[This Transcript is Unedited]
Hubert H. Humphrey Building
Room 705A
200 Independence Avenue, SW
Washington, D.C. 20201
Agenda Item: Call to Order, Welcome and Introductions, Review of Agenda
MR. REYNOLDS: Good morning. This is a meeting of the Standards and Security Subcommittee of the National Committee of Vital and Health Statistics. NCVHS is a primary health policy advisory committee to the Secretary of Health and Human Services.
I would like to remind everyone that this meeting is being recorded and is being heard over the Internet. Also for members and those testifying, please speak into the microphones to allow all involved to hear.
I am Harry Reynolds from Blue Cross and Blue Shield, North Carolina and co-chair of the subcommittee, along with Jeff Blair.
I will now ask each member of the committee and staff to introduce themselves and members to state whether they have any conflicts of interest in today's hearing. I have no conflicts.
Jeffrey.
MR. BLAIR: Jeff Blair, director of health informatics at Lovelace Clinic Foundation, co-chair of the subcommittee and to the best of my knowledge, there are no conflicts with today's testimony.
DR. CARR: Justine Carr, Beth Israel Deaconess Medical Center. No conflicts. Member of the committee.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and Quality, liaison to the full committee and staff to the Subcommittee on Standards and Security.
MS. GREENBERG: Good morning. I am Marjorie Greenberg from the National Center for Health Statistics, CDC, and executive secretary to the committee.
DR. OVERHAGE: Marc Overhage. I am director of medical informatics at the Regenstrief Institute and CEO of the Indiana Health Information Exchange, member of the committee and I have no conflicts.
MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services, staff to the subcommittee
DR. WARREN: Judy Warren, University of Kansas School of Nursing.
This morning, Betsy Humphreys is going to be talking, I think, about the SNOMED and depending on what her report contains, I may have a conflict because I am on the SNOMED Editorial Board.
MS. BUENNING: Denise Buenning, Centers for Medicare and Medicaid Services, lead staff to the subcommittee.
MS. JACKSON: Debbie Jackson, National Center for Health Statistics, committee staff.
MR. BIRNBAUM: Adam Birnbaum(?), Blue Cross Blue Shield Association.
DR. COHN: Simon Cohn, associate executive director for health information policy for Kaiser Permanente and chair of the committee and a member of the subcommittee. No conflicts of interest.
MR. REYNOLDS: Okay. Since we don't have our first presenter until 9:30, Denise, why don't you go ahead and put the letter up if you would and we can maybe go ahead and take care of that -- finishing that up with the modifications to it and maybe have that out of the way before we even deal with our first set of business.
While she is getting that up, after we hear the NLM update and take a break, we need to deal with our proceeding forward on 5010 out of our discussion yesterday. We need to discuss getting the letter done that we talked about yesterday on NPR and we also have to decide how we are going to go forward with the security recommendations that came forward yesterday, as far as moving forward to a reg.
So, with that, Denise, why don't you if you would point out the changes that we made, including back when we renumbered them on the front. If we could go through that, then my goal would be is if we approve this today, then, obviously, we can forward it on to the Executive Subcommittee to look at and then have it ready in advance of the June meeting.
MS. BUENNING: You all have hard copies of this document in front of you. I do apologize in advance for some of the typos on this. They will be corrected. I did this at home last night on a different system and it was kind of difficult to see things.
I think the first change you will see in the document is in the renumbering of the stats. This was at Justine's suggestion because the first and the second stats that were originally designated step 1 and step 2, really run concurrently with each other. So, the suggestion was made to change 1 to 1(a) and 2 to 1(b).
MR. REYNOLDS: Would you read those together so that --
MS. BUENNING: 1(a) is the development of new versions of health care information system standards. 1(a) is development of new versions of health care information system standards by ANSI accredited standards development organizations. Estimated time 1.5 to 2.5 years, concurrent with 1(b). That was language that Justine had suggested.
Then 1(b) is ANSI certification that new versions were developed in accordance with ANSI consensus-based process. Estimated time three quarters to one year concurrent with 1(a). I believe that the other -- No. 2 and No. 3 reflect no changes from the previous version.
MR. REYNOLDS: So that keeps the time line intact because the first two overlap.
Marjorie?
MS. GREENBERG: This is just style, but it is hard to read on this hard copy. So, you might just want to space between 1(a) and 1(b), 2 and 3. I don't think you really need to say concurrent with 1(b) after 1(a). I think you should say concurrent with 1(a) at the end of 1(b) because we haven't heard about 1(b) yet. So, I wouldn't put it there.
MS. BUENNING: I am sorry. So, you are saying delete concurrent with 1(a) --
MS. GREENBERG: I would delete concurrent with 1(b) and then just keep concurrent with 1(a).
DR. FITZMAURICE: I would also suggest a comma before concurrent.
DR. COHN: Marjorie may have said this. I wasn't quite clear what -- was your recommendation consolidating 1(a) and 1(b)?
PARTICIPANT: No.
DR. COHN: I guess I am struggling to figure out why you are differentiating between the two steps. I don't see it really referenced uniquely later on. Maybe I am missing something there. I see 1(a) -- this is concurrent. I don't know that we --
MR. BLAIR: Part of it was that in the actual proposal to us they had broken it down as separate steps. So, in a sense, we are talking about a legacy of tradition.
DR. CARR: My only thought was just that we ought to be able to do the math on the front sheet. I don't have any investment in terms of how it is, but there are three consecutive steps that amount to the amount of time it takes to do this and, yesterday, what is now called 1(b) was actually counted as a separate step. So, it was confusing.
MR. REYNOLDS: Are we saying that 1(a) and 1(b) would take a maximum of what will take between 1 1/2 and 2 1/2 years total? Yes. Then why don't we just say that.
MS. GREENBERG: And get rid of 1(b)?
MR. REYNOLDS: Well, yes, listed both, both the development and the certification by ANSI will take between 1 1/2 and 2 1/2 years. That includes both of them and then I think we have a much cleaner statement.
MS. GREENBERG: It would make it easier.
MS. BUENNING: I am sorry, Harry. Would you repeat that again, the development and certification?
MR. REYNOLDS: Yes, the development and certification all in one
MS. BUENNING: Of new versions of health care?
MR. REYNOLDS: In other words, use the words out of here, but just put them together and say 1 1/2 to 2 1/2 years.
DR. WARREN: No, then it is not the same. If you say development and certification, you change the meaning of 1(b) because what they are doing -- and if ANSI is certifying that the standard had been developed, using the ANSI process, you are not certifying the standard itself.
MR. REYNOLDS: Fine. I am saying use the words here.
MS. GREENBERG: So you would have to say development of new versions of health care information system standards and certification by ANSI that new versions were developed in accordance. That is a better --
DR. CARR: The only -- I don't know if this matters, but the intervention that is recommended has to do with the standard development, not with the ANSI certifications.
DR. WARREN: Can I make a recommendation about that? I would really like to keep these four steps that were presented to us and at the end of step 2, which up there is step 1(b), is just say this occurs concurrently with step 1 and leave it at that. Then on the second page where we talk about the steps, we will only have interventions for steps 1, 3 and 4 and it makes more sense.
Step 2, there is no intervention for. There is no way to do anything in there.
MS. GREENBERG: You want to keep it because it is in their proposal?
MR. REYNOLDS: So, we are going back to 1, 2, 3, 4. Is that what you are saying, not 1(a) --
MS. BUENNING: That is the recommendation.
DR. COHN: I guess we are getting down into style issues at this point. I guess I will defer to the subcommittee. It just seems confusing. I mean, if we are having to reference concurrency twice within two paragraphs and then not further commenting on it beyond that, it just, I think, adds additional confusion in the letter.
This is something we can probably handle off line with the leadership here.
MR. REYNOLDS: Okay. Let's deal with substance and then we will work off line with the actual wording. So, the substance is we need to make all four points. We need to make them in an appropriate spot. Everybody agree that all four statements are real. We need to now make them in some kind of an order that will make sense. We have agreed on the content. We are work at it and make sure that the subcommittee sees it before it goes to the Executive Committee only as a courtesy that we see that we have done what is -- is everybody in agreement with that?
Let's go to the --
MS. BUENNING: The next change is, again, in the paragraph starting on September 26, with the addition of step 3 and the such and such starts, they observed that based on industry experience in terms of approval to implementation, we will have to do step 3 as a major delay in the process. We can again take a look at that when we redo -- I think it would remain the same, but we will have to just make sure that the step that we are referencing is the one that is correctly numbered in the previous page.
DR. FITZMAURICE: When we talk about to implementation step 3, I think of implementation as when people out in the real world are actually using this. I wonder if we can suggest another word than implementation.
MS. GREENBERG: That is what it is talking about is implementation in the real world.
DR. FITZMAURICE: I thought it was -- when the Notice of Proposed Rulemaking was issued was that --
MS. BUENNING: I don't believe there are any changes in the next bullet points. I believe that the next changes occur in the paragraph that starts on January -- the next change occurs in the paragraph that starts on January 25th, 2007. Again, the addition of the references to the steps, italicizing the words "Federal Register" and I believe there were some changes in the midsection, where it says opportunities -- the essence of these changes is that they encourage earlier participation of all interested parties in health care, including payers, providers and vendors in the development of the standards at the SPO level by announcing SDO meetings in the Federal Register, step 1(a), shortening the time for NCVHS review and approval, step 2 and significantly shortening the time for the NPRM process, step 3.
I think that the changes there were the addition of the words "earlier participation." And I think there was another word that was just again for clarity for the readers.
At the bottom of that same paragraph, actually the last sentence, however, testimony from industry representatives as opposed to pharmaceutical industry expressed the desire that written comments as opposed to written testimony to HHS still be permitted within the new proposal framework.
This last paragraph is completely different from the one that we had in the previous version and this reflects the --
MR. REYNOLDS: But it is the one we read yesterday afternoon.
MS. BUENNING: We read yesterday and it reflects the subcommittee's input. The NCVHS endorses the spirit and intent of the proposal and asks that the Department investigate how the proposal could be integrated into the HIPAA transaction standards updating process. This would ensure a predictable and timely process, while at the same time maximizing opportunities for public/industry input. The Department should investigate all appropriate options or the Administrative Procedures Act to shorten the time for the regulatory process.
DR. COHN: Every time we look at these paragraphs we see new things. I guess I was just wondering on the paragraph that is before the recommendation, which is, I think, this last paragraph, we talk about streamlining the health care standards, development and approval process. I thought that we were talking primarily about -- we were talking exclusively about updating of administrative and financial transactions. Administrative and financial transactions updating not new development. Am I wrong about that?
MR. REYNOLDS: That is correct.
DR. COHN: Okay. So, I just think we need to be sort of consistent in that message.
MR. REYNOLDS: This is only for changes for existing records.
MS. BUENNING: I am sorry. Would you include that in the change to the copy.
MR. REYNOLDS: Where was that sentence, Simon?
DR. COHN: -- whether we make that point strongly enough --
MR. REYNOLDS: We should match it to the HIPAA standards.
MS. BUENNING: I am sorry. I did not get that change.
MR. REYNOLDS: I understand. We are going to use the same wording that we used in the recommendation. Should be integrated into the HIPAA transaction standards updating process. So, we need to use -- that is what we are talking about throughout the letter. So, everywhere we say anything we are going to do should be related to that process. So, it doesn't sound like all new regs and everything else are going to --
DR. FITZMAURICE: Let me get the scope of what we are recommending.
MR. REYNOLDS: Which is what we have been asked to streamline.
MS. BUENNING: So, that part would now read to streamline the HIPAA transaction standards updating process.
MR. REYNOLDS: Correct.
Okay. Any other changes? Michael.
DR. FITZMAURICE: Maybe the fourth paragraph, the resulting memo, five year time, I would put a hyphen between five and year.
