[This Transcript is Unedited]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL CENTER FOR VITAL AND HEALTH STATISTICS

SUBCOMMITTEE ON STANDARDS

March 1, 2012

Doubletree Hilton Hotel
8727 Colesville Road
Silver Spring, MD 20910

Proceedings by:
CASET Associates, Ltd.
Fairfax, Virginia 22030
(703)266-8402

P R O C E E D I N G S (4:08 p.m.)

Agenda Item: Welcome

DR. SUAREZ: I think we need to call the meeting to order. This is the National Committee on Vital and Health Statistics Subcommittee on Standards. My name is Walter Suarez. I am a member of the Committee and Co-chair of the Standards Subcommittee. I am with Kaiser Permanente and I don’t have any conflicts.

DR. WARREN: Judy Warren, member of the Full Committee, Co-chair of the Standards Subcommittee, University of Kansas School of Nursing, no conflicts.

DR. SCANLON: Bill Scanlon, National Health Policy Forum, member of the Full Committee, member of the Subcommittee, and no conflicts.

DR. TANG: Paul Tang, Palo Alto Medical Foundation, member of the Full Committee and the Chair requested that I spend time here so thank you guys, thank you and no conflicts.

MS. DOO: Lorraine Doo with CMS, Lead Staff to the Standards Subcommittee and no conflicts.

MR. SOONTHORNSIMA: Ob Soonthornsima, Blue Cross Blue Shield Louisiana, member of the Full Committee and this Committee, no conflicts.

DR. FITZMAURICE: Michael Fitzmaurice, Agency for Health Care Research and Quality, Liaison to the Committee, Staff to the Standards Subcommittee and if I had a conflict I would probably be fired.

MS. PICKETT: Donna Pickett, National Center for Health Statistics, CDC, staff to the Subcommittee.

MS. WILLIAMSON: Michelle Williamson, CDC’s National Center for Health Statistics, also staff to the Subcommittee.

DR. CARR: Justine Carr, Steward Health Care, Chair of the Committee, member of the Subcommittee, no conflicts.

DR. WARREN: And Seth, you are on the phone. Do you want to introduce yourself?

(No response)

DR. SUAREZ: Who do we have on the phone – members of the Subcommittee on the phone? We are going to go around the room very quickly and introduce people in the room. I think Seth Foldy from CDC, Liaison from the CDC, was going to join us. He might be on the phone but we can’t hear you, Seth, if you are.

(Introductions around the room)

DR. SUAREZ: Thank you. I did get an e-mail from Seth that he is on the line now. He can hear and hopefully we will be able to hear him.

DR. CARR: Walter, the one thing I asked Paul to stay just for a minute but the question I have is whether we think NCVHS ought to send a letter to the Secretary in response to the ICD-10. And if we did, I spoke with Jim earlier who said that we should respond to the NPRM but should we say something sooner and if we did, what would we say?

DR. SUAREZ: I would just comment. We were planning to address the ICD-10 issue, and mostly with an announcement in our regular process which was again, as I mentioned, having a hearing later in June or who knows, depending on if we can do it sooner. Then preparing the letter and submitting it, which would include of course, all aspects about ICD-10 and specific points and recommendations about if there are potential intents to delay ICD-10 then these are some of the consequences and implications for all different organizations.

At some point, we will have to come to the Full Committee and ask whether our position should continue to be that there should not be a delay. That aside, that was one of the intents.

Now, depending again on how quickly the regulations are being written, whether they are currently underway in terms of drafting regulations to modify the date and how quickly that is, whether by providing that advice there would be some information that the Secretary can use in drafting the letter. Not so much again responding to implications of NPRM, which we would be able to do later on as well. Aside from that actually sending a letter ahead of time, in the process of preparing these rules to provide advice in the drafting of those rules.

Again depending on how the timing of that which we don’t know necessarily what the timing of the development of those rules is, we would want to do that. If there is an interest in preparing some initial letter that identifies one or two issues, high level issues, and then mention about the upcoming more in that letter, I think we could certainly do that.

DR. CARR: Let’s go around the room and get everybody’s input.

DR. WARREN: So speaking in my co-chair role and looking at the time, we have three letters. One letter is fine the way it is. One has a small edit. The other one has a couple of edits. I would like to get those done before we adjourn.

Speaking of responding to the Secretary, you all heard that I was fairly passionate about ICD-10 because I have been around a lot, and I do think that we need to respond to her. Not wait until June because I don’t think this has anything to do with the status of the implementation. We can continue to do that per our work plan but I do think we have some insights and concerns about the process and that this is a typical pattern. We have seen it before, as you said, put in implications of what it means to slow down the process and what the costs are. I think it needs to be the complexity of everything is going to increase in the timelines and the requirements on the industry, when I look ahead and see what is coming down the pike. This is just the first brick to fall.

DR. CARR: The only thing just to clarify, I would not favor chastising the Secretary in any way, but rather to just respond to say we stand ready to help we are aware of the implications or something like that. Bill, what do you think?

DR. SCANLON: What you have just said is very different than I guess I thought a letter might be. When I say that, it is not that I had a notion of what that letter might be, but it was going to be more specific, and that wasn’t necessarily chastising the Secretary but it was in some respects taking more of a position as opposed to sort of expressing sort of a willingness and simultaneously, a concern.

I mean Judy’s point here is valid. Leslie’s point earlier today is valid. We can’t think of these things as a list of serial sort of events that doesn’t matter sort of when they happen. If there is simultaneity involved in some of them then we need to think about sort of that. I keep talking about the issue of priorities and bandwidth. I think that is also a factor sort of in this. Not to make you feel bad but I will describe your letter as innocuous in the sense that it is not taking a stance on any of these issues because we don’t have the time to sort them out before.

DR. CARR: Also, the Committee is not of one mind.

DR. SCANLON: But that was good. I mean if we were going to focus on a letter that was going to take a position that would be sort of my first reaction. The conversation I heard here this afternoon was divided and that when we brought out a position say tomorrow, we were going to spend a significant amount of time and it would not necessarily be a unanimous letter.

DR. TANG: As far as the possibility of the ICD-10 delay, she is obviously going to propose something and then you can react and ask for a reaction. The part about a NPRM is from NPRM to final rule, she cannot do something more strict or introduce new ideas.

So the reason for introducing a letter now, which may be actually single topic not even dealing with what you were planning to do is to plant the notion and Lorraine said at least wasn’t aware of discussions about alternatives to ICD-10, the sole focus. So if in our role as advisors on health information policy and data, is that the country needs to move to a clinical terminology and let the classification system fall from clinical terminology, rather than try to grab it the other way around, then this seems like an opportune moment and probably our only moment. You know that – I don’t think the world is going to slow up. There will not be a vocabulary stage, part two, in our professional lifetimes. I think we need to make a statement. I think this is actually just a wonderful; we just got presented with a wonderful opportunity to do something.

DR. SCANLON: You and Justine have just described two dramatic and different letters.

DR. CARR: Well, no. I actually was being neutral so that Paul could put that forward, but I agree with Paul.

DR. SCANLON: Well okay but I think that.

DR. TANG: Two different is that what you are saying?

DR. SCANLON: In the sense of I a am not sure we can reach consensus tomorrow. Not that your point is all sort of –

DR. TANG: Well I think we have to present the context and we didn’t say this particular point, which is our opinion is moot after tomorrow. She is working on an NPRM, I presume, and once the NPRM is out and it does not include this as an option, there is no option. So I am saying we don’t come up with a decision tomorrow, it is moot. We can just go on with our lives. That is not the new NCVHS we want. Right?

DR. WARREN: Yes, because of the time.

DR. SUAREZ: Let’s hear Ron and see what else. Lorraine, do you want to? I don’t know how much you can say or.

MS. DOO: I really can’t. I think everyone is aware that if we are going to publish something quickly it is being done now.

DR. CARR: So what Paul was saying is that if we make reference to the NLM clinical terminology mapping to this new development that was just announced yesterday contributes to resolving some of the issues?

DR. TANG: Why twist it? Those were not the only issues that – if they were almost parallel. The country was focused on ICD-10 a la 1996. It so happens that 2009 came about, 2010 came about, and the economic situation as come about since 1996. We have the opportunity and there is the possibility, which we did not have before of delaying.

