[This Transcript is Unedited]

STANDARD & SECURITY – June 20, 2007

Room D – Breakout

MR. REYNOLDS: Do you have the letter? When we say we are going to edit it, are you passing something out?

MS. BENNING:: What letter?


MS. BENNING: No, I just got handed the version that Karen and Justine had recommended.

MR. REYNOLDS: Well then good, we don’t need to …

MS. GREENBERG: When did Justine have a chance to prepare a new version?

MR. REYNOLDS: No, she didn’t prepare a new version. They prepared it, I reviewed it, and then they had Justine look at it.

MS. GREENBERG: During this meeting?

MR. REYNOLDS: Yes, oh we were moving. Hey we got nothing to do here, we got to move. They were out there doing it, then they stopped me – so the point was, I think first thing in the morning won’t be any problem with having a revised letter. We were pretty much able to take one section out – I think they did a great job with that.

So, we have a number of things to cover. We want to cover the NPI letter, any NPI feedback, we will talk about the streamlining we just went through. We want to talk about the 5010 issues in preparation for the July meeting.

Side conversation [“Do we have a quorum?”

“We still don’t have a quorum, but it’s Okay.”

“Three out of six is a quorum?”}

“Three of our members are missing”

MR. REYNOLDS: Simon, we just give a quick update that we will have the NPI letter in the morning, we pretty ell have it done already. Karen and Denise worked on it, I’ve reviewed it, and Justine reviewed. We don’t have anything to pass out, but it was more pulling some stuff out, restructuring, not adding, anything. Is that a fair statement?

If we could just spend a few minutes talking

about the streamlining. Then we want to talk about the 5010 in preparation for the July hearing and we can talk about what we’ve done and what we’ve sent to WEDI what we’ve sent out to others and what we’re going to be sending, as far as them answering, covering different things.

Then I wanted to just spend a minute as to whether or not there were any things that we could hear from this committee that we would want to make sure that we consider as we do the secondary uses. And if there’s anything out of standards or anything like that that would be a subject or situation that anyone would want to consider, I’m not saying there is, but part our effort as we’re going forward is to at least see if there were any subjects or situations anybody wanted to talk about.

And then, just briefly talk about some things past the July hearings as we get there, we may have to take up claims attachments, ICD-10, whether or not after the way NPI occurred again, whether or not we need to do anything else on continuing to improve this process of implementation. You know we did the lessons learned out of HIPAA and the industry didn’t appear to learn a whole lot about grouping up because NPI, which may be the easiest of the ones we’re going to do didn’t really finish on time and we had to put a contingency in place, and then the next couple we are going to have, the next probably three we’re going to have are going to be bigger and tougher again and is there anything we need to do as far as anything there. I’m not recommending one way or the other; and then Simon you had mentioned today whether or not we needed to do anything extra with security for the NHIN.

DR. COHN: I’m still unclear on whether we need to do anything more in security period. Given that my understanding is that there may some changes coming up in NPRM, whether or not there is anything more we need to be doing around that.

MR. REYNOLDS: All right. We’ve talked about the NPI letter; let’s spend a minute just re-addressing the streamlining. We will be sending out to the Full Committee the proposal that came out. Bill Scanlon just stopped and talked to Judy and I, and he will be reviewing that intensely and he is going to recommend some wording for us on how to go about doing that. So that’ll be good. So as we work with him and hear any other input, we’ll start restructuring that – Jeff and I and Denise will take the ball on that – take what Bill has and try to get something back together that’s worthwhile from a discussion stand point.

DR. COHN: Will that be a topic where we come to finalization at the July hearing?

MR. REYNOLDS: That’s what we’d like to try to do, yes – for approval of Full Committee in September. We may have to work on it between July, in a call or something as part of anything else we’re doing.

5010. Denise, why don’t you go ahead and let’s walk through what we talked about as possible agenda and discussion items and everything for the 5010 please, if you would.

MS. BENNING: OK, we had gone through a number of issues that we thought WEDI could address at the upcoming subcommittee hearings on 5010 and some of those included what are the current issues and/or implementation barriers on 4010 and 4010A.1, which is the addenda. We wanted them to provide separate comments for providers and health plans since their issues might be different.

What was it about the current version that lead to the creation of the companion guide and what was missing from 4010 and 4010A.1 that necessitated the companion guides? One of the most significant improvements between 4010 and 5010 for providers, for health plans, for clearinghouses – one of the most significant improvements that have been made to 5010? Are those improvements technical? Do they enhance business processes and in what ways? Are there any timing implementation issues for adopting 5010?

MR. REYNOLDS: Back to our discussion again – is there any reason to consider sequencing? Is there any reason to consider any of this stuff? You know, right now we run everybody to the goal line at the same time – using a football analogy; everybody be ready May 23, 2007.

So basically, even the way its set up now, everybody could be ready at the same time but not ready together. So as a pair, we could be ready May 23, 2007 to do NPI. Provider could be ready May 23, 2007 to do NPI but not with each other. So as we think about 5010 and as we think about timing, and what it does – is there anything we feel – so that’s our timing so the testifiers will give us input on that.

MS. GREENBERG: When is that?

MR. REYNOLDS: July 30th or 31st – prior to one of our marathon weeks. It’s right before the ad hoc.

MR. REYNOLDS: OK, so go ahead.