DR. CARR: It is 4.5 years. I don't know how specific you want to get, but if you do the math, it is 4.5 years not 5.
DR. FITZMAURICE: Second thing on the last paragraph, NCVHS is asking, we are saying should investigate, it would be consistent with all of our other letters to say that we endorse the spirit and the intent of the proposal and recommend that the Department investigate and then for the last sentence NCVHS recommends that the Department should investigate or recommends the Department investigate all appropriate options because that is what we do.
MR. REYNOLDS: Any other comments? If not, we will get this together and get it to everyone and give you a couple of days in case you see something else. Then we will get it to the Executive Subcommittee.
Is there a motion to approve it with making sure that we do the right wordsmithing?
MR. BLAIR: I will make a motion that we approve it with the wordsmithing.
DR. CARR: Second.
MR. REYNOLDS: Justine, second. All those in favor? Opposed? Okay.
Thank you very much and right on time.
DR. COHN: Harry, is this something that will go to the Executive Committee for at least review in the next day or two, next 24 hours or is this going to be a separate review process? I mean, my question basically is is this going to need more substantive work or is this something that just requires more wordsmithing?
MR. REYNOLDS: It is just wordsmithing.
DR. COHN: Okay. To be reviewed and --
MR. REYNOLDS: So, speaking to you not as a member of this committee but as the chair of all the other committees. Do you want this to be given to the Executive Subcommittee in the next day or so?
DR. COHN: I think it would be useful. I mean, the more things we can get done, speaking as the full chair and trying to move things --
MR. REYNOLDS: That is why I was asking the question.
DR. COHN: The more letters that can be dealt with in terms of for full committee review now would be I think useful.
MR. REYNOLDS: Okay. I will work with Denise and at the latest we will have it tomorrow.
DR. COHN: But it can be obviously brought forward recognizing that there is wordsmithing -- okay. Good.
MR. REYNOLDS: Thank you everyone.
Let's move into our next scheduled agenda item. I would like to welcome Betsy Humphreys, who is going to give us an update from the NLM. So, if you could go ahead and introduce yourself, Betsy, as you are getting that up.
MS. HUMPHREYS: I am the deputy director of the National Library of Medicine and am reporting on behalf of myself and Vivian Auld, who is at an HL7 meeting this morning. I am going to give -- I can update you on other activities but I am starting by updating you on the recently completed transition of the ownership of SNOMED CT from the College of American Pathologists to an international organization.
This is something that both Vivian and I have been involved in and working on for some time. So, to remind you, in 2003, NLM set up the five year license with the College of American Pathologists for the U.S.-wide use of SNOMED CT. This license allowed us -- was essentially a perpetual license. It allowed us to continue and use and distribute the last version received under the license and for everyone in the U.S. to be able to do that. It covered the ongoing updates to the English and Spanish versions in the five year period. It gave NLM the right to distribute the SNOMED CT through the UMLS. It was freely available to anyone in the U.S. and to U.S. people, you know, government agents working around the world and so forth, but not internationally under our license.
Now, the terms of this agreement were determined with extensive input and advice from an array of HHS agencies with the VA and the DOD. The fact that we had hammered out these charms as perhaps not being ideal, but certainly acceptable and good for the U.S., meant that in this transition, we were trying to make sure that as Don Linberg says, "Don't get less. Don't pay more."
So, in 2005, the CAP, representatives of the CAP and the National Health Services came to the National Library of Medicine and spoke to me about the fact that they were trying to orchestrate this transition because they felt that having SNOMED CT owned and governed by an international organization would promote adoption in other countries, which would be beneficial for those who -- you know, for the U.S. and everybody else. They were essentially coming to see if we had any objection to this because, obviously, the new organization, the new arrangement was not going to be viable unless the U.S. was paying an annual update fee to the new organization at roughly, you know, the level of what we were contracted to pay to the CAP.
As you can well imagine, we, as U.S. Government agents, agency with an existing contract with a private U.S. organization, we sort of had two statements to make. One was that we were not going to participate in any negotiation that -- about the transfer of the intellectual property of this private organization, that it was other people that were going to have to have those negotiations because we were not thinking that it was at all appropriate and it was a conflict of interest in many ways since we have this existing contract to be seen as at all attempting to pressure a private organization of the U.S. to give up their intellectual property if they didn't want to do it.
Now, obviously, they did want to do it, at least in theory they wanted to do it because they were involved in this activity. So, that was one thing. Then the other thing we said was we certainly wouldn't stand in the way of them transferring their intellectual property if they wanted to do it. But we would certainly be very concerned about the retention of the U.S. rights to use SNOMED CT in this transfer. We didn't want anything to be lost in that and we were pretty firm and shortly after this initial meeting, David Brailor(?) had another meeting with them and I was in that meeting, too.
We were all pretty firm on the fact that essentially the amount of money that we had allocated for this was the amount of money we had and we were not going to be able to ante up more for this activity. So, as this slide says, we focused on the rights and responsibilities of members in the new organization because we had to -- we wanted to get the right rights for the country, but we also had to have this organization formed in such a way that it was actually legal for a U.S. Government agency to join it. So, that was another big part of our concern and then obviously the license terms that the international organization was going to provide to licensees, which in this case would be everybody else in the U.S., except NLM. We would be a member on behalf of the U.S. and then we would be providing SNOMED CT to licensees as we do to UMLS licensees.
So, we were obviously very concerned that we get good license terms. So, that is what we have been focusing on. So, just to remind you, obviously, this would not occur or this would not have happened without the active involvement and consent of the College of American Pathologists. The new organization, which you see spells Organisation with an "s," this is quite confusing.
The British spelling, we were all working on the articles of this association, which is sort of like bylaws, but they actually have to be registered with the Danish Government because this is established as a nonprofit organization in Denmark, and the lawyers that were working most heavily on the articles were in the U.K. So, these articles came out with the British spelling and they were registered. Then everyone suddenly realized that that was the official name and we had to call it that.
That was fine with me, but, in fact, they had decided separately that the official language of the organization was going to be North American English. So, therefore, you have these documents where the only things that are spelled with the British spelling are the official names, like the affiliates licence, which is part of the article. So, that is CENCE. So, it really doesn't matter, which is a good thing, right?
So, I have put the -- it will defeat every spell checker because no matter which way you change it, you will be wrong.
MR. REYNOLDS: You make us feel better about our process. Thank you.
MS. HUMPHREYS: Look, anything about this could make you feel better about your process. Let me tell you.
Anyway, the asterisk countries, six of them, were the countries that had agreed that they would join, that they were likely to join this new organization at the time that the basic terms, the financial terms and sort of the basic outline of the deal was agreed to between the CAP and really five of the six countries because the U.S. was not involved in that, but they knew that the U.S. would join the organization, given other --
MR. REYNOLDS: Could you provide that -- read off the asterisks?
MS. HUMPHREYS: Australia, Canada, Denmark, Lithuania, the U.K. and the USA. Those are the original six. The deal was made in terms of the financial aspects of it were agreed to when those six had agreed to be initial members. Then between that that happened, those five members or the organization said to everyone else, there are certain benefits to being a charter member.
If you want to be a charter member, then you must join up by a certain time. Three other countries joined up before we actually officially formed the organization and the three others are The Netherlands, New Zealand and Sweden. So, that means that there are the nine countries are the initial countries.
Each country is represented by one entity and NLM is the initial entity for the USA. You may not want to read the article of the association for, you know, bedtime reading, but essentially the U.S. Government, you know, HHS, whatever, could decide that NLM would be the member for the U.S. and they could substitute somebody else in at a future point if that was desired.
So, you know, they are big on flags and this is the front page of the IHTSDO web site. So, the articles outline the following principles, which are openness, fairness, transparency and accountability of members, responsible, ethical conduct to ensure the long term viability, value, utility, clinical and technical fitness of the SNOMED CT and other terminology products if they have them in the future.
Collaboration with others to facilitate interoperability and encouragement of intellectual contributions under terms that permit others to use and distribute their own work. I can tell you that I have encouraged them to put something in that fits that last one, the fourth one.
So, the key steps in all of this, it all had to be carefully choreographed in order. The organization was formed in Denmark at 4:00 a.m., Eastern Time on March 9th, 2007, and all the meetings of this organization, the management board, the general assembly, people can participate at a distance. That is written into the articles. So, I called in to Denmark at 4:00 a.m. on March 9, 2007, to vote in the initial general assembly to create this organization.
So, then the SDO purchased the intellectual property from the CAP for $7.8 million and provided a three year support contract or executed a three year support contract where the CAP is going to provide support to the SDO. Those were finalized on April 24th, 2007. We all considered it became final when between March 9 and April 24, they collected the initial upfront payments from the countries that were going to make them, not NLM and not U.S. because we paid for our perpetual license in 2003, with the other countries and the check was actually in the hands of the CAP and that is when the deal was considered really final. That was April 24th, 2007. The public announcement was last Thursday and our contract with the CAP ended yesterday and then there is going to be a set of meetings in Chicago actually beginning on May 22nd, where the Management Board is going to meet and ending with another meeting of the general assembly on the 26th.
In between, there is going to be a meeting to sort of transfer priorities, understanding, ideas between the existing editorial board and working group infrastructure under the CAP and the Management Board. Subsequent to that, new sets of committees will be formally established. We will have a new contract with the SDO in place by June 30, 2007, which means there won't be any interruption in us getting updates to SNOMED. The reason why we were able to end the contract with the CAP on the 30th was we just had received the Spanish update, which was really the last thing we were going to get under the fourth year of our contract.
Our contract now runs or has run from like July 1 to June 30. That is when we executed with the CAP. The new one, we will pay for half a year and then we will be on the schedule with everybody else because they are going to have an annual budget year with the payments due shortly after the beginning of the calendar year.
So, the member countries pay annual fees. These are based on World Bank GNI values, which are sort of pegged to the current U.S. fee, which is 5.5 million in 2007-2008. As I named before, the charters members, other than the U.S. also contributed to the upfront IP payment fee and after startup, new members are going to pay a joining fee as well as annual fees.
There is a concept of sponsored countries that for countries below a certain GNI threshold and that can be negotiated. A one time payment of either times the annual fee will provide permanent rights to use and the idea of this sponsored country fee is that it could be paid by anyone, as long as there is agreement of the Ministry of Health or the Department of Health in the country.
So, for example, if they wanted to, the Rockefeller Foundation or the Gates Foundation or the CDC Foundation could pay for a particular country that thought this would be good. These countries can later join if they want to, but they are not voting members. However, they do have perpetual use rights from then on to the terminology and the updates of it.
In non-member countries, there will be an annual fee for each user of a product that contains SNOMED committee. So, there will be a royalty fee or a fee due back to the SDO and these fees are set to make -- obviously, to make it desirable to join the organization, but they are also cheaper in poorer countries.
So, the member rights and here, remember, that the member is the organization that is the member. So, these rights at the moment are NLM's rights. We can use and reformat the international release. We can create national extensions in accordance with their SDO standards. We can create derivatives, subsets, mappings, et cetera. We can distribute the international release to affiliates. That is the term they use. We would use licensees probably, under standard license terms.
This is very nice because there is one license internationally for the international release of SNOMED. We have to distribute in native format as well as in other formats. So, what this means is we will have native formats, SNOMED files available on the UMLS FDP sites coming soon.
Anyway, we also have the same use rights to continue to use and distribute the last version received if membership ceases. Just to let you know that there is an escape clause written in if the surviving rights of members who leave are ever changed. So, for example, if the general assembly decided they were going to change these rights and make them less liberal, the existing members have an amount of time where they can cancel their membership and retain the preexisting survival rights. So, I don't think any of this is going to happen, but what it means is we can't end up with less than the surviving rights that are written in there now because we could get out and still keep them.