If you take the change in our world and the opportunity to delay, because we in a sense didn’t want to delay until we were forced to but now we might be forced to, why not take advantage of it? We would be speaking only from our data point of view. Then we say, and also fortunately, NLM, so because part of our theory is if we coded simple terminology, we still have the mapping. We still have to build an ICD-10. We didn’t, until yesterday, have evidence that there is this already federally created and maintained not only mapping that will cover, she said 95 percent of the billed diagnoses, but a tool that actually, that was the other answer that physicians could use and end up coding in SNOMEDS.

DR. SUAREZ: Quickly, Paul to your point, I could see that to be used as an argument for saying now that we have the tools there is no point to this.

DR. TANG: That is the possibility and she could write that and ask for comments. It is not there is no point. I mean the classification system may be the right thing to do for billing for as long as fee for services – not just for filling in populations, et cetera. So we still need 10. It is just that we also happen to have needed SNOMED, which we didn’t have on paper in 1996 when we wrote our paper, it really didn’t matter. But now that we have a Secretarial initiative to push the EHRs it now matters and it is now possible. That is the congruence of all of the timing.

DR. SUAREZ: On the other hand, the question would be are we for delay. Are we for delay of x amount of time or are we not for a delay. Those are the three.

DR. TANG: Delay to do this.

MR. FOLDY: Does anyone have any expectation as to whether or not waiting for eleven is part of the decision process or has that not been talked about by anyone anywhere. Where does 11 enter into this?

DR. TANG: We are trying to make that moot by moving the SNOMED and then let the mapping flow.

DR. CARR: I think Marjorie was saying you can’t go to 11 without going to 10.

DR. SUAREZ: That was Seth, right Seth? We are going to go to Ron and just finish up this conversation.

MR. SOONTHORNSIMA: What I heard is really maybe three things. One is to delay or not to delay. I think that is already a moot point. It is going to be delayed. But really the next question is for how long. That is really the primary question.

What you were saying, what I am afraid is where it may come across as saying whether or not we are going to do ICD-10 at all. I prefer for us not to appear to come across as saying that because I don’t think we have enough evidence or information, this SNOMED mapping thing is too new. There is a lot of opportunity. It does require some time to get through so that gets back to the second, the primary question is really we are going to delay for how long. If you wait too long, I would strongly recommend against that because of the investment the industry has made, significant investment with ICD-10. A lot of companies and a lot of the industries have moved towards ICD-10.

DR. SUAREZ: That raises a good point. It is just really we are not, we are assuming then that under that perspective that there is going to be a delay. There is no point of taking a position of saying, we don’t think there should be a delay. That is one decision we actually need to make because there might not be agreement on that.

MR. SOONTHORNSIMA: I personally think that we have to avoid coming across as saying is there an alternative to ICD-10.

DR. SUAREZ: I think the letter rather than necessarily taking a position about there should be a delay or not the delay, it is more about we want to bring up to your attention this kind of new tool that will help facilitate.

MR. SOONTHORNSIMA: So are we expressing our opinion?

DR. SUAREZ: Well, providing the perspective.

DR. CARR: We observe that with the delay, we use this time to leverage the new tool that could reduce some of the burden of ICD-10.

MR. SOONTHORNSIMA: In order to facilitate the adoption of ICD-10.

DR. CARR: Yes, yes, right.

MR. SOONTHORNSIMA: If the matter is sooner, anyway.

DR. WARREN: Do we need to be careful about this tool?

DR. SUAREZ: Let us finish up going around and then we can continue.

DR. FITZMAURICE: I am looking at something that is not even as good as an anecdote perhaps but it says an Edifecs survey of more than 50 health executives participating in this 2012 ICD-10 summit finds that 64 percent think pushing back the ICD-10 compliance deadline won’t boost readiness. Sixty-nine believe a two year extension would be either unrecoverable or potentially catastrophic. It affects estimates a one year delay would cost the industry $475 million to at least $4 billion.

Now I am not posing these numbers as something concrete, but I am saying is if there are reasons not to delay if the Secretary feels that she has to delay, we might come out and say for no more than a year. While we would like to have an immediate acceptance of ICD-10, we would recommend no more than a year. It gives her something on which to base a decision of delay on and puts a limit on our professional judgment as to what we think could be suffered.

DR. SUAREZ: Great point. Thanks Mike.

DR. PICKETT: There is not much that I say but I did want to go to Judy’s point about the tool that we saw this afternoon, historically when we have seen a new tool of any type, the Committee has generally recommended a pilot or additional study before having an opinion as to the readiness. Parallel to that would be with the GEMS. CMS and CDC have created the GEMS but we were also instructed to make the GEMS available to the public for public comment and review and improvements, if necessary. I kind of see this as being a very similar issue in that we need to know a little bit more. It looks great but to use that as the basis for a recommendation might be premature.

DR. CARR: I think we could say though the concept of a clinical language tool which backend mapping to ICD-10 and SNOMED is a valuable concept. For example — no?

DR. PICKETT: I am a little uncomfortable with that. I think we are kind of jumping the gun. We just got the tool. We just saw it. I think we need time to analyze it.

DR. CARR: I think the concept. I am not saying this tool, but the concept that Paul, never having seen it, could go through three diagnoses in under a minute and find exactly what he was looking for.

DR. SUAREZ: This is a tool that exists in many cases today.

DR. WARREN: Every major vendor has the ability to map between terminologies. It is already there. What turned Paul on will turn on all of the small physician offices. It is a tool, Paul, for all of the reasons you did.

DR. CARR: Well and it is standardized and maintained by the federal government.

DR. WARREN: But the scenario is we tell people go use the tool. So I am out in western Kansas and I pull up my EHR. I have a small vendor. He doesn’t have that tool on his because he is not one of the big guys and so it is okay. I will go to the web and I will look up stuff. Magic, it is not connected to what I have so I try to enter in the numbers. Do I transpose the numbers? Do I hit the right code? Do I put it in the right slot? I mean the errors that could be generated until that was fully tested out and people knew how to combine that tool that is on the Internet with what they have on their desktop are enormous. We have had everybody beat us up about usability of EHRs. That would just create chaos to start having two independent tools and to expect a user to be the physical conduit between one system and another.

DR. SUAREZ: That is why I was suggesting earlier and that it could be probably one of the items to comment on is now that Meaningful Use Stage Two is out, it would be valuable to require the EHR tool to have the capability of doing exactly that that Paul did on the screen. So offer that to the providers. Now many EHR tools can start to do it today with ICD-9 perhaps. But I think that is one possible concrete area where we say here we are trying to align the opportunity that we have with the EHR Meaningful Use Two and the adoption of SNOMED with the reality that out of that EHR there had to be a bill generated that has to comply with the national standard for billing. That standard for billing only supports the submission of an ICD code. It could be an ICD-9 with 5010 or it could be ICD-10 with a 5010 version of the 837. But you cannot send a SNOMED code inside an 837 and so you have to, and by 2014 I expect that we will still be sending claims to Medicare. By 2016, I expect that we will still be sending claims to Medicare, so there is that reality that we have to align that and say we need to look for the requirement on the EHRs to be capable of doing that but also look for the entire industry to move to that option for billing purposes. Those are the two steps, I guess.

DR. TANG: I think I would go back to what Justine was saying in terms of the proposal is to shift our concept from migrating to another classification system to migrating to clinical terminology with, in this case, a federal endorsed mapping from the terminology to the classification system. So they track, yes, we have to have this tool but what was attractive about it was it spoke in and this has been around for a long time, the concept ID and the concept descriptor, which is really in professional terms. That is easy.

That is what I was reacting to and then behind the scenes using its semantic network, it maps to SNOMED, which then gets mapped to ICD-10-CM. That is what they have been working decades on and maintaining. That is their forte, more than almost any other people in this space do. So the primary thing is to move to clinical terminology. That is our primary.

DR. SUAREZ: Aren’t we doing that already?

DR. TANG: No, we are moving to a clinical classification system.

DR. SUAREZ: So would you say moving to a clinical terminology for billing?

