said it and I just want reemphasize it is that this probably will not be as strong a standard as -- with the same kind of teeth as the previous ones, the ones that are required by HIPAA because of the complexity, et cetera. As you said, it might just be recommendations. It might be an NPRM with encouragement or softer stuff in it, but it is unlikely to be, you know, as teethful as the administrative standards.
MR. BLAIR: I think that that is also correct and teethful is something that I think we will say it will not be. Probably from looking over our choices of what is out there today, plus the fact that these mission critical applications that deal with patient care, we will really have to be very, very careful. They probably won't be as teethful.
DR. COHN: Jeff, can I make a comment or two?
MR. BLAIR: Yes.
DR. COHN: I think we all realize that we really didn't have adequate time to discuss all the issues in November. So, recapitulation of some of them is very helpful. Clem, I actually appreciate you making a couple of points there also.
I do want to say that I think the focus -- I just want to focus on what we need to be doing over the next two hours because it could become very complex very quickly, but what we need to make sure to do by the end of this discussion is to feel that we are prepared to do a set of hearings in March. So, we don't have to have all the answers today, but we have to have a view of sort of where we need to get more information, what sort of feedback and views from the industry we need.
So, the good news is that we don't have to come to complete consensus today about everything. Now, as I was thinking about all of this stuff, I sort of -- and I think I mentioned this to you sort of in passing yesterday -- it seems that we have two things at least to think about. I mean, one has to do with, as you commented, about the area of low hanging fruit, to identify things that we sort of need to acknowledge and reassure the industry that that is, indeed, the right path for them to be going on, things that have fairly significant market acceptance and they have really become sort of a -- where we should be making the investment in these standards, in these implementations, in these areas.
So, I think that is a whole set of activities that the committee needs to be involved in -- and, Kepa, you may comment.
Let's finish off -- okay. But then there is also a need to have -- for us to think about catalysts. There may be some areas where things are not quite so developed in the marketplace, where the National Committee and HHS could provide some leadership and direction to the healthcare industry to prevent them from having multiple inconsistent standards to address an important area, if you think such a thing exists.
Now, the other piece is is that we need to look very hard at these transactions and things that we are talking about because, as we know, clinical and administrative, financial all merge and often -- clinical information system coordinated for Kaiser Permanente varied for many years, I got confused after awhile about what wasn't clinical information and depending on where you sit, what isn't financial and administrative.
Certainly, whereas for some of these things we may want to describe a more or less toothless set of recommendations, it may be that there are some areas where they may look a lot like --
MR. BLAIR: Less --
DR. COHN: Less toothsome.
[Multiple discussions.]
But there may be some as we look through these that whether you say, gee, that really is an administrative and financial transaction, even though it may have some clinical data associated with it, you don't really think it needs to be a next stage HIPAA standard, along with the lines or the fact that the Secretary has the authority to create other HIPAA standards to improve the efficiency and effectiveness of the healthcare system.
Anyway, that was my comment and as I get to be fixated on California time, I get a lot brighter.
Kathleen is raising her hand.
MS. FYFFE: I would like to reiterate the importance of focusing on the low hanging fruit and in the hearings having some very rigorous presentations and discussions about the costs of all this. I believe it was yesterday or the day before in the press, the American Hospital Association has requested that the White House review the privacy rules because of the enormous cost to the hospital industry.
There has also been some criticism about the cost estimates that appeared in the --
MR. BLAIR: I respond to where --
MS. FYFFE: Let me finish. Let me finish.
There has been criticism about the cost estimates of administrative simplification and the privacy regs. So, we have to be very careful and very cognizant of that as we proceed.
DR. MC DONALD: Could I just respond?
I think that the degree to which we make the absolute requirement, the degree to which -- and that we get -- with the market, we will get into more trouble. The degree to which we kind of reinforce what is happening and don't require too much more, we can't get into as much trouble because there -- I think yesterday the lesson about NDC versus J Code was --
MR. BLAIR: Yes.
DR. MC DONALD: So, if we end up saying you have to do this and they are doing that, we are not so strong that we can resist the political forces that will throw out the whole baby with the bath water. So, that is why I am really starting to say we want to be -- let people know that these probably won't be the same level of intensity as the administrative ones.
MS. FYFFE: Let me just finish by saying that in general one-third of the hospitals in the United States are in the red.
MR. BLAIR: Could I add to that because I -- I am just going to briefly indicate that as I began to go through this information and as we go through it during this next hour and a half here, I think that you will find that no matter what we pick, the most -- whatever standards we pick, no matter how high the market acceptance might be for some of them, we are going to wind up seeing that there are a lot of open issues and that we really are going to have to be very careful in terms of scope, in terms of balance, in terms of framework, in terms of cost.
So, yes -- and I think, hopefully, we have designed this six page document where it is going to raise a lot of those questions and have as a committee start to think through at least some of them. We will wind up at least raising some of them and then I think we will maybe hear more when we hear testimony in March.
MS. HUMPHREYS: I just think that in these areas the issue that you select a standard that has a reasonable market acceptance and you basically -- or maybe you say this is the one that looks like it is going in the right direction and -- the issue is when do you require people to use it. It seems to me that you can say, look, if you are going to do XYZ electronically, you must use the standard, but we have no timetable that forces you to do it next week or six weeks from now or -- and then you reevaluate the timetable issue as acceptance becomes more broad.
I think it is the issue of having a different approach than we have with HIPAA, which is okay, everybody, and in two years you are going to do it or three years or whatever it is, depending on your case. I mean, I think that is the -- this could be handled differently in that respect.
MR. BLAIR: Could I encourage the committee because I think we all are beginning to realize the exposures, the risks of whatever we wind up finding is the best solutions that we could offer and that even when we come to the best, there is going to be limits and caveats on that, much more so than with financial administrative transactions.
Could I suggest, please, that we go through the process because exactly what those caveats should be, exactly what the limits should be, we are not going to have a good sense of that until we go through the process and we wind up seeing where it leads us in terms of the standards that are selected with whatever problems those standards may still have.
DR. FITZMAURICE: Just a thought. As I remember the HIPAA law, I am not sure where the authority lies to adopt a patient medical record information standard. It seems to me that there is a distinction being made of here are the administrative simplification standards. Let's study the patient medical record information standards. The Secretary can adopt addition al standards under the administrative simplification portion. That may be a question for the lawyers, but I think that we can do our job and we can make recommendations to the Secretary.
What the Secretary then does with the recommendations will remain to be seen within the boundaries of what the Secretary can do.
DR. COHN: Could I make a comment, too?
I actually thought that Betsy made actually a very interesting point that I am just sort of curious if it is -- it is a useful frame for us to think about. I may not have been this smart or thinking as hard about this as I might have, but the view of at least beginning as we look through these things, the idea being of no time at which these things have to be implemented, but if you are going to do it, do that particular transaction, you ought to do it this way, as opposed to another view of this, which would be, yes, that is the direction, but --
MS. HUMPHREYS: You could pick something else, too.
DR. COHN: But you could pick something else in the meantime also.
MS. HUMPHREYS: It would be nice if we could point a few to the other, in my opinion.
DR. COHN: Well, exactly. I think it is an approach that one would want to recommend to the Secretary, potentially. So, I want to just stop for a second and sort of see if that sort of makes any sense or whether -- because I actually listened to that and sort of a light bulb went on in my head.
MS. HUMPHREYS: Well, I agreed actually with Jeff's point, which is that right at this moment that strikes me as potentially a useful strategy for some of these standards. But we haven't heard from all the people and, so, I actually agreed with his point that that might be an approach to something and maybe we will think of a better one after we have heard all of this information.
DR. ZUBELDIA: I am wondering if that could be supplemented by the government entities adopting the standards recommended and then telling the industry this is the direction we are going. This is the direction we recommend you go, but it is up to you to know.
MR. BLAIR: Could I do this at this point if I may because we are beginning to theorize different possibilities and I think that we could do this in a more structured orderly way where we begin to build consensus if we step through the process because the process that we are about to go through with these six pages is going to touch on these points and bring us more to, I think, a convergence as we go through.
So, all these ideas, I think, will germinate as we go through the process. Would that be okay?
DR. MC DONALD: Two good ideas came out and I think we at least ought to capture them. There is no sense in trying to go back and dredge them up again, from Kepa and from Betsy. I think we should make sure those are in our records, our minutes or whatever we are doing.
MR. BLAIR: What would you restate as the ideas?
DR. MC DONALD: Well, Kepa's was that the -- generalize that the government will adopt these standards and encourage -- just encourage the rest of the world.
Betsy's was that we suggest using these standards, but put no deadline on them. I am not trying to say which is better, but these are both good thoughts.
MR. BLAIR: Okay.
DR. MC DONALD: Did I paraphrase those correctly?
DR. COHN: Yes. Thank you, Clem.
MR. BLAIR: Would it be okay if we begin to start to look at the six page document at this stage?
DR. COHN: Sure.
I think, Dr. McDonald, you sent a -- well, actually I received a four page fact from you.
DR. MC DONALD: Single space, small print.
DR. COHN: You do good work on airplanes, I can tell. It isn't that far to Indianapolis.
MR. BLAIR: Clem, is that going to be something that -- let me put it this way. We have got about an hour and a half. I remember the last time you faxed us something, that was all that we went through during that last meeting.
DR. MC DONALD: It is a strategy, Jeff.
MR. BLAIR: With the document, the six page document that we had hoped to go through, is this --
DR. MC DONALD: This is dealing with some points in that, but I guess if people could browse it and you could go through your order, then things will happen as they happen.
MR. BLAIR: Could we do this because the -- you know, you wound up having a lot of very important ideas and I am sure that in what you just did now, it also has some. As we start to go through this process, would you point out as we go through where there are ideas where your fax begins to pertain to it?
DR. MC DONALD: Yes. Now, has it been passed out, though?
MR. BLAIR: Yes.
DR. MC DONALD: Yes, that is a good way to do it.
MR. BLAIR: Thank you.
Okay. And then, Simon, I guess I would really like your help because I think the first page that we would go through are these areas of focus with these issues and maybe we could begin to focus on that. Is that a good way to do it?
DR. COHN: Sure. Sounds good.
MR. BLAIR: Thank you.
DR. COHN: You didn't want me to do anything, though?
MR. BLAIR: Yes. I did commit this one to memory. Maybe if Simon reads each one and we make comments and observations as we start to step through these issues related to the areas of focus.
A lot of these, I think, Clem, are things that you and I had discussed at one point and chime in when you feel like there are things that relate to your document.
DR. COHN: Okay. And, obviously, Dr. McDonald, I think, has almost made comments point by point for almost each of these lines that we have here.
So, really, the content issues -- it starts out should --
DR. SHORTLIFFE: Simon, before we get started on this -- and I don't want to deflect the progress here, but coming in as a new person, who has not looked at these or had a sense of what the issues are, there is a kind of presumption about context, which I would like to just of get explicit.
I come to this with a full understanding of why we might want to see the development of standards for medical records and the data that are in them. I think, both for me and for people on the Internet and so forth, if we could just sort of state why the NCVHS is looking at this, how we view our role relative to the development of these kinds of standards, what kind of scenarios we sort of see for how this would play out in presumably benefiting the way in which the general world of health care relates to these issues.
I realize that that may be a shared understanding that people on the committee already have, but, you know, it hasn't actually been stated and I would find that useful.
MR. BLAIR: Thank you, Ted.
The HIPAA legislation, administrative simplification provisions of HIPAA, had a section in there, which charge the NCVHS with studying issues -- and I am quoting almost verbatim from the law. Okay? -- studying issues related to the adoption of uniform data standards for patient medical record information and the electronic exchange of that information.
Producing a report to the Secretary of HHS with these recommendations and legislative proposals -- and it turned out to be by August 21st, 2000. Our subcommittee -- we also had a work group within the subcommittee and the full NCVHS approved a 60 page document, which was submitted to the Secretary in July of this last year.
Now, that document -- and I am going to just be, you know, very brief on it. Okay? That document wound up indicating that we wanted to focus on the impediments to uniform data standards for patient medical record information and we related that to national issues as well. In focusing on the impediments, the three major impediments that we identified were interoperability, comparability and the third is data quality, data accountability and data integrity. Those were the three major impediments. Okay?
Our recommendations focused on that I would say in five areas. One area was that the NCVHS could make recommendations that would be catalysts that would advance adoption of existing standards. Another one of our recommendations, another set, was focusing on things that we could do to accelerate the development of good standards that had characteristics that would advance and address interoperability, comparability and data quality.
A third wound up encouraging international -- you know, coordination with and consistency with international standards. A fourth wound up putting in place incentives that would help create a balance between different sectors of the healthcare delivery system so that the provider sector was not unreasonably burdened with the implementation cost. Okay? That we could define some incentives to be able to distribute those costs and I believe the fifth was essentially to encourage and promote federal legislation and protect the privacy of health records, along with federal legislation that would wind up addressing areas where the diversity of state laws might be an impediment to interoperability and comparability of patient medical record information.
So, that is where our foundation rests. That was a framework document. We chose to not at that time select specific standards, but to ask the Secretary for support in going forward, based on a set of guiding principles for the selection of standards and we wound up, you know, sort of setting forth the process that we are.
Ted, does that address your --
DR. SHORTLIFFE: Yes, that is very helpful. It is amazing how that three minutes really helped me put this in context.
MR. BLAIR: Well, excellent. Excellent.
Simon, can we go back to you as you begin to step us through the focus.
DR. COHN: Anyway, within that context, the way this, I think, had been sort of discussed as potentially areas that we would want to focus on to get your testimony, written input, et cetera, the relationship included transactions -- it is sort of transaction focused, at least at this moment, as described. It has to do with the mission, the discharge, transfer and -- I am trying to -- should I just step through the entire list and then we can go back up and make comments about whatever we want to do?
Clem, is that okay with you?
DR. MC DONALD: Sure.
DR. COHN: Okay. Because you commented on each of these also and maybe after we go through the whole list we can sort of say, yes, no or maybe, et cetera, et cetera, as we go through them. But the admission discharge transfer, otherwise known as ADT; laboratory orders. The next one is laboratory observations and results.
The next one is organizational charge information. The next one is master file delivery. The next one is radiologic images. The next one is decision support. After that is prescriptions to retail pharmacies. The next one is vital signs monitoring, ICU. The next one is medical transcriptions and finally there is one described as code sets for diagnoses.
Now, these are not necessarily things that we will all suggest, but these were areas that I think had been identified previously as something we should be discussing about whether we should be delving into these areas.
Jeff, how would you like to handle this? Do you want to go through them one by one and ask people for comments?
MR. BLAIR: Let me make a comment before that and then that would be a very good idea.
This is sort of our initial thought list. There may be a number of areas that we don't have on this list and at the same time this is not saying that we are going to pick standards or we are going to recommend standards for everyone of these things.
There has sort of got to be a first cut, where we wind up saying where will we solicit feedback from SDOs. So, my thought on this list is that it might be helpful for us to start broadly to make sure that we are inclusive and we include all possibilities. When we set up our criteria and we have people respond to those criteria, this list will narrow based on those standards that meet our criteria and which we select.
So, at this point, my inclination would be for us to identify any groups or areas for message format standards where we may have failed to list these.
DR. MC DONALD: Well, Jeff, is this -- I mean, this could be pages and pages. I thought originally this was the low hanging fruit list. Am I correct?