So, the governance is there is a general assembly. There is one vote per member country and I am the initial U.S. member and Vivian is the alternate. The Management Board has up to 12 members and these people are the ones that research really running the organization. There are nine members now. There have to be at least three. There can be up to 12. So, there are nine now, one per member country.
Now, NLM cannot serve -- put people on this Management Board and that is because we are going to have this major contract with this organization. So, we can't be sitting on both sides of the table. Yes, you could say we could always absent ourselves, but it is a little silly because I mean we are going to be paying a large fraction of the annual budget of this organization.
So, we naturally -- one of the things that I had to do in working on this is I had to get legal review of drafts of this organization and what was going on here and one of the things that was told to me in no uncertain terms, not that I didn't expect it, by the NIH Office of the General Counsel or the Office of the General Counsel that is situated at NIH, was that there was no way anyone from NLM could be on this Management Board. So, fortunately for us we were able to con Andy Weisenthal of the Kaiser into being the initial U.S. member of this organization, which was very acceptable to everybody. They were delighted because Andy has served in other capacities with SNOMED under the CAP. A lot of the players know him well and they thought he was a great choice and, of course, Kaiser has done quite a lot in terms of implementation of SNOMED. So, that is a nice perspective to have there.
For his sins, poor Simon is Andy's alternate and we know he has a broad perspective on all of these issues. That is good for us.
The chair of the Management Board, which is -- the chair of the Management Board, which is a required position in the articles is Martin Severs at the National Health Service in the U.K. I can state without fear of any contradiction this would never have happened if it hadn't been for him. He has been indefatigable in doing this and has, you know, overcome numerous hurdles and concerns and whatever, herding a bunch of us cats.
Karen Gibson is the deputy chair. She is from Australia, the National Electronic Health Technology -- whatever it is called, NEHTA, and she also has been incredibly important in getting this all done. The deputy chair is not a required position and it doesn't do anything in terms of setting that person up necessarily to become the next chair of the organization.
Martin has agreed to chair for two years. The organization has executive officers. People basically report to the Management Board. There are four of them required in the articles. They are the chief executive officer, the chief terminologist, the chief technologist and the chief quality assurance officer. What the organization intends to do is to make interim appointments of several of these and then I would say probably no later than about six months have an international recruitment for permanent people in these positions.
So, the initial interim appointment of CEO is Ulrich Andersen from Denmark, who is also involved on the Danish side in terms of the negotiations and Kent Spackman is the initial appointment as chief terminologist. I think there is likely to be someone from the U.K. be the first person appointed as the chief QA officer and, in fact, I think the National Health Service is going to in a way donate him. That is, they will pay his salary and allocate him to -- some chunk of his time to this responsibility until this thing gets going.
There are going to be four committees required. There might be others. Content, which I would say is going to be quite analogous to the Editorial Board, as we know it today, not exactly, but information technology, the real objective of the new organization to get on a better IT platform and particularly an IT platform that supports distributed input and maintenance and translations and whatever in a better way than the current arrangement is quality assurance and research and development.
The chairs of these committees are going to be board members and there has been some criticism in the current environment that some of the people who are working on various committees that there was kind of a disconnect between the committees and the higher management of the organization under the current arrangement. I don't know whether that is true, but at least it has been booted about that there was and that things that were of great interest here were not as of great interest here and so people would be doing work at different levels and find out later that nothing was going to happen or something else was going to happen and they are trying to avoid that.
Now, there is no problem with membership of federal employees on this and a point I skipped over previously is that I don't know whether it is acceptable for other -- for people from other government agencies, other than the National Library of Medicine, to be on the management board.
We had a briefing for federal health architecture people on -- and others within the Federal Government about this on April 26th and I encouraged anyone who really thought it would be a good idea for somebody, themselves or somebody from their agency to be eligible to be on the board, to actually take the articles and go through their own agency ethics, conflict of interest review and find out because I think it would be interesting for all of us to know whether there are agencies where there is no problem and it is in the future seemed reasonable to nominate somebody from the VA or the DOD or CDC or whatever for this Management Board or CMS or whatever, to -- so, I am leaving that up to everybody because the processes, the general rules, obviously, of Federal Government ethics are the same but the issue of how close you are to this and what kind of a conflict of interest it would be for you would vary across agencies, I would assume.
So, in terms of the committees, I said the chairs will be board members. The initial membership is probably going to be set after this late May meeting and so we won't have a list of everybody who is going to be on these committees going into those May meetings.
So, the other aspect of this is that there is an official thing written in that there will be harmonization boards jointly established with other standards bodies to try to ensure productive evolution of SNOMED CT in conjunction with other standards so we get interoperability. The one that they are most interested in moving on fastest is one with the WHO in terms of figuring out how SNOMED CT and the classifications can evolve in a productive connected way.
Marjorie, who must be a little jet lagged, was recently in Japan and there was a presentation about this. I think that the standards organization is quite interested in moving, setting something up with WHO as soon as possible and I think they are aiming to sort of have a, you know, specific charter for what is going to be done and get people appointed from each side if they possibly can by the end of this year, sooner if they could do it. That is really because they have heard from countries around the world that everybody really wants a good connection between the two and they would like to see something visible that maybe their hope will be fulfilled.
So, I think that is why the organization is pushing out on that front. So, the affiliate license terms just to review them quickly, it is one license for everyone. So, if Mark wants a personal life and the Regenstrief wants a license and Sonner(?) wants a license, it is exactly the same license. They all have the same rights and responsibilities. Now, they obviously, may not all decide to exercise them, but this is one international license and it gives everybody the right to use -- create extensions and derivatives, incorporate international release into products if they want to. They don't have to collect any use fees in either member or sponsor countries.
They do have to connect -- you know, there are use charges if your product is deployed in five hospitals in Japan at the moment, although Japan, I think, may join the organization. A lot of these countries may. Then at the moment you would owe five fees. You know, if you had five installed sites, you would owe five fees.
The other issue about this is if you are going to deploy your products in a member country, you need to check that member country situation to see if they have a member extension or a release that they require to be incorporated into products that are going to be deployed in their public health departments or hospitals. I mean, as you can imagine, there are national extensions. Drugs is a favorite area for these and there are others.
So, if you were Sonner and you were marketing your products internationally, you could put the international release in your products and the one license you have covers that. But if you were really going to try to make inroads in Australia, you probably would want to put their stuff in because the Australian hospitals would be required to use it. So it wasn't usable in your -- you know, if it wasn't in your product, that wouldn't be a great marketing advantage for you.
So, what is going to be different? There is at least, you know, a reasonable chance that the annual fee that NLM is paying may decrease over time as more countries join. I think it is -- one thing, it is likely to go up each year at a lower rate than it has. The other thing is that anyone who is a UMLS user now, whether they are going to use SNOMED or not, has got to review and accept new license terms -- this is an easy online process -- by May 15th, 2007. This is up on our web site.
Now, you can do it -- the entire affiliate license is now for SNOMED CT, is now an appendix and you are basically accepting that license when you go through and accept the UMLS license. So, SNOMED CT and its documentation, native documentation, will be available in native format from NLM. This is also happening on May 15th, 2007. So, the issue is, of course, everybody has to resign the license because on May 15th, 2007, if you are a UMLS user, you will be able to go in through the protected web site and get access to these files. If you can get access to them, you will have had to have executed this license before you can do that.
Of course, this is in addition to the UMLS format. The current license terms provides better international distribution rights for U.S. users than international use rights. I mean, they are not perfect. It is not free across the world but they are better than they were before and I think there is a good process for moving forward. I think there are very good prospects. You know, this is the intention. I have been highly impressed with all these people that I have literally spent uncountable hours on international phone calls negotiating these license terms and articles with these people. These are very good people from all the countries. They have very positive motivation, all of them, in my opinion. So, I think we are in good shape for, you know, more transparent governance, priority setting, more efficient updating over time and I think some very productive international collaboration on subsets, tools, et cetera.
So, I think that this is quite a good thing. When you talk about the dedication of these people in these other countries, these phone calls, which started about 2 o'clock, U.S. time, think of what time that is in the U.K., the people in Australia and New Zealand were getting up at 3:00 and 4:00 in the morning for days on end to participate in these activities. I mean, people really have worked extremely hard and I think the result is good.
So, you can get more information about this if you go to this page, which is www.nlm.nih.gov/snomed. There are actually pointers to all the rest of this stuff, including the press release that Secretary Leavitt issued last Thursday, but also pointers to the articles, the license terms, et cetera. The license doesn't look -- because it covers everything, the form of the license is quite different from what people might be used to if they had a separate license with a CAP for SNOMED. There is sort of a short form. It didn't end up being called this, but as we were negotiating all of this license business with these lawyers in the U.K. that were advising us, somebody from the -- I think it was New Zealand originally said, look, Joel -- he was the lawyer -- if you don't produce a two page licensing for dummies, we are never going to be able to explain this to anybody.
But I actually think it is not that difficult.
PARTICIPANT: [Comment off microphone.]
MS. HUMPHREYS: Affiliate licence is an official term and, of course, the affiliate licence was itself part of the articles. So, it was spelled this way and it was kind of after the whole thing had already been registered with the Danish Government and we said, oh, we can just change this and the Danish lawyer said, no, you can't and we said okay, we will just forget it.
I kept saying maybe it would be better if you just used British English as the official language, but, of course, the official language of SNOMED, the initial language is, in fact, North American English. So, whatever we did we were going to confuse the issue.
Any questions?
MR. REYNOLDS: I have questions and I know, Jeff, you have one. You can start off.
MR. BLAIR: Congratulations, Betsy.
MS. HUMPHREYS: Thank you.
MR. BLAIR: Gosh, for all of the folks that for years and years and years have been looking forward to an event like this, you know, thank you.
The question that I had is sort of maybe a next step question. This, obviously, removes some of the objections to SNOMED on the international basis in terms of the adoption and acceptance. Within the United States, vendor adoption and implementation of SNOMED has been limited. Do you see that this major step will have any effect on accelerating vendor HIT adoption in the U.S.?
MS. HUMPHREYS: Well, I will say two things. First, I think that it will make the incorporation of SNOMED CT into products more attractive because there is obviously a strong intention in the other eight countries to move ahead and implement SNOMED in some way, shape or form within their health systems. So, that obviously is a good sign.
So, I think that is a positive. I think what we really need to do is the same thing we needed to do in 2003 and maybe we have a better platform for doing it, which is we really need to set up a tighter feedback look with between trial implementations and implementations in real settings and the ongoing maintenance and adjustments and development of subsets and ancillary products and whatever that make it easier to implement SNOMED CT and real systems in the U.S.
I think that this new environment potentially provides a better platform for doing that and it also, I think means that there are likely to be more publicly available subsets, more collaboration among groups perhaps internationally to identify useful subsets and approaches that work in particular environments and I think that if those things happen and move along, then I think that would probably go a long way to promoting adoption and implementation, vendor products and systems in the U.S.
MR. BLAIR: One of the things I was a little curious, maybe you could clarify it, it is referred to as an SDO and, of course, a few years back SNOMED was accredited by ANSI and I didn't hear any mention of ISO. So, what relationship will SNOMED International as an SDO have with ANSI for accreditation and with ISO?
MS. HUMPHREYS: I think that they intend to have a relationship with ISO and there has been some discussion of that. I didn't pick the name and for somebody who spends a lot of time with vocabulary, I am not that -- it doesn't matter to me. I think that the -- I think people in this room have heard my view about vocabulary and standards developments organizations before and that is that consensus standards development activity and the ongoing maintenance of a vibrant vocabulary in a technically accurate and coherent and useful fashion to me are two different things because I think you need to have obviously, a very good project, open, and you need to be able to throw the bums out if they don't do it well, but you really can't have people voting around the world as to whether we are going to add these five terms or whether, you know, we know enough about SARS yet to put it in.