DR. TANG: No, well, that is with classification terminology. So the proposal, just for consideration, is that our major recommendation is that the time when we have this EHR initiative and we have meaningful use that has already, as you pointed out, adopted SNOMED and the single terminology in Stage Two for diagnoses, that we align this new opportunity of shifting vocabularies to a clinical terminology.

The byproduct will be a mapping that comes out of the work that the federal agency, NLM, has done to map it to the billing terminology in ICD-10-CM terms. It essentially gets us to both places. We need to move our billing and our epidemiologic basis codes from ICD-9 to ICD-10. So we have to satisfy that goal. But we are saying at the same time — and possibly one that improves our care, our population management, our reporting to move to clinical terminology for diagnoses. And that aligns with meaningful use and that takes advantage of this decades’ work of that the federal government has already done. It just so happens it is ready. The tool may be icing, but the mapping is what we sought. The tool just uncovered the mapping and to the extent that we go through — if I enter 15,000 terms and said wow, that covers it for 95 percent of what we do, that is true. The fact that the tool uses this other thing that has been a hidden gem, these concept names, which happens to relate to human professionals, that is–

MR. SOONTHORNSIMA: I think we can describe that as a vision but not necessarily as a recommendation. In other words, I think it could be done today. I am not sure it could be done today because if you are trying to say that we are going to delay ICD-10, which we are going to delay anyway. We are delay it let’s say five more years, three more years, two more years, whatever timeframe.

PARTICIPANT: We won’t start getting ready until the year before.

DR. SUAREZ: What you are saying I think we can say today and we are already seeing that with the paradigm shift in meaningful use. So we are already moving to a vocabulary base. There is no question about it. When I am getting lost it is really what does that have to do with respect to the decision of using ICD-10 for billing? That is all.

DR. TANG: I see what your question is. So let me — we are essentially guiding the industry on the way to implement ICD-10-CM. The way you are doing that because we are saying EHR vendors, as we said in Meaningful Use Two, you should be asking providers to code in SNOMED and, by the way, we are going to provide the mapping for you and we do have a tool that we are going to vet, but it shows some of the power. You have been saying, oh, our physicians can’t code in this arcane terminology. It is possible they can code, not sure we want to prescriptive but you have to use SNOMED.

DR. SUAREZ: No, no. It is already adopted.

DR. TANG: I understand that but instead of using ICD-10 for billing.

DR. SUAREZ: That is why I see this opportunity of saying exactly what you were saying. Then adding to it as part of this there should be a standard certification criteria requirement that EHR that is now standard coding SNOMED for problem list and diagnosis be capable of translating that into an ICD-10 using a national standard map developed by the federal government.

DR. TANG: The difference is if we describe this as the way to get to ICD-10-CM. It basically, it is like the National Quality Strategy. It basically lays out a national strategy. People can decide to code in ICD-10. They can still decide that but the national strategy that takes us into a different place is to go via coding in SNOMED.

DR. WARREN: Let me rephrase what Paul is saying because I just got a little glimmer here. What we use, because we have already we are coding in SNOMED, which is a much more clinical useful terminology for our clinician, much more useful to encode clinical decision support, on and on and on and on, we can now use the iMagic that we saw because it ties a lot of things we talked about today. We could take that tell people billing is still going to be in ICD-10 codes. You are used to doing ICD-9 so your vendor should help you make these transitions. It could be that there is a look-up table or you can do a search or whatever. We now tell the vendors you need to provide this and, oh, by the way, you can test your stuff by going to iMagic because iMagic is accurate and it is the benchmark. Remember we have been saying we want the test beds and how we can look at how well they are doing that, and you might also want to contact the iMagic folks, because maybe some of the tables and the relationships that they built behind that might work within your software. If you have got a relation database that is underneath your software, you should be able to pull those tables, add some queries in there, maybe change your code a little bit and get that.

MR. SOONTHORNSIMA: How much more vetting is it going to take and how long is it going to take to test and validate that theory at work. That adds additional time.

DR. SUAREZ: That is part of the reason why the delay. I mean part of what the delay will help us do is test that and ultimately if this gets incorporated into an EHR certification criteria, this ability to map — technically the start of the Medical Use Stage Two is October 1st, 2013, coincidently for hospitals.

DR. CARR: You kind of have engineers that can write the code to meet that.

DR. SUAREZ: No exactly, so the idea is that it would be also delayed I mean that is the use of that capabilities.

MR. SOONTHORNSIMA: I don’t know that. I mean how do we know that. Do we have to validate that with the industry?

DR. SUAREZ: I know, I know but this is just purely staging sort of the overall goal. I mean the vision.

MR. SOONTHORNSIMA: So does that add two years, three years, four years. I don’t know.

DR. TANG: Certification is 2014. That is very coincident, so it is really all about the mapping. IMagic is just an interface to that. So what vendors can incorporate is the mapping of the 95 percent. So I think there is a conceptual point to make so that she can consider in her MPRM and get comments if she thinks that that is something that they can consider. She still can do whatever she wants.

DR. WARREN: Also it ties together like Leslie was wanting. Let’s look at this as one big effort that has multiple faces.

DR. SUAREZ: I think we are coming down to, yes, we want to draft a letter even if it is primarily to do that highlight point. We can mention to the Secretary we are going to provide her with more assistance and really point to this element that we have highlighted. Just in the interest of time I think we will try to draft a letter and then present to the Committee.

MR. SOONTHORNSIMA: We want to time box the delay. Otherwise we are not making a suggestion.

DR. SUAREZ: That is an important point. We just have to know to say that but if they tend to delay then this is, as long as we see it, recommend doing otherwise we have a pointed why, say it. We can discuss the delay details tomorrow as a Full Committee. I want to really get to the other points, but we will and thank you, Paul. I think it was an excellent point that you bring into the Committee. We will have a separate probably very short one-page letter that highlights these elements and advise the Secretary or mention to the Secretary that there will be some more.

DR. CARR: So when is this letter due?

DR. SUAREZ: Tomorrow at ten a.m.

PARTICIPANT: You are free in the morning because we are not in Privacy.

DR. SUAREZ: We will draft it and again present it to the Committee and we will have a chance. I mean certainly we hope that we will be able to clear this letter very quickly and then be able to spend more time on this other letter.

So, okay, the main other purpose of today’s meeting were primarily to review these three letters and then review the schedule of all of the things that we have got to do in 2012. So to start with the three letters, I think we have one letter, the claim attachments letter, which I think there was consensus on pretty much the letter. There are some edits that I know Sally sent.

DR. WARREN: There are some edits that Sally wanted. When I took a look at the substance of them, most of them are grammatical edits but she did want some format changes that I do not understand what she wants. We are going to have to get together with Sally. It is kind of like reconstruct this in the same format as the above sentences. I don’t know what those are.

DR. SUAREZ: I fail to understand that actually because I think the way we have written some of the bullets and some of the description, there is different uses sometimes of a verb.

DR. WARREN: The rest of that is changing instead of and/or it is an or. One of them is this is to this is to say that. They are edits like that. There is nothing that is substantive.

DR. SUAREZ: Substantive or substantial or any other changes.

DR. WARREN: It is more grammar so we can work with that.

DR. SUAREZ: Anything other changes or questions on the claim attachments letter? Again, we will incorporate those changes that have been made. Going once, going twice. Certainly during our work in preparing for this, your input was all very, very valuable.

Okay, so we are going to prepare the final letter and present it tomorrow and mention the changes that we made today. We will do it in redline so people can see what the changes are.

All right, the second the letter is the letter on 10109.

DR. WARREN: Right, and from everything that people gave me there was only one request for change and that is on page three, the second paragraph — and if you look at three lines up from the end that starts licenses, residencies, fellowships and then we have litigation history. It was brought to my attention that we probably want to delete that and insert malpractice claims history because most of malpractice claims never get to litigation. If it is important to have that information then that is what we should have in there. We will make that so.

DR. SUAREZ: Anything else on this letter? Okay.

DR. WARREN: Then on the DSMO letter, we really didn’t discuss it in Committee. Upon reading it again, does anybody have any edits or changes?

DR. SUAREZ: Let’s take first the Committee and then we will take other advice. I think I have one actually and it was more of a timing issue. Recommendation number one as we explain it here, it says that we recommend the convening immediately of this group. It might be somewhat confusing to everybody what this is about and how is it different from the group that has been convened by CMS and all of these things. So I am not sure whether it sees that group has already been convened, this particular recommendation still makes sense.