MR. BLAIR: You are correct. That is a balance that, you know, we are also thinking of. That is true.
DR. MC DONALD: Because if it is one or the other, we could get the whole comprehensive list of all possible standards or we could -- I just want to make clear which we are shooting for here.
DR. COHN: Okay. So, Jeff, would you like people to talk about things that are not on the list or should we talk about things that should be taken off the list?
MR. BLAIR: Maybe both.
DR. COHN: Okay. Maybe I will start then and make a couple of comments and we could then look at this list. First of all, I would just sort of say of low hanging fruit, current sets for diagnoses -- I am scratching my head a little bit on because I think ICD-9 doesn't need further investigation at this point.
DR. MC DONALD: We have already accepted it in
the --
DR. COHN: -- accepted it and ICD-10 is another topic for another set of activities. So, I don't think that we are going to want to delve into that in this activity. So, I guess I would sort of -- Clem, are you in agreement with that one?
DR. MC DONALD: Well, it is already in -- it is trivial, but, I mean, actually it is part of the NPRM in terms of the administrative standards.
MR. BLAIR: Yes. That would probably fall to the time when we start to look at medical terminologies, which we are not going to do on this initial cut.
DR. COHN: Yes. Now, the other issue I would sort of bring up is I think -- I personally believe that prescriptions through retail pharmacies is a real important upcoming -- and the only question I have with it is whether or not -- we don't have to decide. It is just an observation that that may be important enough that it actually gets recommended essentially as an administrative or financial sort of next step HIPAA transaction.
So, I have no judgment for us to be going into that further at this point, but we just need to be aware that the command that we find, we might choose a different route for that particular recommendation.
DR. MC DONALD: I was thinking we would have a couple of rounds and I was thinking this would be better in the second round because it is very much in flux. There isn't, I don't think, a strong market consensus yet. I may be wrong, but I think we need to do some -- I think we might think two threads. One, first round, the good things, we are just going to say this is what is good.
Second, when it starts from hearings over a longer period of time, to get some idea about where the market really is.
DR. COHN: Maybe the answer to this one is that you ask the market and then based on what their comments are, we decide.
DR. MC DONALD: Yes.
DR. COHN: Because if there is some direction or people are screaming that they need some help on this one -- the marketplace needs this one person direction, then that might put it up higher on the list.
DR. MC DONALD: NCPDP clearly has some activity in this area. There is a bunch of ad hoc things, too, and I just don't know who is strongest.
MR. BLAIR: It would be useful for us to think in terms of whether or not the communications to retail pharmacies or whether it is to a pharmacy within a hospital.
DR. MC DONALD: It is a different market.
MR. BLAIR: Right. Exactly. That is what I am saying.
Did you want to clarify that, Simon?
DR. COHN: Well, actually, no, I didn't, but Marjorie wanted to --
MS. GREENBERG: I wanted to make a point relevant to your previous point. If somebody else wants to talk about the retail pharmacy, I will hold my point.
DR. COHN: You were talking about the code sets, you mean?
MS. GREENBERG: Yes.
I mean, I would agree that code sets for diagnosis seems to be a no-brainer at this point, but I just wanted to mention that, you know, the Subcommittee on Populations is working on its report on functional status, that the ICIDH2, which has just been approved by the executive board of the World Health Organization to take to the World Health Assembly in May with an assumption it will be approved there and then published, be included among PMRI code sets for PMRI standards.
MR. BLAIR: Marjorie, for those on the Internet that don't know what ICIDH2 is --
MS. GREENBERG: Or in the room. This is the International Classification of Impairments, Disabilities and Handicaps, which was published by WHO in 1980 as a classification of the consequences of diseases and injuries. Primarily functional status, although broader than that. It is just gone through like a nine year revision process and has been revised as the International Classification of Functioning, Disability and Health, but has so far kept its old acronym, ICIDH2, but it actually has this different name, functioning, disability and health.
If you are going to be -- I don't know whether this is for now or for later. I realize -- I just heard you say that terminologies are going to be for your deferring, but as the classifications for functional status information, which is likely to be information that would be included in patient medical record information, it is something that the subcommittee would like at least to consider.
I think this actually came up when the report was last -- in June, at the meeting. At that point, it was unclear exactly what the fate was going to be of the ICIDH2, but it has sort of completed the revision process. I don't know if you want to say something about code sets or --
DR. MC DONALD: Marjorie, if we get the code sets mixed in with this discussion, we are going to get it tangled because there are different HIPAA rules about them. There is a whole set of things brewing. It seems like -- I mean, I thought the goal here was that we were going to deal with the low hanging method standards and then the code sets was to be another discussion.
DR. ZUBELDIA: I understand that the health community is not satisfied with the ICD-9 and they use a different diagnostic set.
MS. GREENBERG: Excuse me. What?
DR. ZUBELDIA: DSM.
[Multiple discussions.]
MR. BLAIR: -- and Clem's comment that let's focus on the message format standards and defer the issues related to code sets and terminologies to follow on round.
MS. HUMPHREYS: Yes, I would agree with that and I think that having -- when we finish nailing down the drug code issue here, I think that the -- as regular HIPAA follow on, we need to come back at what are the additional code sets that might be approved and even though ICIDH2 may or may not figure -- loom large in the administrative transaction area that would still be a very appropriate place I would think to bring that up.
DR. ZUBELDIA: -- is there something like that on the clinical side.
DR. COHN: Well, actually, there was a document produced -- if you remember the history, it was developed from a summit. At that point, Secretary Sullivan set up a WEDI as an organization to help decrease costs related to administrative and financial transactions. There is actually a separate work group called the Work Group for Computerization of Patient Information. It was chaired by the American Hospital Association that developed a report. Those who have it, you should raise your hand.
I actually have a copy in my office. It does not deal with the cost issues --
MS. FYFFE: I have got it somewhere in the archives.
DR. COHN: I think people would like a copy of it, but I don't think it would give you quite the direction you sought. I would be happy to make copies and distribute it.
MR. BLAIR: What was it what you are looking for?
DR. ZUBELDIA: The world report had two important parts. One was the listing of the transactions that should be implemented by the industry. The other was the cost analysis and if there is something like that, it would be great to start with.
DR. COHN: I will be happy to ship that around, but it doesn't do what you are asking.
MR. SCANLON: Kepa, you will remember, there have been a couple of reports from the Institute of Medicine, the National Research Council, on standards and EDI computerization in medical care generally. Ted actually chaired the most recent one and Don chaired others, but they typically didn't get into the cost estimates and they were
-- I mean, they are clearly different than the administrative simplification.
But anyway, we have those.
DR. COHN: Certainly if, indeed, we are going to take an approach that says you don't have to do this, but if you do it, do it this way, trying to do a cost benefit on that is a very different discussion than you have to do it. I mean, I think that gets to be the other issue.
MR. BLAIR: If we were to get back to this list, are there any areas, domains of message format transactions that have been left off this list that anyone feels should be added?
DR. COHN: Clem has a whole bunch of -- do you want to quickly go through them, Clem?
DR. MC DONALD: -- laboratory orders is extremely narrow, but -- so, whether you want to talk about diagnostic test orders, it might be more sensible. That is all --
DR. COHN: Okay.
DR. MC DONALD: The same with results and observations. If you look at existing medical -- it doesn't look any different. So, either all results or at least those that have numerical and current responses. I don't understand where institutional medication prescription orders aren't in when the retail pharmacy -- they are certainly much more standardized, I think, and more agreement on what to use -- well, at least as much agreement as what to use under retail pharmacy.
It has been in use for about ten years. The charge information, I wonder if that is -- I mean, it is easy, but I don't know -- I am not sure that is really part of the medical record. As to the file, it may be too much to try to tackle. There isn't as much use for those in the industry.
At least ask the question about J Codes somewhere in there. Decision -- it is quite interesting that Version 3 modeling efforts in HL7. There isn't tons of it used in the industry yet. We talked about prescriptions. I don't have a good sense of the market penetration. If it is all penetrated, that certainly would be a good one.
Medical transcription, the question is to whom -- is that going to HISs? Is that really just text reports? Is that the sound managing the sound within the medical transcription area? We will have different standards depending on which scope you are talking about.
That is my summary.
MR. BLAIR: Okay. Is there anyone else that has some additional areas to be added or deleted because if not, then, Simon, I think maybe we could go on to our next discussion area.
DR. COHN: I guess I am sort of looking at everybody, recognizing that out of today we are going to come up with a questionnaire or even begin to put some hearings together. What I am anticipating is is that everybody is sort of nodding -- with comments made by Clem
-- well, I am not sure exactly how to handle the ones that he sort of felt were second level activities.
Maybe we should stop for a second and ask about that. I think what we heard was some of these need to be expanded. I have no problems with that.
DR. MC DONALD: -- right time for them.
DR. COHN: I think what you are asking is to -- we have been asking about decision support at this point. Should we be asking about medical transcription at this point, I think is the issues you are bringing up.
DR. MC DONALD: Yes.
DR. COHN: What do we want to do about those three?
Betsy had a comment, I think.
MS. HUMPHREYS: I was just going to say that it takes awhile to get through this. So, I mean, if you are bringing in people for hearings and whatever, there are only so many people you can bring in at a time. So, if people had a general sense that Clem was correct, that there was less going on or that there was more influx and less market penetration, that you would just of put those at the end of the list and it will be awhile before you get to them, just because we have got a lot of stuff on this list.
If you really want to bring people in to get a feel for real market penetration --
DR. COHN: So, we could easily ask them a question.
MR. BLAIR: My inclination is that for us to -- you know, obviously, we want to hit the low hanging fruit. My inclination is that at this very first initial stage that we don't eliminate areas right at the start, that we wind up when we wind up having the criterias, hearing the testimony and having questionnaires go out and coming back and seeing who meets the criterias and who doesn't.
Let the process winnow out, the ones that we start to look at, rather than for us to winnow out things right at the very start. So, that is my bias.
DR. COHN: Is everybody okay with that?
DR. MC DONALD: I think you are kidding yourself. What Betsy just said, wouldn't that be, you know, two years of hearings, more or less. So, you would at least have to prioritize somehow. Either you are going to say we will do it by mailouts and then we will do something or we are going to do it by hearings and you are not going to get through all this. We can't spend, you know, the next six months everyday on hearings.
DR. COHN: I think Ted Shortliffe had a -- staying here for the next six months.
DR. SHORTLIFFE: It sounds as though the issue here really is finding out enough about what is going on to decide what hearings to hold and who to invite to the hearings. I mean, there is a market research question that many of us have talked about, some of these areas where we don't know what is going on exactly or what the penetration is and it seems to me that if mailing out questionnaires is a first stage and then designing the hearings as a result of what you get back from the questionnaires, that is pretty logical.
I think we may find some pretty interesting things we don't know right now and there is like decision support. I would be fascinated, for example, to know just what the current industrial view is and what they should be adopting in that area and to what extent they really are working on anything from -- my view is cast a wide net on the questionnaire with the full recognition, as Betsy was suggesting, that by the time you prioritize things, you are going to be pushing off some into what is a de facto second round anyway.
While I have the mike, I wanted to comment specifically on one of Clem's points. It has to do with the broadening of lab results and observations. I think that is a very important comment and it means some thought, I think, if not now, then in time before any questionnaire is designed about just how we are going to specify the area of interest in that category.
I think Clem's caution that we might not want to move beyond numeric or other clearly codifiable results is important. As soon as you start getting into, for example, path report results or dictated radiology reports or so forth, you are really getting into that medical transcription category.
So, I would think reports of a sort that are in some way either numeric or codifiable becomes an important subset and maybe that is the way we should be thinking about this category. I am thinking, for example, of codified results of pathology, histology reports, for example, with real codes associated with diagnoses. Those are the kind of reports that we may well want to be able to manage and look for standards for transmission and management.
DR. MC DONALD: Ted, in terms of the casting net, the truth is an awful lot of systems are sending the same length, the text and other ones, right now. So, maybe we should just make that a market question. I mean, you agree with me so I can't disagree with it.
DR. COHN: Rob Kolodner.
DR. KOLODNER: One of the points that Clem made, I think, is -- another point that Clem made is important and that is what is the purpose that we want to use this information for. Having gone back to the experiences that we have had certainly in VA and in our interaction with DOD, there were times were early in the systems we optimized, say, a pharmacy system for the pharmacists and then had to go back and redo it when it had to do with patient care and with the meaning of information to support the decision support.
We are still in that process as we heard yesterday in terms of the code set. I think that in this case actually I disagree with Ted a little bit in that we are finding right now with DOD that some of the important information that can move back and forth that will help the clinicians and, therefore, in a very quick way, help improve care, is the textual information and if we can bring in reports, even if lobs, and at least be able to interdigitate the dates and know who the signers are and be able to read the text.
Although that is not great for decision support, it is something that we may be able to do sooner rather than later among the different hospital information systems, discharge summaries or path reports. So, having something like that can be useful for improving patient care and it is not particularly difficult. We pass over it and I think there are some templates that transcription groups have defined that might be useful just as a simple way of passing some information. You are able to have some continuity of care.
So, I think one of the concerns that I have is right now where we have got the waterfront, we haven't decided which one do we want to really move forward. If that is helping to improve the clinical care and then making sure that that supports the business processes, whether it is billing or the ordering, then that may help give us some focus as opposed to saying, well, what is the low hanging fruit across all the business processes that we might want to support.
DR. SHORTLIFFE: I think Rob's comment is important and valid and I think what I was really saying is we need to distinguish these two kinds of reports and put one in a different category but whether medical transcription in some form is, in fact, low hanging fruit, I think is a subject for discussion.
DR. MC DONALD: Medical transcription is always in it per se, because in some of them they are entering them voice entering them directly. Some of them they are entering them directly. It just results in a textual. The transcription side is different when you are getting into a voice converted into paper and that is almost a sub-message in some of these systems.
So, what you see in the radiology systems, they sound just like lab results. That is the only way they are being sent right now. Now, when you are going to the physician dictation, there is a little different story again. So, I think that maybe Rob's point -- the names are tricky. I guess that is the bottom line.
I would almost say don't be political and then do the cast the net as well as the transcription. So we get the difference between what has happened inside the transcription system versus what has happened in the reporting things to the boards.
DR. COHN: So, I think I am hearing sort of people are sort of nodding that probably a wide net in that particular area that handles both codified and non-codified information --
DR. MC DONALD: And see what comes out of it.
DR. COHN: See what we come back at and maybe that is the way to think about it as opposed to specifically the world of transcription.
DR. KOLODNER: Right. I think the label "transcription" may not be it, but to include things, not only results of procedures, but also discharge summaries and progress notes or admission physicals that may be the things that are captured more and more, whether it is by somebody typing it or being transcribed, but they are in more electronic form, but there are blobs of text with a few fields, such as dates or who dictated it or what type of text information it is.
DR. COHN: I think we are all sort of agreeing on it. Once again, I think we would all rather -- narrow down as we get more information. This is an important area. I would observe that what you are describing almost begins to talk about Item 3 of the content areas also or begins to overlap a little bit.
DR. MC DONALD: I have to get off to the -- it is a great discussion. I wish I could stay on.
DR. COHN: Do you have any other comments?
DR. MC DONALD: The thing about the future, I have some strong thoughts about the business of balance and talking about future possible -- versus present realities and I think we shouldn't get too hung up on vaporware. That is the short answer. If there is something that exists now and we are going to compare it with something that might exist, I think it can only be decided -- without good output.