It just doesn't work with the way vocabularies need to be developed. So, I might have named it something else, but --
MR. BLAIR: Will it continue to be accredited as an ANSI accredited SDO? Because I know that in a number of the movement towards HTSBE and all is that there is preference given to ANSI accredited SDOs. So, will it still retain that relationship?
MS. HUMPHREYS: I have to tell you that as a member of the HTSBE Executive Board, I have made them -- that is wrong -- I have pointed out to them that they need to be careful when they are talking about vocabularies and classifications and whatever, not to say that the same requirements must be laid upon them in terms of membership of in a particular standards process. In fact, they have modified the selection criteria to put in some of this language that I suggested to them saying, you know, it just really doesn't apply.
My understanding -- I guess I would have to go back and look. I know that SNOMED got a standard -- I mean, the CAP got a balloted standard for the format of the vocabulary, but they don't -- they are not an accredited for the content of it with the format. Am I right about that, Judy?
I just want you to know that I was entirely consistent. We are a member of ANSI or had a right to vote on this and I voted against it. I guess my view is that we are not there yet. One of the things that I don't believe is that we know sufficient about the format of vocabularies that will make them best able to be maintained and used in clinical systems for us to worry about standardizing the format of them today. That is my view.
I mean, standardizing how we are going to transmit data encoded in them or use them, that is a whole other issue. But as far as I am concerned the format for a vocabulary is the -- the best format is the one that allows integrity and updating and use in the best way and I -- we have spent a lot of time on this problem at the National Library of Medicine and we have a number of vocabularies and I actually think that some of their formats are absolute things of beauty. But do I want to standardize the rest of the world on any of them? No. I don't see that as particularly useful.
DR. WARREN: I have a possible conflict of interest since I am a consultant to the SNOMED Editorial Board, at least until the end of May, at which point we don't know what is going to happen.
One, I just would like to say you have done brilliant work on this, the intricacies of this, the little that I know had to have been amazing.
MS. HUMPHREYS: Well, you know, really as I say this was an excellent -- this was an outstanding group of people to work with. Everybody wanted this to happen. They wanted it to happen in a good way. It was just extremely difficult and time consuming to work out the details and it wasn't that people's motivations were bad or that they were unintelligent or unmotivated or interested people. It was just that you have to look at this a long way and then everybody has to be able to join the organization you are talking about. Nine different countries, you know, and people have their own approaches to this and it was a major problem for them that we couldn't just join and be a member and write a check, that we actually had to execute a contract.
They had to make changes to the articles in many things in order to make that be okay and, you know, people were very accommodating, but it was not easy to do it.
DR. WARREN: I think that is the cost of being global and certainly that has been some of the experiences that I have had. What I would like to do is take off my NCVHS hat and ask a question because I have been getting a lot of phone calls. Currently, I chair the International Nursing Working Group in SNOMED and what we are finding is the nurses in the other countries are already being talked to by their country in order to continue the work of evolving SNOMED.
There has been no discussion in the U.S. and I am also hearing that from other workgroup members in the U.S. that there is this big black hole for information about how we will continue our work as U.S. members. So, just wondering since NLM is the contact, if there has been any discussion about how you will organize the U.S. affiliate for membership or things like that?
MS. HUMPHREYS: That is a very good question. I think that I can tell you that we will be working on this issue and we will come up with an approach, but I want to tell you what my general view is. I am going to be obviously discussing this with Rob and John and the ONC office, who, of course, I have been in touch with. When this whole thing happened, when they started these negotiations, David Brailor was the national coordinator. He called me -- he just said to me, Betsy, you are the one that knows this. Do this and keep us informed and if there are any issues or problems, just call us. So, that is the way I have been handling it. But I think that in the U.S., we intend to use a variety of standards together and we have a variety of processes in place.
I am not necessarily -- I would like to see if we could have a more concerted view of the issues and the functions, rather than having the LOINC people meeting in this room and the SNOMED people meeting in this room and, you know, I mean, and HTSBE is attempting to make these things that will work together. We have the NCVHS. We have HTSBE, AHIC, let's say that, and I really want to see if we can come up with a process that allows us to select appropriate people in the U.S. to work internationally around some of these issues with SNOMED without maybe necessarily having to have 52 parallel workgroups in the U.S. I mean, how many people are there and they are all meeting in the same room and it would seem to me that if we could say all right here are the major priority areas for the U.S. and for this organization, now if there are some that are priorities for the U.S. and are not priorities for any other country, well, then, of course, we would have to put something together to work on those.
If in the more likely case that there are probably multiple countries that are quite interested, then I think what we need is a good process for getting the best people in the U.S., who are interested in that to work with those other countries, to be reporting here or to HTSBE, all over, but I am just tired of seeing the same people in so many rooms. Then we end up with the people in that room had a -- you know, they had a wonderful idea about how this would work in conjunction with Rx Norm or whatever, but there was nobody from Rx Norm or LOINC there at that day and then they lost the thread.
So, I actually am not too thrilled about having 50 dozen working groups with SNOMED at the head of them. What I am really interested in is how do we have working groups on issues and problems we want to solve with standards and make sure that in the U.S. we have all the players there, HL7, whatever we need, you know, so that we can really implement these things.
So, that is a view.
DR. WARREN: Actually, I agree with Betsy's view. The concern that I am faced with is all these people who know what today is. They don't know what tomorrow is. They come from organizations that are willing to, you know, send them to work on topics. They have done some very good work, regardless of what work has been there and have expressed a desire to continue and to funnel stuff up, you know, through this board and get the terminology.
So, I think somewhere there needs to be a message that work is happening to ensure that the U.S. have a voice because what they are hearing right now is that all the other countries have ensured how the average person is interested in participating has a voice and there has been nothing.
MS. HUMPHREYS: I think as you can probably appreciate, in most of the other countries there is a very different organizational structure. These people were, in fact, already affiliated with that organizational structure. The group in their organization already had -- you know, NITA(?) already had the nursing committee and so did Canada InfoWay(?) had an approach about how they were going to involve the nurses. All they do is just transfer that group to this. So, I think that -- I understand why it is very easy for them to sort of just send a message to their people and say now you are going to be doing this with this other group. I think that it is an issue and it is one where we will come up with some rational approach and we will pursue it. If that rational approach turns out to be too rational or we only thought it was, we will come up with another one.
The U.S. is going to have input in this and, you know, I am hoping that we can nail some of this down over the next even a few weeks. We have been dealing with some of these problems by seriatim. But I would really appreciate this group and anyone on it providing any suggestions about what you think would be the most effective way. I really am not interested necessarily. I mean, I really, as I said before, just to reiterate, I don't think that the best way is to say, well, let's have a separate SNOMED committee of U.S. people for everyone of these things that we are interested in, where SNOMED is part of the solution.
That instinctively doesn't seem like the right answer to me.
MR. REYNOLDS: We have got Simon, Marjorie and then Mike and then we will take a break.
DR. COHN: Betsy, again, congratulations, very good work and, obviously, I think you know where I sit on this one. I already sent my pound of flesh over to the NOL to help on this piece. But I think it is a wonderful thing.
I did want to, I mean, just ask a question or two and some of this stuff is like old issues that we have dealt with for many years, both in NCVHS, other conversations. I, obviously, am reminded that as you talk about how terminologies are different and code sets are different than standards, that maybe HIPAA was right, but then, again, I have been around awhile and remember they handled them differently.
Now, one of the issues that I think the committee has obviously, been -- has had long concern about is the issue of mappings. Obviously, I was, obviously, very pleased to hear about the harmonization boards because I think we all know those who have gotten into mappings, it is a little more complex than meets the eye and you get into calculus and independent variables and systems research very quickly in terms of how you continue to map, continually evolving separate bodies. But, obviously, having said that, though, I am curious about really where we are with sort of industry standard mappings, knowing that to my view one of the -- and this continues to be an issue, obviously, as an implementer of systems and terminologies is is that you continue to discover sort of problems and inadvertent mis-mappings and, of course, you don't get paid on these things.
CMS has compliance concerns. So, where are we with all of this?
MS. HUMPHREYS: Okay. Well, one of the places -- let's just go through. The one mapping that as far as I am concerned is in the best place and for ongoing development and we need to promote implementation testing and whatever is actually the map between LOINC and CPT and it won't be locked upon you, those of you who understand all these vocabularies that the reason that that one is probably in the best places because it is actually easier to do than some of the others.
Let's be frank. The initial one is up there now for testing but we are likely shortly to get an expanded one, which will include radiology and some revisions to the other one. So, you know, I mean, I think there is maybe 2,000 items up there now. The new one will have more than 6,000 because it will include radiology.
So, that one is moving along well. The mappings between SNOMED CT and other organizations, I mean, and other things, the SNOMED CT to CPT mapping may actually emerge fairly soon. What was holding that up was a protracted set of negotiations between the AMA and the CAP, not on technical issues, not on matters of principle and I wasn't in the middle of them. So, I don't know what they were, but it just was a long time coming in terms of this.
Now, I think that -- and, of course, in the middle of it, we formed this SDO. So, I still think that this is going to be set and be available soon, but I am going to have to actually follow-up and find out whether the minor change involved with the SDO means that we are in for another set of these negotiations. I am not quite sure about that.
The one that has been very problematic, although a lot of work and a few dollars has been spent on it, is the one between SNOMED and ICD-9CM and the reason for this was that in the technical review of it, it turned out that there were substantial variations between the initial mapping and what the technical review group thought was appropriate across a certain sample of things.
I think that at this moment we are now at a position to figure out how we are going to -- we have been trying, let me just say, but we are going to be in a better position to figure out how we move ahead on that one. Now, what this harmonization board wants to do is deal with -- everybody wants a robust map between SNOMED CT and ICD, but as you can imagine -- and Marjorie could verify -- that the rest of the world is much more concerned with the robust map to ICD-10. So, that is, of course, going to be the thrust of the harmonization activity, both to ICD-10 and to making sure when we move on to ICD-11, a thought that bothers me, not that we would evolve for classification, but that I just have a nervous reaction to 11, just because I feel that that means that somebody might forget that they are supposed to have a graceful evolution forward and decide that they could have a discontinuous break between 10 and 11, which I think would be an utter disaster. So, I always thought couldn't we call it, you know, like ICD-10 plus or something.
But be that as it may, I do think that this international harmonization activity is going to be good, but it is not going to solve our problem about 9CM and so we have to figure out whether we can afford to fix this situation that we uncover.
This was a lot of good people working on this. Let me just tell you. I just have to say that it is -- those of you who know how antiquated the scientific view is in portions of ICD-9 will know that trying to map this to SNOMED committee, which is taking much more current view of the world and of science and medicine is a dicey proposition. So, you know, that is where we are with that.
The other mappings that we were asked to look at involved MEDRA(?) and we have still yet to find somebody with a set of data that can be used to test and be the use case. We are very loath to do a huge effort without that. That is because we can't find anyone yet who is actually encoding a large amount of adverse drug -- adverse reaction data using SNOMED. So, since in general MEDRA is the thing it would be mapped to,
Everyone sees this as a future problem, but I think the issue is we need to figure out how to get some data so that we can do this. The last conversation I had about this was literally about two or three weeks ago, with people from MEDRA, FDA, NCI, all interested in this problem. We still hadn't any of us come up with the set of real data in SNOMED that could be used for this.
Now, in the meantime, there is fortunately a very large overlap, synonymous overlap, between SNOMED CT and MEDRA. So, the situation is particularly at the preferred charm level in MEDRA. The situation is not, you know, totally bad, because there is a basic level of synonymy already identified and in medical -- as it exists today.
MR. REYNOLDS: Okay. Marjorie.
