Hubert H. Humphrey Building
Room 505A
200 Independence Avenue, SW
Washington, D.C. 20201
DR. BLAIR: This is the second day of the hearing ¾ it is not the hearing but the review of the sixth and final draft of the report to the Secretary. This is the National Committee on Vital and Health Statistics, the CPR Workgroup. We are going to apologize for starting late. We are going to just introduce ourselves and dive right into the rest of our review of the report.
I am Jeff Blair, Chair of the Workgroup and Vice President of the Medical Records Institute.
DR. COHN: I am Simon Cohn. I am the National Director for Health Information Policy for Kaiser Permanente, a member of the workgroup and committee.
DR. FYFFE: Kathleen Fyffe. I am a member of the National Committee and the Workgroup, and I work for the Health Insurance Association of America.
DR. BEBEE: I am Suzie Bebee, Health Informatics Specialist with the National Center for Health Statistics, and I staff the group.
MS. AMATARA: Margaret Amatara, independent consultant under contract to the committee workgroup.
DR. JACKSON: Debbie Jackson, NCHS Staff.
DR. BEBEE: There are very few people here today.
DR. COHN: I am assuming that we are going to be getting some people calling in during the course of the day. Kepa Zubeldia and Kathleen Frawley will provide input also. I guess the question of how should we lead off. Should we start on page one and work our way through, or should we take a look at these revised recommendations for a couple of minutes.
DR. BLAIR: Let's focus on the revised recommendations.
DR. COHN: I think that makes sense. We are going to give everybody four or five minutes to look through these revised recommendations. We apologize to the people on the internet. Why don't we have the music on for four or five minutes, and then we will reconvene to look at the recommendations.
DR. BLAIR: The only thing is if they call in and hear us talking, then they will know they are connected. They will get music? If they get music, they will know that they have reached it.
[Brief break.]
DR. BLAIR: Hello. Those of you who are listening on the internet, we are convening. Dr. Cohn will read us through the rest of the recommendations.
DR. COHN: Okay. I think we have just taken a couple of minutes for the workgroup to review the most recent version of the recommendations. I suggest that we take them on a point-by-point basis to see if there are any issues. Margaret, will you help lead us through them?
MS. AMATARA: Yes. Do you want me to start with the introduction?
DR. COHN: I do not want you to read it, but I think we read through the entire thing yesterday. I think we need to sort of ask the workgroup if there are any issues regarding the introduction.
MS. AMATARA: Okay. Let's look at section A. If there are any recommended changes there.
DR. BEBEE: I just have one question as far as wordsmithing. It is the paragraph that is under the bullet that refers to, on that third line, that the PMRI in a manner that will leave the content and structure. Do we want to use leave? I am not sure what our intent is.
DR. FYFFE: PMRI in a manner that will leave the content and structure of health records flexible.
DR. BLAIR: Maybe that will allow.
DR. FYFFE: Yes, I think allow.
DR. FITZMAURICE: Allow to be flexible.
MS. AMATARA: Allow flexibility in content.
DR. BEBEE: Is what we are trying to say that we want to leave the content and structure intact but allow it to have flexibility to adapt?
DR. FITZMAURICE: Maybe allow sufficient flexibility.
DR. COHN: I think that since we are ¾ so we will allow sufficient flexibility in the content and structure.
MS. AMATARA: So it reads, in a manner that will allow sufficient flexibility in the content and structure of health records to adapt to new medical knowledge, et cetera.
DR. COHN: Yes, sounds good. Anything else in the introduction area? I think it is fine otherwise. Let's move into the recommendation. Maybe we will read the recommendation that we are talking about. Do you want to read recommendation one?
MS. AMATARA: Okay. Do you want to do that before guiding principles?
DR. COHN: that is part of the guiding principles.
MS. AMATARA: Recommendation one is adopt the guiding principles for selecting PMRI standards, see box, as a criteria to select uniform data standards for patient medical record information.
DR. COHN: The one change here from yesterday is actually going back to the old number five guiding principle which reads, will be supported by an ANSI-accredited standards developmental organization or other private or local organization that will assure continuity and efficient update of the standard over time.
MS. AMATARA: What are you talking about?
DR. COHN: The guiding principle. The changes ¾
MS. AMATARA: Oh, in the guiding principles itself. Gotcha.
PARTICIPANT: Number five.
DR. COHN: This was a reversion to an old version of the guiding principles. It was also consistent with wording in the notice of proposed rule making related to administrative and financial transactions.
MS. AMATARA: This is absolutely, precisely, the same wording.
DR. COHN: Does anybody have any questions or problems with that? Okay. The only change that I see, the note that I made as I reviewed the final selected PMRI standards was under 13 which was consider the degree to which the market has accepted EPMRI standards. It is probably each proposed or candidate PMRI standard.
DR. BLAIR: Good. I do not know which word we want to use, proposed or ¾
DR. BLAIR: Candidate.
PARTICIPANT: Why don't we do candidate.
DR. COHN: Candidate, okay.