MS. BENNING: Can we be sure any of the survey results after comments they’ve received on 5010 and also can they put together some industry panels to testify to 5010’s impact and all its different industry categories we talked about. And that’s pretty much the laundry list of what we’ve got.

MS. GREENBERG: Is that a half day on the 31st?

MR. REYNOLDS: Half day on the 30th and full on the 31st. The 30th is a Monday. Some people could come in Monday morning if necessary. I know Simon and some others from California can’t but at least we again would be back to looking at not bringing everyone in the night before.

PARTICIPANT: Are you starting at midday?

MR. REYNOLDS: No, around more like 1pm or


Ok, so that’s what we plan to do on the 5010 and

again WEDI will be a significant portion of the presentation plus we’ve asked people across the industry to come and discuss it – again with the goal of by the September meeting having a somewhat of a basic update as to what we see – and some of that may be just even reiterations of ok we’re going into the process again and its kind of like the primer – everybody’s has to do what they have to do so as the schedule’s put out, those are the things the Secretary and everybody else has to keep in mind.

DR. COHN: Can I ask a question about that? And actually just a curious about GOTS – I mean are we anticipating that one hearing will handle 5010 or is this just the initial salvo –

MR. REYNOLDS: It may it depends upon how much people know about it and again I think the reason for a preliminary type letter would be to give CMS some kind of input along with the department some kind of input so if they are going to put out a proposed rule at least have had some input, we may not be done with it as a committee, but we may be able to share some early ideas before the actual proposed rule comes out which would allow all that to be considered in a proposed rule – so No, personally I don’t think the subject of 5010 is a one hearing completely. Another thing is I think a number of people in the room will become educated on 5010 from the industry and others, and I think that will create some discussion and also create further activity that we would need to do.

DR. COHN: Well I guess I was maybe _________ in a different way and reflecting back on all of course Karen knows so well as do I at this point – but I think we have to do more than just hear about it, I think we actually have to be sort of advising HHS to go forward with it.

MR. REYNOLDS: Yeah, right. No, that’s exactly right. Now the other thing that’ll be interesting to tell is since we’ve given them the break down of the three different things – is it a technical change, is it something, was it a fix from 4010, is it cosmetic (so somebody did wording changes), or is a significant business change. Now, pending upon how the – I’ve heard numbers from 850 to 1000 to 1200 changes – where ever they group up, so if 60 percent of those are business process changes then the move forward may say one thing as far as whether it’s a big deal or whether its going to be a significant change to people or whether its actually an update of a format. So I think you got kind of two spectrums and nobody can answer that. We’ve tried to get WEDI and others to come talk to us about it and nobody’s been willing to say anything, so I would say to you right now in looking at it I’d say we’re going to have something in each of these categories and just the extent of it. For example if its just adding the indicator, as someone mentioned today present and admission, you know, that may not be a traumatic – it may help the data capture, it may help reporting but its not necessarily going to change everybody’s business process upside down inside out. On the other hand if some of the situational items that are no longer situational and are actually identified as to what they should be then that may change business because some people had it as situational and maybe never got it, other people had it as situational and always wanted it. Well now if you make it something that its all the time that’s exactly what it is, you’re just forcing people into some new business practices; but again you know we have not been able to get that – we’ve asked for it twice so we’re anxious for the July hearing for the industry to step up and do it so we can help CMS and the department understand what they’re going forward with because right now all it is is templates and formats and technical discussions – it hasn’t really been given the light of day

MS. BENNING: And will they be able to do that for us?

MR. REYNOLDS: Yes, they say they will. That’s why we moved it to the end of July. In other words they didn’t feel they could have it by the middle of July and so we planed that they will have it then. And again I think another point is if we cant get as robust a discussion as we would want that also tells us a lot about the fact that it must be either bigger or different because its gone all the way through the SOS – so, the reason why I continue to be a little interested in the streamlining letter is if its gone all the way through the SDO process, we have struggled, in other words, to get honorable discussion. It took Karen and I 30 minutes, I made a few calls and it took Karen and I 30 minutes to put together the primer. We could not get the industry to do the primer. We tried to get the primer at the last hearing and we tried to get the primer for this. Because the SDO’s are over here in the very detail and nobody has thought about the raw impact nor do they want to even allude to what the impact is here. Remember, we got surprised at the last hearing we had, remember Denise?

MS. BENNING: Yep, we sure did

MR. REYNOLDS: Basically didn’t come. We had some people didn’t come. Wouldn’t do it. So I guess what I’m saying is if its been all the way through that process and nobody can do a primer and they aren’t willing to start really putting it out there and say ‘lets go’ this next hearing is very important because if a proposed rule is about to come out and people haven’t really –

DR. WARREN: Given what you just said, these are the same people who told us they want to streamline the process and yet it sounds like they are unable to follow the streamline process they proposed.

MR. REYNOLDS: I will temper my comments to say we could not get it from them – no, we could not get it from them, I’m not trying to expound on that – we asked them to give us a primer at our last hearing that we had.

DR. WARREN: An overview of changes.

DR. STEINDEL: I have a comment about this whole discussion which goes back to what we heard during the streamlining process, and one of the comments that was made during the discussion of the streamlining process was that the people who are sitting down at the SDO meetings are not necessarily the people who have the boots on the ground that are going to implement these things in the business offices.

MR. REYNOLDS: I asked that question a number of-

DR. STEINDEL: Now what we’re asking is okay, 5010 is sitting there, its canned, its ready to go and what I’m concerned about is the only people that we’re going to get addressing the subject, because they’re the only ones who have really looked at it are the people who put together the standard.