MS. GREENBERG: Oh, my. Thank you, Betsy. Having participated in similar marathon international calls, usually I don't have to do it at 4:00 in the morning, but I definitely empathize and congratulate you, et cetera. So much to say and so little time.
I will try to just kind of hit the highlights. I think my bottom line is I really hope that the National Committee on Vital and Health Statistics, which was established in response to a recommendation of the World Health Organization, that national committees be established back in 1949, to work with WHO on the international classification, really would see this as part of its serious portfolio. Obviously, ICD and SNOMED have been part of your agenda all along. I think you received an invitation from Betsy. I think this -- to work with her on approaches to how this transition is going to work, particularly U.S. involvement and expert -- U.S. expert involvement, et cetera, and I think this is the ideal committee to do that.
It sounds like you agree. Anyway, I certainly would support that. I will say a little bit more about that in a minute, but I have a question on the license, which -- or the contract. It currently goes through 2008, you said.
MS. HUMPHREYS: The original contract would have gone through July or June 30 of 2008. As part of this negotiation, the SNOMED CT -- I mean, the CAP agreed that the U.S. could -- you know, they agreed. We would terminate the contract at the end of the fourth year for convenience. The SDO people who were negotiating with SNOMED had negotiated on our behalf that there would be no penalty for termination of the contract in advance of the five years. There was a small one, not very much, but like, you know, $140,000 or whatever, but they negotiated on our behalf and the CAP readily agreed that if would terminate for this reason then they were not going to charge us that fee.
We will put into place with the new SDO a 4 1/2 year contract. So, we will pay --
MS. GREENBERG: That was a question I had.
MS. HUMPHREYS: We will pay for the second half of this year and then we will have a four year arrangement with them going forward.
MS. GREENBERG: So, that was my question, whether it was just going to go year to year or it is your plan to essentially like a -- well, something equivalent to the five year contract that you have.
MS. HUMPHREYS: Yes, it essentially is a little different because the other one was truly a five year contract. This is a contract that has an initial six months with four one year options, which is slightly different in contract terms and is actually better from the point of view of the SDO because it allows -- and us because it allows some level of negotiation on the fee in the four years as opposed to having it laid out for five years, which it was in the contract with the CAP.
MR. REYNOLDS: Michael.
MS. GREENBERG: No. I have much more to say. I will be brief. I think I need to respond to some of these other things that have been said. They are very relevant. I had that one question. That is helpful and I wanted to make the comment about the NCVHS role.
I am also very interested in the issues raised by Judy Warren but since a member of my staff, a medical officer, is currently the HHS representative to the SNOMED Editorial Advisory Board, whatever they are called. So, I certainly will follow that with interest.
I just wanted to make a few comments on this harmonization board because this was discussed and on ICD-11. If ICD-11 strikes terror in your heart, you can only imagine how I feel, except for the fact -- I mean, since, of course, in my other role I am still attempting to implement ICD-10CM in this country. I would say, however, that -- and I did just attend the launching of the revision process. I am currently on the revision steering group and I can talk about this more in June at our meeting. I think we are going to have a follow-up.
You may know or may not know that Chris Shute(?) is the chair of the revision steering group for ICD-11. The good news is that I certainly agree, first of all, that the transition from 10CM to 11 needs to be as seamless as possible. I would have to say that I think the earliest we could implement 11 on the current schedule is probably 2020. So, it is not like it is going to be in the next few years. But I can go through that at a later time where I cam up with that deadline, with that time line.
But I think the public face of ICD-11, the idea is that it will be very similar to ICD-10CM and other versions of ICD-10, but under the hood, as it were, and that is Chris's terms, we are hoping to build in an oncological and terminological framework that really will link the -- I mean, right now, this mapping, as Betsy said, is kind of artificial. I mean, you are trying to do a concept based map, but, you know, you have got old concepts, new concepts. Having to do this with 9CM is frankly a very sad situation and shouldn't even be the situation, but it is.
It would be a much more beneficial to be doing this with 10CM, which is -- well, it is obviously aligned with 10, but also is based on much more current language. But the idea is this would not just be a kind of mechanical map, but that their really would be a terminological underpinning to ICD-11, probably based in significant ways on SNOMED CT and other appropriate terminologies where SNOMED does not currently have as good coverage.
So, I think this is actually quite exciting. The hope is that we can use working with Chris and others, we can use 10CM as a kind of platform for working on this evolution of the ICD to be -- have a stronger terminological underpinning. I will tell you more about that in the future, but the one area where we are lacking both for WHO work on the harmonization board and even for what I have described is that there are not adequate resources. So, I don't want to indicate that there are, to do all of this. But I think it is very important work and I will look to you for guidance.
MR. REYNOLDS: Michael.
DR. FITZMAURICE: I too want to congratulate Betsy and Vivian and the National Library of Medicine for performing this great service to the country.
There is a scenario that I want to bring up that deals with the seizure rights that are kind of laid out in the articles of association with this SDO. The scenario would be I invent -- I am a health plan. I am a private company. I invent quality measures or I invent quality improvement using SNOMED terms. Maybe it is a classification. Maybe it is an algorithm. You divide one thing by another to get something. So, I develop this. Other countries say, hey, that is pretty good. Uses SNOMED terms and the articles of association roughly says that if a member does develop material in their country, which is of interest internationally, then the SDO has the power to request that the intellectual property for this material be given to the SDO so it can be incorporated into the report.
Now, one can say NLM is the member and as long as you don't give it to NLM they can't grab it. If I am a country, I may want to have it distributed through SNOMED or if I am a company, I may want to have it distributed through SNOMED, but can the SDO -- can SNOMED legally sell this intellectual property, this modification of the SNOMED standard, in competition with the developer of this intellectual property if it should wish to do so or is this a matter of private company negotiation with the SDO?
MS. HUMPHREYS: Well, there is a distinction in the -- thanks for bringing this up. I should have mentioned it. There is a distinction between an official -- an extension, which is developed according to standard methods and involves the assignment to the developer of an official named space and then there is -- that is an extension. That is sort of an official extension. Then there is the notion of derivate work and that would include subsets or things that were designed to help work and whatever.
The way it works with your affiliate license, if you get a name space and create an official extension, then if the international organization decides that that extension has great value and should be part of the core, then, yes, you have to turn it over to them. If you create a derivative work, they could ask you for it, but if you didn't want to turn it over, you wouldn't have to.
So, I think that the issue is really in anyone who is going to do this type of development deciding whether their extension will be developed in accordance with sort of official SNOMED approach and with a name space and in that thing or deciding that they will create something, which in essence extends SNOMED but it does go in another format. If the latter, it would not be subject to this. So, I think people could make their choices and, of course, there might be a lot of people who would develop something in academe or as a research project for whatever or a particular professional group, who would think that this was a good thing, that if everyone decided their stuff was great -- now, of course, once it gets taken over by the SDO, then the SDO has some level of responsibility for being the one who continually updates it. So, this might actually be considered a boon even by a commercial group, depending on how they viewed it.
So, I think that the way -- I think that some of those -- let me just say that I believe if people carefully review that section, then they can do whatever they want in a way that will have the end result that will be acceptable to them, you know, if they feel great if I develop something, it would be great if it was incorporated into SNOMED core. They can do it a certain way. If they don't want to go there, they can do it another way and they will be okay.
DR. FITZMAURICE: Thank you, Betsy.
MR. REYNOLDS: Thank you very much. Very informative. I echo everybody else's -- you have done a great job.
For the committee, a 15 minute break and come back prepared to move quickly through a significant amount of issues. Thank you very much.
[Brief recess.]
Agenda Item: Executive Subcommittee Planning -- Session Preparation
MR. REYNOLDS: Okay. Let's go ahead and start because I want to go through the list and make sure we have the complete list. I can run through it very quickly when they join us. The items that I want to talk about today are -- it would seem to me we have three or so compelling things that we need to get done. More importantly, we only have one more hearing scheduled this year and that is October.
We were asked to stay within the budget of what we were authorized. So, I think our other discussion will be whether or not we need to have more, which I think -- I know with the items that we are doing, that will be our request. But I am going through the process of what the structure is. Okay.
Obviously 5010 will be our next most focused item. We need to have an --
MR. SHUPING: Harry, this is Jim Shuping. Can you hear me?
MR. REYNOLDS: Yes, sir.
MR. SHUPING: There are a bunch of us on the line here. We have been trying to talk and nobody has been hearing us. So, I just wanted you to know that we were here.
MR. REYNOLDS: I knew you were there. We just got started on this subject.
MR. SHUPING: Okay. But you can hear me okay?
MR. REYNOLDS: Yes, sir. I can hear you just fine. Thanks.
MR. SHUPING: Thank you, Harry.
MR. REYNOLDS: So, obviously, at our first hearing on 5010, we are going to need the first part of it to be some kind of an education process, again, to get us up to date on the differences between 4010 and 5010, the number of those issues, the breadth of those issues because some of them you may be able to take half of them and say that is nothing but, you know, change in the cosmetic, but if there are other significant -- first you would want to understand what they did -- what it did to the formats and then what it might do to business in general because that is going to help you understand the breadth of how we do this.
We would then need panels to respond to how they think 5010 is going to affect the industry in general and the implementation. Further, we would want at some point and it may be in the September/October time frame, comments back from WEDI, based on their surveys as to what they see that it is going to affect and so on. I think equally important is we are going to have to have some time because we have kind of focused -- helped focus as a committee how to make it better. We wrote the letter on lessons learned from HIPAA and we did a few other things.
We had our discussion yesterday on NPI and we find ourselves in exactly the same position, somewhat at the end of the implementation of NPI as we may have found ourselves in HIPAA as we still struggle to get the industry to do it. So, some of the comments that were made yesterday, I totally concur with. So, we have to step back and look at how we would recommend this occur on 5010 and then obviously as we start talking about ICD-10 and the other things, is there some kind of order? Is there something else that we would recommend to help do this as far as does somebody get ready first? Does this happen? Does that happen?
How do we group this industry up as we continue to do these things so that especially if 5010 and ICD-10 come in any close proximity to each other? They will both be large changes and ICD-10 will be a large change, not only in format, but in business process. So, those together will need to be modified in a way and we need to make sure we understand how we can help the industry do this.
So, those are the thoughts that I have had so far. We have got the people from WEDI on the phone. I would like to ask the committee if anybody else wants to add anything to what I have said as to how we need to structure what we are thinking about and then we will -- Jim, I would like you guys to make any comments you have.
So, Marc.
DR. OVERHAGE: Marc Overhage.
I guess the question that I continue to wrestle with and it may be a boundary question of what our remit is, but, for example, the issue of 4010, 5010, we can't even use 4010 right today because we can't find where to go ask and, you know, a whole set of implementation issues that I think are probably larger impediments to the industry moving forward than format changes from 4010 to 5010.
MR. REYNOLDS: And I would like -- and my earlier point, how can we do it better and what do we need to have in place to do these next set of things better, I think it would fit nicely in that subject. Okay? So, those kind of things if you have some feelings on those, who would be good people to present that, then please add that and make sure we get that to Denise so that we can start thinking about panels we are putting together to do this.
Jeffrey.
MR. BLAIR: One thing we might consider to try to -- I won't say accelerate it, but maybe to help us digest and get to a decision point, being NCVHS a decision as to recommending, going forward, not go forward or do it with caveats or what the recommendations are is there are certain decisions with 5010 and I almost feel as if we could identify the key decisions one way or another. If WEDI and the SDOs could provide WEDI structured education for us in the weeks prior to October so we don't have to wait all the way until October.
MR. REYNOLDS: We are not going to wait until October. That was my earlier point. We have got to have a hearing well in advance of October.