MS. AMATARA: Each PMRI candidate standard or standard candidate.
DR. COHN: How about each candidate PMRI standard, probably. I think it should go before PMRI.
DR. ZUBELDIA: [Via telephone.] Good morning. This is Kepa.
DR. COHN: Hello, Kepa. Good morning. Do you want to introduce yourself to the internet, please?
DR. ZUBELDIA: This is Kepa Zubeldia with ENVOY Corporation, a member of the commission and of the subcommittee. I am sorry. My email was not working yesterday. I found out this morning, so I sent some changes, but you have not received them yet or you should be receiving them now.
DR. BLAIR: So you did have a chance to get the overnight delivery package and review the draft 6.1?
DR. ZUBELDIA: Yes.
DR. COHN: Have you also received the revised recommendations?
DR. ZUBELDIA: I received a fax this morning with revised recommendations, yes.
DR. COHN: Great, okay. We are actually in the midst of going through those recommendations, so you are calling at a very good time. We had just finished up an agreement that with one wordsmithing change in the introduction, which had to do with the second full paragraph, which basically now reads; this is the second sentence in that second paragraph. Now, it says, NCVHS believes that it is important to improve the interoperability and comparability of PMRI in a manner that will allow sufficient flexibility in the content and structure of health records to adapt to new medical knowledge, et cetera.
DR. ZUBELDIA: What page are you on?
DR. COHN: That is the first page of the recommendations under introduction A. It should be some of the faxed information that you received this morning.
DR. ZUBELDIA: I lost you.
MS. AMATARA: Kepa, there are seven bullets. Do you see that?
DR. ZUBELDIA: Yes.
MS. AMATARA: Okay, it is the paragraph immediately after that.
DR. ZUBELDIA: Six bullets.
DR. COHN: Six bullets, yes, thank you.
DR. ZUBELDIA: Okay.
DR. COHN: I am just commenting about some wordsmithing changes there.
DR. ZUBELDIA: Got it.
DR. COHN: Now, we were talking about recommendation one, which is both the recommendation around the guiding principles and then the guiding principles themselves. The point that I was just making just now had to do with guiding principle 13, which was commenting that we are really talking about the market acceptance of candidate PMRI standards as opposed to PMRI standards. That was really the only change that I had to make. I was looking to see if anybody else had any comments about any of the guiding principles at this point.
DR. ZUBELDIA: I have a comment, not about the guiding principles but about the introduction above recommendation one. At the bottom of the introduction, in the fax that I have received, it is the last half of that page, in the middle of the page. It says, "The NCVHS makes the following recommendations. After the box, which has recommendations, and then there is another little introduction that says, "The NCVHS recommends to the Secretary of HHS…" That does not flow quite right.
DR. COHN: Okay, so you would like to see that consolidated.
DR. ZUBELDIA: Yes. What I would do is take out the one that is in paragraph D. Take that out completely.
DR. COHN: Yes, and probably make this first page, "makes the following recommendations to the Secretary of HHS."
DR. ZUBELDIA: Exactly. "The NCVHS recommends to the Secretary of HHS," go on, and even though the box is kind of disrupting the flow, I am assuming that the box would appear on another page, like front and back.
DR. COHN: Yes, I think that was the intent. Is everybody okay with this wordsmithing change here?
DR. FITZMAURICE: What does it read?
DR. COHN: Okay, what we are going to do is to add on the final paragraph of the introduction, where it basically says that the NCVHS makes the following recommendations. We are going to add or basically we will say the NCVHS recommends" ¾ what was that, "makes the following recommendations to the Secretary of HHS."
DR. FITZMAURICE: Recommends to the Secretary of HHS the following recommendations?
DR. COHN: That is too awkward.
[Simultaneous comments.]
MS. AMATARA: Just "makes the following recommendations."
DR. FITZMAURICE: Yes.
DR. COHN: Okay.
MS. AMATARA: I think that ¾
DR. COHN: We have already commented ¾ go ahead, what?
MS. AMATARA: I think if we ¾ if at the end of the introduction we say right here, "and in consideration of broad industry testimony, the NCVHS recommends that the Secretary of HHS" ¾
DR. COHN: Okay.
MS. AMATARA: Because then it will be consistent with the wording of all of the ¾
DR. FITZMAURICE: Right.
DR. COHN: Great. Okay, thank you.
DR. FITZMAURICE: So we then get rid of the first paragraph under recommendations.
DR. COHN: Yes. Are we ¾ so we are okay with that? Let's move into recommendation number two.
MS. AMATARA: Oh, Simon.
DR. COHN: Yes, Margaret.
MS. AMATARA: I just happened to notice when I was reviewing your notes. There was a comment on guiding principle number eight. Do you want to consider that? It is, guiding principle number eight says, "are precise and unambiguous but as simple as possible," and your reviewer asked simple to do what?
DR. COHN: No, I think we should leave that alone.
MS. AMATARA: Okay, thanks.
DR. ZUBELDIA: Are we going to go over guiding principles later today?
DR. COHN: No, we just have, Kepa. If you would like to comment, this is the time to do it.