DR. COHN: Yes. I think you are talking to a group that has spent too much time waiting for both of those. So, I think we will probably be inclined to accept your --
DR. MC DONALD: I would rather be on, but I have to go. So, thank you very much.
MR. BLAIR: Clem, thank you very much.
DR. ZUBELDIA: Before you hang up, on that question of vaporware, you said that the answer is "no." I think the answer is "yes." Right? Did I hear you right that we should not look at vaporware?
DR. COHN: That is right.
DR. FITZMAURICE: But, Clem, on the other hand where we see absolute standards should be developed, we should send a signal out to the marketplace, right?
DR. MC DONALD: I don't know -- I think there is a little bit of hubris there. The marketplace is worried about all this stuff, too. There are hundreds of standards of activities going on across the industry. There are lots of companies worried about all that. So, there are lots of organizations worried about it. I think we can speak out with them, but I think that we are the only guys that know what -- wonder about how proud I am.
DR. COHN: Clem, I actually agree with you on this one. I think the issue is usually when we talk about standards in plural as opposed to standards with zero in front of it.
MR. BLAIR: Let me just indicate that -- Clem, I think we have widespread agreement that for this first issue as we head for the low hanging fruit, that is true. When we start getting into medical terminology and we start going further into areas where things are needed, we are going to have to struggle with that. We may not be able to recommend a standard, but we may be able to recommend support for the development of standards. But that is in the future.
DR. COHN: Clem, we will let you go off to the wards and let's move on here.
We have about an hour to an hour and 20 minutes to sort of wrap this up, which is not bad. I think we are actually on time but we can't dwell on those that are off point. So, I think we have done No. 1, I think, along with the comments from Clem.
Now, Jeff asked the question No. 2 is should we recognize the importance of reference information models. I don't know what we are going to do with this particular one, but do people have thoughts on this one? I would be curious. I mean, my tendency is -- I don't know what to do with this one. So, I will ask for comments.
MR. BLAIR: I don't have any private agendas on this. The reason that I put that in there was because it is clear that there is a strategy within HL7 to come up with reference information models, which will enable and facilitate faster development of standards in the future. So, it is a subject that influences future standards development.
Other than that -- and a lot of people from time to time point out the importance and value of models, but I do not have anything beyond that recognition and I just didn't know -- I felt it should be brought up for discussion in case there were any thoughts here at the table, but I don't have anything that I am recommending or encouraging on this.
DR. FITZMAURICE: Jeff, this is Mike.
I think in our hearings in the past two years we had to ask on occasion different standard developing organizations, what model they use and we got answers -- as I remember, it has been a ways now -- we got a lot of different answers. Some of them would lead you to believe that maybe they didn't have a model, but they certainly had a framework for their own standard.
Personally, I could use a reference information model that wasn't too detailed. Yet, when you get down to the level where you are developing codes, for example, you need something very detailed. So, something that is up here that could bridge down to where they are, something you could explain to congressional staff and to bosses and even new people coming into the administration, that it is important to think about things in an orderly manner, but, yet, not get people bogged down in the detail.
So, something that is useful for us at that level may not be useful for the coding people. I would like to know what they think would be most useful through any coordination needed in modeling.
MR. BLAIR: Let me add one other point to this and that is that we considered the idea of reference information models when we were doing the report to the Secretary and even though we recognized it as an important enabler at that time, we really avoided discussing it in the report because the complexity -- it is a subject that was so broad, we didn't know of a way to really get into it without confusing the reader who was going to go through that and understand the recommendations.
But I thought it would be important for us to not gloss over it this time. This is one other time if anybody has any cogent concise ideas, we don't want to overlook it.
DR. COHN: Betsy, I think has --
MS. HUMPHREYS: I think Clem had a cogent, concise idea. I am going to read it right off his piece of paper. It is easy to say they are important but it could be difficult to endorse one reference information model. So, the question might best be delayed until the second round when we will have a better understanding of what message standards are included.
MR. BLAIR: Excellent.
DR. COHN: If anybody has any other thoughts --
DR. SHORTLIFFE: Just a suggestion that we should make this an explicit issue that we ask about as each person comes in and testifies about their own standards development activities and just try to find out, you know, as Michael was saying, you know, what is your view of the room you are using, if any, and are you trying to share with any other organizations the room that is guiding the effort.
DR. COHN: Great. Okay.
Rob.
DR. KOLODNER: I think there is a difference between endorsing a particular model or set of models or at least acknowledging that there is something called modeling that has importance, particularly in retaining meaning over a lifetime of an individual because at least I haven't heard of anything other than a reference model that allows us -- and a complementary terminology model that allows us to retain meaning over time given the changing medical knowledge base.
So, I think it may be worth just a high level statement that is in simple terms that models will be important but not something that we get hung up on in the current realm.
DR. COHN: Okay.
Let's move on to 3 then. Shall we recognize or provide incentives for structured document standards? And then in parentheses, XMLDTD?
I don't know. Maybe we should start with Clem's note, which I think is very pertinent. Jeff, I will read it for you. It says we should be very careful about what we do here because, one, XML is a standard for writing standards. It is not a standard in itself and people get that mixed up.
The helter skelter set of locally defined XML messages are cropping up all over, leading to wanton non-standardization. Most of these are not standards. Most have no relationship to ANSI as required by the HIPAA regulation. Further, any f the current message standards can be trivially converted to XML and many are in the process of doing so. So, we don't need to encourage a thousand non-standardized goals to bloom if our goal is to get XML syntax.
In short, I would argue vigorously against the encroachment of XML for its own sake. If it is important to get to XML, encourage the industry adopted standards to evolve to XML syntax before using a common model so they could all interoperate.
Now, I see Peter Waegemann wants to make a comment. I would sort of say I actually appreciate Dr. McDonald's notes sometimes because of their honesty and straightforwardness. I do, however, thank that as we talk about medical transcription area and maybe not medical transcription but non-codified text that will move to this area in some way or other, but I don't think it is a separate issue is my conclusion.
Peter.
MR. WAEGEMANN: I disagree with every word said in this text. Maybe there are a few words I can agree with. But the total meaning of it is from my point of view totally incorrect.
I would like to make a point that HISB is currently in the process of coordinating the XML as standards words under the leadership of Steve Steindel and I would recommend that if the group here waits until HISB comes up with some kind of result from this coordination process -- we also have to recognize that some of the XML standards work is going on in ANSI accredited standards organizations and it is something where some countries are ahead of us and, therefore, it is very important that we include this into the work. But I would really say once we have probably in three months or six months a handle on what is going on in HISB, then it might be the right time to address this again.
DR. COHN: Actually, Peter, thank you very much. Though I actually think you are sort of agreeing with Dr. McDonald, which is my judgment from your comments.
MR. WAEGEMANN: I try to reconcile both positions. I think XML is a standard syntax and you can express standards in that standard syntax.
MR. BLAIR: We are really talking DTDs, healthcare DTDs.
DR. COHN: And I think just to sort of short circuit the conversation, I think if we are talking about the wider view of results in non-codified text, we will begin to sort -- XML will get sort of in -- and the DTDs get sort of involved in that discussion. So, it gives us an opportunity to sort of see in that context sort of what is going on.
So, I think you have a little bit of that, but to deal with XMLDDTs on their own in a vacuum is probably not the way to approach that. Probably the next issue is one of dealing with terminology and you know I spoke vigorously against us dealing with terminology in a vacuum at this point in life.
DR. FITZMAURICE: Simon, I agree, but would insert that what I see is important is not so much the syntax of XML, but variable definitions and the labels that you put on them that if you get a bunch of labels with different definitions, then you don't have a hope of having the syntax join common meetings and common concepts.
So, there ought to be some attention paid to that that we say that is important, if only that we say that is important to make sure the definitions are in common as much as they can be.
DR. COHN: So, any thoughts on this one? Do people have comments? Okay.
Let me ask a question on No. 4, which is something I just made an assertion on. What I am hearing is that we are not going to be able to specifically agree with XMLDDT, except in the context of these results coming back and sort of seeing where the standards in relationship to that.
I am making an explicit assertion is that the focus of this effort is not at this point specifically on looking at terminologies, but we will handle terminologies through a separate effort we will discuss either today or later on in February.
Is everybody comfortable with that one? I mean, terminologies are obviously, part and parcel of any standard we talk about. But it is one thing to talk about terminologies in their own right, but it is still another thing to talk about an overall transaction and the code sets used within that.
That is out of scope for this particular effort. Everybody okay with that? Okay.
Balance. How do you balance the value of existing versions that the market has accepted against the potential value of versions under development? Comments? It seems like a vaporware discussion.
Betsy, did you want to comment?
MS. HUMPHREYS: No, just to remind everybody -- I think Kepa picked up on this -- that the second line of Clem just didn't say what he meant in the second line of his comment on this. He meant "yes" not "no." I mean, basically he is saying we should prefer existing really implemented things over future hopes
DR. COHN: Okay. You suggest we stay away from speculative decisions.
DR. ZUBELDIA: That is why I asked him that question. He clarified it. He meant "yes." He said "no," but he meant "yes."
DR. COHN: Other comments? Jeff wants to comment.
MR. BLAIR: I just wanted to share with you because, you know, this -- I guess the word "transparency" is here. Okay? Clearly, right now when we begin to look at the criteria, there is eight criteria. The ones we talked about back in November put a priority, a heavier weight on market acceptance and when you wind up doing that, you are really looking at things like a lot of the HL7 message transactions that are in the version 2X viewpoint. So, I just wanted to share some information that I picked up with the rest of the committee -- this is just information, okay, but it is background and then we can go on.
I had a conversation with Stan Huff(?) at the HL7 meeting and I wanted to get his thoughts on this because as many of you are aware, HL7 has been working for some time to try to move forward to correct interoperability limitations and improve the comparability, improve the data quality and their vehicle to do that would be HL7 Version 3.
So, let me just share with you some information. It doesn't change anything we have decided to do here. And that is that they are hoping they could get Version 3 balloted by the end of this year. If they do, it may be a year or two before you have some leading edit institutions implementing Version 3.
If they do, the application that may be the thing that adds value may turn out to be the clinical data architecture, which are the DTDs defining documents because many institutions that have already made investments in committing to HL7 version standards. That is 2.3 and 2.4 and there may be a 2X that nobody really wants to talk about because they really don't want to do that, but it may be necessary.
The Version 2 efforts, a lot of investment has been done out there. It is going to -- there may be marginal improvements with Version 3 to replace those. So, they may actually be in place for four years, five years, six years, seven years or more and the thoughts were that if that is the case, then Version 2X probably will be around for quite some time and maybe even longer.
So, I just wanted to just add that background.
DR. ZUBELDIA: It is not along those lines on Version 2 or Version 3 of HL7. It is more along the lines of the script pharmacy transaction. The NCPDP -- and it is on this topic -- NCPDP has developed a script standard that has relatively low implementation at this point and there is a number of ad hoc proprietary standards that people are working on, XML and others, that -- because they are commercial ventures, they have -- they may have more market penetration than the NCPDP standard.
However, they are proprietary. They are not standards. They are not ANSI. So, we need to look at that very carefully when we look at market penetration of things that are proprietary.
DR. COHN: Peter, do you have a comment?
MR. WAEGEMANN: If I may just rephrase the question in front of us. The question from my point of view is should NCVHS recognize imperfect standards or should it consider work on better standards for the future? I think it is not a question for HL7. There is substantial work going on in many sectors. We have to recognize that the industry is changing and, therefore, what we have currently is very imperfect.
The worst that I would see as an outcome of this work is that it recognizes a system where if you take just outcome, I get -- almost every second we get called where they said we bought a system, which said it is compliant with the standard and may be HL7. Then we bought a second system and the two didn't work together.
So, the criterion -- the main criterion is missing this whole work, how much interoperability does -- how specific is the standard. We do not need to continue with standards where you can do up to 70 percent customization and the marketplace needs interface engines and all of these issues. So, the question really is between imperfect current standards and work on better standards in the future.
DR. COHN: And actually, Peter, I actually want to thank you. What I am hearing from you is that we need to make sure the -- reminding ourselves that the key questions were interoperability and comparability, that in -- this looks at the standards. That becomes a key issue. Unfortunately, even new standards are imperfect. So, I don't know -- but I think the -- we have to be reminded of that in our questions.
Mike, you had a comment?
DR. FITZMAURICE: What Peter's comments bring to my mind is that when we hear from people who are developing standards, when we hear from people who are the users of those standards, that we need to be asking what functions do you want the standards to serve. How is it going to improve the health care, the efficiency, the delivery of care and patient outcomes and we may want to ask them what are the criteria they would like to see in a standard that would work best for them so that we get into the habit of saying a standard for this particular use should meet the following criteria as told to us by the industry.
So, a lot of what our deliberations are is based on what the users want.
DR. COHN: Great. Okay.
Any final comments about today versus future issues?
DR. ZUBELDIA: I would like to follow up on Peter's comment. We had exactly the same situation for our administrative simplification standards. We had the NSA from the UB92 with 400 different implementations of the standard and they didn't talk to each other. We have a similar situation we are trying to address now with the signature standards where it is not just to have a standard. We need to have an implementation.
I think on these clinical standards, just to have a standard, we need to have implementation and the SDOs need to work on getting implementation guides to be adopted by the industry, not just the standards, so we achieve comparability.
DR. BRAITHWAITE: I would just like to add to what Mike said. Yes, I think it is important to keep in mind what the users want and need and keep in mind that most of the people who are involved in developing the standards themselves are not the users but the implementers for proprietary vendor solutions. The users don't want to have to deal with multiple proprietary implementation of a standard. They want implementation of a standard that is totally interoperable. I think that is the viewpoint that we have to be supporting.
DR. COHN: Other comments on that one? I think we are -- okay.
In general, I think that will help us move to the questionnaire.
Final piece here, which is -- actually I should comment. I don't know that we have any plans for the question about the future, except to know that we have to sort of balance there.
Jeff, do you want to --
MR. BLAIR: Yes. I wanted to add a comment here. Since I want to echo one comment that has been made here, for full disclosure purposes, Peter Waegemann is my employer and my friend. So, I am saying this before I make my statement, which is to echo what Peter said because in the process that we are going through now, I think the statement that Peter made is very appropriate, is that even when you look for low hanging fruit, you wind up finding existing standards that may have market acceptance, but still fall short of interoperability and comparability objectives that we have set forth in our PMRI report.
DR. COHN: Thank you, Jeff.
Any other comments on this one or can we move on to 3? What emphasis should be put on -- you don't need acute care but sort of institutional, hospital-based care versus ambulatory care. Any comment on this one? I don't know that that -- to me, that is not a major demarcater.
MS. FYFFE: I know less about this whole area than anyone else at the table probably, but my thought here is that with the aging population in this country, we are going to have people moving in and out of acute care facilities versus ambulatory care versus long term care. So, I think that we have to keep that in mind.
DR. BRAITHWAITE: I think maybe the issue here is more the interoperability issue than anything. Let's not focus on one or the other, but focus on the fact that patients are moving across these environments and they have to be as compatible as possible.
DR. COHN: Any other comments about balance before we move on to format?
Jeff, you have written a question here that I will apologize because I am still not even quite sure I understand but I will ask it since it is here, which is should we define areas of applications or as transactions. I had a discussion with Jeff about this and came out still not certain that that was something that I -- what the distinction was on that.