MR. REYNOLDS: No, I disagree

DR. STEINDEL: Unless we can attract the other people and they are willing to openly discuss it, I’m wondering what the benefit is going to be.


MS. BENNING: Just as a sidebar to that, I was approached today by an industry association. They are willing to come and talk about a 5010, so –

DR. STEINDEL: Okay, people actually out running the business office.

MR. REYNOLDS: No, no our testimony, if you

remember, we clearly got a little concerned about this. At the last meeting remember the spreadsheet we got that said the SDO’s were done and they were handed at then to CVHS – remember the columns, and our column was checked off. OK, so process finished filled out our column and then the next columns were what does the industry and WEDI and others think about it? Our testimony is set up from WEDI and the industry to come and present this. Now, remember our hearing was a number of months ago and it was out and now people are realizing and we’ve invited people and made it clear we were having hearings and so I feel we are going to get people at the table.

MS. BENNING: We have asked – I know you’ve had

some conversations with Jim Schupping over at WEDI- and he’s kind of been briefed on this but need to kind of talk about who else we want to bring to the table on this because I know there were a number of people we asked last time who were reluctant to talk – I don’t know whether Jim is coordinating with them or he’s not –

MR. REYNOLDS: No, we need to ask the providers, payers, clearinghouses, the same cast of characters that we talked about. So again, if a proposed rule is about to come out we have to hear –

DR. STEINDEL: Harry, it’s the cast of characters but also the cast of characters within the cast of characters. That we need to be talking to the people who are not the X-12 gurus who are going to say YES we changed this field to make it not optional anymore – you know that’s not what we really need to hear.

MR. REYNOLDS: No, we are not going to hear from them. I’m telling you that is not the hearing we need.

MS. GREENBERG: But you want some kind of matrix that tells you what changes have been made.

MR. REYNOLDS: WEDI has agreed to do that.

MS. GREENBERG: So, then, once you have that, then other people who actually have to implement or who are working the business office, they can look at that as well and talk about the implications – right,


MS. GREENBERG: So we will be educating them if they aren’t already in the process.

MR. REYNOLDS: This is going to be both an informational as well as an educational to everybody, but once we hear it – and again the whole reason we want the three breakdowns – if there is a proposed rule coming out – in other words, we all have to remember is there is a lot of work being done on as to when THIS is done when ICD-10 done and so on, so at the same time when everyone says they are we going to do things at a certain time if we cant even get step one started and we cant get the industry to get serious about step one and they cant get a proposed rule without step one you sure know step two isn’t coming anywhere. So, there’s a whole process here that we are trying to deal with so, and its our duty to help – if we agree in streamlining then its our duty to move along and also I know CMS and the department want input from us before they would put out that rule with some kind of guidance so they can include some things in there. That’s where we are, now remember we’re one hearing late. Reason we were one hearing late is people wouldn’t come tell us the last time. I mean we had it all set. We were all set when we met the last time, it was set to go. We were going to hear from the SDO’s and we were going to hear from WEDI.

MS. GREENBERG: What was their explanation; they didn’t have time to do it?

(speaker): Not enough time

MR. REYNOLDS: Nobody had studied it from a business standpoint. Yes Karen –

MS. TRUDEL: I agree with all the comments about having the right people in the room to answer the right questions and I think part of what we need to do is from the business impact perspective make sure that as we invite people or as we discuss with WEDI we circle back to folks over the period of time before the hearing in July to make sure that everybody agrees to what the expectations are and that they’re going to be able to produce what we need so that we need to make sure that we have more of a content committee perception than a standards, and an SDO perception so we more a business sense from the AMA, the AHA, and from the plans as to what the impacts are going to be – over and above the normal well it all depends on vendor readiness; it all depends on vendor testing. Those issues are going to be with us every single time.

MR. REYNOLDS: Totally agree.

MS. TRUDEL: So we have those issues, but then we have these others that are related to the business of 5010.

MR. REYNOLDS: That’s why we come up with the categories and that’s why we sent the questions out that we want them to answer.

MS. TRUDEL: Exactly and I think we need to keep – Denise and I need to keep circling back and making sure that we’re getting there.


DR. COHN: Well for the record, I just want to remind everybody and I think we tend to forget, I believe there is an NCPDP standard.

MR. REYNOLDS: When I say this, its all about – DR. COHN: I also, well I just want to make sure that we are all getting _______ people invited and all of that – are we? Maybe not.

MS. TRUDEL: I was told you just wanted 5010 right now.

DR. COHN: I’m glad I am bringing the question up.


REYNOLDS: Didn’t you just – well, okay

DR. COHN: I think the question is do we want to at this hearing at least get a briefing similarly and hear pharmacy support.

MR. REYNOLDS: We got a lot more on NCPDP when Lynn Gilbertson presented it last time than we did on 5010.

MS. TRUDEL: They have a business case analysis. They had NCPDP for the script, I mean not for the script –

MR. REYNOLDS: Remember she gave us a lot more on that, we got nothing on 5010.

DR. COHN: Okay, well I guess I would just say it would be useful for I think to at least maybe one panel for more of a review of the business case plus potentially hearing from some either pharmacy or pharmacist or whatever.

MR. REYNOLDS: Some PBMs, et cetera.