DR. ZUBELDIA: I would like to comment on a couple of things. There is ¾ guiding principle number three, bring consistency and uniformity. I see in the revised fax that that one says, "will be consistent with the other HIPAA standards.
DR. COHN: Correct.
DR. ZUBELDIA: Maybe that should be split into two. The "will be consistent" is fine. Another would be Promote consistency and uniformity with the other HIPAA standards."
DR. BLAIR: We actually discussed this yesterday. Should I?
DR. COHN: Yes, please, Jeff.
DR. BLAIR: We discussed this yesterday. As a matter of fact, it is the result of splitting that one out where we were definitive about being consistent with the HIPAA standards. By the way, can you hear me, Kepa?
DR. ZUBELDIA: Yes, yes, I can.
DR. BLAIR: We felt as if the concept of consistency was being carried by several other guiding principles and especially the guiding principle that referenced the characteristics and attributes of terminologies. Because when you ¾ that references the section in the overview of standards where we indicate what those characteristics and attributes are. In there, we actually even get the word "consistency". Margaret, you might be able to help me point to exactly where this thought linkage leads. That was the reason why we did not create a new guiding principle.
DR. FITZMAURICE: Let me just interrupt. Kepa, this is Mike. I staunchly believe as you do, that there either ought to be the old one or have two of them split out. The second one that you brought up is probably the more important one, but I was the only one, and others felt that it was covered elsewhere.
DR. ZUBELDIA: Okay. Then on lines 22 to 25, that is guiding principle five, "Would be supported by an ANSI-created standard developing organization," and then it talks about all kinds of things where an ANSI accreditation does not address the domain, blah, blah, and blah.
DR. COHN: Kepa, you are looking at a wrong version.
DR. ZUBELDIA: Okay.
DR. COHN: The five reads, "will be supported by an ANSI-accredited standards development organization or other private or public organization that will assure continuity and efficient update of the standard over time."
DR. ZUBELDIA: Okay.
Dr. COHN: Which is actually the same as is in the ¾ was proposed in the NPRM for administrative and financial transactions.
DR. ZUBELDIA: Is it not easier just to refer to the "see below" itself and say it will be supported by an ANSI-accredited organization or, if it is not possible, in accordance with the process described in section 1172 of HIPAA.
DR. COHN: Actually, Kepa, this turned out to be a very complicated discussion that we had again yesterday. Because, as you know, it turns out that message format standards are handled differently from codes, and there was a fairly substantial amount of information in the law regarding this. It is just not one part of that subtitle. So, we were either faced with adding two or three bullets to specify the fact that message format standards are handled differently than code sets, et cetera, or going back to what had been identified as one of the guiding principles in the administrative and financial transactions.
If you have some way of handling this in a short sentence that somehow covers this, I do not think that we would object to it, but none of us could do this in a way that would simplify that ¾
DR. ZUBELDIA: Yes. No, that is fine. I see that you have also changed 11 and 12. I would like to, if possible, remove the references to the rest of the text to make this self-contained guiding principles.
PARTICIPANT: [Off microphone.] We did that yesterday.
DR. ZUBELDIA: I would like ¾ that would entail in 11 listing what the characteristics and attributes are as part of 11 instead of pointing to section 3C2. In 12, I fully agree with that listing of the characteristics, and I would remove the parenthetical.
PARTICIPANT: [Off microphone.] Yes.
DR. BLAIR: Could I?
DR. COHN: Yes, feel free to go forward.
DR. BLAIR: On 11, and I suspect 11 is the one on terminologies, is that right?
MS. AMATARA: Yes.
DR. BLAIR: On that one, at one time, we actually did have them in there, but they are long, and they are not explained. We wound up bouncing back and forth on a number of these and on the quality one, the AH-HE-MA(?) references, which was the other one. We felt that was short enough that we could get it into the guiding principles, but on the terminology one, which was 11, we felt that it would not only be long but it is really difficult to explain the concept groupings.
DR. ZUBELDIA: The concern that I have is that the guiding principles will probably be quoted in other contexts, even in an NPRM or in other places without access to a whole document. If the principles are quoted from the document, they will not have that reference.
PARTICIPANT: He is right.
PARTICIPANT: Right.
DR. COHN: Kepa, you are right. I am trying to think of how we handle this. Can we ask Margaret to handle this offline and a way to do it? The problem is trying to figure out how to put this into something that would make sense to anybody. Margaret may have a comment here.
MS. AMATARA: I have a question, actually. I think we could handle it one of two ways if you could give me some guidance. One way we could handle it is simply by referencing the standard, which was the last thing that we did, and then people would have to go back to the standard. Another way of doing it is taking the verbiage from page 21 in which we have described briefly the characteristics and attributes.
The bullet items are general characteristics, structure of the vocabulary model, maintenance and evaluation. That is a very, very summarized and pretty dense description, I think.