I think what we are doing is just sort of reaffirming -- we are obviously viewing this as sort of a transaction view of the world and letting that drive us as opposed to talking about domains. Jeff will describe the applications. Am I doing justice to that?
MR. BLAIR: You are and I will try to help the committee consider this a little bit. I am not sure how well I will do either, but, you know, we wind up very often when we think of message format standards, we think in a traditional format and it is very easy for us to look at the existing message format standards and craft our view of this topic area in terms of existing transactions.
So, my question to the committee for us to consider is whether we should as we go forward define the areas of focus that we have in terms of existing transactions or in terms of transactions at all or whether we should be trying to define our scope and these areas of focus more in terms of applications. If we do do it in terms of applications instead of transactions, it is a different perspective.
It may be a little more challenging but I am offering this question to the committee and to see what ideas you have to offer.
DR. FITZMAURICE: Jeff, this raises to my mind -- I am not sure I see it as a transaction application. I see that to make a clinical decision or to affect the choice, you need to move information from one place to another. You can call the movement of that information from one place to another a transaction. You have to define the elements and you have to get it front of the decision-maker. The particular function that it serves maybe to judge whether a patient has a particular condition or not could be called an application.
And a transaction might be larger or smaller depending on what you already know about the patient. It is more useful for me to think of what is it you are trying to do, what information do you need. Is that information content well enough defined that we can put a standard on it and then move it in a transaction.
DR. ZUBELDIA: Probably our area of focus should be on the applications and then ask the SDOs what transaction they have that support those applications and have the standard in the transactions themselves, but we should be focusing on the applications and see what supports those applications.
MR. BLAIR: Could you elaborate as to what are the benefits? If we do that, what benefits does that give us?
DR. ZUBELDIA: If we focus on something like admission discharge transfer as an application, there could be several transactions, several messages that support that function and probably in order to get the full function implemented, you need all of them. Focusing on the transactions themselves will not achieve the result of having a functional unit that can be implemented.
MR. BLAIR: Maybe one of the benefits is that it begins to identify gaps and it begins to have us look at things more broadly, a little bit more out of the box. I am putting words in your mouth here, but am I putting the right words?
DR. ZUBELDIA: But I don't think we can do much about it unless the SDOs define additional messages to cover the gaps. But as you say, let's take a look how we can have a standard AAT(?). If they identify the gaps, they will take care of them.
DR. SHORTLIFFE: I guess I am still having trouble understanding the distinction. I sort of find myself agreeing with Michael here. I mean, ultimately we are talking about standards for messages, which imply transactions of some sort. Their size could be various and it could be a whole content of an application being shared at one fell swoop or they could be the kind of interactions between two applications over a link of some sort.
Ultimately where the standards become important is in that area of handshaking and communication between application. We have defined a list of applications of interest to us, each of which in order to share information with other applications has to be -- has to have some kind of standard message format. It seems to me that is ultimately what we end up talking about when we talk about standards.
But also what is driving this is the interest in the specific applications and the fact that they need to communicate with one another.
DR. COHN: Bill Braithwaite.
DR. BRAITHWAITE: I would agree. It is the interoperability of information exchange between the applications that is the critical thing, the focus of the standards themselves. I think the only point is even though it is those standards that we are adopting and those are the things we have to focus on in terms of which ones we are going to adopt for which applications. We shouldn't, as I think several people have pointed out. We lose sight of the fact that we need to find in the regulation, the transaction standard. We have to define it in terms of who is sending what information to whom and for what purpose.
So, the definition of the application is critical to our definition of how we, in fact, mandate the use of these transactions. So, I don't think they can be separated. They have to be discussed as a whole.
DR. COHN: Okay. So, I think what I am hearing is sort of an and.
MR. BLAIR: Excuse me so that I capture this information for our next thing. Would you just mind repeating your last piece. I think you said that the definition of the application is critical when we define the transaction because you have to include the purpose. Is that correct, Bill?
DR. BRAITHWAITE: Yes.
DR. COHN: Yes. I think it has to do with the specificity of the implementation guide to a large extent.
So, can we move on to the guiding principles? Is everybody comfortable with that at this point?
In basing our previous conversation, now let me make an observation before we get into the guiding principles. I am just sort of -- as I was sitting here listening, reminding ourselves that interoperability is sort of the bottom line here, that somehow our guiding principles don't explicitly state interoperability. So, I am sort of going -- we have market acceptance. We have consistent with other HIPAA standards. We have relatively low implementation costs. We have ANSI accreditation, timely development procedures, flexibility, data quality characteristics and specific terminology.
I guess I would comment that somehow I see guiding principles as probably specificity and interoperability and as we have all been sort of saying, does it have a specific implementation guide, which is part of really that interoperability. I mean, is that one of our guiding principles that we -- well, it is not a guiding principle, but is it a criteria for selection?
MR. BLAIR: Actually, Simon, one of the things we -- we did a couple of things. You are right. Let me indicate that like, for example, on the clinical specificity piece and on the market acceptance and on some of those criterias, when we get to the questions, which are there, we go in deeper and we ask questions like, for example, on the data quality piece. We wind up saying do you have an implementation guide? Do you have conformance tests? These are ways of us measuring some of these things. But, nevertheless, I think your comment uncovers a little bit of a difficulty here.
We tried to have -- maintain the integrity of the guiding principles and then derive it from the 15 guiding principles and among that, we didn't have interoperability and comparability as guiding principles. We had some other words. So, we derived it from that and then we have tried to fold within that in the questions some of those specific areas that would flesh that out.
Maybe that is not the best way to do that and I think here is where we wind up saying is this the best way to do that or should we do it some other way.
DR. COHN: Comments?
DR. FITZMAURICE: I guess I am comfortable in us stating that our overall goal is interoperability and comparability and using the guiding principles to help guide us along in the choices of whether strict compliance with the 40, 30 or 15 percent is even measurable is a question we will be probably be getting into, but I think we don't know enough already about the answers to some of these guiding principles. We just need to start asking questions of people who will be testifying in front of us.
DR. COHN: So, you are saying we should keep the guiding principles --
DR. FITZMAURICE: I wouldn't spend an awful lot of time on it. I would focus on what information we need from the testifiers since our time is getting short. And these are as good as any to start off with.
DR. COHN: And all I was sort of suggesting is we add one, which is this interoperability -- go ahead, Ted.
DR. SHORTLIFFE: I guess I was just thinking that the problem with this is these numbers. If to any extent they reflect priorities, fair enough, but some of them are absolute requirements, too.
So, calling, for example, consistent with other HIPAA standards, 20 percent, doesn't make a whole lot of sense because if it is not consistent, it basically rules it out. It is not just 20 percent. You see what I mean? I think the percentage game may be a little tricky here and it really is that these are issues we need to be considering carefully and many of them are really either mandatory or very important.
MS. FYFFE: I would not put any weights on any of them. I would have a list.
DR. COHN: Okay. So, I think everybody is agreeing that we have criteria without specific weighting factors.
DR. BRAITHWAITE: In which case, adding interoperability and comparability of implementation would be easy to do.
DR. FITZMAURICE: I would almost make that an overarching goal; that is, these criterion are developed to satisfy interoperability and comparability.
DR. COHN: I hear what you are saying except unless we specify it somewhere -- I mean, none of these guiding principles seem to address that. That is why I am sort of struggling. They are sort of kind of around it, but they don't hit it head on. Otherwise, we could easily sort of forget that we are really -- you know, you have a specific implementation guide, et cetera, et cetera.
DR. SHORTLIFFE: Well, it is clear that our desire for interoperability leads to many of these.
MR. BLAIR: Could I add this piece on? Given that we have decided to add interoperability and comparability, when you do look at the questions, you will find questions that support that, but they are under different topics. So, just keep in mind that you probably -- we probably move some of those sub-questions in the questionnaire under a new topic of interoperability and comparability when we look at that.
DR. COHN: Okay. Well, now I think we are moving onto the questionnaire and, Jeff, I would look to you for guidance on this one. Do you want us to go through the questionnaire? Is that something we want to have people provide some --
MR. BLAIR: I will tell you what, let me just give you a little bit of an idea of how to look -- how you might want to look at it and then I am going to ask you to look at it and critique it. We, you know, clearly can change it, not just once but several times as we go forward and it is something we would like to be able to have in the March session or even prior to the March session when we have testifiers, for them to critique not only our criteria and our areas of focus but a perspective questionnaire as well. So, this won't be the last time.
Now, let me give you some feeling for the questionnaire. The questionnaire is derived from those guiding principles. It is an attempt to try to get information that to some degree can be measurable for each of those guiding principles. It can't be a hundred percent, but we are trying to just get as quantifiable as possible.
So, I think that is all I am going to wind up saying and I am going to open it to the committee to critique it and comment and make suggestions.
DR. SHORTLIFFE: Simon, could I begin by asking what the strategy is for identifying to whom this questionnaire will be sent? It would help me in thinking about the questionnaire to sort of get a sense for who it is going to and with what kind of cover letter and what expectations.
MR. BLAIR: Well, could I indicate that that is something I think our committee will want to, you know, focus on. I could indicate only our history and the history which we had was that three years ago ANSI HISB wound up doing an inventory of standards, which I guess you haven't seen. Would you just pass this on to Ted because he hasn't seen that before.
That happens to be the feedback that was received for the inventory of clinical information standards. In that case, what I am handing to you is just message format standards. We had a two page template that we sent out to each of the standard development organizations. Their responses were six, eight and ten pages apiece.
The kind of information there is -- well, I will just let you look at it. We are now getting a little bit more specific here, now that we have our criterias. I think we are going to wind up doing something different. We don't want to wind up doing a big project, but clearly we have to wind up getting some kind of information that is documented and comparable to help us decide which message format standards we would pick and who -- you know, obviously, the SDOs would be who we would distribute this to, but I think we would want to maybe get input from a broader group of testifiers than just SDOs.
DR. COHN: I was just going to clarify that that questionnaire was actually not done by the NCVHS. That questionnaire was developed by ANSI HISB. Jeff actually did it as a member of HISB. It was actually given to the NCVHS as we were doing deliberations around HIPAA. So, it really becomes -- just to clarify the history of that document.
Certainly, I think Jeff has restated this thing. This questionnaire -- and we probably need to move it up a level, but this questionnaire, as I read this, appears to be specifically focused on sending to SDOs. It is not a -- I think you had commented that we need to do a market research evaluation to identify -- this questionnaire is not going to do that.
So, I think we need to sort of maybe even move the discussion up a level, which is sort of what do we need to do to get to our goal at this point.
DR. SHORTLIFFE: Would it be valuable if this is largely going to go to SDOs to actually get some information from the SDOs about the degree of implementation by industry, of their standard?
MR. BLAIR: Well, if you look under, you know, the questions that you see there, for example, like on market acceptance, you see a subset of questions like what acceptance do you have among vendors, either in a percentage of number ways; what acceptance do you have among providers; what acceptance might you have within government agencies or what other measure of acceptance do you have that may be useful for us, you know.
DR. FITZMAURICE: That gets at it, doesn't it, Simon?
DR. COHN: Yes.
DR. FITZMAURICE: That would give us some indication.
DR. COHN: Of course, I think my memory was that the SDOs oftentimes are not really aware of the market acceptance. Am I right or wrong about that?
MR. BLAIR: Exactly. And that is the reason that when we developed this questionnaire, well, in the past and I, you know, obviously plagiarized from the previous one to some extent -- they don't always have answers to all of these. So, sometimes we not only wind up asking the question in a couple of different ways, like you see under market acceptance, but we also give them the opportunity to express whatever answer they may have that we may not have been able to identify. So, we give them another --
DR. COHN: Jeff, I am going to suggest that maybe -- I am sort of thinking of what we need to do, which, once again, my comment early on, which was that we need to be at the end of this session, which finishes at 11 o'clock, able to move forward with a useful March hearing. If not, we haven't really reached our goal.
I don't think from my view that the purpose of this questionnaire is to now discuss it in March, but we would like probably at the end of today, at least I think, to be able to say, gee, this is good enough that we could send it out to SDOs with the idea that maybe they were beginning to get some feedback and I am just presuming also that we might want to have people from the marketplace and from the healthcare industry coming in March to sort of talk about these areas and their issues and what they need, et cetera.
I am looking at Mike and Jeff. Is that sort of what you are thinking of for March. So, we really sort of need to have this thing agreed to pretty much today. So, we should at least look through the high level issues here to make sure everybody is comfortable with it.
MR. BLAIR: Right. Let me just refer back to our general work plan.
Ted, we were really thinking that this questionnaire would go out to SDOs probably in the April time frame and they might have May and June to fill it out and get back to us maybe in July. so, this would give us time, like in the -- this is saying what Simon was saying, but I am just trying to put it in a slightly different perspective.
DR. COHN: No. I am saying something very different than you. I thought that this would be part of the information that we get back when we talk to them in March.
MR. BLAIR: Yes, it is in the sense that I think that we would also distribute this or a modified questionnaire to get -- for the March testifiers, and the March testifiers would critique not only our criteria, but this questionnaire as well to say do we need to modify this questionnaire before we send it out to SDOs. Am I --
DR. COHN: Well, I was saying something different and I guess we need to look at what we want to do. I guess I am looking around and I am looking to both you and Mike to help structure whatever the March hearing is. I guess I would ask you both what is the purpose of the March hearing, to help guide us in --
MS. FYFFE: Excuse me. I am sorry to interrupt. Have we settled on the dates for the March meeting?
DR. COHN: Yes. There was an e-mail that was sent out, the dates of a March -- the 20th and 22nd?
MS. FYFFE: Because they had --
DR. COHN: 19th and 20th.
MR. BLAIR: The purpose of the March hearings. I think we have a number of purposes. I think we would like to have people critique our areas of focus, critique our criterias for selection and critique a draft of the questionnaire that would go out to SDOs. That was my thought on that. But we could change that if the committee wishes to do something different.
DR. FITZMAURICE: I agree with Jeff that that is what I thought the hearings were for, but I would also not waste the opportunity to ask them more specific questions about their own standards, about the functional areas that they are directed toward and about their sense of where they would like to see the role of NCVHS in patient medical record information standards.
To broadcast here is what we are planning to get feedback on, gee, we think you can do it a little better in this direction or a little better in that direction and then after the hearings develop the questionnaire and arrange to have it sent out to the SDOs and get the information back, process it over the summer and be prepared to talk about that information in September, September, October.
That would then help us -- I would also get their opinion about the low hanging fruit and the problems they see with, you know, our choices, our list of the low hanging fruit.
DR. COHN: Comments, questions? Okay. I mean, I -- under those circumstances, I guess, we don't need to spend an agonizing amount of time on this questionnaire.
DR. FITZMAURICE: I can see where you were thinking that if we are going to send this questionnaire out and then get the results tabulated by the March hearings, we need to really hone it down.
I think that the time for honing is going to be right after the hearing.
DR. ZUBELDIA: I would like to focus the questionnaire a little bit, maybe with one or two questions about not only what they think about our low hanging fruit, but how their standards would apply to these parts of the low hanging fruit. Given the distance in which of these lists your standard applies to and does your standard have mature areas that could be adopted that are not in our list.
MR. BLAIR: Could I ask if maybe, Kepa and Michael, could you summarize all of these additional thoughts because I wasn't able to capture it on my trusty dictaphone as completely as I might like. If there is anybody else that -- you know, as we expand what we want to accomplish for that March hearing so that we can pull it together.