MR. BLAIR: Even prior to whatever hearing that is so that we start getting educated in stages so that when we do meet together, a lot of the education offline, you know, by power points, by e-mails, whatever, we could go right to a decision making meeting or a meeting that is a closer to decision making than taking a lot of time in the meetings for education. So, if we could move some of the education prior to the meetings, then maybe our meetings can focus more on the decision making --
MR. REYNOLDS: Which had been our goal for yesterday, which what we had planned for yesterday.
Yes, you are right. Okay.
Judy.
DR. WARREN: Mine is kind of a follow-up to Marc's. One of the kind of the offline conversations I have had is it is my understanding, which has not been validated, but my understanding that some of the changes in 5010 are to correct the problems with 4010. Given that, when we asked for education, it would be nice if they could structure those changes in 5010 that are to correct the problems in 4010, if those would be clearly identified for us because I think then we can make a deliberation better on whether or not 5010 enhances or supports --
MR. REYNOLDS: Okay. I put out a brief structure. Let's go with this then. Three different categories. One is cosmetic. One is fixes to 4010 and one is new.
Jim, you guys are on the phone. Is that a structure that you think is a worthwhile structure to think about 5010?
MR. SHUPING: The last part of what you said, Harry, was kind of breaking up. I heard identify specific changes in 4010. I heard cosmetic and I didn't hear the last --
MR. REYNOLDS: The first one is we would want to talk about it in three buckets more or less. One is cosmetic changes, which are things -- you know, you are basically just fixing the field or something. Second is actual fixes to 4010 because there were problems with 4010 and the third is things that are new.
So that then we could deal with in three ways and if they truly are -- the ones that truly are cosmetic, you know, as we are going to try to think, grab the idea of 845 changes, putting that into the kind of thing where that may be really only, you know, ten major changes to 4010 and, you know, 35 new is a whole lot different than dealing with 845 changes in something that we are trying to learn.
Then I like the idea that Jeff mentioned about getting some documents ahead of time. I might term that familiarization rather than education because sometimes you need a dialogue to really become educated. So, I think it would be good if you and others could help familiarize us and then we could have some sessions to at least discuss it if that session could go half as fast as we would want it, as we scheduled it because we were familiarized enough and really could do it, that would be good, but I would still like to make sure we have issue --
MR. BLAIR: Can I add some structure to that that might really make it more liable to work well is if WEDI and the SDOs could provide education to us about three weeks before a conference call where we would have time to read it, have a conference call to ask questions on the education pieces and that the -- and the conference call would be two or three weeks prior to an actual NCVHS meeting. Then we would have gotten the education out of the way, the questions on the education and we would come to a meeting ready to only have brief questions and make a decision.
MR. SHUPING: In that regard, this is Jim again, do you all have a time line that you have already determined as to when you would want this education process to begin. In other words, when I look at the calendar, I see that there is a meeting coming up in June, but that is the full committee.
MR. REYNOLDS: Jim, we have not adjudicated that yet. It will be decided here soon. Okay? As part of this, hopefully. Okay? We will maybe able to talk to you better about a time frame here in a little bit.
MS. GILBERTSON: Just FYI, Lynne Gilbertson and Alex Goss(?).
MR. REYNOLDS: Okay. Thank you.
Yes.
DR. WARREN: I understand the need to kind of parse this out. I would appreciate some of the education to occur at a face to face meeting.
MR. REYNOLDS: I am in total agreement with that.
DR. WARREN: It is just I hear very differently on the phone than what I do when someone is --
MR. REYNOLDS: I am totally comfortable. We need to have a discussion so that we understand the subject well enough because then if we talk about these things and how can we make it work better that you and Marc have mentioned and other things, we will have a firm context.
Now, it is my understanding on this and I would like to deal with each of these subjects one at a time because if you start throwing the whole list in there, it gets real confusing.
I believe it is the goal to move this as quickly as we can through this committee. Is that correct? Okay. So, right now we are -- our only hearing is in October because we were budgeted for three. We scheduled three. It appears to me from the discussions that I have had and so on, that October would be the -- getting something to the full committee in October would be what the target would be of everyone that is interested in this subject at 5010. Is that a fair statement? Can we wait later? Give us a --
MS. TRUDEL: I don't want to draw artificial time lines, but we do need to have NCVHS input before we can move forward with 5010 and 5010 is clearly on the critical tasks for ICD-10 and we have heard that the sooner we do 5010 and the more time we leave, the better that implementation is going to go.
DR. COHN: I do apologize. I missed the very beginning and the framing and Harry, I will be happy to treat you if you -- I just want to sort of make sure that I guess the last couple of comments that have been made almost sound like some sort of a rush to judgment. I think it is important obviously that we get informed about all of this stuff, to identify industry, get industry input in a timely fashion. I think that is really the important piece here and make sure that we really have heard from the industry. Obviously, I left yesterday's presentation being
-- I think we all sort of feel like we need to know more, need to understand better what is going on. I guess I am supporting what you are saying, but I am also sort of trying to resist a deadline for a report absent a process that assures that we get the input that we need from the industry and the understanding that we need.
MR. REYNOLDS: I will catch you up quickly. What we had talked about a little bit ago was we obviously need education. We need panels. We need to hear from WEDI, from their survey. We need to also talk about how we can -- are there any comments we would want to make to make the process better as to how it would be structured to implement 5010 because as we have gone through HIPAA, everything took longer than expected. We heard the same thing from NPI yesterday. So, whether or not we would do that, so, yes, all that was in place as a structure of our discussion.
Now, I was just trying to get a time frame because, again, we always have to -- we need at least a couple of hearings prior to resolution, I would think, considering when the full committee meets, which is obviously something we always have to keep in mind. That is what I was working back from, not being directive, not setting a thing, but making sure that we understand the framework, which we all do and the structure because until we get input, until we do our adjudication, we can't even begin to think -- to take something forward and if we need two of those, then that is all I was trying -- that is what I was trying to get to.
DR. COHN: I guess all I was sort of referencing what the industry thinks. I mean if we started from the industry and everybody thinks that this is absolutely wonderful, timely, needed, that is obviously, a much different conversation than people having serious concerns and --
MR. REYNOLDS: Not setting a hard stop, setting a structure to get to an end is what we are trying to do.
Mike.
DR. FITZMAURICE: I guess I would remind all of us that while we need to be sure we understand it fully and make good comments and good recommendations to the Secretary, that there is going to be some new people probably as you get closer and closer to the end of an administration. Sometimes new people get brought in and another education process. Once the administration ends, everybody is often new. So, to the extent that we have educated people now and that can move as quickly as we can comfortably, we are more likely to get something done than if we go at a much slower pace, slower than we need to understand it and make the those recommendations.
So, it is kind of an argument for let's do it as fast as we feel comfortable doing it.
MR. REYNOLDS: This is not a slow committee. We usually move briskly.
So, with that as a -- that is 5010. So, let's have that on the table. Everybody kind of sees where we are going. We obviously, need to create an NPI letter out of yesterday. We will do that and we will try to have that for the June meeting. That is the second item that we need to adjudicate. We will try to have that for the June meeting of the full committee. We will adjudicate it between now and then. Okay? Most of it will be based on the recommendations that we got yesterday.
MR. SHUPING: Harry, Alex Goss and Lynne Gilbertson have been trying to ask you questions and you are not hearing them, are you?
MR. REYNOLDS: That is correct.
MR. SHUPING: I wonder what their problem is. We are all on the same line here.
MS. GILBERTSON: Can you ask them a question for me, which is are we talking 5010 or are we talking CPDP.0?
MR. SHUPING: -- focusing your discussion on 5010 now or on NCPDP.0?
MR. REYNOLDS: I believe we are talking about both of them. I am sorry. I consider it all one discussion. Excuse me.
MR. SHUPING: Okay.
MS. GILBERTSON: Could you also them to confirm when they are looking for the education?
MR. REYNOLDS: We will adjudicate that shortly.
MR. SHUPING: Harry, it would be very helpful to all of us -- there is about five of us on the call here on different lines -- I am sorry you can't hear them directly
-- it would be helpful to us if we could get a list or something in writing that details exactly what it is that you are looking for from the SDOs, as well as WEDI --
MR. REYNOLDS: Jim, we will be more than happy to do that and -- yes, I won't say anything more about yesterday's hearing. We will be more than happy to do that and make sure that it gets done this time as it was supposed to have been done yesterday.
DR. FITZMAURICE: Jim, this is Mike Fitzmaurice. I just wanted to -- maybe the technical problem is that their voices don't come through when your phone is muted. So, when your phone is unmuted, they can speak through your phone to us and we can hear them.
MR. SHUPING: I am not muted.
MR. REYNOLDS: Whatever. We can hear everybody.
All right. The other thing we heard yesterday is security. Okay? And we were requested -- now, what I would like to ask and maybe, Karen, you or somebody else can help me since I have never chaired this when we were actually sending something new through like this.
Is this a change to the existing regulations? Is this an update to the existing regulations? What exactly is the process that we do to help move this forward as requested yesterday?
MS. TRUDEL: It is a modification to the existing standards and I think we are in somewhat unknown territory because we have not done a lot of modification. We have done no modification to the security standards. But there is a requirement in the legislation that the Secretary consult with NCVHS in addition to a number of other organizations. So, we know that we do need to have that input before we actually proceed.
MR. REYNOLDS: Which means that we would need to have that input through panels and so on through some kind of at least a hearing, an open forum. Otherwise, it is just coming from us not from our process. Is that a fair statement or not?
MS. TRUDEL: I don't know that that is a requirement.
MR. REYNOLDS: Again, I have not been involved in anything where we send something forward as a position without having had an open hearing or discussion on it. So, Simon, help me or, Mike, help me.
DR. FITZMAURICE: I am not a lawyer, but if I look at the words and say the Secretary must consult with NCVHS and so I come to NCVHS and say here is what I plan to do and you say, gee, we don't like it. It is horrible. Now, NCVHS doesn't say that. NCVHS says, you know, here are some things that might be better. So, it is really a positive experience, but legally the lawyers and the Secretary's office would have to define just -- if any response at all is needed from NCVHS.
MR. REYNOLDS: But Lorraine yesterday asked us for something.
DR. COHN: I think there is actually something you probably ought to bump up to the Executive Committee for a more thorough conversation. My general view is is that consultation and advice means that we have to decide ourselves the nature of the industry input we need to have. I certainly -- I mean, my own mind, I guess I had actually thought what was discussed yesterday, as well as what was sent out in December as guidance -- was that when it was? -- and given that it appeared to be guidance, that -- and we can appreciate them trying to put it into regulation. It appeared to be different than some of the things that come before us, but I think we should talk about it.
MR. REYNOLDS: We will move that one forward.
So, let's go back there. NCPDP and then, obviously, at some point we will begin hearing this year about ICD-10. So, again, we would have to do some work on our thing again where we have to go back to the education.
DR. COHN: Well, actually we have already advised on ICD-10, which as you will remember, is the process is that they need to ask -- they want to consult with us prior to decisions whether to put out an NPRM. Now, we do have a choice when the NPRM comes out if we want to send a letter to CMS as once again another effective body to advise on our views on the NPRM.
I don't know that for ICD-10, there is a need, unless we have I think -- we won't provide additional advice in the interim.
MR. REYNOLDS: Let's go back to 5010 and NCPDP.
DR. COHN: Harry, I guess I just have a really odd question about the 5010 and I will apologize and maybe I need a little clarification because I was looking through the annual report and I saw -- I guess maybe I am not finding the right things in here in the annual report. I was obviously looking at the recommendations for adoption, new or modified standards in the annual report, which only seemed to be a couple of the 5010 X12 recommendations. I didn't see anything here on NCPDP, but maybe under a different category. I may just have missed it. So, maybe you can clarify with -- somebody on the phone can clarify that it is just in a different section and I just maybe -- just didn't see it.
MR. REYNOLDS: Which annual report?