DR. BLAIR: Could I suggest this. I think we are going to get in trouble if we condense the attributes and characteristics for terminology in several different ways, some of the things that would be left out. The others would be the lack of people understanding it and putting it into context. The suggestion that I would make on that is either referencing the standard or referencing for the other location within the document, or a third thing is that if somebody is going to wind up dealing with the guiding principles that there be an additional ¾ well, now we are creating an additional document. Anyway, those are my concerns.
DR. ZUBELDIA: Jeff, what I would do, I kind of go along with what Margaret was saying. Consistent with the characteristics and attributes for cases of specific PMRI terminologies such as generality, structure, maintenance and evaluation as described in the standard, but at least say what those attributes are. Just name them, and then refer to the standard, which is a self-contained document.
DR. BLAIR: I would feel okay with the wording that you just gave. Let's see if the rest of the workgroup does.
PARTICIPANT: Yes.
DR. COHN: Yes. Probably the only other thing that we need to do, one of the issues that we had yesterday was in terms of describing an external document that we are not including in this document. We probably need to say, "As described in Section three, page 20 and 21, and in the ASTM standard," so that people at least know ¾ do not have to start doing a literature search to find the ASTM standard.
One of the issues that we discussed was whether or not we could put that ASTM standard as an appendix. We decided that was not going to work very well since that is obviously a copyrighted, separate document from ASTM.
Are you in agreement with that generally, Kepa?
DR. ZUBELDIA: Yes. I think if at least we ¾ those four characteristics, generality, structure, maintenance and evaluation, and then refer to the external standard. Even though it is copyrighted, so people will have to pay for it, at least they know what it is talking about.
DR. BLAIR: Not only the external standard. I think we want to refer them to the overview of standards where we describe those and put it into context as well.
DR. COHN: Yes. Unfortunately, I am not sure that the generality is probably the right word for the first one.
DR. BLAIR: It was general.
DR. COHN: It was general characteristics and general attributes that do not have much to do with generality.
PARTICIPANT: Yes.
DR. COHN: Well, I think we can let Margaret play with this and see if there is better words that may describe some of this stuff, and we might wind up with five or ten key attributes. We say those and others.
MS. AMATARA: I will fix it up.
DR. COHN: It is actually probably just as well that we are dealing with this right now because this is an issue where we like an executive summary begins to bite you also. We cannot perform in the executive summary; continue back to other parts of the text in the main document.
DR. FITZMAURICE: This may make it easier for the full NCVHS committee when they review it. If they see some of this in front of them, they may not want all of the additional information.
DR. COHN: Well said. Kepa, do you have anything else in relationship to ¾
DR. ZUBELDIA: No.
DR. COHN: Okay.
DR. ZUBELDIA: The guiding principles look good.
DR. COHN: Let's go to item two here, recommendation two. I actually have a ¾ does anybody else want to start? I have a couple of issues with this one now. I think maybe I should just read it for everyone, and then I will just make my comments. Basically, it says, "Consider acceptance of the forthcoming NCVHS recommendations for PMRI standards. These recommendations will be delivered to the Secretary 18 months following submission of this report. The recommendations will identify an initial set of PMRI standards using the criteria, guiding principles as described, include implementation time frames, which consider industry readiness, identify mechanisms to accelerate the development of these standards that are not ready for implementation. Following the Secretary's acceptance of the NCVHS recommendations, the NCVHS is prepared to assist the HHS with the prompt initiation of the rule making process, provisional comment periods and publication to adopt a final rule to adopt the standards."
This has been considerably changed from what we did yesterday.
MS. AMATARA: Yes.
DR. COHN: And I am not sure to the better. I just have the following comments to make on this one. First of all, this one from last night, but it seems that we are missing the obvious here. I think what we are really ¾ first of all, what we are really recommending to the Secretary is that HHS approach the issue of PMRI standards in the same way that they have approached financial and administrative transaction standards here to date. That is fundamentally what we are talking about throughout this thing, is it not? Am I missing something? Is that so obvious that we should not mention it here?
DR. BLAIR: I do not know that it is the same in the sense that we wound up choosing to do this report instead of to go ahead and just select the standards.
DR. COHN: What I am saying is that the process is effectively ¾
DR. FITZMAURICE: The process may or may not be the same. Let me just describe a little bit. Whenever there is a change or a new HIPAA standard, there is a process dictated by the memorandum of understanding that was presented to NCVHS about a month ago. It goes through the steering committee and then out to a standards developing organization, where it is approved. It comes back to the steering committee, then to NCVHS for final comment and submission to the Secretary.
This seems to describe a different process for updating and new standards, which may be appropriate because it is clinical information and not the administrative information found in HIPAA. I can find a compatibility with the existing process, and I can also find a difference and a reason for the difference.
DR. COHN: Okay, so I think what you are saying is that ¾
DR. FITZMAURICE: Essentially this bypasses the SDOs.
DR. COHN: We do not know if it does or not. We are not specifying that.
DR. FITZMAURICE: That is true. That would be up to the Secretary to determine the process.
DR. COHN: Right.
DR. FITZMAURICE: We are saying that we see parts of the process, and we would be very prompt with any help that she wants from NCVHS.