DR. FITZMAURICE: Yes. Let me ask, will we have a transcript of what we are talking about today? Yes. So, we will have it codified on paper and I will also summarize it.
DR. COHN: I guess the question I would have then is it seems like the best use of the remaining time would be for us just to talk about, to make sure that we are all comfortable with what we are talking about doing in March and the steps to get us there.
At least, that is what I am sort of sensing as sort of the remaining item. I am presuming that people can provide feedback off line to the questionnaire if there is anything that is grossly inappropriate. This will go through a whole vetting process between now and then and people can e-mail you both if there are issues that are specifically related to the questionnaire.
Is that correct?
MR. BLAIR: Can I ask a question?
DR. COHN: Jeff, please.
MR. BLAIR: Ted, I had the feeling that in addition to this questionnaire, which would wind up ultimately going out to SDOs, you know, for us to analyze in some depth, that you are saying that in March we probably need an additional set of questions. And I think I am hearing this also from Michael and from Kepa, that our broader, general questions about the appropriateness of what we are doing about our basic assumptions, about the ideas of the low hanging fruit -- so, is that correct, that we are looking for a different set of questions in addition to the questionnaire and --
DR. SHORTLIFFE: And we might pick those who testify in March with some of those broader questions in mind, specifically to try to get that kind of input. I think that is right. I think I heard that from the others as well, and maybe in particular because I think it is true that the SDOs don't always know what is going on in the industry, is to try to get a few folks who can really talk about, you know, here we are sitting in Malvern, Pennsylvania, trying to figure out what to do and here is the way we see what is happening right now in these various standards organizations, which ones we have been adopting, which ones we feel are mature enough for us to actually put into products and just begin to get that vendor sense of where they would find input from us most valuable to them in terms of really sort of coalescing their market efforts and their product development efforts.
MR. BLAIR: Simon, could we kind of build a little bit off of Ted's comments just now and maybe think a little bit about who we would invite for the March meetings? Because I think that I am hearing from Ted that we would not only want to hear from the SDOs, but maybe some of the major vendors that use and implement the standards as well.
Am I hearing that?
DR. COHN: You know, I had circled a comment that you had made earlier about a market research effort, the market research question. I think that is what you are referencing, which is, you know, a part of the market is obviously the large vendors. Probably, I would imagine that there may be academic medical centers that might be doing things -- Ted is nodding his head vigorously in terms of that one since we know they do independent development efforts. There is, I can imagine, some large HMOs that I could imagine that might have some view about what works and what doesn't.
I imagine the hospitals -- I mean, part of this is in cost and benefits, which is an important issue, which Kathleen, I actually value having you here to sort of talk about what the value and the benefits and the costs are.
MS. FYFFE: [Comment off microphone.]
DR. COHN: I do have to say in terms of -- and let me just give you my own perspective in costs that I think part of what the National Committee and HHS are trying to do is to help protect health care institutional investments in information technology. I mean, there is very little worse than either spending a lot of time on your own developing a unique proprietary piece. Then you can't move forward or -- but then you discover that you can't move forward.
Those sorts of dead ends cost the industry hundreds of millions of dollars. So, I think if we are doing the right thing, what we are really doing is benefiting the industry by helping assure them that the investments are making are the right investments and that they have the government backing, that we are sort of saying to them this is a good path, not that we can reduce risk to zero, but the more we can reduce risk, the more we help the industry and help them make sensible investments.
DR. SHORTLIFFE: That is why doing this right is precisely a win-win. I mean, the industry clearly benefits. At the same time that the quality of care and the quality of data and then they will need to develop reasonable policy benefit as well. So, everybody -- I think there is strong support for this notion, so long as it doesn't -- as is always the case with standards, so long as it doesn't prevent innovation, you know, and it is done with a willingness to see the need for innovation and to encourage that, at the same time that you are trying to develop viable standards to support the industry and the other laudable goals that we have.
MR. SCANLON: I wonder if at that March hearing we can also try to think of kind of an industry overview session where it is not a specific vendor but it is a market analyst or industry analyst, who can talk about a lot of other issues and how the standards effort fits in. I don't know whether it is a Gartner(?) kind of a consultant or -- but someone who doesn't have a particular system to sell or an axe to grind and just sort of saying where does the industry look like it is now, what are the issues and where do they see it all heading.
Then we can have the SDOs and the providers and --
DR. SHORTLIFFE: It will be a very interesting question whether those kinds of analysts know the answers to these questions within the companies. I mean, I think there is reason to believe it will be -- I mean, I don't hear good assessments of where these standards are penetrating into the industry, many of them. I mean, HL7 --
MR. SCANLON: Well, we think they are more worried about HIPAA. I mean, the first thing we are worried about Y2K and now they are worried about HIPAA as sort of the biggest, you know, influence on IT, but -- and they may -- but they influence investment and other things.
DR. ZUBELDIA: If they don't know the answers, we give the questions far enough in advance, they will do the research for us.
DR. SHORTLIFFE: So, yesterday -- now I have got a feel for how you do things -- the folks who testified yesterday had a set of questions that they went through. Now, the questions we are talking about for March then are not these questions, not this questionnaire. There is another set of questions that we have to develop and ask in order to get responsive testimony at the March meeting. Right?
DR. COHN: That is right. I think what we are beginning is to hypothesize what those sorts of questions might be. My bet is is that in February later on when we have our full NCVHS meeting, in our breakout, we will have an opportunity not to work on them but to review them and add any that we want to so that, I mean -- and we will begin to have a list of people to testify at that point so that we can sort of add names, et cetera.
I am looking at Mike and Jeff. Is that a correct assumption? Jeff, unfortunately, is not going to be there, but Mike will have to carry the day.
MR. BLAIR: Just clarifying because I am not -- my thought was that, yes, we would clearly need to create a questionnaire, you know, for -- you are talking about the meeting in March, the third week in March, yes. I was hoping, as well, that we could get some outside critiques of the areas of focus, the criteria for selection and the questionnaire, as well.
DR. SHORTLIFFE: As part of the oral testimony or written --
MR. BLAIR: Well, you know, I guess that -- maybe we have to talk about that a little bit. I guess that clearly it would probably be too much to do it as part of the oral -- well, I don't know. What are your thoughts on that? We will have to see what the committee thinks about this.
DR. SHORTLIFFE: It does seem to me that in defining the questions that we want to ask, although we have some specific market type questions and so forth, that some of what we could do is actually get some testimony about this process and these issues as we have begun to see them today and then actually get discussion going with those who are testifying, to really allow us to be sure we have got the right questionnaire and the right emphasis on issues by the time we do the effort of sending out the questionnaire broadly for responses.
DR. COHN: I guess I would add, just going back to the people that we might want to testify, I would imagine the GCPR effort is one that probably has at this point some experience with what is working and what is not out there and what their needs are and are going to be.
Now, I guess I am assuming in all of this -- it is not quite a well-oiled machine, but it is -- I do know that Mike and Jeff, I think, have some ideas of who the testifiers are likely going to be, in our time frame, which is, unfortunately, only about four weeks after the NCVHS meeting. I suspect that they will be taking the liberty to begin to invite some people that are likely candidates in advance, based on some of the input we are providing here. Is that correct?
DR. FITZMAURICE: Yes. Simon, what I have heard is that we should be hearing from among people from academic medical centers, vendors, large HMOs, hospitals, physicians as well, since they are primarily -- I would probably give an invitation certainly to the American Medical Association, maybe NCQA, because they are going to be more and more involved in how do we get all these expensive HEATUS(?) measures so the systems can produce it for us.
I heard also market analysts, places like Gartner and Young, Anderson, and GCPR.
DR. COHN: And vendors.
DR. FITZMAURICE: Yes. Vendors was second on my list.
MR. BLAIR: Public health as well?
MS. FYFFE: The financial rating services, don't they do research, like Fitch? Are you familiar with that, Kepa?
DR. FITZMAURICE: They may be further away from the use of patient medical record information standards.
MS. FYFFE: Fitch came out with a report several months ago saying that compliance -- in the industry, compliance with the HIPAA, the privacy standards, would be approximately two to four times the size in terms of cost as Y2K. That got some attention. I don't know if they have started focusing on this yet or not.
MR. SCANLON: Well, there are a lot of estimates around about how much it is going to cost. I wouldn't pick one and I don't even think that that is the issue at the moment.
DR. ZUBELDIA: Beare(?) Sterns has a report on the health care make of record vendors and they go over maybe 20 or 30 vendors. They monitor their progress and all that.
MS. FYFFE: Well, yes, that is in the ballpark of what I was talking about.
DR. FITZMAURICE: What I think we would probably get from them is their financial health and how likely their price earnings ratio, to the extent they have earnings is going to hold up. I have heard them. They are very interesting.
MR. BLAIR: My perception is that the overall direction that we are taking, the overall framework, our overall recommendations, those ten recommendations based on addressing impediments that we went through for a year and a half, so to speak, was summarized in the PMRI report and I sort of feel as if what we are going through in March is rather specific to our mechanisms for how -- what will be the criteria that we will use for specific selections of message format standards.
So, my thought is that -- and we want people to critique our criteria and our assumptions for that. I sort of feel as if we do invite people from public policy or other areas, I would hope that we would wind up trying to get individuals that have the knowledge and are familiar with message format standards and issues of interoperability and comparability.
I think that is the level that we are at. Is there general agreement on that or not?
DR. SHORTLIFFE: I agree and I think the way you can assure that that will be the case is through the questions you ask them to respond to. I have occasionally gotten a request to come testify before some body and I look at the questions and say I am not the guy to do this one. You know, it is not my area. So, I think people will self-select and you will get the right folks if you have the right questions.
DR. COHN: Marjorie, you have been patient.
MS. GREENBERG: I don't know whether it was Jim or Simon who asked about public health. I think the Association of Public Health Laboratories --
DR. FITZMAURICE: American Clinical Laboratory Association?
MS. GREENBERG: No. It used to be the Association of State and Territorial Public Health -- it had a very long name. Now I think it is the Association of Public Health Laboratories and the Council of State and Territorial Epidemiologists would be two. Actually, the Public Health Data Standards Consortium Steering Committee is meeting here the 21st and 22nd. So, Dick is going to be coming in for that, like on the 20th. This is the 19th and 20th, right? So, maybe the same person could come in a day earlier.
DR. FITZMAURICE: Marjorie, could you suggest some names to me from people from those organizations or at least contact points? If you could just e-mail me -- and for everybody. You have seen the categories that we have solidified on here today. I would feel free to ask other associations if they would care to testify, but if you have names of people or contact points in associations, please feel free to suggest them to both Jeff and myself.
Suzie Bebee is helping us out -- has volunteered to help us out as well.
DR. COHN: I actually want to bring up a slightly different -- an issue but an expansion of what we are describing, which is is that as we are sitting here talking and especially as I look at the prescription standard, which has to do with prescriptions to retail pharmacies, I am reminded that there is a whole new economy out there and many web vendors and others that -- HIPAA doesn't apply to me except for privacy and security or what do the HIPAA standards have to do with me, you know. You guys are out there doing something real different.
We probably want to as we are asking make sure that we capture some of these sorts of mid-economy people, the ASPs, the people developing some of the web solutions, sort of see what their thoughts about what is important -- especially to ask them about the issue of interoperability because most of them have not ever thought about that issue.
Certainly, somehow in HIPAA you think about interoperability, but you go to the web and it is going like interoperability, that isn't going to give me any advantage.
MS. FYFFE: Some organizations like -- they actually like a lack of interoperability because it increases their consulting fees.
DR. SHORTLIFFE: The point I was going to make was that some of the web companies that are actually amassing data or are providing services, either to physicians or to patients; for example, access to their lab results, access to pharmacy data, et cetera. By their partnering with PBMs(?), their partnering with lab companies, et cetera, they care a lot about what the standards are for this kind of data communication on the back end. They care about HTML and GABA(?), too, but -- but on the back end, I think they are beginning to worry about this and also, frankly, are wondering just how HIPAA applies to them.
DR. COHN: I think we ought to try to find some people -- but is what?
DR. FITZMAURICE: Duly noted. I think it is --
DR. COHN: Okay. Other thoughts in relationship to this one?
DR. FITZMAURICE: Let me ask how much time do we have for the hearings? Are we talking about a day and a half? Are we talking about a day? There is a tradeoff between having -- you know, filling it up full of hearings and also having time to discuss what do we hear and where do we go from here. But I want to leave some time for that as well.
MR. BLAIR: Would it be possible if we crafted this in a manner similar to the way we did some of the things when we had the CPR work group, where we essentially have our hearings on one day and then the next day we wind up having time to discuss and digest and organize what we have heard?
DR. COHN: I actually have a different suggestion because my concern is that first of all a lot of people, people such as Dr. McDonald, for example, oftentimes will zip in for one day and disappear for the second. Plus, even though we do get smarter after sleeping on the issues, sometimes it makes sense to craft things in ways where we have a chance to talk about them right after.
So, I would say let's set this up in a way that we are hearing from testimony and then later on that day having a chance to reflect on what we have heard and think about it and on the second day maybe hear some testimony and then have a chance to reflect it.
Is that okay with you?
MR. BLAIR: Sure.
DR. COHN: That is just my observation about how things have worked here over the while.
Ted, do you have a comment on that?
DR. SHORTLIFFE: The reason that I like it is that it means that if somebody is here for one day, they hear both the testimony and the discussion and they are not coming just for discussion of things they didn't hear the testimony on.
DR. COHN: That is a good point. I think what you are asking for is making sure that there is time to discuss and digest what is going on, as well as hear testimony.
DR. FITZMAURICE: That is good guidance.
DR. COHN: Other comments on this one? Okay.
As I say, I think for later on this month, I take it we are expecting to see sort of a final set of questions. We will expect that people have already begun to be invited, based on this input. I think we have a general sense of the type of questions we are going to be asking, but I think we will reserve the right to further wordsmith, as well as identify areas that we have missed at the meeting later on this month.
DR. FITZMAURICE: And, again, please send me names and telephone numbers of people that you think fit into these categories that should be approached.
DR. COHN: Okay. Other questions or issues on this one?
DR. SHORTLIFFE: I think it is going to be easier to send you names once we have seen the questions, you know, that we want people to be able to answer. I think that will help trigger suggestions.
DR. FITZMAURICE: Simon, do we have a list serve of the people and the staff around this subcommittee?
DR. COHN: I don't know if we have a list serve, but I think we have an e-mail list.
DR. FITZMAURICE: I will work with Jackie on that then.
DR. COHN: Yes, I think Jackie has everybody's e-mails.
DR. FITZMAURICE: We will make sure that everybody sees everything.
DR. COHN: Great. Okay.
Ted's comment on the list serve is a good idea. I think we actually have a choice. We can -- the technologies sort of work the same way. We can either use the list serve, which, obviously, Dr. Braithwaite is an excellent example of, with his HIPAA list serve or you just have a nice distribution list you send out things to.
DR. SHORTLIFFE: Each of us need to have an up-to-date distribution list; whereas, the list serve becomes a single e-mail address that you know is being maintained centrally. I, for example, might have known about the March meeting if the list serve was used and I was -- I never received any messages about the March meeting.
DR. COHN: Let me check and come up with what makes the most sense on this one. I think we need to balance this one a little bit. We will think about what makes the most sense on this one.