DR. COHN: DSMO. So, that is not part of the annual report.
MR. REYNOLDS: Lynne, would you like to comment on that, please?
DR. COHN: I guess I was just confused because I obviously -- there were two documents, but I guess I considered the annual report to be the authoritative document. I just wanted to make sure that some of these -- all these things have, indeed, been cast or been recommended by the DSMOs to come forward.
MS. GILBERTSON: As I mentioned yesterday, the status report had newly updated information in it. So, I am looking to see exactly what the annual report detailed because they may not have pulled for that last bunch. It is still all part of the -- let me see, I am trying to see what we sent in there.
MR. REYNOLDS: The annual report finishes with Item 1054.
PARTICIPANT: NCPDP starts with what, 1055, Lynne?
MS. GILBERTSON: Yes.
MR. REYNOLDS: But obviously what you presented yesterday included that. Correct?
MS. GILBERTSON: Correct.
MR. REYNOLDS: That is the reason we had it.
So, let's talk process. So, we are scheduled right now for our hearing -- our only other hearing scheduled is October. Do we need to request an earlier hearing to start the process extensively on 5010 and the NCPDP and if at such time the Department or anybody else would want us to start or we would hear any updates from anyone on ICD-10, then we could do that also and prepare whatever we would want to prepare accordingly.
A 5010 has a clear focus. So, do we need a hearing prior to October to begin the deliberation of 5010 and make our recommendations on it? We are going to get educated if we don't.
Marjorie, could you help us on the budget standpoint if we could align -- for example, there is a full committee meeting in June. This one was talked onto an Executive Subcommittee, which we tried to show some improvements in.
MS. GREENBERG: This is your third --
MR. REYNOLDS: This is our second hearing this year.
MS. GREENBERG: Since October 1? Debbie, do you have that information?
DR. COHN: Let's just try to bifurcate some of these issues. I think the question is is does the subcommittee recommend whether or not we need to have one and then what we need to do as the Executive Subcommittee, we need to try to put all the various pieces, all the multiple priorities together, figure out how to do what when in a way that enables us to be successful in 2007.
MR. REYNOLDS: Obviously, we felt that 5010 was important enough that we had it on the schedule yesterday to start significant deliberation of it, which would say that it is important to continue and do fairly soon again to help -- since we are part of the process and since we are all talking about streamlining the process, we need to get in the process. We are not in the process on 5010 right now as far as what we think about the changes, what we think about what it means, what we think about we recommend, what we would want to recommend as far as implementation or anything else. We are not in the process.
So, we need to do that.
MS. GREENBERG: Are you thinking you might, for example, want to have a hearing in August?
MR. REYNOLDS: Some time before October. Maybe it is June. Maybe it is July. Maybe it is August. Whatever. I mean, in other words whatever works out. I think we at least feel that we would probably need to have a hearing sometime between now and October and in October.
MS. GREENBERG: And also have one in October.
MR. REYNOLDS: That is correct.
MS. GREENBERG: I would say this is -- I am sure this is your third of the fiscal year and that is what we budgeted for just three -- no, two. We budgeted for two meetings per subcommittee or workgroup for the fiscal year.
MR. REYNOLDS: Do we get credit for three quarters for this one --
MS. GREENBERG: I would say we have to discuss this at the Executive Subcommittee because the current budget does not allow for a fourth meeting with subcommittee unless some other subcommittee or workgroup wants to give up its second meeting, which has probably already happened, but as you said, this is in combination with another meeting.
Actually one of your other meetings may have
been --
MR. REYNOLDS: Yes, it was. So, our goal is to help -- from a time frame, to help some of those that may be putting together educational material for us, what would be a reasonable -- so, what is the will of the committee, assuming this can happen, until we meet with the Executive Subcommittee, not confirming this can happen, what would want that time frame to be?
MR. BLAIR: Again, this is an if, if we are able to have another subcommittee meeting at all, my thinking is that either at the beginning of August or late July, if we have a conference call to --
MR. REYNOLDS: Let's just go with the hearings and then we can obviously do whatever we -- we can worry about conference calls and other things.
MR. BLAIR: August seems like a good time frame.
MR. REYNOLDS: Karen, is that acceptable to you guys as far as us moving forward for information?
MS. GREENBERG: I would just have to say certainly that this is about the 5010, I personally don't see any need to have any testimony on ICD-10 prior to the issuing of a notice of a proposed rulemaking since the committee has already recommended that the Department should go ahead with the notice of proposed rulemaking.
If you were going to include testimony on ICD-10, August would not be good for me.
MR. REYNOLDS: I am adjudicating 5010 right now. I had mentioned the other was just so -- it is one of the things that is always on the -- that is coming forward in some way and I just wanted to understand where we fit, how we fit and I am -- we have got a big enough problem making sure we do what we need to do 5010. So, I am not adding anything to it yet.
Yes, Justine.
DR. CARR: Harry, with respect to the educational materials, I think you talked about first can we get some educational materials. Then can we get here, have some dialogue about it. I wonder if we got the materials before the June meeting because we will have a subcommittee meeting at that June meeting.
MR. REYNOLDS: We could sure ask for some. We can see what we can do there.
Judy.
DR. WARREN: I guess I would ask the Executive Committee to take a look at the timing and that another way to look at this is that if there is money in there for a conference call, we can certainly have our education sometime this summer. I don't know how readily reading the DSMOs can put together our education, but it would seem to me that two or three weeks ahead of June is tomorrow and that that might not be a good time line. But if we could get ourselves educated and have a conference call with them, we could certainly have our hearings in our October meeting and then make a decision at that point.
Stay within the budget and the time line. So, sometime during the summer, like July or August, we would have a conference call with the DSMOs for the education that we need for 5010 and at that point determine what kinds of testimony and stuff that we would need to hear and then set up the panels for our October meeting. I don't know when our full meeting is in the fall. Is it like in November again? So, we would still have time then to develop something out of the October meeting and get it to the full committee in November.
MR. REYNOLDS: I was under the -- I have been put under the impression that we need to move quicker. I am more than happy to take it at that pace. I am fine with that. I was led to believe we needed to move sooner than that and, no, I am not -- I am saying that is what I understood. So, that is why we had scheduled it for yesterday and so I am in total agreement, whatever dates we set. I just want to make sure that we are doing --
DR. WARREN: I would say what I was trying to do was stay within the guidelines of where we were, given everything that has happened to this point and then let the Executive Committee determine whether or not there is something within the budget that would facilitate a faster time line --
MR. REYNOLDS: No, I totally agree with you. Yes.
MS. GREENBERG: I think CMS is the -- we have to weigh in -- whether the timing is really critical to get something to the October NCVHS meeting or to wait for the November NCVHS meeting.
MR. BLAIR: The October meeting, if I understand it --
MS. GREENBERG: I don't mean the October. I mean the September.
MR. BLAIR: That is correct and you remember in September we would have a full committee meeting. In October we have a subcommittee meeting.
MS. GREENBERG: The idea is that the subcommittee would want to bring forward a recommendation to the full committee, which it can either do in September or November.
MR. REYNOLDS: In deference to WEDI, I know that their survey was probably going to be available in the late August/September time frame. I am trying to take all the other inputs that were listed as -- since we were handed a document yesterday, checking off what was supposed to happen, I am just trying to array all the collateral that we have in front of us.
MS. GREENBERG: This is the survey on implementation of the 5010?
MR. REYNOLDS: Yes. And impact of the industry and cost and --
MS. GREENBERG: So, we wouldn't even have that until September.
MR. REYNOLDS: Well, that is why we were trying to have a hearing to learn as much as we could about -- or some kind of discussion before that to hear as much as we could, then get that. Then we could go ahead and go forward to the full committee. That is what I am trying to balance here so that we don't wait too late. We don't start too early and we kind of get ourselves where we are supposed to be. So, that is what I am trying to drive to.
DR. COHN: I guess I am a little confused about the time line. So, is your proposal that we try to -- that we move to try to prepare recommendations to the full committee in the November time frame or was your optimal choice to try to get it for September? If so, I guess my question is is that -- I guess once again I am referencing back to HIPAA and of course, you have not had a lot of practice doing modification to standards. We have probably had DSMO recommendations, but not anything of the gravity of moving to a new implementation guide.
But just referencing that we obviously have a variety of groups that we need to see -- not foremost, but very importantly is WEDI and it sounds like, Jim, just to remind me, you said that you would not be ready to give us any guidance, which I think would take the form of the survey reports until sometime in the fall. Is that correct?
MR. SHUPING: Well, I am going to be meeting with the appropriate task group this afternoon, as a matter of fact, Simon, and I hope to get a better reading for you on that, which I will communicate. We are about to launch the one on the 2-7 and we are trying to get additional information on the 835, 837.
DR. COHN: Are you going to provide advice ont the NCPDP change also or is that planned?
MR. SHUPING: Yes. We will give you the results and then any recommendations that would be appropriate. I am just trying to sense here when you are going to need this information. I will ask them how quickly they think they can turn it. We will need some guidance as to what level of education you want and when you want it.
DR. COHN: I apologize. This clearly is a circular -- this conversation. I will apologize. I will pull back my question.
MR. REYNOLDS: I guess one question that would help me is is the information available on 5010? Is the document -- are the documents ready? Forget education for a minute. Are the documents ready? Are the layouts ready? Is everything related to it ready? Is the 5010 information available? Forget the education. Could I get a copy of the 5010 layouts?
MS. GOSS: Yes, Harry. This is Alex. 5010 technical report 3 is commonly referred to as implementation guide, what we are considering the HIPAAesque suites are all available.
MR. REYNOLDS: How about the NCPDP?
MS. GILBERTSON: They will be available this summer.
MR. REYNOLDS: When. Give us a date.
MS. GOSS: By July.
MR. REYNOLDS: So, when we talk about education, if these things had gone through -- I guess where I am struggling a lot -- if these things have gone through the SDOs and have gone through this much deliberation and it is going to take somebody a huge long time to explain it to somebody and build education material, I personally struggle with the understanding of how could it have gone that far and nobody be able to have some documents that would explain what is actually going to happen.
MS. GOSS: The education that you are looking for is much more detailed type of education than we were provided as a standard body. We provide change logs and general information regarding what was changed in that implementation guide from a prior version. What I am hearing from this level of dialogue is that NCVHS would like to have the overarching information categorized and then communicated at both a business and a technical level for the audience of NCVHS.
That level of detail is not something that is normally provided as part of an implementation guide specification and as such, our volunteers would need to prepare that in accordance with the request and then make sure we are all in agreement with it before it was presented to you. So, although we have produced benefit analysis reports for the DSMO process that supplement our implementation guide, change logs, this is an additional item that was not factored in.
MS. GILBERTSON: And we have already had web cast for the industry in January and February on one of the standards being brought forward, the Telecom. So, we do have some executive summary type information that was presented during those web casts. So, it may meet the needs of what you are looking for.
MR. REYNOLDS: So, my next feeling then is we are about to forward a letter to the Secretary agreeing to streamlining a process. What I just heard is that -- and we are touting the SDOs as giving it a full look and then it would come to NCVHS for hearings to be passed on to the Secretary and there would be public comment and so on.
If there is no business level, executive level, understanding level, coming through the SDO process, then that will have to follow squarely on the shoulders of NCVHS to make sure that all of those kinds of discussions and issues are dealt with before a recommendation would go forward to the Secretary. So, all of the sudden a light went off for me because I thought we had heard in the testimony that it was -- and I actually asked the question and we can go back and look at the transcript -- I actually asked the question, well, how do the business people that could be affected get involved and it was said they could be involved in the SDOs, but I am hearing with the one that we were just handed, that it is nothing but change logs. It is not discussion about how it affects the industry.