DR. COHN: Okay. Do we have the old recommendation two, the one that we did at the end of the day yesterday?
MS. AMATARA: Oh.
DR. COHN: Because I find this ¾ I mean, there is a lot of wordsmithing here, but I am just trying to think, it might be easier to just look at yesterday's version and see ¾
MS. AMATARA: I do not think that I have yesterday's version because this is draft six, June 1. I am sorry. Basically what we did was we pretty much took the same words, and we structured them differently. What we did was we made bullets A and B, but we basically took ¾ there was a very, very long sentence with that information in it. I do not think that we changed any of the meaning.
DR. FITZMAURICE: But we did take out the time limit. You remember there was an 18-month time limit in there.
DR. COHN: I guess we will get back into wordsmithing this since you do not have the version. I think we had talked earlier, for example, about this being an ongoing process. It now sounds like we are sending in one set of recommendations. I think we had decided, for example, in C that we might identify mechanisms to accelerate the development of standards as opposed to "will". I think the way that I read this now is that this is going to be a one-time set of recommendations.
MS. AMATARA: It has got an initial set. That is the same wording that we had before, "identify an initial set of PMRI standards," and then "following the Secretary's acceptance, NCVHS is prepared to assist with the prompt initiation". We took 18 months out of there.
DR. FITZMAURICE: I think Simon is right, though. Following the Secretary's acceptance of the NCVHS recommendations of the initial set of PMRI standards not these recommendations. There could be a confusion between the two.
MS. AMATARA: Okay.
DR. BEBEE: That was in there.
DR. COHN: I guess I was first of all ¾ I guess that I mean, once again, I need you to look paragraph by paragraph here because I find myself kind of jumping around in areas that I am having some problem with. The first sentence, when we say, "the forthcoming NCVHS recommendations", I once again read this as one. Do we mean, "consider acceptance of forthcoming NCVHS recommendations," getting rid of "the"?
Once again, as I say, I still read this as being that we will be delivering sort of a final document in 18 months.
DR. ZUBELDIA: Maybe if we put the word "starting" before the "18 months." It would be "to the Secretary starting 18 months."
DR. COHN: Okay. That is another good way to handle this. That is actually an excellent way to handle that. Okay. We are saying ¾ that may solve some of my problems then. We say, identify an initial set; include implementation time frames. I think we are fine with that. I am having a little trouble with C only because we ¾
DR. FYFFE: Can we use the word "beginning" instead of "starting". "Beginning 18 months."
DR. FITZMAURICE: Aren't we redundant, though? "Initial set beginning." I would thin that we would wind up saying one or the other. I do not care which one that we do, but either it is an initial set or it would give the selections beginning at a certain time.
DR. COHN: Oh.
DR. FYFFE: We do not have the word "initial," do we?
[Simultaneous comments.]
DR. COHN: I think it is fine. I do not think that it is redundant.
DR. BEBEE: The beginning is that they will be delivered to the Secretary beginning 18 months following submission of this report. The recommendations will, A, identify the initial set of PMRI standards. Do you think that is redundant, Jeff?
DR. BLAIR: No. That is fine.
[Simultaneous comments.]
DR. COHN: Are we funding B then?
DR. ZUBELDIA: If we said, "identify an initial and subsequent sets of PMRI standards."
DR. AMATARA: Or how about a series of? Identify a series of PMRI standards.
DR. BEBEE: I think we need to say initial.
DR. ZUBELDIA: Identify PMRI standards.
DR. BEBEE: The whole idea here that we discussed yesterday, the idea was that we are recognizing that this is not going to happen all at one time, so we wanted to start someplace. That is where the initial set was born.
DR. FITZMAURICE: There is a way of handling the initial, and that is to change initial to specific. At the very beginning of two, it would read, "Consider acceptance of forthcoming NCVHS recommendations for specific PMRI standards."
DR. BEBEE: We had that, too, yesterday, I think.
DR. BLAIR: We had considered "specific," we had considered "first," and then we evolved to "initial".
DR. COHN: We had a lot of these before, and we are sort of reconstructing what we did yesterday, which is fine.
MS. AMATARA: I think the issue, though, is if we say these recommendations will be delivered to the Secretary beginning 18 months, then we say the recommendations will identify an initial set. It does not talk about when any subsequent standards recommendations will be made.
DR. BEBEE: That is the whole point, I thought.
DR. BLAIR: Right. It leaves the door open to us to determine that.
DR. BEBEE: Right. We did not want that. What was Kepa's again, identify an initial and subsequent set? I think that would be alright and still maintain the beginning 18 months. I think that would be okay.
DR. COHN: I guess the question here is are we saying that we want to change that to identify on an ongoing basis PMRI standards.
DR. FYFFE: That is good.
MS. AMATARA: I like that.
DR. FYFFE: Identify on an ongoing basis.
DR. AMATARA: I think that is much better.
DR. COHN: Okay, so basically, now have "identify on an ongoing basis PMRI standards using criteria in the guiding principles for selecting PMRI standards.