DR. COHN: Exactly, I wouldn’t really spend a

whole day on it. The other point that I just wanted to – Judy made a comment earlier about the issue of streamlining and I think I at one point earlier in the day today I did some out-thinking about this letter being linked potentially to a streamlining letter that I do want to, as Judy was commenting, did cause me to observe the streamlining concept included from the beginning to the end and of course we are only half way through so it may make it less relevance to this particular view, but probably something we need to think about –

MS. GREENBERG: I just wanted some clarification – will the NPRM which we anticipate, include both the 5010 and the NCPDP changes or would they be separate NPRMs?

MS. TRUDEL: Separate

MS. GREENBERG: They’d be separate.

MS. TRUDEL: They’re on the agenda as separate documents.

MS. GREENBERG: We’d have to do separate letters in any event.

MS. TRUDEL: No, they could be the same.

MS. GREENBERG: But they’ll be separate NPRMs. I mean, we had the transactions rule included them together, right?


MS. GREENBERG: But these would be separate.

MR. REYNOLDS: I think what will be important to us as we look at this streamlining and especially if this streamlining goes through at some point, whether it’s through legislation or whether its through some process. I mentioned earlier, and I knew all this already, the words that the streamlining process may put a larger burden on us, and this may be the first test case because if the SDO process can’t discuss and doesn’t see themselves as discussing whether they get input or not the actual implementation and business type issues other than the format and what the fields are, and so on. Then under the new process that would fall solely upon us. Ok, so that’s why – those words were not accidentally crafted today – as I said that and obviously I feel a little different bout the streamlining process because of what’s happening to us right now as far as the whole thing. So at the same time, I’m thinking PROCESS but watching REALITY, and reality leaves a significant gap, so if that gap is that large ongoing, the answer is that we will need more hearings, probably per types of standard than we would have maybe recently thought. It might not be as well though through, crafted, or discussed as we would have hoped. Again – and this one will be a great one to find out because this one is a structure change of things that already exist. So it should be able to be pulled off reasonably straight forwardly. You got to be able to look at a change and decide whether it’s “do I change that field or do I change what’s in that field – that really doesn’t matter that’s this” – or I just change the way we all do business. That’s why this is going to be very important to watch this one very, very closely. We first have to help get it out as far as the proposed regulation and they want our input and that’s kind of what part of the process is – but we’re going to really kind of have to sense where we fit in this faster and different process. Yes –

MS. GREENBERG: I was just thinking that some of the substantive changes of 5010 as opposed to final clarification, some of them will enable certain things then it’s a separate question as to whether those things will actually be required. Then other changes, like you said, either be a required new data element or going from optional to required which will have, just by adopting 5010 will have an impact where some of the things are enabled by 5010, but other types – I mean like with ICD obviously -adopting 5010 won’t adopt ICD, it’ll just enable the adoption of ICD.

MR. REYNOLDS: Right, but what it will do is make the field alphanumeric and the minute the field becomes alpha numeric every system that is only numeric now is going to have to change.

MS. GREENBERG: That’s true.

MR. REYNOLDS: Yes, you’re absolutely right, there will not be and ICD-10 data put in that field but if you say you’re 5010 compliant you have to be able to take alphanumerics in that field. That changes your databases throughout your system and throughout your company, so that’s where we’re trying to get to. So yes, some of the capabilities might –

MS. GREENBERG: Like the present on admission thing

MR. REYNOLDS: Good example

MS. GREENBERG: Medicare is going to require it,

and then it’s up to others whether they are going to require it or not.

MR. REYNOLDS: But the point is the databases have to be able to do it.

MS. GREENBERG: You have to be able to collect –

MR. REYNOLDS: And that’s where we’re going to go with this. So those are the kind of discussions we have to have because that tells you whether it’s this big, this big or what else it is and what other kind of issues and questions that we need to deal with. Is that helpful in the discussion? So that’s why this will be interesting to watch because if we jump in this other process we’re going to have to be that player that maybe brings a lot of that long, or some of our recommendations to some of our testifiers in the end may be that they need to basically step up the people that they have in their initial sessions and other things where they have another process after say they’re finished before it gets to us which is bringing some more people in the room and saying “here’s what it is now how’s it affected” then they come see us rather than us trying to drag that out of everybody.

DR. WARREN: I have a question. Back to the streamlining, given the scenario you’ve just painted if it requires us to hear more testimony then are we still streamlining, because we estimated our process our time limits in that process based on a current volume and meeting budget and stuff like that so if that increases that means we don’t some of the other work if we stay within the same number of meeting and budget or we pas on some new things that are coming down the pike because we don’t have the bandwidth to handle that. Am I tracking where you’re trying to go?

MR. REYNOLDS: You are tracking right on. If you listen to the testimony, the testimony was the more indifferent people would be included in the SDO process.


MR. REYNOLDS: I’m talking about what we were talking about. And, if you remember, I challenged it. I said are you saying you’re going to have business people that are going to be involved in that because if not, where do they go – cause right now they put a lot of their stuff through the NPRM process, they put it through, they send them in and then people have to react to them so if that’s gone – so it SDO us secretary.