DR. WARREN: I have a suggestion for that, that we not make it recommendation one, but say in collaboration with CMS we recommend the following and then at the end this did occur and put the date on there.

DR. CARR: Actually we met once right but the recommendation is that we continue to meet and so maybe that is how we frame it.

MS. DOO: Also this one is specifically related to the Capital DSMO which is the organization made up of the SDOs and the co-contact so it is not quite what we did.

DR. CARR: So it is not the Tuesday meeting.

DR. DOO: Right, it is not even an adjunct. The DSMO is an issue and there are issues about their role with respect to the change request. What we were doing is really related to how the industry is responsible. Whether we had a DSMO or not, this is more on how the actual organizations were working together. So you would be safe with that.

DR. CARR: It was different than what happened Tuesday.

DR. DOO: Do we want to capture anything about what we did on Tuesday?

DR. SUAREZ: I don’t know that we wanted the letter to capture it but my sense is more this group, that is why I was thinking instead of you know we recommend to the Secretary, encourage her to convene a group, I was thinking we can recommend that Secretary continues to convene an intensive working group for the purpose is to address this issue so that there is a continuity of what started on Tuesday. That is an opportunity that we want to see happen.

DR. WARREN: Is that going to confuse people that they think that what happened Tuesday was this activity. This activity is different from what happened Tuesday. This is specifically about the Capital DSMO, that organization.

MS. DOO: This is to evaluate the strengths and weaknesses of the DSMO process of change requests.

DR. SUAREZ: We can keep it that way. Just leave it that way and not even modify it. That group could be a different group.

MS. DOO: This is supposed to be about the November hearing so the other option is you could do a postscript. After the hearing we got feedback additional feedback about issues within the standards and operating organizations and we should notify that we had the first of what we hope is expect to be many meetings. So you could do a postscript or leave this as is.

PARTICIPANT: I say leave it as is.

DR. WARREN: I think there are going to be other opportunities to refer to the meeting Tuesday as we go on with the operating rules.

DR. SUAREZ: So what are we saying again?

PARTICIPANTS: We are going to leave it alone.

DR. SUAREZ: Leave it the way it is and not say anything? Okay good. Any other comments from the Committee members? Anybody else want to make a comment?

MS. LOHSE: Gwen Lohse from CAQH/CORE. One quick comment on recommendation three, which is a testing. I think talking to a few people during the lunch period everyone was extremely supportive of that recommendation but two things they wanted to ensure were clear. One was the rationale for why because the rationale on the other two recommendations are really clear. So is the rationale for the testing that it be technically feasible or is so that its implementation is easy or is that there is industry buy-in and support. Why for the testing? There could be a number of reasons all of which are good.

Then the second is there may be some instances where the testing isn’t necessary so ensuring that it is not all encompassing. There could be instances where you have a new operating rule for instance where you don’t necessarily need testing because it is more of a policy. Just ensuring that is not all encompassing and it recognizes —

DR. WARREN: Is your question about those standards and operating rules?

MS. LOHSE: Yes, I think it should be across that.

DR. WARREN: That is what the recommendation is about.

MS. LOHSE: Absolutely both standards and operating rules so rationale for why for both and then ensuring that this is not all encompassing for either standards and operating rules recognizing sometimes you may not need testing.

DR. SUAREZ: So I totally understand the second point and we can probably insert in the beginning of the recommendation of it too where it says of an existing standard operating rule when appropriate.

DR. WARREN: We want to be careful, because right now we are implementing 5010 without testing and we are finding out there are all kinds of problems. So that is what we are referring to here. Whatever it is needs to be tested so that we can work the problems out before it is a problem or implemented rather.

DR. SUAREZ: Whatever is being implemented we want to test it whenever it is appropriate again, whenever it makes sense. In other words because there are some like, I think when it is mentioned, there are some operating rules that how do you test?

MS. LOHSE: You may go for instance from twenty seconds real time requirement to fifteen seconds real time and there really is no way to test that. I am sure there are examples within the standards I am not thinking of.

MR. SOONTHORNSIMA: Gwen, to your point, I think when we were discussing this, there were a couple of things that we talked about. One is practicality in terms of an applicability but practicality is really the main issue. It is whether or not these rules, if we were to implement it or the standards, is it even practical. The second thing is, is it implementable. Those are two areas. In fact I remember I know there were other dimensions we discussed but those are two critical ones that I think.

MS. DOO: I think you are safe if you use something like appropriate because we have done this now twice, the 4010 and 5010. We have not implemented operating rules across industry yet. I don’t think you want to give up the opportunity to figure out what you need to test before you take that off the table. So I think saying as appropriate is appropriate but do not lose that opportunity again.

DR. SUAREZ: I definitely see that it is very critical and that is why I wasn’t sure about your second or your first point about the stating better that purpose or the rationale for testing because.

MR. SOONTHORNSIMA: That is why if you just apply examples or qualify it by saying testing for practicality.

DR. WARREN: Don’t you think by example people think those are the only and we don’t want to get into one only. We want to keep the options open.

MS. DOO: Again implementing it, the version 4010, it is to make sure that these things will work. You don’t know what is going to be wrong. Just to use one that has been trampled to death is the P.O. Box issue. All good intentions were there. You don’t know yet. What you want to make sure is that there is going to be a good foundation for implementation and personally I wouldn’t want you to limit yourself by saying only because of this experience. You need this door open so that we can figure it out.

DR. SUAREZ: So do we need to add a sentence someplace to that point?

MS. BANKS: Just to qualify the term appropriate and to determine, when appropriate. When appropriate is kind of scary. What are you trying to measure and how can you get it in a different way. When would you not do a pilot test and I think pilot is what is scary. It is costly.

DR. SUAREZ: There is no word “pilot” in here. We talk about testing only. There is no word pilot in here.

MS. LOHSE: Maybe there is a sentence at the beginning to say there is strong support for mandating a form of testing throughout the standards and operating rules to have successful implementation. Then you have a sentence as is, and then say there may be some instances where this is not as appropriate. So you are ad in two sentences. Just an idea but it is one about the rationale and one about the appropriateness.

DR. SUAREZ: We already say there should be a mandatory testing requirement so that author and entities. I guess standardization and authorization. We should insert that definitely.

DR. WARREN: Read the first sentence before you start editing back. The recommendation is should require that before a new standard or operating rule is to be adopted or a new version of an existing standard or operating rule is to be implemented, testing is completed and findings included in the submission of the recommendations to NCVHS for consideration to adopt.

My thing is do we conceive of a time that NCVHS is willing to recommend something when they have no information about it. That is what testing is. It is like giving us a black box and saying, take the black box and go with it and I don’t think we would want to recommend that. We would want testing of that. We have been in situations before where that has happened and the results have not been good. So I am not sure adding the words “when appropriate” is going to do anything.

MS. BANKS: I think what the comment was generated was ran into with the pilot testing and when the definition of testing was used and they then.

MR. SOONTHORNSIMA: That is why one of the comments I made was testing to be interpreted in a different way, this way. I wanted to refine it a little bit further. I know exactly what you are talking about. We were not talking about the pilot. We are not talking about technical NEN testing. Those are the primary limitation issues. So we are trying to finds words in our conversations.

PARTICIPANT: Yes, but is the goal to help the implementers to have.

MR. SOONTHORNSIMA: Before we make this NCVHS rule we want to make sure that these things have been vetted. Once the industry embraces it, it is practical, pragmatic and it is implemented.

DR. WARREN: We further say though, NCVHS will work with HHS to refine existing criteria and develop existing criteria to consistently evaluate the readiness and adoptability of the new standards and operating rules. Doesn’t that say what we want?

DR. SUAREZ: I think and really when you read it that way I think we are covering basically the concept.

DR. WARREN: It said the same thing about three different ways in the paragraph.

DR. SUAREZ: Conceptually it should be required and the criteria would be developed. That is where we can insert in that criteria some of the concepts.

DR. WARREN: HHS should also consider working with the industry to establish some simulation and testing in laboratory environments where a new or revised versions of transactions and code sets can be appropriately tested prior to adoption.