DR. BLAIR: The thing is, are you saying that these criteria will not change on an ongoing basis? I would like to believe that they are pretty stable.
DR. FITZMAURICE: I think it comes early enough in the sentence that it probably does not modify the criteria. It modifies the set of PMRI standards.
DR. COHN: Yes. Yes, I would agree. Are we okay with that one now? Okay, then B is implementation time frames, which consider industry readiness. Now, C, I am having trouble with. I am not sure why C is even there.
MS. AMATARA: We have ¾
DR. FITZMAURICE: What does C say?
DR. COHN: It says, "Identify mechanisms to accelerate the development of those standards that are not ready for implementation." I thought we had changed that yesterday from a "will" to a "may" with an idea that there might be some cases of that, but if we are approaching this in an interim, ongoing fashion, the rest of the recommendations are really about identifying mechanisms to accelerate the development of those standards that are not ready for implementation. I am not sure why in 18 months we are then going to come up with recommendations to accelerate the development of those standards that are not ready for implementation. Is there ¾ I guess I would ask the rest of the group. Kepa, you can comment also on that one. I sort of saw that as redundant with the rest of the report.
DR. FITZMAURICE: I think it is redundant. I think that at any time, NCVHS could send a letter to the Secretary that says, "here is a mechanism that we think is needed to accelerate the development of this particular standard." There is enough leeway to do it without pledging to do it. It will depend upon the will of the existing NCVHS at the time.
DR. COHN: Yes. I think the key thing here is that we are saying that we are going to start coming up with specific standards. This is not that.
DR. BLAIR: Is there a consensus to remove that particular sub-bullet?
DR. ZUBELDIA: Yes, I would remove it, too.
DR. COHN: Okay, great. Then the last paragraph here, "Following the Secretary's acceptance of the initial set of NCVHS recommendations, the NCVHS is prepared to assist the HHS with the prompt initiation of the rule making process to adopt these standards." This is actually very different than what we had yesterday.
MS. AMATARA: We had ¾
DR. COHN: We had something yesterday which talked about urging the Secretary to promptly initiate the rule making process. I am not sure what the point of this particular paragraph was.
DR. BLAIR: May I explain that a little bit. When we were looking at it, it just sounded ¾ we were saying, as a matter of fact, the wording was even stronger than urging. It was like we were telling her to move quickly on these things. It sounded ¾ it sounded, at least to our ears, a little bit ¾
DR. FITZMAURICE: More directive than advisory.
DR. BLAIR: More directive. Thank you.
DR. FITZMAURICE: Sorry for jumping in.
DR. BLAIR: Thank you for the proper words. That is very good. More directive rather than advisory. We were looking for a way, and maybe we fell sort, of trying to be in a supportive and encouraging role rather than in a directive role.
DR. COHN: I am actually just wondering as I look at this, and I had asked others for an opinion. I look at this paragraph, and I think it could easily be deleted, the entire paragraph.
DR. BLAIR: Oh, I would be very concerned about deleting this. The reason is, this is ¾ there were several people who commented on the draft that were confused. Clearly, they just did not recognize that these recommendations were the beginning of this rule making process. This winds up clearly stating here for many outside readers that this is the next step. So, I ¾
DR. COHN: That does not actually ¾ what this says is that we are now assisting the HHS with the prompt initiation of the rule making process which, at least as I understand the role of the NCVHS, is actually not our role. Our role in this is to recommend the standards. It is the role of the HHS to develop the NPRM, deal with the comment period, and publish the final rules.
DR. FITZMAURICE: I think you are right on that, Simon, that NCVHS cannot initiate the rule making process. HHS has to initiate the rule making process. It does start with the preparation of an NPRM.
DR. COHN: But I think our role in this is to come up with the actual standards that need to be put into the rule making process.
DR. FITZMAURICE: One could say that NCVHS will stand ready to assist the prompt development of whatever, of the process of getting to the goal of having a national standard. Some of these things may be better said in the letter that transmits the standard to the Secretary.
DR. BLAIR: Yes, but I really felt like with the comments we have received from intelligent, knowledgeable people who had already been through the first part of this. They were reading these recommendations, and they did not see in the recommendations that the rule process was going to be invoked. So, I really ¾ this is something where I guess I feel pretty strong that we have to have some piece here in the recommendations where these folks could see that these things ¾ now, I think we could change the wording on this. If you do not want to say that NCVHS will assist, I can understand you would pull that part of the phrase out.
DR. FYFFE: I have a suggestion.
DR. COHN: Kathleen has something.
DR. FYFFE: We could say that the NCVHS is prepared to provide continuing assistance to HHS for the adoption of these standards and then have a footnote that explains the steps in adopting the standards such as the NPRM, the comment periods and the publication of final rules.
DR. BLAIR: You know, it might not even take that because when you propose, say, a code set, a code set can be changed without the rule making process just by publicly announcing it rather than going through an NPRM and then a regulation. It will depend upon what is being recommended. I like what you said, but I would add "adoption and implementation".