It is almost 11 o'clock and Mr. Scanlon wants to point out -- maybe we should adjourn for a couple of minutes.
MR. SCANLON: The new Secretary, Tommy Thompson, is welcoming and addressing HHS today. You are actually HHS employees today. So, we probably want to go down at about five minutes to 11:00, just for security reasons and other things. It is in the Great Hall.
DR. COHN: It is five minutes to 11:00. So, I think we should adjourn for about a half an hour is what you are thinking and then we will come back about 11:25 to 11:30 and at that point we will do that -- okay.
The next item is our favorite topic, which is the annual report, but we will have a chance to review it later on the month.
[Recess.]
DR. COHN: The topic now is to discuss the fourth annual report to Congress on the implementation of the administrative simplification provisions of HIPAA. We are now, I think, in our -- this is our second version of this particular document. Just to remind everybody what the intent here is, to be a document to help inform Congress and the Secretary of HHS on the status of implementation and issues in relationship to the general area of implementation.
I want to thank Jim Scanlon for his work in terms of helping to draft that. The intent, of course, of this document is is that we will go through this, at least to produce another version that can be reviewed with the full committee late -- at their meeting late in February, hopefully, get final sign-off, get sign-off with changes that can be made between the February and the June meeting so that this can be submitted in a timely fashion to Congress and the Secretary.
So, I think our intent here is to review the executive summary and probably the body of the text at least at some level, to make sure, not so much wordsmithing at this point, but to make sure we have the right issues, have the right tone to the report and to make sure we aren't missing anything or we don't want to in some way reference issues in a different fashion.
Okay? I know some of you have already had a chance to read this and have marked it up like I have. Others may be reviewing it for the first time.
Jim, I guess, my suggestion is is that we start by going through the executive summary and then we can sort of quickly go through the main body of the text. The issue is, once again, do we have the right things in, do things need to be taken out or do other things need to be substituted.
MR. SCANLON: And not wordsmithing so much as are we missing areas and do we not want to continue on a certain path.
DR. COHN: Exactly. I guess I am going to go through -- have you go through this in a way maybe somewhat presuming people at least have some familiarity with this, more on the level of being from header to header, as opposed to necessarily sentence unless somebody has identified that there really does need to be significant changes in those areas.
Is everybody in agreement with that?
Jim, do you want to start?
MR. SCANLON: Okay. Thank you, Simon.
This is the fourth of the annual reports to Congress on administrative simplification and it covers the period of January through December of 2000. The kind of approach that the committee has been taking, as Simon indicated, there is sort of a look back at the year in terms of progress and then a look forward in terms of the issues that the committee sees and may be devoting attention to in the coming year.
So, there is a factual component to this in terms of what actually happened and where are the regs and so on. Then there is a look forward about how is it all moving forward.
You will all recall -- I won't repeat it -- that there is a requirement in HIPAA that the report annually to the Congress on the status of implementation. The exact wording of that charge is encoded in the report.
Let me go right into the executive summary. We begin with a short overview of what the original law required and the role of the NCVHS. That is more or less factual, though.
Obviously, if there any questions or ways we should say it differently or updating, we will certainly take any comments on that.
Let me go right into what progress has there been in the past year on the standards. The first item that we have included is the issuance of the final regulations for privacy of individually identifiable health information. We note that the final rule was issued in December and what the effective date is and what the ultimate compliance date is and we include a note that describes the status of the new administration's regulatory review program, indicating that the reg is at least in general subject to the review. We don't know the outcome of the decision yet on that.
A very brief couple sentences of what the privacy rule actually says. We say nothing further there. In past years, the committee has indicated that while applauding the effort on the proposed rules, there was a much greater desire to have a statute.
Simon and I discussed this and we did not include it in the draft, just because it raises a lot of other issues that may just make matters more complicated.
We then go on to the admin standards, security and the --
MS. TRUDEL: You decided not to include in it the committee's call for --
DR. COHN: This new and to my view more comprehensive final rule, I wasn't clear whether the committee still felt that way or not.
MS. TRUDEL: I guess that is under -- what would have to be under discussion by the -- by the subcommittee first, I guess. That was the position, I know, of the committee when the committee send -- comments on the proposed rule, but now, as you said, we have got another --
DR. COHN: Yes, and I think there was to my mind a little bit of confusion since the final rule includes both people, as well as electronics, which was one of the issues we had. Now, it doesn't, obviously, include comprehensive antidiscrimination policies, but I don't know whether that would make the full committee say, well, gee, therefore, we should not have this or whatever.
MS. GREENBERG: I think the committee had maybe talked about those not being combined in the same legislation anyway. Both of those were needed, privacy and confidentiality legislation and antidiscrimination legislation, not necessarily all --
MR. SCANLON: But some of those have been covered in HIPAA as well. It is up to the committee. I think the committee would also have to consider what the value of such a statement would be and what a strategy would be.
Clearly, there are going to be hearings on the hill, looking at our privacy regulations. Whether there are any new statutes on the Hill regarding privacy is quite another matter. You have to be a little careful, I mean, the committee does, about what exactly it says about the privacy legislation.
But anyway I just note that is one change. We can certainly consider that.
MS. GREENBERG: Because I am just thinking that the 50 year history, I think, still states that, which is if it has been approved by this executive subcommittee --
DR. COHN: Well, maybe, you know -- it all depends on what day you are approving things.
MS. GREENBERG: Yes, I know. I was just thinking of kind of consistency.
DR. COHN: It all depends on what day you are approving things.
MS. GREENBERG: I know. I am just thinking of kind of consistency.
DR. COHN: That is true and maybe we need to -- it hasn't been formally published in book form.
MS. GREENBERG: No. It has to be actually approved at the full committee meeting. I mean, it was basically give -- the executive subcommittee has basically approved it. It needs just a final kind of pro forma vote at the meeting.
I don't know whether you want to raise this or not. I mean, it is --
MR. SCANLON: Yes, but an annual report states what the committee has -- the positions the committee has taken in the past.
MS. GREENBERG: I think that would still be in the history.
MR. SCANLON: It doesn't bind the committee to anything that is happening now.
I would just be cautious about what we say, I mean, what the committee says about privacy because it may be the only framework around and if it looks like this committee doesn't support it, you have to be a little -- I mean, I think you have to look forward to what the options are.
DR. COHN: Jim and I were having some discussions about whether privacy should be the first bullet after the overview or should it be further. I hate to say that is a political decision, but that is a decision probably in some way based on what we see happening with the sort of reevaluation and whether the privacy rule is even part of that.
MR. SCANLON: We will know a little bit more about the status of the regulation and what the Hill may be doing. I think they are planning a hearing on February 8th. So, you know, the committee could weigh those factors in terms of what it wants to do.
Let me go on to the next -- for the next, we talk about progress during the past year on the issuance of -- on the final rules and on the proposed rules. This is more or less just describing the situation.
Thankfully, the final rule on transactions and code sets was published. And we talk about the effective date and the compliance date, as well as the requirements for small plans. More or less, we have updated the figures on savings, cost savings. This comports now with our -- the estimates that were published in the -- I think, in the privacy role.
DR. COHN: I wanted to point out that we bolded the final -- not the final, but the next final paragraph in that area, which I would draw your attention to on page 3.
DR. ZUBELDIA: Jim, the progress on the transaction and code set rule, I think it is significant enough to have its own heading and I would separate that part out from the one that says, "Progress continuing on the adoption of other HIPAA standards."
DR. COHN: Good. Okay.
MS. TRUDEL: I would ask that you consider expanding the sentence that talks about, "The NCVHS is pleased to note that industry attention and energy has turned to implementation." Possibly consider expanding that point to talk about the fact that there is so much volunteer participation in the industry to develop best practices and address implementation issues and possibly to commend that.
Just a suggestion.
DR. COHN: Great. Thank you.
DR. ZUBELDIA: Maybe to submit an industry initiative to create uniform implementation.
MR. SCANLON: Well, in fact, I wonder if we shouldn't have a little heading, Kepa, that actually says "Industry Initiative."
Then we go through the status of the various -- the proposed rules and the final rules and when they are expected. Then, Simon, we used the -- we bolded a statement here about a need to bring them altogether.
DR. COHN: Yes. And let me read this paragraph just to make sure -- Jeff, you haven't seen it since it has been bolded, I don't think.
It says, "The NCVHS reaffirms the importance of the HIPAA administrative simplification initiative and urges the Secretary to expedite the publication of the remaining rules. The full economic benefits of administrative simplification will only be realized when all of the standards are in place and implementation activities and resource planning in the industry will be more effective when the regulatory framework for the entire suite of standards is final."
Now, I am actually going to suggest that that be the final paragraph in that section and that -- once again, I am doing some editing but we have another paragraph here that goes to this language that we repeated ad nauseam around unique health identifiers, which everybody knows is off the plate and I don't know that that -- as an executive summary, I think it is a much stronger ending to a section to have the bolded main point as opposed to, oh, yes, by the way, we want you to know that we aren't touching unique health identifiers, which they -- I don't think they even think about that at this point.
Comments or questions? Is that okay?
MS. GREENBERG: Put the end of the paragraph there and then put this later or remove it?
DR. COHN: Remove it. Leave it in the body.
MS. GREENBERG: Leave it in the body.
MS. TRUDEL: I am sorry. I think there may be one accomplishment that we might want to highlight and that is the signing of the DSMO agreement in March.
MS. GREENBERG: We got that into the body.
DR. COHN: Well, no, actually, it is not actually here at all and it needs to be -- I mean, it sort of mentions our DSMOs, but there is nothing ever about the signing, what this is all about. I think that -- I guess I am sort of looking into this relatively soon. There is a whole area here where we are talking about implementation issues. Maybe it needs to be retitled, but maybe that is where we talk about the WEDI/SNIP, the industry activities, the DSMO formation, all of these things. Maybe it isn't just industry issues, but it is industry activities and all of this stuff.
MS. GREENBERG: It wasn't in the first draft, but on page 16 --
MR. SCANLON: There are a couple of sentences about the effort, but I think you are right.
MS. GREENBERG: -- expanding on that whole section would be good.
DR. COHN: Page 16?
MR. SCANLON: So, this could be under industry, industry initiatives or we could --
DR. COHN: We just have to figure out how we organize that, but -- thank you.
MR. SCANLON: The next heading is the "Standards for Patient Medical Record Information." There are two paragraphs here that describe the requirement and then describe the report itself that was submitted. The only content we include here about the report itself is for the couple sentences that describe the major impediments that the committee identified and then generally refer to recommendations, but there is not a lot of detail. We may want to include, not in the executive summary, but maybe later, the actual recommendations.
DR. COHN: Well, I actually think there needs to be. I thought this was sort of underwhelming personally. I think that my own view is is I was actually going to -- looking towards Jeff and Mike to help us with fashioning something a little stronger only in the sense that I would read through this and I wouldn't have a clue of what the recommendations were.
I might have a sense that there might be some interoperability issues, but I think we need to come up with something that isn't in pages here in the executive summary, but something that really points out what the issues are since that is one of the new things that happened this year was the development of those recommendations and maybe the fact that we are going to be moving forward and all of this stuff.
I know that Jeff has already gone on vacation. Hopefully, we can have your help in terms of coming up with something to strengthen this.
MR. SCANLON: However, you want to expand that or rewrite it, I think we would be very open. This was more factual than anything. We might want to even include the recommendations in the body of the report in the major thematic areas.
DR. COHN: We thought that there needed to be an extended area in the body that began to look very much like the final -- like the executive summary from the PMRI standards, but just somehow we need to condense it even further into something that is manageable, but makes the point.
Agreeable? Okay.
MR. SCANLON: The next heading deals with continuing consultation and implementation effort. It just describes sort of the process that the committee and HHS is using in moving to the next stages. It is kind of a generic -- there is nothing specific to the past year, I don't think, other than updating the general process.
MS. GREENBERG: This might be a place you want to mention the DSMOs, two of which are already here, as part of this group and then the others.
MR. SCANLON: We could use a little paragraph on the DSMO process.
The next section actually is sort of looking ahead and discusses a number of implementation issues that the committee has already begun to identify. They have come from hearings. They have come from letters and recommendations and we may even want to be -- as a result of the past two days, we may even have more that we may want to include here.
DR. COHN: I think we need to think about this one. In my version, in the second paragraph where it said based on public hearings conducted on a date, I got rid of those dates. Basically, I think that this needs to be viewed as all of the issues that we have identified this year, beyond January -- July 13th or 14th or at our digital signature hearings or earlier hearings in the year. This is just sort of a report of the implementation issues we have identified, as well as, I think, our recommendations related to mitigating those issues.
So, for example, we have electronic signature down here as one of the areas and I think people need to look through to make sure that they adequately reflect what it is we sort of thought. They probably also aren't quite strong enough at this point. I think that is more of a wordsmithing.
Comments?
MR. SCANLON: Now, the other issue is if the committee would want to say anything more about the data gap issue than came up yesterday in terms of complying with the standards or where do we -- this issue that we heard from --
DR. COHN: That is a good question. There are a couple of things that have come up since January 1st. I mean, the data issue is only related in a sentence here, where is says, "The committee also is concerned that vendors or provider systems have products that cannot produce HIPAA standard transaction messages." That is as close as we get to it. We have said in letters that there was an issue that we were going to further identify.
Now, we also -- so, we could include some of the issues that we have identified here as well, work from Helene Golfoy(?) and others to begin to identify that there were some data gaps. We also have a letter, which we actually haven't discussed in these two days of hearings in response to our letter of July 13th and 14th from HCFA?
MS. TRUDEL: From HHS.
DR. COHN: But I guess the question gets to be is how much of this do we want to include in there? I guess I would look to the committee -- the subcommittee because we had some responses, some of which I think are adequate and some of which I don't think are.
DR. FITZMAURICE: When was the letter sent? Is that something for this year's accomplishments, as opposed to last year's accomplishments?
MS. GREENBERG: The subcommittee sent its letter like in September, but the response --
DR. COHN: It was January 29th, 2001.
DR. FITZMAURICE: So, there is some leeway into how we build it this year versus last year. The annual report that we are working on now versus the annual report for next year.
DR. ZUBELDIA: But we started identifying these last year with Helene's testimony and all that.
DR. FITZMAURICE: I am just talking about do we want to put in the Department's response and then comments on that? I just don't know where it ends.
DR. COHN: Well, that is the question. The Department has responded. I think many of you probably looked -- I think it is in your packet to review. I thought some of the responses were adequate. I thought some of the responses probably deserve an additional letter. The question is is do we want to get -- when do we want to get in that conversation.
What? You don't think that is appropriate for an annual report?
MS. GREENBERG: Not really. I think it is appropriate for you to look at the -- obviously, look at the response and then see from, you know, what else would you want to carry forward from that, but I -- even if that were to included in the annual report, it would probably be for next year's report. Then you are getting into February, March --
DR. ZUBELDIA: I would take this part out on the vendors and provider systems have products that cannot produce data and make that another heading also.
MS. GREENBERG: Where is this?
DR. ZUBELDIA: Second paragraph on page 5. This is because of the unavailability of the data in the electronic format and make that a separate topic.
MR. SCANLON: The first of these issues in the list -- there is about half a dozen issues -- is HHS resources in promoting industry, HIPAA implementation. Second was the committee was indicating that there were testifiers and other sources of industry information over the past year that indicated the need, obviously, for funding to actually deploy and implement the national identifier.