So you even have the opportunity to participate in developing the test.

DR. SUAREZ: It actually reads good I think.

PARTICIPANT: Would it be appropriate to ask for funding?

DR. WARREN: Yes, I got funding for this year.

PARTICIPANT: I didn’t know if you needed to ask for funding in here because if you do do the pilot or you do any of the –

DR. SUAREZ: I think they already have funding. Steve, do you have a comment?

MR. LAZARUS: I have an observation and I don’t have a hard copy of the document. I saw it online this morning so I haven’t had careful study of the other documents.

DR. SUAREZ: Could you state your name?

MR. LAZARUS: Steve Lazarus, Boundary Information Group. I am here with CAQH/CORE. We actually went through an exercise similar to this very recently for this Committee. The eligibility and claims benefits operating rule had gone through a fairly rigorous operational experiment if you will with a number of voluntary providers and health plans for over a year with a formal ROI study before those operating rules were brought to this Committee. I think what we are asking for is enough leeway in the wording of this such that if the Committee would accept that kind of test, if you will, that they could in their own judgment use that as evidence to go forward with adopting and implementing standards or operating rules, as opposed to being dependent in every case by funding through the federal government, structuring a test through the federal government and taking the two to three years that that whole process would take. There will be times when that won’t be necessary.

DR. SUAREZ: I don’t think that the only way we are expecting testing to happen is through the federal government. We are just saying actually one laboratory could be that.

Number two, I think that example you gave is a perfect example of a testing and experimentation of the specific standard operating rule that is coming forward to the Committee. So I think that is a perfect example of the kind of thing that we are looking for and I think thirdly, as Judy pointed, we are saying NCVHS will work with HHS to refine the existing criteria and adopt additional criteria for that testing. I think we are leaving it very open to allow us to adopt and to correctly define the requirements and to based on the type of standard operating rule, expect the type of experimentation or testing that would be needed. So yes, I think that would take care of it.

PARTICIPANT: I am trying to think of lots of whether it is not just standards, OASIS internet, all the different aspects that may have to do with a standard or rule so just consider those.

DR. WARREN: But we don’t want to specify that.

We want to have the process so that helps so if you do have RO1 testing we can take that and there is money in the feds. We can use that. If we get to prescriptive in the recommendation, then we eliminate all of that.

PARTICIPANT: Agreed. We just wanted to make sure that it was viewed as open ended and that there would be that flexibility.

DR. SUAREZ: Great, okay thank you. Yes, go ahead.

MR. BARTOW: Pete Bartow, Price Waterhouse Cooper, just one consideration on the last sentence where HHS, you say new and revised versions of transactions and code sets. I would include operating rules there. Like leave the intent of the ACA is not to implement another transaction or new transaction operating rules. We are in catch up mode right now with existing transactions.

DR. SUAREZ: Thank you, yes. The last line of where it says new codes and operating rules can be appropriately tested.

DR. WARREN: Right, thank you.

DR. SUAREZ: Any other comments from anyone on the Committee or anybody else? Anyone on the phone with comments? Okay, well I think the appropriate procedure here is to take a motion if that is okay. We can take a motion of the three letters at the same time if people feel comfortable. So I will entertain a motion to approve the letters that we have presented with the small edits that we have discussed and agreed on and move it forward to the Committee.

DR. WARREN: So moved

DR. CARR: Second

DR. SUAREZ: We have a motion and a second. Any additional comments or discussion? All in favor say aye; Any opposed? Any abstentions?

(On motion duly made and seconded the three letters presented were unanimously approved.)

All right, thank you very much. We have approval of all of the letters.

The second item that we want to discuss is the work plan that we have developed for the Committee and I believe it was included, the PowerPoint presentation to the members of the Committee. I don’t know if it is loaded. If not, I can present it.

While we wait for the presentation, I think the other important point of discussion, and I forgot about including it in the agenda, but we do want to discuss the process for identifying and recommending an authoring entity for operating rules for the remaining transactions. Let’s take that one first before we go to the entire work plan for the year because I think that is part of actually the work plan in there.

The point is basically or the need here is basically out of the meeting that was convened by CMS a consensus agreement came out on identifying a single coordinating organization that will help prepare or will be ultimately responsible for preparing and delivering operating rules for all of the remaining transactions. That organization will be the main function will be that it will be the accountable organization for delivering those operating rules. That organization could play a coordinating role. It could play a role of drafting and preparing some of the operating rules and it could also work with, in partnership with other organizations, to develop the operating rules for a specific item.

For example, an organization can prepare operating rules for some of the core elements of the transmission and security and some of the common business requirements of transactions. Then when it comes to specific operating rules for a specific type of a transaction like claim attachments, that organization could partner with the appropriate SDO and appropriate other entity that has the expertise in that content to help develop and prepare those operating rules. That was the essence really of the consensus of the group and so at the end of the meeting the question was so how do we proceed. How do we call for that?

What we wanted to bring to you and present to you was a simple process basicaly, which is the following. Number one we have in the past been very open in terms of asking for organizations that are interested in serving in that role, in the role of an authoring entity to come forth and present a proposal. Then we evaluate that proposal based on a very strict set of criteria. We ask the questions in advance of that proposal and they respond to those, that has been the process that we have followed. I think what we want to do this time is open it as well and send a request for any entity that would be interested in serving in that role.

But then specify the criteria and the requirements that this organization will have to play the following roles and define those roles as coordinating, expected to partner with others, expected to engage all of the other partners. We did hear from all of the partners on Tuesday, all of the organizations that were present, their commitment really to play an active role in the process, whichever organization is appointed and selected. We expect that whichever entity gets selected and recommended by NCVHS that the other organizations will be engaged with that organization that has been selected as sort of the entity to coordinate all of this. They will be then altogether working toward delivering the operating rules for all of the remaining transactions.

Clearly one of the concerns I think that we incurred and we pointed to was the fact that there are five new transactions, number one, new transactions in terms of operating rules. So five transactions remain to have operating rules be written. One is the claims transaction: not an easy one, a very complex large one. Number two is enrollment transaction, the transaction between the purchaser and the employer and the health plans that enroll the employee and other exchanges like that. Premium payment, payment for premiums; referral authorization, the pre-op if you will transaction, another very complex one and then claim attachments, a very extensive one that deals with all of this attached that we talked about earlier.

Having five transactions, having all of those transactions, no operating rule whatsoever being written at this point that we know of. There are some things about the business component of those transactions that have been explained and expressed in different documents, but really a lot of companion guides written about how to conduct those transactions, but really no operating rules developed at that point to do this on the content side.

So having those five transactions, brand new operating rules will be developed, is a very complex task that if this selected organization will have to work very collaboratively and in partnership with all of the other organizations.

The idea again would be for us to put out a call, a request for entities that are interested in serving this role, and then define a criteria based on this new concept, based on this new expectation that this organization will play according to rules. It will have to engage and actively engage other partners. It will be expected that they will have to partner with some of these other partners to help develop these operating rules.

All of those elements and then ask for submission of the responses very quickly. We are really trying to turn around this very quickly because of course that entity will have to begin working immediately on those five transactions to be able to develop operating rules over the next year. There will be prioritizing. There will again be partnerships, all of these things.

The idea, and we are not prepared here to present to you all of the criteria, but the idea is to develop in the next few days, the criteria that we will use to evaluate them and present it to the Subcommittee. We will probably have to convene a Subcommittee meeting in the next couple of weeks to present the process and then put a call for this solicitation I guess for the entities interested in the submission. Then very quickly turn around that and be able to analyze that and prepare a recommendation that we would then present to the Full Committee at a meeting that I think we will have to call for.

The Full Committee I know we have, we reserve certain Fridays, one Friday of every month to a Full Committee meeting so we will probably ask for that Full Committee to present the recommendations of that.

That will be the process. Ideally it would be able to be completed by the end of April or sooner. I don’t think sooner, but as soon as possible and we really don’t want to go all of the way to June because by June it would be way too late. The entity would not have enough time. So we really are trying to target like the end of April to present the recommendation to NCVHS. Let me stop there and see if there are any questions. I know it is a lot to try to discuss here, but are there any questions or suggestions of the process or concerns about the process? Anyone from the Committee?