DR. WARREN: See and I think the use case they were using was the HL7 experience with the EHR recommendations where they did get business people coming in. They got a huge influx of folks coming in for those very special meeting as they were writing up the description of the EHR that HL7 balloted later and they also allowed those people to ballot without paying HL7 dues. But there was also a huge effort, a lot of done by people in the Federal government who are going out and saying you need to come to these meetings, you need to be process and suddenly there was a solicitation kind of experience and that while it made for wonderful meetings, I mean, Paul is absolutely right – it just lengthened the dialog in trying to get those documents ready to go to ballot. So there was a lot of extra effort and even some extra funding that HL7 had to go to find to support that process. What, you don’t remember that?

DR. STEINDEL: No, I remember it all too well because I was involved with it from basically day one and yes, what you’re saying is absolutely true – we did attract a lot of business people. One of the key drives was a new member to the HL7 process – AHEMA, who is continuing it to this day and I actually think it enhanced the process faster than the normal HL7 ballot. I think we got it through quicker because of those people. We are able to drive the meetings faster to closure and conclusion. These were people who were goal oriented and that’s not common a lot of time in the SDOs. What I’m seeing today – and it not necessarily has shown up at HL7 though they’re starting to spot in a little bit – within in HITSBY and within CCHIT we have the business people.

DR. WARREN: That’s good.

DR. STEINDEL: A lot of the CCHIT groups have

business people in them. They may have M.D. after their name but they are located in the business office, they’re located in the process, they are trying to figure out “okay how is this certification going to affect my product.” And HITSBY is starting to see the same sort of things especially when they’re putting together the use cases.

DR. WARREN: I guess my concern is the TC that I participated in and chaired at one time at HL7 was patient care, and we desperately needed to have clinicians to come and tell us the appropriate content of the messages. We had plenty of techie guys and computer guys to help us model it and create those things but the actual content of what needed to be in there was difficult to get out.

MS. STEINDEL: And they’re still not showing up.

DR. WARREN: Still not showing up.

MS. REYNOLDS: Remember we asked the question, when we heard the hearing we brought this up as a significant issue so what I’m saying is this next hearing’s going to allow us to build a body of work that is changed and is a little bit like the EHR and it’s going to move along, we’re going to hear it and we’re going to give good input to CMS and we’re not going to have to have six hearings to get it or we’re going to find out there’s a hole.

DR. WARREN: So you’re expecting him to come back and talk about this new process?

MR. REYNOLDS: No, we’re expecting them to –

DR. WARREN: I’m missing something here, Harry

MR. REYNOLDS: We are expecting right now the people that are that conduit between the SDO and us is WEDI

DR. WARREN: Right.

MR. REYNOLDS: Plus the industry – fine – but I’m saying the actual one to kind of explain in business terms what it is, that’s what WEDI’s taken on as an aside.


MR. REYNOLDS: Okay now, we’ve got to see the quality of that and if that’s going to be it, and if it works good, good – then we got what we wanted. If it doesn’t work good then we’re going to have to ask the questions we were just talking about – some of the SDOs are going to have to step up and so when they come in and check our box off, which again still was to some of us rather interesting, to get a spreadsheet that said “we’re done its yours.” If you remember that so I want to make sure as co-chair of this committee we understand what ours means because if that process passes, whatever way it passes, of the streamlining and we end up being in the game, we have to know what game we’re in because that affects budgets, that affects time, that affects effort, that affects what we do or don’t do. So that’s where we’re headed. So we’re schedule to have the hearing. I can tell you this much, if we don’t get quality stuff and it isn’t going to be worthwhile, I’m not going to spend the money. I mean I’ll call it off in a heartbeat. You know because that’s just not the right thing to do. I mean us sitting their just kind of reminding ourselves that we’re not getting something that’s going to be worthwhile to send forward because the whole purpose for this is to try to get something to the department so they could go ahead and get a proposed rule out and have some good input which we are part of that process, but I’m not going to through money down the drain. I’m in constant contact with some of them – Denise and I are on some things – and if it doesn’t look good and we’re not getting people stepping up; in other words if we cant get the AMA, the AHA, the payers and others to step and want to talk about 5010 there’s no reason for us sitting in a room looking at each other because we gave you all we know which was five slides and that’s not going to recommend how we do an NPRM. So now the industry’s got to step up, they said they wanted to they said they wanted to streamline so if they want to do it they have to step up

DR. CARR: What did they promise to do at the end of that hearing? I know we had a little bit of back and forth.

MS. REYNOLDS: They did not promise anything at the end of that hearing.

DR. CARR: Well we were trying –

MS. REYNOLDS: Basically WEDI was not prepared to say anything.

DR. CARR: So –

MR. REYNOLDS: They now have committed that by the end of July they will do this. That’s our hearing, end of July.

DR. CARR: Well I mean so is there any preview before the hearing of what they’re putting together – I mean what if they don’t have anything?

MR. REYNOLDS: That’s what I’m saying, we will cancel the hearing.

DR. CARR: When will you know this?

MR. REYNOLDS: We have given them the set of questions, we have given them everything that –

DR. CARR: I guess my question is if we find

out the day before the hearing that they’re not ready –

MS. TRUDEL: I think that’s the point I was trying to make I think while you were out of the room Justine, that we need to chunk up this workload and put some deliverables and dates on the table so that we can keep checking the progress as we go and at some point make a go/no go decision.

MR. REYNOLDS: I totally agree with you. We have sent them the list of questions and that will be Denise’s and my responsibility, we will do that.