The third major heading was testing in compliance with HIPAA standards and I guess the new heading would be what Kepa suggested, which would be the data, the data gap, however we want to call it, the data gap issue.
The next paragraph deals with the concern about the progress on the electronics. It is pretty standard.
DR. COHN: Electronic signature standards?
MR. SCANLON: Electronic signature standards. The middle of page 5. Again, you may want to take a look at the exact wording. I think we described where in terms of the regulation it stands, but -- and we sort of concluded that there were still not -- in a way that HHS was looking to adopt -- could only adopt consensus industry standard and we were not at that point yet.
DR. COHN: Kepa, I would have you look at this paragraph to make sure -- it is sort of the view that I have articulated to others, which is we held hearings, identified there was an issue and need, but no industry consensus. So, we are trying to push forward with industry consensus.
MR. SCANLON: I think it is perfect. I wouldn't change anything.
The next two issues related to, again, as a result of the hearing on implementation, a set of issues related to code set standards that the committee heard and secondly relating to externally maintained codes, as well. Much of this language is summarized from the committee's letter to HHS, but it may be too much. It may be too little.
DR. COHN: What is even more complex, I think, as Karen mentioned, which we are all aware of, which I think occurred under BIPPA(?), I believe -- is that where it came out, under BIPPA?
But at least the local codes were HCFA local codes, Level 3 codes have been given an extra year of life. We somehow need to observe that in this, as well as noting that that does not apply to industry, usage of their own non-standard code.
That is probably something that does --
MR. SCANLON: Okay. So, we need -- Karen, you will give us some better wording and --
DR. COHN: -- in her letter.
MR. SCANLON: We just use what is in the letter.
Those were the main issues that we identified for implementation.
DR. COHN: I guess the question is is what are we missing in terms of general issues?
Suzie.
MS. BEBEE: When I read the PMRI information, it sounded as though it was done, no more activity. Then when I looked to the body and progress to date, I don't see anything additional about PMRI. There is 18 months worth of activity that is continuing. Should we, maybe from Mike and Jeff add something in that area.
DR. COHN: We were sort of asking them to come up with something that is suitable, as well as probably putting much of the executive summary in the body of the text. I agree with you about that.
Now, I guess the question is -- one of the things that I was sort of trying to figure out in terms of the privacy piece is should we be referring that to the Subcommittee on Privacy and Confidentiality for their review. I mean, I am sort of struck that unfortunately we are dealing with sort of an interim chair, development of work plan. I know most of the effort is now trying just to figure out what the privacy reg is, most of us in the industry, of course.
MS. GREENBERG: Well, at the February meeting, we are going to have an acting interim chair because Richard Harding is not going to be there. So, Mark Rothstein is going to be chairing the working session of the subcommittee.
DR. COHN: So, it may not be appropriate for us to look too hard at them to help us with what we need to be seeing here about privacy at this point.
MR. SCANLON: It may be a full committee issue anyway because I think it really is --
MS. GREENBERG: This is something that they have ahead of them really, but I don't think they have had much
-- you know, they are going to be talking about it later in the month.
DR. COHN: It is hard to try to remember what happened in the last year. I think we just sort of need to sort of remind ourselves if there is anything else and we ought to look through the minutes and all of that to see if there is anything else that occurred during one of our hearings or otherwise that needs to be reflected in this. But I think we have pretty much gotten the issues and I think that that bulleting -- earlier in the year we did sort of make much noise. We sent some correspondence to the Secretary of HHS asking for expedite publication of the first rule.
That doesn't appear to be something that we need to reference, other than the fact that we want really everything published. Once again, it goes along with all the other comments that we make.
MR. SCANLON: But actually, Simon, you raised the point in the transmittal letter, I think, the idea of the importance of moving forward with the remainder of the standards. That is in the second paragraph, the importance of continuing and moving forward and getting the whole sweep of that.
DR. COHN: Good. Everybody is sort of nodding their heads. At least we are on the right planet here.
MR. SCANLON: I can go quickly. I think you have seen a lot of this before. This is the detail pretty much on each of the sections and, obviously, we are open, I think, to updating and refreshing or even deleting things we no longer need or relegating them to an appendix. But on the other hand, people seem to always ask whenever we think something has become a second tier issue, they keep calling. Well, what about the identifier.
So, in a way, this is the reference where we could at least say this is where everything stood. So, at any rate, just a bit of updating on the background, the purpose of the report and the basic content of the report, other than it is more or less just updated a bit.
DR. COHN: I actually do want to just bring up for the subcommittee a question. Maybe an unfortunate error of actually quoting the law. I actually have it on my computer and I look at it frequently.
I was looking under his version of 263 in terms of what this report should be as included under "E," the extent to which timetables under such part are being met. Obviously, we have been alive in terms of not mentioning that. The question is is did we want to -- I mean, we could sort of comment but I am not sure at this point that it makes a whole lot of --
DR. BRAITHWAITE: Only three years behind, you mean?
DR. COHN: That is it. That is really what I was -- I don't know what that does --
MR. SCANLON: I think it still needs to be said, but, I don't know, do we want to --
MS. GREENBERG: I think last year when none of the final rules were out, you did make a fairly --
DR. COHN: That was in the transmittal letter, I think, that we made that point.
MS. GREENBERG: I think it was in here, too. It initially wasn't, but it was added.
MR. SCANLON: Because we were very concerned that, you know, so many years had passed without -- we were losing momentum.
DR. COHN: Well, I guess the question is is I mean, we can -- I mean, I am looking at everybody for some direction on this one because I -- I mean, the way I approached it was a strong statement that we needed to expedite publication. We can also add to that sentence we are three years late already or we could put that in the transmittal letter or we are multiple years late and the way we are going we can get later.
MR. SCANLON: Even being three years late, it sounds like the industry still would like a little more time. So, I am not sure we need to beat a --
DR. BRAITHWAITE: But it makes the point that in fact it is worthwhile to say the law was first written in 1994, was passed in 1996, both rules in 1998. Our rule started in 2000. I mean, this is an ongoing thing that has been going on for a long time and we think it ought to be moving as fast as possible. Maybe just as a bit of a counter to the pressure to put it off some more because we don't want to do anything for awhile.
DR. COHN: Well, maybe that is a -- I am sort of looking to see where that might fit and that might be -- maybe that is a paragraph that occurs below that -- in the executive summary where we somehow make a note of the history of all of this.
MR. SCANLON: Or even towards the end in the conclusions --
DR. COHN: Or at the end, rather than --
MR. SCANLON: Although, again, I don't know if you want to end on a negative note. I mean, it is -- sometimes the executive summary is all that anyone reads. What conclusion do we want to leave people with? We often said that the reason some of these things took so long was because of the extensive consultation with the industry. We added two years probably to do a good job there and then -- and we needed some rationale because we were so late.
DR. COHN: -- enough staff and enough help. It is amazing how long things -- I actually don't think that that is the final conclusion. I think it probably something that is in the executive summary, but this is an ongoing process. It is almost maybe despite the fact that this has taken so long and we want to reaffirm the processes.
Jeff, did you have a comment?
MR. BLAIR: Maybe since we are looking for a positive phrase to end this on that would blend in with the other points that we are making in terms of the fact that, you know, we might be able to move faster with additional resources and all of the other points that you would be making, maybe the final point we could make is despite the fact that it was a struggle to get the two final rules out, when we do look at the health care industry, we find that implementation of HIPAA regulations right now is often considered their No. 1 objective for this next year or two.
I am saying that from the standpoint -- and I don't know if you need survey data or anything else to substantiate that, but if you wind up looking at the industry conferences or if you look at the newsletters or the publications, at this particular stage, implementation of HIPAA regulations appears to be in many cases the No. 1 priority Internet he industry.
So, it is having a positive effect, even if it is not moving as fast as we would like it to.
MR. SCANLON: It is sort of although this happened in the past, the committee is gratified to note that after Y2K and all these other things that HIPAA is probably the highest priority, what you said, Jeff. That is actually a nice way to say it.
DR. COHN: Probably that is, once again, not a concluding sentence, but --
MR. BLAIR: Just above the implementation issues, before that.
DR. COHN: I am just sort of thinking that somehow with a little bit of history, noting it is the No. 1 objective and then basically reinforcing the importance of expediting -- Marjorie and then Karen.
MS. GREENBERG: I was thinking about the privacy
-- the treatment of the privacy regulation and in a sense by taking out -- which is fine -- I mean, taking out the thing about the legislation, you are also taking out any kind of
-- I think, although it may be elsewhere -- strong statement about privacy and the importance of it. You might want to say something, I mean, supportive of the fact that this basically sort of reports that the regs came out, but that was kind of a prerequisite for moving ahead with all the other parts of HIPAA because we know that there are groups that are now going to want to roll it back or say that it has, you know, gone too far.
Without getting into specifics, as the committee hasn't really studied it, but something kind of supportive of the fact that, you know, this is a good foundation now to be able to really move ahead and not only with the electronic transactions, but also with the PMRI and everything else.
DR. ZUBELDIA: I like the concept of a good foundation. I like to stay away from prerequisite --
MS. GREENBERG: All right. Well, I was just talking literally, you know, without thinking -- I mean, I am not tied to prerequisite, but something kind of supportive of it, I think, would be -- if -- I mean, I think is the way the committee feels. I mean, it certainly has been always in the past.
In a sense, that is why I assume why it went first, even though chronologically it came afterwards and would probably be supportive.
MR. SCANLON: It would help to actually -- I mean, you know, usually we say what the status is and then there is a little statement, sort of an interpretation of how this committee feels about it and maybe that would be a way of --
DR. COHN: I think even in the executive summary, we need to make a sentence or two saying -- you know, talking about the fact that it is a foundation to the other standards. Because I agree with you that is -- rather than just saying it is there, try to explain the rationale briefly is, I think, sort of the key feature of saying -- of course, we all talk about how we are going to start seeing things electronically. You need a foundation, security and privacy laws to keep this stuff safe and secure.
MR. SCANLON: We just have to be careful that we don't end up using the committee's words against the whole effort and we will have to say it in a way -- if you say that is a foundation or a prerequisite and something happens with the privacy reg, you are basically making the case that we shouldn't go further with any of HIPAA.
So, you have to be a little careful how closely you link -- how you characterize things. I mean, all of us do. I mean, there were actually concerns that all of HCFA would be derailed. They couldn't get agreement on privacy and --
DR. ZUBELDIA: That is a great concern now in the industry that if the privacy is postponed for another two months and it is not out, what is going to happen to the transactions. That is a great concern.
MR. SCANLON: It is really a matter of how we say this.
DR. COHN: What do we want to say about that, Kepa?
DR. ZUBELDIA: I like to stay away from prerequisite but say that it is a foundation that lays a foundation for all of the HIPAA standards and all of the HIPAA requirements to be based on a foundation of privacy.
DR. COHN: We can look at the next version and see what --
MS. GREENBERG: I think, there needs to be something here, but I would defer to those of you closer to what is the right way to say it.
DR. COHN: Karen had another issue.
MS. TRUDEL: It just occurs to me as I look through this that there isn't any place in this report that summarizes at a very high level industry responses, industry feelings, feedback at a general level. And is there a need to do that in this report?
MS. GREENBERG: I can't hear you, Karen.
MS. TRUDEL: There is nothing in here that talks about industry responses in general at a high level. It talks about some very specific issues, but, for instance, there is nothing that talks about what the industry response to privacy or to the transactions or to all of this as a whole.
DR. ZUBELDIA: And it may be good to say that the industry in general is very supportive of the transaction goal and is forging ahead with strategic implementation plan to coordinate the implementation of the transaction codes for the entire industry. I think that is something positive that we have to say.
MR. BLAIR: I think we are agreeing here through the paragraph on industry in the executive summary on industry response and initiatives.
MS. TRUDEL: I would suggest adding to that a statement similar to, you know, while they are supported, there are concerns about being able to complete all the work in the time frame. There is an understanding that there is a very significant amount of work load and there are some concerns about enforcement.
MR. BLAIR: I think we all wind up tending to abbreviate things because we are familiar with them, but I would encourage the committee to -- especially in this report, is to be careful to refer to the first rule as the financial and administrative transactions, not just transactions because I don't want to give the impression that those are all of the transactions that we are considering, you know, because we will down the road, hopefully, be looking at some clinical transactions.
The other piece is that with respect to industry reaction, in terms of maybe a reference where we can quote industry reactions, it might be the annual HMSIS(?) leadership survey. I think that we might be able to find some things in that. The other reason that I mention that particular survey is that I think we will also be able to find in that survey the industry priorities for implementation, which may also support our statement that it is if not the No. 1 priority, then a very high priority for the industry for the next couple of years.
DR. COHN: The timing is such that we probably need to get it. The next time we see Jeff will be actually at the NCVHS meeting.
MR. BLAIR: I can get it to you on the 9th or the 13th of this month.
DR. BRAITHWAITE: We can roll it into a revision for the --
MR. BLAIR: If I get it to you by the 13th, will that be okay?
DR. COHN: You probably could call HMSIS directly in Chicago. That is where their headquarters are and they might be able to just send it e-mail.
[Multiple discussions.]
DR. BRAITHWAITE: Industry reaction to the privacy rule -- obviously, since it only was published on the 28th of the year we are reporting on, we probably can't say much about that.
DR. COHN: That is a good point. I am beginning to get worried that -- I know Jim Scanlon does other things here than help us write the report. I know. Obviously, we want to bound this activity so we can actually get it done, but probably talking about the initial implementation --
Other comments or response here. Marjorie, did you have a comment?
MS. GREENBERG: I had provided comments earlier.
DR. ZUBELDIA: I would like to make sure that whatever the change in the executive summary is also reflected in the main body.
MR. SCANLON: In reference to that, I guess, rather than go through each section, Simon, maybe we should -- we have provided a lot more detail, I think, in the final -- implementation issues, page 22, there is more detail relating to some of these things. There may be too much detail relating to the code sets.
We may there want to cut back. If you would take a look -- we pretty much included -- we included the whole letter from the committee in terms of the code set issues, the local codes, the externally maintained codes, as -- in the implementation issue section of the full report, not in the executive summary. If folks would take a look at that
-- it may be too much. It needs to be updated, Karen, with what we in our response to the committee -- what we said about HCPCS and other things.
It literally includes all of the issues and the detail that the committee described in the letter, maybe too much.
MS. GREENBERG: Well, if this is what the committee said, I don't know that it needs to be updated because we weren't going to really include the response, unless there were some errors in what was said.
DR. COHN: I do think we need to note that under the GPRA rule -- I mean, just like we did the executive summary. That is really what the question is. Are we going to take a response for the HHS and include this? I think we decided that probably it was a -- I guess we need to each of us review the response from HHS and see if based on that there are some particular comments that we want to make.
I mean, generally I thought that the HHS response was well thought out and reasonable, but I did think that there were one or two issues that I reviewed and sort of thought that this was not really a satisfactory response.
DR. ZUBELDIA: But we just got the response. It wouldn't be in last year's report.
DR. COHN: That is right. But it gets to be problematic in making all these cases without a -- sort of leaving them hanging there. You are probably right. It probably makes sense for us just to leave it alone.
DR. ZUBELDIA: At least make sure that we don't contradict ourselves, if nothing else. Right?
MR. SCANLON: Let me just -- in the body of the report, we did update on the Section E on page 17, "Outreach to Public Health and Health Services Research." Marjorie updated on the Public Health Data Consortium. You may want to take a look at that as well.