DR. FYFFE: Okay. Okay. That is fine.
DR. BLAIR: So you are saying that there would be a footnote so that people who got a copy of the recommendations would still see ¾
DR. FYFFE: I am sensitive to what you are saying, Jeff, because there are a lot of folks in the country who are quite intelligent and may even have a PhD or two, and they do not understand the steps in legislation, in regulation, and implementing law. We have to say it someplace, and if it is appropriate in a footnote, let's do that. Yes, I am very sensitive to what you are saying. I think that you are on target that we need to remind folks of what the steps are.
DR. COHN: I guess the question is, is this recommendation aided by identifying the various steps or is the issue here moving toward adoption and implementation?
DR. FYFFE: I look at this document as a communication vehicle, and you have to think of the audience who is going to read it.
DR. BLAIR: The main point in what is there is this is telling a lot of people in SDO organizations that are concerned about this, that are concerned about how this is going to affect what has happened already. They are concerned about how it may affect their SDO or terminology developer in the future. What it is saying here is there is going to be an opportunity for an NPRM end comment for them to comment further. T his is not the end of the road.
DR. FITZMAURICE: I see what you are saying, that they want to make sure that they have a voice in what comes out.
DR. BLAIR: Absolutely. Absolutely. They were very concerned that this was the end of the road.
DR. FITZMAURICE: But that ¾
DR. BLAIR: That we would go ahead and select it and that would be done.
DR. FITZMAURICE: That would really be the Secretary's decision as to how to do this. You are always wise to get comments from knowledgeable people and from the people who are affected by what you do. One could say, after having said what we have said, "whether this is done by regulation or otherwise," but your point is not the process, it is exposing it to the public.
DR. BLAIR: Yes. It is letting the readers who go through this see that they still have an opportunity to comment.
DR. FITZMAURICE: How about we recommend that the final ¾ the specific standard be published in the Federal Register for public comment? You could do that without it being a notice of proposed rule making. That is, you are not trying to change a regulation; you are simply alerting people, "We plan to adopt this code set," which does not require a change in the regulation.
DR. BLAIR: There are a lot of people who are not monitoring the Federal Register, especially the small vendors.
DR. FITZMAURICE: That is where the notice of proposed rule making would come out.
DR. BLAIR: Help me understand, because we could fall back to that. I am just not sure it is as reassuring as the phrase here, but maybe you are saying that the phrase here is too prescriptive. Is that what you are saying, and we ¾
DR. FITZMAURICE: It presumes a process ¾
DR. BLAIR: ¾ might not have an NPRM? Is that what you are saying?
DR. FITZMAURICE: It presumes a specific process. What you want is openness and public notice of the changes.
DR. COHN: Margaret, I think, had a comment.
MS. AMATARA: I have a question. This section here is substituting for he recommendation that we had before that says, "Issue a notice of proposed rule making, gather comments, publish the first set of a series of final rules for PMRI standards within 18 months after acceptance of the NCVHS recommendations, require implementation of PMRI standards within the time frames recommended by NCVHS." That was what we had originally. People seemed to be comfortable with that except for the placement within the sequence of recommendations. It had been recommendation four. Essentially ¾
DR. COHN: We thought it was a little presumptuous to start giving her timelines.
MS. AMATARA: So my question is, are you now backing off of the suggestion that the whole thing be done in a rule making process? I guess that is what I am hearing, that we had originally talked about that this be a rule making process, whether or not there were timelines in there or not. Now, I am hearing you say this does not necessarily ¾ this should not necessarily be in a rule making process; it should only be an open process where there is input from the community.
DR. FITZMAURICE: that is the sense that I get from Jeff, and I am aware that some of the changes can be made without going through the rule making process, without changing a regulation. There is a proposed adoption of PMRI standards.
MS. AMATARA: Is that broad enough to include NPRM process?
DR. FITZMAURICE: Oh, yes. Yes
Dr. COHN: Actually, maybe what we want to say here is assist the Secretary with an open process that leads to adoption and implementation. That would leave it open. There are a number of different ways to have an open process.
DR. FITZMAURICE: Yes.
DR. COHN: I think that we are all talking about the open process. Jeff, maybe I am misunderstanding you. What you are talking about the one hammer that we know is open is the notice of proposed rule. There are probably other hammers and other nails and all of that.
DR. FITZMAURICE: What I was suggesting, normally the official way to do it is that you put a notice in the Federal Register. That gives you all of the government activities. Once you have done that, the Secretary has met the legal obligation to give public notice.
DR. BLAIR: Could I throw that to the way Simon was phrasing it. That maybe if we were to say something to the effect that once the NCVHS submits its recommendations that we encourage the Secretary to have an open process, without defining what it is, an open process to give the industry an opportunity to comment on these before the final rule is made. Something to that effect. Is that okay?
DR. FITZMAURICE: Yes.
DR. BLAIR: Simon, is that all right?
DR. COHN: That is close. Of course, the question is, isn't that what we are supposed to be doing?