MS. BENNING: We’ll, touch base with them immediately after this meeting and kind of see where they are and get and idea as to –

MR. REYNOLDS: The latest we would call it off is

the middle of July – two weeks ahead of time. I mean I’m not going to recommend anybody spending the money if we don’t have a good hearing coming.
DR. COHN: I think this is also sort of a will be a statement around industry readiness

MR. REYNOLDS: That’s exactly right.

DR. COHN: Which is one of the things, I suspect, CMS would be very concerned about.

MR. REYNOLDS: Right, that’s exactly right. But again I think we all feel a significant pressure anybody that’s in the industry, there are a succession of things that are trying to happen and there are things in Congress talking about timing of certain things so I feel a real responsibility to try to help make sure we think about these things in sequence, so 5010’s got to move, one way or the other, its got to move somewhere because if it doesn’t then the rest of the train is not going anywhere and then that’s fine, if we say that the industry has not even prepared itself to deal with 5010 then attachments may come out at some point. You know at some point, what’s been interesting watching it from a viewpoint, there are so many things going on that its funny because the same people that these two just mentioned would go to the EHR hearing about what might happen in the business are probably the same people that would may be have been looking at 5010 and some of the other things at least from a standpoint of how they may do it or not because there so many committees doing so may things, when does a new reg – lets take 5010 – when does it jump to the front of the line versus use cases versus other things that are happening that appear to be tomorrow, the next day, or the day after. It’s going to be interesting to see the capacity of the industry to do what it needs to do and step up and do what it needs to do.

MS. STEINDEL: We had a comment made earlier about the other HIPAA transactions that are going to be coming out which are based on 4010, right? There’s going to be more, we have a claims attachment and some that – are they all in play?

MS. TRUDEL: They’re all 5010.

DR. STEINDEL: Are they all in play Karen?

Everything except the claims attachment?

MS. TRUDEL: Claims attachment is the only one that’s in play now that’s not –

DR. STEINDEL: The only new one

MS. TRUDEL: And we have gotten comments in the public comment process that said don’t do 4010, go to the 5010 version.


MS. TRUDEL: I mean, we have gotten a lot if industry comments on that and if that’s the way we were to go it would give us –

MS. STEINDEL: So what I’m actually thinking about then when I started my statement is that there are a bunch of the 4010 transactions that are really not being used well today that we’re aware of.

MS. TRUDEL: Oh for the 278 for instance?


MS. TRUDEL: Right, they’re not, and one of the reasons that their not is not because the transactions don’t work but because there are business flow issues that nobody’s tackled and that’s a different issue that I definitely think is of interest to the committee because when you have a standard transaction you don’t necessarily have the business functions behind it as we discovered very graphically with the 270/271.

MS. STEINDEL: One thing we need to find is if 5010 addresses some of these issues.


MS. TRUDEL: I don’t think it does in that as I said, a lot of the transactions are not used as business flow.

MR: REYNOLDS: It has nothing to do with it, it has nothing to do with data missing, it has nothing to do with capability it has making it part of the workflow, making it part of the vendor packages, making it part of things that would make it automatic and their workflow issues. Everything we wrote up is to, where’s the RRI and some of things is not because of 4010, 5010, 6010, 8010, its because if you don’t make it part of your business process where you’re automatically everyday somebody’ in the hospital you’re automatically pinging with a 270 to see if they’re still covered, and you don’t have to have somebody pick up the phone, or go to a transaction and key it in, that’s what makes the difference in whether these things get implemented and whether start really saving money. I haven’t heard a single – anybody we’re dealing with talk about “well I can’t wait until 5010 and I’ll do these other transactions”, that’s never been a discussion that we’ve had, you haven’t had it either. No that’s got nothing – zero to do with where we’re headed; but its good that its coming out in 5010 because you wouldn’t want the industry to do everything else in 4010 and we get a brand new come out, a 5010, and a brand new one comes out in 4010 – so I think that’s the right approach. So, had enough on 5010, we’ll keep you tuned – were trying to work with all the people to do it. It is our duty to give the department something before they put this out as part of the process and so we’re on it. We’ll do it diligently and we will be good stewards of the Governments’ money and your time.


MS. GREENBERG: Is there any publication (low speaking)

MR. REYNOLDS: There is a desire though to hear from us soon.

MS. TRUDEL: I don’t actually recall whether its in the regulations agenda or not, but I k now its not on the quarterly provider updates, the CMS QPU, because that only goes out two quarters, so the QPU only goes through December.

MS. GREENBERG: The reason I ask is because you said this probably won’t be the only hearing.

REYNOLDS: No, I’m sayng it was my understanding working with Karen that it may be good for us to have something in September, not as a final, for their planning.

MS. GREENBERG: Might have something –

MR. REYNOLDS: Not as a final for their planning.

Yes, again, we may hear a lot. In other words we cancel the hearing we may have something in September that we couldn’t even get enough interest to have a hearing. That is a statement, that is a definition of where the industry is, it’s not right or wrong, its that as a fact. So we’re taking it seriously, as to the process we’ll see whether or not we have enough information to actually make something go. Try to filter everybody’s needs, come up with something that makes sense. Okay.