DR. COHN: Of course, as we have commented, Michael and Jeff, we think that there needs to be a fairly significant expansion to the PMRI piece to make it a look a lot more like the executive summary in the PMRI report because I think we have to assume that these people have probably never seen the PMRI report and wouldn't know it if they had.
DR. FITZMAURICE: Put that in the body as well as the executive summary.
MR. BLAIR: Yes. In fact, we have more leeway in the body.
DR. COHN: What we want in the executive summary is sort of -- it will be a relatively confined bulleted -- these are the issues. These are sort of the main recommendations. You recognize those remarks. but here we have the luxury of really expanding, further explaining, something much more like the executive summary, which as we know was a couple of pages long.
DR. ZUBELDIA: Do we have anything in here for the vision for the 21st Century statistics and the NHII? Those draft reports were released in the summer.
MR. SCANLON: We didn't more or less because of the -- this was more of HIPAA and those are broader.
DR. COHN: I think the question, though -- NHII work, but unfortunately there are only so many hours in the day and I actually do have a day job. So, it causes me to not do everything, but I think the only question I would have is is there anything that is of relevance to HIPAA? If there is, then we should --
DR. ZUBELDIA: Maybe when you are talking about the PMRI, you say that not directly related to HIPAA but there was a report on the NHII that was released that provides a view of the future or a perspective that could influence the HIPAA decisions.
DR. COHN: Was that actually a formal release or was it a draft?
DR. ZUBELDIA: It was a draft release, an interim report. But it is being --
MS. GREENBERG: Rolled out at the 50th anniversary and --
DR. ZUBELDIA: Broadly circulated. It is on the web site and it is circulated everywhere.
DR. COHN: Okay. Maybe we can ask Mike and Jeff to -- if there is a sentence or two that could be connecting that.
MR. SCANLON: It could be more of a thematic sentence that says in addition to the HIPAA specific kinds of issues, the committee continues to focus on broader NHII issues.
Again, in the body of the report, progress to date, we go through each of the standards and talk about where it is. Should we leave the unique health identifier status in there?
DR. COHN: Yes. I think there is where -- I think that is the place you stick it in.
MR. SCANLON: Standards for security and electronic signatures, we hear talk about --
MS. BEBEE: I have a question about the code set part. Just for clarity for me. Was this the January 29th letter?
DR. COHN: This is what the January 29th letter responded to.
MS. BEBEE: For 2001? So, I was just saying the same type of thing, I think, about the privacy where that was released the end of the year and are we bringing January information into a 2000 report?
DR. COHN: No. Actually, this -- what is indicated is basically what we sent in July.
[Multiple discussions.]
I mean, from the July hearings.
MS. GREENBERG: The answer just came.
MR. SCANLON: There was an update of outreach and education. Though, there is not a whole lot added to that part. I think we do want to add here the DSMO web site.
DR. COHN: And industry response. I mean, it is briefly in the executive summary, but we need a little more here. There may be something from the -- if they had something that we could pull out, that would be very useful.
MR. SCANLON: How much in the industry response do we want to actually -- it is one thing to say that the industry has done these things and that it is now the No. 1 priority or one of the top three priorities for IT and health care.
How far do we want to go in terms of issues that have been raised about --
DR. COHN: There is the industry response and industry issues. I am not sure in any of the hearings I have heard commenting about that. The response, I think, can be dealt with in terms separate from the money part but the issues -- you are right. The question gets to be a money thing if you want to raise that issue.
MR. SCANLON: Do we have enough evidence at any rate that it is an issue? We have what we heard yesterday.
MS. TRUDEL: I think what we know is that there is a wide variety and I think we can try to summarize some of that. One example would be just awareness. We know that large providers, plans, vendors, many of them are aware and are actively building HIPAA infrastructures. When I go to meetings now and I see people sign in, a lot of their titles say things like HIPAA compliance officer or HIPAA project manager. But what we are hearing, just anecdotally is that we need to do more work with the small providers and they are not really aware of what they need to do.
I think just something that shows the fact that there is a wide variety of responses at a real high level would be helpful. I can send you some language.
MR. SCANLON: Well, there is the issue of awareness and then it was like Y2K. Awareness was the first issue and then there was some actually education and actually movement forward. I just don't know how much we want to raise about cost estimates and budget issues. I don't think we actually have a solid balanced assessment yet of that.
DR. COHN: I think that issue is going to really come to the floor as we move to privacy. Administrative financial transactions and implementations cost a lot less. That is the benefit of the cost benefit equation on all of this stuff. The benefit is EDI. The cost is good privacy and security.
DR. COHN: I guess that is sort of my thought on it.
MR. BLAIR: Let me ask this question. I think we can anticipate not only is there a concern about cost and time frames and resources on the privacy regs, but when the security regs come out, there will be an additional wave of concerns. I am wondering if this document is the appropriate place or not to kind of include an executive heads up for Health and Human Services to -- it is actually going to Congress, isn't it? Is that correct?
DR. COHN: Yes.
MR. BLAIR: For Congress to expect these concerns to be voiced and for us to put those concerns in a little bit of a perspective about overall industry support and reaction for these, that we do have to address those concerns, but they are in the context of help us address it, help us get through this transition, but the main objective and purpose of the administrative simplification provisions is widely supported, something like that.
I can't see expressions, so I don't know whether people were --
MR. SCANLON: Well, the other thing is I am not sure that the NCVHS can say anything about yet. We haven't had -- when you say that we have learned from testifiers or whatever that this is the case, it is based on hearings or it is based on something we can point to, I think on the privacy area and even on the security area, we haven't -- we don't know yet. I mean, the committee doesn't. The committee hasn't had any hearings related to the implementation issues, privacy or security -- a little bit on security, I suppose, but -- and even only very recently on the transactions themselves.
Here, this is very preliminary information we are hearing. So, it may or may not hold up. So, at any rate, it is finding specific words to say that won't later come back to haunt you. When you are pointing out potential problems, you have to be careful that they don't become ammunition for not proceeding.
MR. BLAIR: My only thought was for us to wind up -- I sort of feel it might be to our benefit if we indicate some of the issues that we have heard raised but put that in the context of the overall acceptance for the direction of HIPAA. That is all.
MR. SCANLON: Well, we haven't heard anything about privacy and we haven't heard anything about security or other -- or identifiers. All we have heard about is a couple of issues related to a detailed look -- a beginning detailed look at the transactions. So, I just don't know.
Obviously, it takes -- I think Congress understood this was going to take additional resources and funding. I mean, presumably, it is just like Y2K and it is like any progress, the NIT(?). At any rate, we will -- whatever, Simon. The only thing we have to be careful of is when we say something in the reports of the NCVHS, they are often used by others to argue a case. You don't want to necessarily inadvertently give ammunition to undermining the effort when, in fact, it is not clear or it is a little more open or there is nothing specific to point to anyway, other than -- and we could say we will be holding hearings on some of these issues as understanding of the requirements.
DR. COHN: I think we probably need to do that as it is certainly -- I mean, you can make an observation that due to the fact that the privacy reg was only released on the 28th. But we can't make comments about we expect to hold hearings and identify implementation issues and barriers. At the time the security regulation is finalized and published, there will be similar oversight on that.
As I said, I mean, it may be -- I don't think the privacy subcommittee has any other views on this one. We can certainly ask them and maybe will ask them for their input on all of this stuff. They may have a slightly different view, have something more that they can point to. But I, having sat in on most of those meetings, I don't believe that there is anything that --
MR. SCANLON: I don't recall that they have -- I think there was a general plan to -- depending on what the status of the privacy reg would be, to actually plan some hearings on what the impact would be. It could have been the reg in general or it could have been specific areas, but I think they were holding off to see, you know, what transpires.
MS. GREENBERG: They discussed that on their conference call but they are going to -- they will be discussing that in February.
MR. SCANLON: But I think we could certainly add a couple of sentences and indicate that the committee is planning to hold hearings to assess the potential impact of the privacy and security and so on. It would be looking forward.
DR. COHN: Is there anything else on this for the moment? I mean, we are getting around 1 o'clock. I want to talk a little bit about the March breakout
MS. GREENBERG: February breakout.
DR. COHN: We have had so many meetings scheduled that it is hard to keep it straight.
Obviously, I think, what is going to happen, Jim, is you are going to come up with another version of this. What would be the desire of the subcommittee on that? What can happen is if he does something, I will review it and then you get it out to the full committee or we could have everybody review it a final time. What would be your preference. Good idea to review it. Okay. I am happy to do that, but I just wanted to check.
MR. SCANLON: In the agenda book or e-mails.
DR. COHN: No, no. I think the agenda book -- people need enough time to read it and it is not appropriate to send it out the weekend before the full meeting.
MS. GREENBERG: I think we are going to be wanting to mail those by the 14th.
DR. COHN: The 14th is -- so, what that means, Michael and Jeff, is as you can help, recognizing I know you are going to be at HMSIS, is that we need some parts for the PMRI.
MR. BLAIR: I will get it done.
DR. COHN: You need to get it done so you can get it to Jim, so he can fold it in and I will try to do a day or two day turnaround so that we can get this back and out. The 14th is the right date? So, you have that in e-mail for printing on the 14th we will be all set.
MS. GREENBERG: Well, actually, if we want to mail the agenda books on the 14th, we would really like to have it by the 12th. 13th at the latest.
MR. SCANLON: We will send what we have at that point.
DR. COHN: Jim, I don't understand what you are saying.
MR. SCANLON: I am saying if our deadline is the 13th, we will have a redraft by then, but if we haven't gotten some material, we will have to add it later. Otherwise, you are holding up the full committee.
MR. BLAIR: I figured that it will be the 12th or 13th by the time I will be able to get the material to Jim. If it could be at least the end of the day on the 13th.
DR. COHN: I think that is what we are saying.
MR. BLAIR: Okay.
DR. COHN: Now, did you have a comment before I go into the agenda for February? This is just beginning to --
MS. GREENBERG: If we don't get this mailing out on the 14th, although it is supposed to be the next day -- sometimes it takes two days. If people don't get it by Friday, the following Monday is a holiday so people aren't getting their materials then until Tuesday when they are already starting to travel to the meeting or something. So, we really do need to mail this stuff on the 14th.
DR. COHN: Agreed.
Now, let's talk about February, February breakout, is what we are going to be dealing with. Now, I think we heard yesterday and I think we are all in agreement that be reviewing sort of the status and implementation with the work that we had talked about yesterday in terms of getting -- having the DSMOs and a representative from X12 return to us to give us an idea of what is going on with all of these changes and modifications and all of this to the X12 standards.
I know that Karen has been moaning a little bit about the issues regarding to our ability to make those changes and how we can best expedite and maybe at that point we will have some further legal opinions that may advise us and assist us in that. But it is really sort of a check in time in sort of understanding where they all are.
At the same time, I think we can also ask the X12 representative to clarify for us the level of participation in relationship to digital and electronic signature efforts that are being worked on by the other SDOs since we would observe that there was no one here yesterday to give us a report on their degree of commitment to that process.
So, that is No. 1. No. 2 is our favorite topic, which is the annual report and whatever the full committee has talked about or otherwise decided earlier in that day. I think we will be expecting Mike Fitzmaurice and Jeff Blair to come back to us with a version of questions, as well as potential speakers for the March hearings related to PMRI.
I think at that point we also need to be talking a little bit about the letter received from HHS sent to John Lumpkin in relationship to our letter of September, to see if we have any further response or comments or otherwise in relationship to that.
As you all know, I have sort of a list of available dates for hearings in April and May/June. I think before that you will always get an e-mail with a date to hold. I think at that point we will be talking a little more about what and if we will do on both of those dates.
I am sure we will do at least one of the dates. Whether or not we do two of the dates needs to be decided and hopefully it will be a little clearer between now and then.
DR. FITZMAURICE: Are you talking about the hearings on PMRI?
DR. COHN: No. PMRI is already scheduled. I am talking about additional hearings between the February hearing -- the February full committee meeting and the June full committee meeting.
MS. GREENBERG: You mean the March PMRI meeting and the June full committee meeting.
DR. COHN: Thank you. Yes.
We will also, time permitting, have a discussion on code sets strategies since one of my action items -- I decided to keep an action list -- is developing a work plan for 2001 in the area related to code set issues. Now, our response to this may be there isn't enough time and that may be a legitimate response, but we at least need to discuss it and see what and if we need to do anything about that.
I don't know the answer to that one, but it is an issue of time and energy, et cetera. It is an open discussion. I will come prepared to present some thoughts and we can further refine them. I suspect this is something that Marjorie may want to assist in terms of developing a work plan in relationship to that.
There are actually two different issues. Let me just make sure that we are all aware. One of them is the subcommittee agenda, but we have also asked to develop the full committee agenda and strategy around code sets for the year 2001.
So, we need to come back with a strategy. Okay?
Anything else? And there is not a lot of -- I think that is going to handle that and then some for the breakout.
MS. GREENBERG: Yesterday, did the subcommittee agree to write a letter?
DR. COHN: Oh, thank you. Yes. Letters. I actually have responses to HHS, but I had the wrong response. A letter to Secretary --
MS. GREENBERG: Is that is something that we wanted to bring to the full committee, get the full committee's approval in February?
DR. COHN: Yes. I think we also wanted to draft a letter potentially expressing our pleasure with the fact that they are working together on electronics standards. It was a little bit -- from the full committee to the SDOs and DSMO.
MS. GREENBERG: Well, you could do that from the subcommittee probably.
What was the letter to the Secretary?
DR. COHN: It was on NDC.
MS. GREENBERG: Oh, right. Okay. So, is that something that we need on the agenda on --
DR. COHN: That is an action item.
MS. GREENBERG: Full committee, yes. So, that -- presumably we will try to get that -- maybe when you present the HIPAA report, you also produce that letter.
DR. COHN: That will be the next step. Sure. Yes.
MS. GREENBERG: But we need to add that.
DR. COHN: I think that we had actually put a place holder for a digital signature letter in that and I think it turns out that there is not an action item related to digital signature unless we decide that we want this letter expressing appreciation of the SDOs working together needs to be from the full committee or the subcommittee. We could probably do both or one, depending on what we get.
I agree with Karen that there is a little confusion in my mind about whether we are waiting for HISB to let us know, but I am not sure --
MS. GREENBERG: Weren't we waiting to find out from Kepa whether X12 is really on board?
DR. COHN: Yes, because it would change the nature of that letter. That is right. But I think he will be able to let us know about that next week.
DR. ZUBELDIA: I will let you know as soon as I know next week.
DR. COHN: It will just change the tone of the letter a little bit.
MS. GREENBERG: On these letters, I mean, I think you can -- they don't have to go in the agenda book. I mean, provided that they are not five page letters, they can be -- we can have them to people at the meeting.
DR. ZUBELDIA: I am thinking it will be just a one or two paragraph letter, something very simple.
MS. GREENBERG: On the digital signature?
DR. ZUBELDIA: On the digital signature.
MS. GREENBERG: But then on the NDC, that will be longer. But it is not going to be that long.
DR. COHN: Okay. Well, you know, it is interesting, I was wondering what we were going to talk about during our breakout later on in February. I was actually worried about a couple of days ago. I can't think of any reason why I should have ever been worried about that.
With that, why don't we adjourn the meeting.
[Whereupon, at 1:20 p.m., the meeting was concluded.]