DR. CARR: Just the time line, I think really we owe it to the applicants to make the application process as streamlined as possible, the application itself. Then have that process move quickly.

DR. WARREN: Tell me what you mean by streamlining. You mean not submit as much material as we have had them do in the past?

DR. CARR: I think we have to look at that because the amount of work that needs to get done in a short amount of time. I think we have to re-look what we would want the first time.

DR. SUAREZ: I think the idea is to make sure that the applications are not so extensive that it would take a month to submit.

DR. WARREN: I think that would require that Walter, Lorraine and I get together and take a look at the previous applications and really analyze on this to what information was essential for us to make our decision with and what wasn’t. Is that what you are suggesting?

DR. CARR: I am afraid to answer that but, yes.

DR. SUAREZ: Then after that, a development of new criteria, which is the new criteria that came out of the meeting on Thursday. I honestly think we can do that in the next probably week and a half, the three of us get together, develop it.

DR. CARR: But I think we also looking for a new skill set. This is a coordinating body that brings in the content experts so there will be new criteria.

DR. SUAREZ: All of that is already listed. I mean I personally have already drafted some of that, believe it or not, based on the meeting that we had. We need it to move very quickly. I am not ready to present it because I haven’t shared it with Judy and Lorraine but I already have the draft of sort of the new criteria built on the old criteria. We will have to go back and see which things make still sense and all of that. But then what we would do is convene a call of the Subcommittee very quickly, probably in the next week and a half, two weeks, to present the criteria, discuss it and agree on it and then solicit or basically put it out for responses.

MR. SOONTHORNSIMA: Since you are not telling us what the new requirements are then how extensive do you think these requirement are.

DR. SUAREZ: No, they are not. They are not extensive. They are basically more expectations and understanding of what is expected from the organization that will come forth.

MR. SOONTHORNSIMA: I guess what I am talking about in terms of extensive is qualification, I guess if you ask for specific qualifications in order to fulfill this role. That it is a different role.

DR. CARR: It is a different role and I think the qualification is demonstration of previous effectiveness in these types of activities.

MR. SOONTHORNSIMA: So I think we have to balance these additional criteria, specific role expectations and what not plus the skill set in the qualification. With the scope of more commitment and the responses that the organizations have to respond to and how we evaluate those things and how we score them. I am just thinking that two months is very tight.

DR. SUAREZ: We understand and the good thing is we have already a process in place. The new criteria are very important, very critical so we have to adapt that and make sure that it is documented and that the documentation is simple. We are not going to ask for a 500-page application or anything like that.

MR. SOONTHORNSIMA: So you are saying that within the next week or two we will vet through that as a committee?

DR. SUAREZ: Absolutely.

MR. SOONTHORNSIMA: Got it. Before we get the RFP?

DR. SUAREZ: Oh yes, exactly. The idea is with this subcommittee we will hear first the criteria and evaluation and this timeline, the actual timeline by days.

MR. SOONTHORNSIMA: Do you think the Committee can get an early peek at what you are thinking that way we can be prepared?

DR. SUAREZ: Early peek?

PARTICIPANT: For example, I mean this s not exhaustive but some of the things the Committee.

PARTICIPANT: Otherwise, we won’t have time to react until the day of our meeting.

DR. SUAREZ: Like today or right now, here? Well some of the criteria clearly included an organization that has, the basic criteria we had before. It is open. It uses online processes. It is documenting the process. It is transparent. It is inclusive of organizations or all of the different types of organizations involved. I think that some of the new criteria is really the ability to not only write the operating rules but also partner specifically with certain entities that provide the technical knowledge for certain specific transactions that can be then put together.

The expectation will be that the entity that responds will be able to demonstrate an ability to partner with those other organizations. They have already, in some cases, partnership agreements between these organizations so they can demonstrate some of that too. It is really those areas and of course there are five transactions that we are going to have to really point to some general evaluation criteria and then some basic criteria about how do you approach the operating rule development for this transaction and those kinds of things. But in very short and particularly very short simple sentences. Not only do we not want them to be spending a lot of time preparing and have to give one or two months for them to prepare it, but on the other hand we don’t want to have a major, massive document to review, or a series of documents. We won’t have time to do it. Lorraine, do you have?

MS. DOO: Well you might not have seen the original application if you will which pretty much was taken out of the statute which said, as Walter said, that you have to be a nonprofit organization and so we said please provide documents that demonstrate you are nonprofit. We have to have a transparent consensus-based approach, please give us the document that descries your voting procedure, so they provided that. It wasn’t, it is not that it is onerous. It is that to do it multiple times when you have done it is cumbersome when you can pull out that information.

Then there were a couple of other requirements again from the statute like the operating rule that you write has to accommodate acknowledgments, so there had to be some description. Given that we don’t have anything on a piece of paper yet for these next five, then it will be more of a strategy of how they are going to determine what would be in this first set of operating rules.

I think the other thing that kind of hit us on the head is that this next set of operating rules, it is not inconceivable that somebody could come forward and say we don’t even need operating rules for enrollment other than let’s say the security requirements, or the fact that it goes over the Internet or the response time. We have that in what I refer to as the infrastructure. We have those and so you don’t need a comprehensive thing. But for referrals and authorizations, given that very few people are using it because there are issues with the standard, there might be some operating rules that industry could come together around.

It is to demonstrate that the organization has the capability and skill to bring the right people to the table to determine that and not feel like they have to come with a done cookbook for everything that is really extensive.

One thing that would improve the use of the standard or increase the use of the standard might be what would be okay. So much of that is done and it is not that it is onerous. It is putting together a package and we also limited every response to one page. I can send you what was done, what the application if you will looked like. That might give you some sense of what it is. Would that be helpful?

PARTICIPANT: Yes.

DR. SUAREZ: Okay, so everybody understands the process that we are going to follow. Again very briefly, we are going to develop a criteria — first Lorraine, Judy and me, build on the previous criteria plus the new. I will send it to the full Subcommittee. We will convene a call to discuss to it and then we will release the request and then expect a relatively quick turnaround. Then we will review the responses and make a determination and make that recommendation to the Full Committee. Is that a good summary? Any additional comments or questions from the Subcommittee? Okay, we will move forward with that. Thank you.

Then the last item is this discussion that we had on the work plan. Was this included in the books? This was included in the books. Has this been distributed to the Subcommittee? The Subcommittee has seen these slides. So you should have probably received these slides that summarize basically what has been done in 2011. So the previous two slides really is a quick summary of what is completed in 2011. In the interest of time I am going to skip those and go to the proposed work plan.

The proposed work plan we tried to organize it into the various activities we regularly do, some new activities we are going to potentially be able to do, and then in the timeline basically sort of a round of meetings of the Full Committee just because of taking advantage of everybody coming.

The first three months, between now and the end of March I guess, the first quarter, we are now completing these letters on claim attachment, Section 10109. We are completing the process for identifying and recommending an authoring entity and actually again that is probably going to move more into the March through April. That is the bulk of the first part of the work that we are going to be doing. Then what we were recommending was to hold our hearing on the status of 5010 and the preparation and transitioning plans and then now that at the whole discussion about ICD-10. And then also a hearing on the preparation for the upcoming implementation of operating rules on eligibility on claim status which start next January. The deadline for compliance is January of next year. Potentially other topics like the health plan ID if that is something that comes out before that. So there is an opportunity to have a pretty significant hearing in June dealing with all of these issues. That is one topic.

The ICD-10 discussion we can see if we need to move it forward, do earlier to try to gather feedback and make a more formal recommendation of ICD-10. Then we would receive our annual DSMO report that is in the previous slide still. At the bottom you see the previous DSMO report. Usually we will ask for a DSMO report by June, I guess, to understand what is the status of that. Usually the DSMO should give us a report explaining not just what kind of changes are coming but we would also hear about the evolution and work being done in the new version, the next version of standards.

Now just a point of information, you all might have heard or hopefully all heard that the committee that is developing the next version of the X12 Standards, X12 Committee is evolving a new version of the standards, decided not to formally recommend to the DSMO. The X12 Committee, which is a member of the DSMO, is not recommending to the DSMO the adoption of 6020, the next version of the standards. 5010 is what we started adopting in January of this year. So they are not going to recommend to the DSMO and so the DSMO is not going to recommend it to us for us to forward to the Secretary.