MS. GILBERTSON: The streamlining process cannot be invoked yet because we are all under the original HIPAA requirement and the original HIPAA steps. So, that is what we are under right now. We would like to be under streamlining and perhaps the next versions that come forward we can start at the very beginning and implement the streamline effects, but all we have been able to do is operate under the HIPAA process right now and try to educate as often and as soon as we can, but under the guise of the current process.
While we agree o the streamlining, we would like to go forward with that, we cannot execute any of it yet.
MR. REYNOLDS: Lynne, I understand that. My point, though, is that there is a hole in whatever process that needs to be dealt with from a -- the full look at initiatives -- the difference between a change log and an industry -- entire industry changing its business processes and other things. That was my only point. I understand the -- I clearly understand what you are under. So, let's step away from that, but that just means that as we do this, as we look at this, that we clearly have a need to look at this from an overall standpoint about the full impact and that is what our hearing will need to be able to do. So, our education will be extremely important whenever it can be produced by somebody and are making sure that we have a full vetting of it will be important because when it comes to us, none of that vetting has occurred at the level that we would want to recommend how it does or doesn't affect things.
Michael.
MS. GOSS: But, Harry, building on your -- the importance of -- from also having the designated standards maintenance organization have their subcommittee members actually review the documentation, come to determination and also the WEDI survey efforts are asking people to get at the concept of what does this mean to your business and what is it going to cost you and give that feedback. So, I think that the framework has been started and I think that the hearings will then put the cap on that to really make sure we vetted it out.
MR. REYNOLDS: Good. Thank you.
Michael.
DR. FITZMAURICE: I think Alex said pretty much what I was going to say. I was going to reiterate what I heard you say and that was we need to have one or two educational sessions we would hope maybe in July to get us up to speed on the 5010 and the NCPDP standard and learn not only what they are but maybe what the expected changes would -- impact would have. Then we would need to hear from the industry at some later date to find out if there are unintended consequences that they bring to us, that we didn't hear when we learned about the standards themselves.
After those two bits of information, whether it is one or two educational hearings or one or more industry hearings, then we would be in a position to say what is reasonable for us to recommend to the Secretary. Is that what you said?
MR. REYNOLDS: That is right, yes. Now, what I would like to do is obviously Jeff and I as co-chairs are members of the Executive Subcommittee. Simon chairs that committee. So, we have got a good enough quorum here. So, we need to obviously adjudicate this through the process to make sure that we -- you know, what hearings we can or can't have. We will need to fill in -- Jeff, I think your point of whether we should have a conference call to do some education.
Jim, I would like from both you and Lynne some kind of a time frame at which somebody could prepare education type materials for us that we could use so that is coupled with the fact of our discussions in the Executive Subcommittee would allow us to start putting a schedule together that could take care of this.
MR. BLAIR: Let me clarify something here and this was an idea -- and am not sure WEDI and NCPDP and ASC X12 really might need to respond to this question that I have. Okay? Because I was trying to see how much education we could appropriately move prior to hearings. Hearings, as Simon and Judy pointed out, would need to hear from the rest of the industry on this issue. So, my thought was that if we could receive educational information, which we could individually read and then have a conference call where we could ask questions about the educational information we have received, we might be able to get that stuff done beforehand and then have the in-person testimony maybe in the August time frame if that gets approved.
So, I was really looking at three steps, not to receive the education in a phone call, but for us to ask questions in the phone call, conference call, from the educational material we had received and red on our own. So, that was just a clarification of what I was thinking. I am not sure that WEDI and the SDOs could get that information, educational information, to us in time. They probably have to get that education information to us either late June or early July in order for that time frame to work out.
MR. REYNOLDS: Marjorie.
MS. GREENBERG: I just wanted to say that because when the committee becomes educated, it also serves an educational function for all the stakeholders to the committee, that if we did do some of this through a conference call or teleconference, which I think is perfectly acceptable, we would make it open to the public.
MR. REYNOLDS: Sure. No, that is fine. That is good.
Jim, what I would like to hear from you and Lynne if at all possible if you could get us something like this by June 15th. If not, what would be your next available date. So, if both of you could communicate that to Jeff and I, I would appreciate it and then --
MS. GOSS: This is Alex. Are you also asking X12 for that education?
MR. REYNOLDS: I am asking whoever -- yes.
MS. GOSS: You specifically asked Lynne and Jim. So, I just wanted to clarify.
MR. REYNOLDS: I am sorry. I am not locking through your corporate structures well. Let me put it this way. Jim presented yesterday. Yes, I would like whoever are the best people to do that, if that is X12 and WEDI and the NCPDP, good. So, whoever needs to give us education and wants to give us education, because once we hear who is going to do it, then Jeff and I will work with you as to what the structure and the format of that would be, along with Denise and we will make sure then that we have an appropriate package that everybody could review and get something done when we get it.
MR. SHUPING: Question, Harry. Did you say you wanted it by June 15th or you just want us to let you know how quickly we can get it packaged together for you?
MR. REYNOLDS: I would like you to shoot for June 15th, the material.
MR. BLAIR: To get the educational material to us.
MR. REYNOLDS: That is correct.
MS. GOSS: Could you then because it has been very difficult to hear, allow me to just clarify what I think you are looking for in the educational materials, which is a breakdown of all of the transactions and the changes within three categories, cosmetic, fixes and new. You want to know if we are able to provide you with that transaction and educational information by June 15th.
MR. REYNOLDS: That is correct. But what we will do is we will put together an e-mail to send to you as to what that package should be.
MS. GOSS: Thank you.
MR. REYNOLDS: Yes. We will make sure then you -- Marjorie?
MS. GREENBERG: I know sometimes it is semantics, like what is cosmetic, what is a fix, whatever. I wonder why you really -- why what you really don't want to focus on is just new things and then the impact.
DR. WARREN: Some things in 4010 currently don't work well.
MR. REYNOLDS: No. Here is the reason I broke it into three pieces. There are 845 of them. We need to understand -- in other words, whenever you give me a number, if you give me 500 new out of 845, big change. You give me 500 cosmetic and they really are cosmetic, different size change. At least you are looking at a -- we can take that 845 and come to some kind of understanding of it, at least as a structure. Now, if we find out that in cosmetic are things that change people's lives, then it is not cosmetic anymore and it moves to another one. So, all we are trying to do is -- I am just trying to come up with some kind of structure for the discussion, more than anything, not -- otherwise, this goes through all 845 to try to get some sense and we can't go there.
MS. GREENBERG: Do you want them, though, to provide this breakdown separately for each of the 845 or just say of the 845, 300 are cosmetic.
MR. REYNOLDS: And here is our definition of cosmetic. Here is our definition of cosmetic because we need to make sure we understand that. We will have it into some kind of reasonable structure.
With that, is there any more reason to discuss -- we have a process. We will work with the Executive Subcommittee. We will work with Denise and Karen and Jeff and I will work on what kind of educational material we think we need. We will put that together and we will keep the committee heavily informed as to what is next, upcoming steps might be.
Is there any other -- yes, Judy?
DR. WARREN: Following up on Betsy's testimony, I would like for the Executive Committee to begin to start thinking about how NCVHS can support the movement to the SDO to handle SNOMED. I mean, she obviously said she saw a role for NCVHS. So, if the Executive Committee could start exploring what that might be and maybe bring something -- now, we are not going to know any details until after the May meeting that Betsy will be at, but it might be a brief discussion at the June full committee meeting or at some time later on, but I hate to drop an invitation to get involved in something like that, especially when we are seen as a key person or group.
MR. REYNOLDS: Any comments on that?
DR. COHN: Since Judy brought it up, what does she as our role?
DR. WARREN: I think that there are so many unknowns at this point, about how the U.S. will proceed to help SNOMED evolve and there has been a tremendous amount of work done by volunteers that have made significant improvements in the SNOMED structure within the last year or two, as we have educated enough volunteers to engage in sophisticated terminology development. As I shared with Betsy at the break, I have spent the last two months with people e-mailing me and phoning me very concerned that they will no longer have a voice and, you know, if this is a done deal and the rest of the world is going to develop SNOMED, then, you know, why should we even bother.
So, there is a void out there and whether it is advisory the way we have done with, you know, ICD-10, whether it is to make recommendations to Betsy about how to handle this new activity that people -- I mean it is so uncertain at this point, I can't even project without this final meeting what our role might be, but I would like for us to have it on our plate to consider and have input on it. It might be to have Betsy come back after the May meeting and discuss what went on and then explore what the NCVHS role might be.
DR. COHN: I wasn't sure exactly what you were thinking of. So, thank you.
MR. REYNOLDS: Jeff, did you have a comment?
MR. BLAIR: We have SNOMED, which has a potential to have significant impact on our industry. We have ICD-10. We have thoughts about ICD-11. I have not heard anybody pull together a long term plan for either how these converge, how they complement each other or anything. I sort of feel like since no one has stepped forward to say how all of these things are going, a long term plan for terminology for the industry, whether we do it or whether we set forth framework for how this be done or criteria, it seems to me like there is a very critical need for us to begin to think about long term strategies for terminology in health care.
MS. GREENBERG: I would just say that at the meetings I was at a few weeks ago, Chris Shute as chair of the Revision Steering Group, is working on sort of a road map for review by that group as to kind of how these things, how ICD-10, 11 and its relationship from our point of view
-- were interested in ICD-10CM, but of course, in Canada, they have 10CA and in Australia, they have 10AM, et cetera, how this might all fit together and how this will evolve.
So, I think that once that is vetted through that process, that will be a resource, which you can, you know, react to, et cetera, but that doesn't mean you don't want to do your own thinking about this, but I think it might be a little early to take this on independently to see kind of what comes out of that process.
I just wanted you to know that work is going to be going on.
DR. COHN: Just following up on what Marjorie was saying, I actually think it is an important issue. I used to dub it the grand terminology strategy.
MR. REYNOLDS: We had that listed on our charter.
DR. COHN: But I do think it is an international topic, as well as a national topic. I think it is an important issue for the subcommittee and includes people like Betsy and Chris and also our hearing about international activities but knowing that we also have unique national interests, the CMs, the CPTs. There is a variety of things that are national in terminologies that we need to figure out all this plays.
MR. REYNOLDS: Judy, I would like to ask you about your words. You recommended that it be taken to the Executive Subcommittee. That would say take it to the full committee. Are you saying that this would be a matter adjudicated by the full committee or a matter that you would think should be adjudicated by this committee? Just using your words, not putting any words in your mouth.
DR. WARREN: To me it would seem as the full committee has heard issues. They have been kind of clarified by the Executive Subcommittee. So, I am recommending to the Executive Subcommittee to consider monitoring, whatever, SNOMED that one of the things that might happen is in the June full committee meeting, we have Betsy come back and report on the May meeting of the SNOMED SDO.
MR. REYNOLDS: Then I clearly understand your position. I just wanted to make sure for purposes of this meeting.
DR. WARREN: At that point, it may get turfed to the subcommittee. But I am comfortable with how the Executive Committee and the full committee would respond.
MR. REYNOLDS: That is why I wanted a clarification to understand that.
Michael.
DR. FITZMAURICE: I was going to try to put some words in Judy's mouth, but her words are better than mine. I was going to suggest that we might monitor the advancement, the opportunities and the applicability of SNOMED CT in the United States as a kind of a general thing we periodically take a look at.
DR. WARREN: I would go along with that, but the concern I have and this is why I would like the Executive Committee to look at it because it is deciding what is appropriate for NCVHS. I am still concerned about the ability of U.S. citizens participating in this process. At this point in time, their ability to participate as a U.S. voice ends on May 26th.
MR. REYNOLDS: Is there any other new business for the committee? We have obviously a lot of unfinished that we need to take care of. Is there any other business? Hearing none, the meeting stands adjourned.
Thank you, everybody.
[Whereupon, at 12:00 noon, the meeting was concluded.}