MR. REYNOLDS: Then again, one of the things we put on here to discuss, was there anything that as Justine and I and Simon especially go full speed into the ad-hoc secondary uses work group, is there anything having to do with standards or anything like that that you would like us to make sure we keep in mind as we are adjudicating that matter, that would be helpful. I mean for example, we had a discussion yesterday in the privacy session about what is the kind of the base data set – is it the CCD, what is it? Because if you think about capturing data, using data, making data interoperable you kind of have to come up with some standard package to put it in or definitely some standard way of thinking about it; or you use some current standard packages whether that’s a claim or whether that’s THIS or whether that’s THAT. So that would be one item that I know that at some point’s going to have to come to bear otherwise I’m not sure how you start really coming up with a good way to do it you don’t have standard data that you’re moving around in one way or the other. If you set these are the quality measures or this is what it means, it can’t be a free-for-all. Judy –

DR. WARREN: One of the things I think you should consider, and I can forward the documents to you, is I literally this morning in my email got a document AMEA is pulling together a group that is going to be developing a taxonomy of secondary data use and they’re putting this taxonomy together so that people can start talking about the different kinds of secondary data use that are there. My preliminary screening of the document is that it is very physician centric, so as we’re having hearings and stuff, again a reminder that there are other people that use secondary health data other than physicians to do research, so we need to consider that. I don’t know, does this group – I guess I should find whether or not I can share the document – but if I can share the document does this group want to see that ahead of time?

MR. REYNOLDS: We already have it don’t we?

MR. REYNOLDS: Yeah, Simon and Justine were


DR. COHN: Yea, Justine and I were there.

There will be testimony from AMEA in July

(Speaker): AMEA document?

MS. GREENBERG: Which presents this taxonomy or the status of the work?

DR. COHN: It seemed to me that is was not at

least – and I’m looking at Justine – I don’t think as I was listening to them that they had sort of a draft taxonomy but I think that they were meeting –

DR. CARR: Pretty much everything that was at

the meeting was on the website.

DR. COHN: Is this the AMEA document?

DR. WARREN: Which I got this morning to take a look at and respond to.

DR. CARR: Is that the draft? I didn’t go to the website to look at –

MS. REYNOLDS: Yea, that’s what I got – Simon you gave me the link and I went on and got it out there so – but again, I didn’t want to spend a lot of time on it today I just wanted to make sure since we have the Standards group together and at some point, whatever is going to happen I just want to make sure that we at least discussed it here if people think of things let us know so that we take it into consideration as we are doing what we’re doing. We probably ought to do that with each of the committees, and subcommittees that we have.

DR. WARREN: I just think that given everything we’ve talked about throughout the day everybody ha some of the information and until you talk about it you don’t know that you may be holding a piece that no one else knows about

MR. REYNOLDS: That’s why I put it on here.

DR. STEINDEL: Harry, the ONC just released the final version of the use cases and HITSBYs meeting this week but the population health work TC of HITSBY has taken on the quality use case and one of the things they’ve been asked to do in that is to define a dataset for quality and defining the standards for using that data set.

MS. REYNOLDS: Okay because see for this committee

DR. STEINDEL: To identify the standards which are appropriate to use in that area.

MS. GREENBERG: And also the data set. One group worked on the data set

MS. STEINDEL: Well HITSBY actually also developed a bio-surveillance data set as well until AHIC took it over.

MS. REYNOLDS: But the filter we’re using is obviously the NHIN. And so if every subject is going to come up with their own standard and their own data set then that could put us right back where we came from, which was everybody having their own thing. We’ve talked about adjudicating this, you keep the NHIN in mind you look at the datasets but we make sure we don’t – if you sell out, basically/philosophically sell out to a use case as to what, that’s the data set or the only data set, and that data set doesn’t come from other standards or so on, an interoperability is a word as we go forward that immediately as you try to build it in one way you crush it in another way.

MS. STEINDEL: But the charge to HITSBY, and this is from the very beginning, is they are to harmonize interoperability standards for use on the NHIN.

MS. REYNOLDS: Right. Okay.

MS. STEINDEL: So, they’re focused

MS. REYNOLDS: As we listen to these people in other words we need to also be the ones who make sure we keep that filter in mind also because if there’s going to be standards then and you’d be standard not 26 standards.

MS. STEINDEL: And that’s the whole purpose.

MS. WARREN: I have another concern though – if HITSBY going to driven only by the use cases that AHIC has, there are all these other folks out there, I mean right now there’s a big RFP out of NIH for medical centers to develop Centers for translational and something research – I cant remember – maybe its clinical research or something. But I mean our university is going for it, I’m on the writing team, and they are going to be having here at NIH a council where there will be an informatics person from each one of these centers coming together to determine data standards that these centers will be using. Its still in very broad terms but you know my first comment to that was interoperability. If each health science center is going to be doing this I can see doing it in within their own science center but now there is going to be this council of these folks trying to come to consensus on these centers and a big part of this is going to be KBIG which also is looking at data standards to participate in that effort; so this could quickly get out of hand on this secondary data.