Then there is going to be questions about what is the next version of the standard that is going to be developed. In fact, part of the issue about the adoption of 6020, any recommendation of any adoption of 6020 was a concern about would we be talking about the testing and the ability to show the practicality, the implement ability of this new standard. The fact that 6020 had been completed in terms of the development just a few months into the implementation of 5010 which was the very first time we were really going to be able to implement and test and see how 5010 worked then be able to improve 6020. There are a number of decisions and points about that and so we are probably going to ask the DSMO to tell us a little about what are the plans for the next version of the standards.

That is what is happening the first I guess six months of this year. The next slide is a proposed work plan for the remaining of the year. Certainly one of the items that we always work on is the HIPAA Report to Congress. It will be the eleventh report. We expect that this will not be the extensive report we prepare but more of an update and summary. I am sure it will include a number of points about 5010 and ICD-10 adoption and all of the things that are going to be happening. That will take us through September, I guess.

Then the other items here are really more activities that we are looking at doing as well that are new work items for us. These are not necessarily coming from any federal law or requirement, ACA or HITECH or otherwise. These are new areas that we are proposing to consider the Subcommittee begin to focus on.

Let me talk about a couple of them very quickly. The first one is public health data standards. I think our Subcommittee, the Standards Subcommittee has been focusing so much in HIPAA for so many reasons as you all know. Really one of the major aspects of what NCVHS is all about, the National Committee on Vital Health Statistics, which is public health, and one of the major elements of what our Subcommittee is about, which is standards, we have never really brought them together in this Subcommittee.

So what we are proposing is to put some dedicated focus and attention on the issues around public health data standards. This we can do actually jointly with the Population Health Subcommittee. It is really looking at the status of the development and implementation of public health data standards, standards being used in the public health realm, messaging and vocabulary standards and how they relate to all of the other work that is happening in terms of EHR adoption and exchanges of EHR with the public health as well as the standards that public health uses to collect population based data, all sorts of things.

We thought it would be a great opportunity to bring those two together, including this additional topic of public health information technology architecture, which is evolving. It is a very interesting area that is being developed and bring together a hearing by September of this year where we would invite testimony from different organizations that are dealing with the public health data standards. Then be able to make recommendation to the Secretary on how to accelerate the adoption of the standards and how to take advantage and perhaps even provide some support for this work on public health data standards.

There is a lot of organizations that are working, of course, on this starting, of course, with CDC and naturally there is a Joint Public Health Infomatics Taskforce, JPHIT, as we call it, which includes seven national public health associations representing the commissioners of health, an epidemiologist in every state, representing all these organization, the individuals and offices in the state, association of health statistics that has been representing the Center for Health Statistics in every state.

All of these organizations join the Joint Public Health Infomatics Taskforce and they are very interested in engaging this discussion of public health infomatics standards. So there is a great opportunity to bring that back, if you will, from the HIPAA world to the public health realm and really provide some important contributions to the advancement of the adoption of public health standards in the country.

That is one opportunity and we have between now and September to organize this hearing. I know a number of organizations that have expressed a lot of interest in this type of idea. That is one.

Then the other topic is really a topic that I am even wondering about now. This topic is about personal health records. Interestingly enough there were some comments being presented and discussed at the HIMSS meeting. This happened a week or so ago. Almost declaring and then again this is the perspective of some people, but declaring the person health records death, the concept that the personal health records that the vendor is really putting out products that are sold to consumers to allow them to maintain their personal health record information and then be a profitable endeavor or business opportunity, I guess, not really being very successful. We all know what happened to Google Health and even to Microsoft’s Healthvault and some of that.

Beyond the fact that whether or not, and I am not supporting or judging or giving full credence to that, but certainly there was that posing of that question. Where are public person health records? In any case there is some questions or some interest around what are some of those standards around personal health records or whether we call it patient portals as another way of looking at this or whatever we call them.

That was one topic that we thought could be looked upon and brought in to the work of our Standards Subcommittee, and could be the focus of our November meeting.

As we were debating or discussing this one, another topic came about: a very interesting topic too and that is the topic of mobile health, mHealth, and its relationship and use in public health again. There is a lot of work being done in the mHealth space. I mean ONC and others naturally are working towards how that relates to EHR standards or how it relates to all of the work that is being done for EHR adoption and implementation. But the perspective that we can add to it is really the perspective of mHealth as it applies or relates to public health.

Those were some of the topics that we wanted to bring to the attention of the Subcommittee. Let me stop there and begin to get some feedback on that, Bill and then Justine.

DR. SCANLON: I agree with your rationale for why these are very important topics. But I also remember what you said at the very outset. We do not have a statutory charge to deal with these topics. I think this is one of these cases where we are going to have to worry about the perfect being the enemy of the good. We may be sort of HIPAA overdosed, but the problem is HIPAA is still so important and so massive in terms of our capacity that I am not sure we can afford these in this timeframe.

Part of our letter, one of our letters is we have to have a strategy about how we are going to deal with all of these conflicted HIPAA priorities. That is really worrying me because administrative simplification is in some respects should be the one no-brainer where we get some control over some aspect of costs. It is like nobody should be arguing with us that they want to keep things complicated so we can send more. So our goal here is really I think very important and historically the Committee has been a public health committee but then it got assigned the HIPAA task and the HIPAA task has suddenly exploded. So I really worry about trying to take on something like this in addition to all of the things that talked about with respect to HIPAA.

DR. CARR: I am looking at this because each of these items, if you look at all of the hearings, that is already commitment of a day or a day and a half, and the work to synthesize and develop the themes and integrate that is really, I don’t even know, countless hours that you guys have put in to do these things.

I think I would like to see a column that says how many hours is expected. I think we have to have a threshold number of hours a Subcommittee can take on. It is just an extraordinary amount of worthy but very labor intensive work.

DR. SUAREZ: One quick comment about the timing. We were putting this, aligning it throughout the year. After our June hearings, as we plan it here, between June and December, fortunately for us we are not really going to have the intense workload of HIPAA because there is nothing that is coming during those timeframes that we have to prepare and present. The next cycle will come early in 2013, when we have to, and there is actually some slides about that, but 2013 at the beginning is when we would have to look at the attachments and all of this other stuff. But between, if we don’t do any of this, that would be great. I can take off for six months.

DR. SCANLON: We do have the issue of the 10109 sort of topics. Let me just sort of make a more general principle. I think we need to start to program in more time for committee discussions face to face. Again, that last hearing, it was unbelievable, a marathon of 50 sort of, testifiers. We got a stack this high of the written material we got and to go through the transcript, it is a huge amount of information. Except for conference calls, which are not nearly as good as a personal, in person discussion, we never had a chance to really digest and have a conversation about that.

So in thinking about these things, if we can parse out here is how we have to gather the information and here is the time for analysis of that information as a group, I think we will be much better off and in a much better position. It maybe would introduce some leisure into your life. Leisure is a good thing. There is nothing wrong with it.

DR. WARREN: I would like to second that because the experience I had with the Quality Subcommittee this week was phenomenal. We had one day of very intensive hearings and then we had a half day to figure out what we heard. We came to some different understandings about the testimony as we had a dialogue, much like the dialogue we are having now. I think we need to put that in our pocket and any time we have hearings, build in three or four hours of discussion.

MR. SOONTHORNSIMA: If we want to add any additional work, I would find work that is going to compliment the work we are currently doing. For example, the conversation we had earlier today was rich around SNOMED to ICD-10. That is not what we were trying to solve is how do we knock down these barriers. Perhaps if we can focus some of our attention to identifying those barriers concretely, and find ways to therefore we don’t keep pushing these dates out. Therefore we can actually achieve the goal.

Also, while we are doing that, we can balance oh by the way, these requirements are no longer, don’t apply anymore because those were written back in the ‘90s. That is the vetting that I think could be very, very valuable to our committee and to the industry in realizing the investment the industry is making.

DR. SUAREZ: I think that is very much the intent of what we were thinking for the ICD-10 hearing, which we would later. So like I said, we have a series of activities happening. I am not sure what the 10109 activity itself for our committee will be between this June and December. I do see personally, an opportunity to specifically take one of those and these were again ideas so this is a great discussion. I do think that we owe to our responsibility to as a national committee and as a Standards Subcommittee to look at the public health data standard part. Is there anything of all of this in the other parts we can probably not do one. Nobody is going to jump in, but I know that nobody else is focusing and devoting time to this, and there is a lot of interest and a lot of value and opportunity really to have a committee like the National Committee to focus on that. That is the only one that I think in my view, would be very valuable to take on, if any.

MS. WILLIAMSON: I am just going to say you know I am passionate about population health and public health data standards, so in looking at this and I have talked to you offline. Some of the things that we are doing as it relates to developing standards for vital registration. I participate in HL7 in the Public Health and Emergency Response workgroup and the work that is going on there in terms of developing standards. We hear so much from the states complaining that with meaningful use and all of the things that are being developed, no one is looking at their side of the coin of being ready to receive everything. We are building on the EHR side, but population health, will they be able to receive it. I think there is tremendous value in population health.

DR. WARREN: I think instead of that being a Standard Subcommittee issue, it should probably be a Population Health Committee issue with Standards members represented at the committee. Again the Quality testimony that we had on Tuesday, standards came up all of the time and because I was there, I was able to frame where that part of the standards work belonged or to bring where they were not considering standards that would facilitate the work much like you are talking about how do we break down the barriers and facilitate.

I am still trying to find the six months that Walter says we are not working, because HIPAA is going to be, the HIPAA Report from April to September. Every year they say it is a simple little report. It won’t take any time. Consider those resources like crazy and with multiple telephone conferences and multiple group editing, and multiple things, and I am wondering if that might – maybe what we should do is add some face time and decide what the eleventh HIPAA Report will look like instead of having a report show up, having it more fall over the place until we get it where we want it, do some planning like that.

DR. SUAREZ: Nobody is going to write the tenth report again. This will be, in my mind a —

DR. WARREN: Walter, every year I participated and walked right into –

DR. CARR: But what I would say is that we took, you did Yeoman’s work, that was just extraordinary. We don’t need to do that but we need to take that direction that we are the voice to Congress of what is going on: what is working and what is broken. What got fixed this year; what is still broken. Even in terms of what Leslie said and Judy said about the sequential, there is important things that we need to point out. I think the smaller report will be even more effective potentially.

DR. WARREN: Wouldn’t that be a better report being developed by the Full Committee instead of Standards going around asking everybody.

DR. CARR: I think that you raised an excellent point of us working together to do that because we want to take out the re-work, the redundancy.

DR. WARREN: That might be something good to add a three or four conversation to the June meeting about what are we going to do with that report and then have a subgroup or something, that would go on and work on it and bring it back in September.

DR. SUAREZ: Now the public health data standards topic as you can see there, it is expected to be done jointly with the Population Health Subcommittee, but the reality is this dives down into the specifics around the standards part of it. So it brings of course, a perspective and a value of population health and that is why we put it in there as a joint effort.

MR. SOONTHORNSIMA: If we have to take off something, maybe standards of personal health records.

DR. SUAREZ: Clearly, I think that one we can draw upon some of these other areas. I am just really honestly advocating and concerned about the fact that if we leave public health out and this year specifically, where public health is going to be expected to be a major partner with providers and payers, and providers typically on meaningful use, I think not having a place where the focus –

MR. SOONTHORNSIMA: It compliments well with what Jim brought up this morning –

DR. SUAREZ: Absolutely.

DR. SCANLON: Maybe it is an issue of them taking the lead and really doing the bulk of the work, the Population Health Subcommittee, and just as Judy said, there will be some type of participation for Standards but it is not truly a joint effort I mean in terms of it has to be every step has to be the full subcommittee’s turn to prepare and plan this. We are trying to save your leisure time.

DR. SUAREZ: To tell the truth, there is one that is very near and dear to my heart so that is why I was bringing it up. I am a member of the Population Health Subcommittee too, but I think it is very much a Standards work as well.

I guess I am hearing that we are going to drop basically the personal health record and some of the other elements, and we are going to work jointly with the Population Health Subcommittee to discuss the public health data standards activity in the second half of the year. Certainly, the 11th HIPAA report of Congress, will be the focus of a lot of the work on the second part.

DR. CARR: And the claims attachment remember, that we really need to bring that for discussion and vetting to the Committee and to the Full Committee, plus all the departments. I think taking a deeper dive into those things will be valuable.

DR. SUAREZ: How would you suggest we take a deeper dive? You are not saying the full series, right?

DR. CARR: No, I think within the Committee just to define –

DR. SUAREZ: As a committee work. Absolutely.

DR. CARR: That’s right, that’s right but I mean everybody will have work from that. I think we always find, when we set aside time for us to have dialogue and discussion, it helps direct our work and focuses us. I am making my June topics: HIPAA Report; public health standards and population. We will about that tomorrow, the claims attachment, then ICD-10, so far.

DR. SUAREZ: Okay, well I know we are taking a lot more time than we wanted to but the next couple of slides are really about the work on 2013 already. We have to begin to look beyond 2012. Some of the work that we have to do includes the second hearing on claims attachments, complete the process for evaluating and recommending operating rules for all of these new transactions. Again, the process for that and the development of the rules that CMS will be publishing in January of 2014.

Following up on the work of Section 10109, as Bill was mentioning, whatever work plan we develop for that. The next slide is just some of the ongoing hearings which we mentioned hearing on the status of 5010, ICD-10, the status of implementation of the operating rules by that point, the ongoing activity that we have. I think what we wanted to try to do was lay out some of the basic elements of our work plan that are consistent in every year, and some of the opportunities wherever we see there is a space where we can bring up some new issues that are important clearly to the Committee.

DR. CARR: We are seeing that there is no space. What would be helpful actually is to put that on a timeline. Who had a timeline today, in one of the presentations, and really map out this is the hearing day one, day two the discussion. Here is the next hearing; day one; day two and map it out of where are those discussion times and the writing times.

I think that that fail to identify that is and we are drowning. I think we need to put it back into the Committee if we need resources or whatever, but there is work that we are obligated to do. I think that you guys have been heroic but I think we need to not mask the needs of the Committee because you are heroic. We need to map out here is the work that needs to be done.

DR. SUAREZ: I think we need to also be careful not to lose relevance as a committee. As Justine, as much as you bring up the point, I think we are been able to fulfill in incredible ways the responsibilities of the Committee. I am seeing that there is an opportunity to address very important issues and we are just feeling that we need to walk away because there is not time. I think there is an opportunity to bring those and to address those. If we don’t bring it up then that is fine.

DR. CARR: So again, even if you could hand sketch out here is what the next 24 months looks like. I think that would be telling and it also impacts with the rest of this.

DR. SUAREZ: That is exactly what these slides are doing. It is presenting.

DR. CARR: Each one has the thing that says the day and not the work time.

DR. WARREN: Not the time to get the writing done, to get the phone calls in, to get the various committees because we were struggling trying to get all of the calls scheduled. Each person’s calendars are just bad.

DR. SUAREZ: Part of it is also good planning because we should be establishing a monthly meeting. I am a member of the HIT Standards Committee. We meet every month with that committee.

PARTICIPANT: They have a different –

DR. SUAREZ: I understand they are different but I think there are ways to organize progressively and make sure that we can. I am not saying that we meet monthly but we can sketch out a series of times and reserve those times for the year as a subcommittee, also.

MR. SOONTHORNSIMA: That is what she is asking because then we will definitely have agendas and targets every month. It is only gander at the timeline.

DR. CARR: We ought to reserve those times standing. We already have those Friday monthly times, but if we need to have more than that, you really have to get very detailed with the hearings then the follow up, and make sure that there is no overlap and then integrate with the other three subcommittees and now the work group, the data work group.

I just want to commend this Subcommittee for an unprecedented amount of excellent work this year. It really is unprecedented and I thank you for the great work that you have done.

DR. SUAREZ: Okay, any other comments before we adjourn. Great, we stand adjourned. We will be meeting back again tomorrow as the Full Committee. Thank you.

(Whereupon, the subcommittee adjourned at 5:56 p.m.)