MS. REYNOLDS: Which is exactly why I’ve put on this agenda today so that we make we keep in mind as we are adjudicating any of these matters; that for example there’s a subject quality and there’s a use case quality. The subject quality if it has a standard then that can be used for whatever use cases of quality that you could do, but if you go dive into a use case and set up a standard ONLY on a use case then the other uses – I mean Carol Bickford – I was in the quality session yesterday and Carol stepped up and made that comment towards the end of it is there are other entities other than specific ones? So please, as you think about it and you think about our charge as a subcommittee whether we’re sitting in other committees, will still have to keep that picture. Just like we’re messing with the HIPAA transaction we see now there’s a clear definition in the Unites States what a claim is – its 837. Its absolutely 837, I mean you add anything else to it its not the claim as it is. Well as we build these other ideas and discussions and everything else we’re doing you come up with a linear record that’s called quality needs to be the subject of quality not just the use case of quality for a specific thing or else then you lose the longitudinalis; you lose the ability to really be part of the NHIN, its just part of a single application. And that’s why I wanted to at least have this discussion – we all have to watch that – so Judy as you’re a member of this committee as you’re sitting doing your day job and your looking at other things that the kind of input I think all of us are going to need as we administer this on an ongoing basis. Let me let Marjorie comment –

MS. GREENBERG: I’m still back at the taxonomy that AMEA is developing. I know it was a recommendation I think of the first meeting but am I correct that the work that the National committee is going to be doing in this ad-hoc workgroup where the initial at least developing the framework and then drilling down to the use case but the overall framework will need to have some kind of high level taxonomy?

DR. COHN: That’s actually from my introduction this morning. That’s actually what I was discussing with everybody. And there’s no reason for us to develop _______.


DR. COHN: Its really more a question of

adopting/identifying whether the right example – I think we have problems with pseudo-organization and all of that stuff and trying to get the best thinking we can to sort of say those are the right firms and I think they’ll

MR. REYNOLDS: Yeah, one input

MS. GREENBERG: Oh no, I agree.

MR. REYNOLDS: Yes, yes.

MS. GREENBERG: So by AMEA will, I mean WEDI will

be working together on that part of it because we certainly don’t want these two different taxonomies.

MS. REYNOLDS: One important thought

MS. GREENBERG: Well, I mean unless executives don’t agree or something –


DR. STEINDEL: This is getting back to the other discussion and just pointing out that there may be some light at the end of the tunnel about the work that we are doing in harmonization and the work of HITSBY I was just on a HITSBY conference call when I stepped out mid-afternoon and one of the things that came up there was with regards to the medical management use case that just came out this year there was a lot of discussion earlier in the year about how some of the aspects of the medical management use case which just coincidentally in part overlaps with some of the e-prescribing –

MS. TRUDEL: You mean medication management?

DR. STEINDEL: Medication management, yes. And it was said on the HITSBY call today that the foundation standards will be used. When you’re doing your harmonized use cases make sure they fit around those standards so we have made tremendous inroads

MR. REYNOLDS: In other words we need to make sure that that is the rhetoric that continues and that’s the rhetoric that we all listen to and if its not then we understand what else is going on. That’s the only reason I wanted to put it on the agenda today was just to make sure everybody – Justine you have a comment…

DR. CARR: Yeah, it’s very hard to keep track of all the groups that are working on the same topic and what the hierarchy is – is it just me? Can you make a diagram or something?

DR. STEINDEL: Justine, I’m on about most of those groups and I can’t keep track.

DR. CARR: No, but I thought the discussion earlier in terms of privacy made a lot of sense to at least have everybody at some point at the table to decide what is their contribution because –

DR. COHN: It’s late in the day so maybe I will hold my comments until tomorrow. I think you may be asking for a level of organization that maybe the United States has not ever really been keen on. I think there’s sort of different ways that you arrive at best. I mean one is an organization approach where you organize, you put everybody into slots and you develop the long range plan; there are other more indigenous chaotic or whatever where really the best rises to the top. And I would suggest that this has really been the history of the United States when you look at standards.

MS. GREENBERG: The question is whether this is controlled chaos or uncontrolled chaos?

DR. COHN: That’s another story. Really what I’m suggesting is where as you look, for example, in Europe where they did a very structured, very planned out standards development activity that riddled the whole health care environment, where as the United States it was much more HL7, X12, NCPDP all sort of fighting for parts of the action and indeed as you look at things now the stuff that happened in Europe really never got the traction that it needed. I’m using another example, obviously, rather than what’s going on now but I think that we’ll see iterations of exactly how things work as opposed to I think the more sort of structured whether they take your part and sort of move forward

DR. CARR: Well I think duplication is just my concern.

MR. REYNOLDS: Well I’m not sure, I think its duplication on the same subject but it may not be duplication of the same result and I picture this more and more like a conveyer belt and there’s lots of stuff on it, and that’s why I said what I said earlier – and we need to stay our course with our rhetoric and our focus like we did with the functional requirements like with privacy framework we kind of go about the same thing with the quality- and then we pick of the things that come by and they just keep going aground and then you say ‘oh well good we’ll take that one because they’re following the standards and that’s good and we want everybody to follow the standards’ because if there’s going to be 50 of them, as long as they follow the standards it doesn’t matter that that’s 50. It’s a fact that they’re all taking it from the same data sets they’re all thinking about it with the same standards and when we say that’s a quality record, that’s a quality record – I don’t care if you’re doing quality for THIS or quality for THAT or quality for anything else, you got all the right stuff. Now that going to take a little courage by all of us to stay because it’s a whole lot going on and it looks like some of things are running way ahead but they’re not ,they’re thinking about pieces and we have the stay the course I think – and we have to have the courage to stay there because we’ll have the tendency to run and say “well that’s a good one,” we have to have that courage to stay up there – that’s the way I see it, so –

DR. COHN: And I think, Harry, you were being probably much more global in your views.

MR. REYNOLDS: Than yours? Okay. Is that good or bad? Oh, Okay, thank you.

MS. REYNOLDS: Thank you very much. We’ve covered everything. You will hear plenty more from us on 5010. Thanks.