DR. BLAIR: Actually, in a sense, the process seems to have two. Number one is we wind up having hearings like we did for financial administrative transactions. Then there is the NPRM after that. It is almost like a two-stage process. All of this is winding up saying is that we are also expecting there to be this two stage process as well.
DR. FITZMAURICE: I think Jeff is right. We are forming a recommendation that goes to the Secretary. The Secretary then forms the process whereby it is adopted and implemented. We are asking that in the Secretary's process that there be open consultation with the public, for the industry and for the public.
DR. COHN: That actually is not too bad.
MS. AMATARA: I have, "Once the NCVHS submits its recommendations, the Secretary is encouraged to have an open process to give the industry an opportunity to comment on the PMRI standards proposals."
DR. BLAIR: Yes, before the final rules are adopted.
DR. FITZMAURICE: You might make it even broader. Instead of industry, putting "and the public" which includes not only the industry but care providers and consumers.
MS. AMATARA: "Give the public"?
DR. COHN: Yes, I think this will need a little bit more wordsmithing, but I think it is probably good enough to go.
PARTICIPANT: Yes.
DR. FITZMAURICE: Yes, I would put it in terms of "NCVHS encourages the Secretary," make it a direct encouragement.
PARTICIPANT: Yes.
PARTICIPANT: Jim Scanlon is here. He is waiting.
PARTICIPANT: He is gone.
[Comments off microphone.]
DR. COHN: I think that is going to need a little bit more wordsmithing.
MS. AMATARA: There is something screwy here, but.
DR. COHN: Part of it has to do that it is ongoing recommendations, so it once again sounds like we are doing it one time only.
MS. AMATARA: As the NCVHS?
DR. COHN: Submits our recommendations.
DR. BLAIR: Is that the beginning of the sentence that we are working on?
MS. AMATARA: I think it ought to start with encourage, actually. Encourage the Secretary to have an open process.
DR. BLAIR: I would rather it start with, "After the NCVHS has made the recommendations, we encourage." The time. It positions people when they start to read it that we are ¾ what the time frame is.
MS. AMATARA: "After the NCVHS submits recommendations, NCVHS will encourage the Secretary to have an open process to give the public an opportunity to comment on the PMRI standards proposals before the final rules are adopted."
DR. BEBEE: Can we just say after the recommendations, "After submitting the recommendations, NCVHS will encourage..."
DR. COHN: Okay, my feeling is that we are not going to come to the final wordsmithing on this one in this room right now. I think Margaret needs to work on it. I will personally defer to Margaret to come up with the final wordsmithing on this. I think we have made significant changes. Margaret, is that okay with you? It still does not feel right, and I just do not think that we should spend more time on the workgroup's time dealing with the wordsmithing there. I would urge you to keep prior versions of the recommendation just in case, later on in June, we need to go back to earlier versions.
Okay, so we will talk about further recommendations here. Number three is a set of recommendations around the media funding. Number one, to support for government participation in standards development as members of SDOs and as a department member of the NCHISB. Any comments or otherwise on that A section? Kepa, do you have anything?
DR. ZUBELDIA: No.
DR. COHN: B is broader participation of expert representation in standards development, rural outreach projects, encouraging SDOs to make greater use of the internet, and making existing government facilities available for teleconferencing and other uses. Are there any comments there?
DR. FITZMAURICE: No. It looks good to me.
DR. COHN: Okay. C, enhancement, distribution and battements of clinical vocabularies which have the potential to be PMRI standards through ¾ Richard, the word is "through" or "by" actually? It is probably "by". You can figure that one out.
One is government-wide licensure for comparable arrangements so that vocabularies are available for use at little or no cost. Continue development and testing of the National Library of Medicine unified medical library system with body-enhanced mapping capabilities among and between medical vocabularies and between ¾
DR. FITZMAURICE: Does it say library? I thought it said, "unified medical language."
DR. COHN: It says, "unified medical library system."
[Simultaneous comments.]
DR. COHN: It should be language system. Thank you. "To embody enhanced mapping capabilities among and between medical vocabularies and between medical vocabularies and the more general statistical classifications and reimbursement code sets designated in the HIPAA standards for financial and administrative transactions and other uses." Now I can take a breath!
Three is development and testing of applicable portions of multi-agency projects such as the GCPR framework project in conjunction with SDOs.
I guess under one, I guess I would wonder why we are specifying vocabularies as the only thing that can be licensed at little or no cost and why we are not using the term "terminologies" there.
DR. FITZMAURICE: I would suggest, following what you said under C, "enhancement, distribution and maintenance of clinical terminologies," and change "vocabularies to "terminologies" in both places.
DR. COHN: Yes. Is that ¾
DR. FITZMAURICE: Given our definition that terminologies include the code sets and the classifications as well as the vocabularies.
DR. COHN: There may be occasions when you want to actually use a classification here.
MS. AMATARA: Can I ask a question?
DR. COHN: Sure.
MS. AMATARA: You know, you commented on National Library of Medicine's unified medical library system. I thought that sounded strange to me, too. That is what Betsy's note says.
DR. COHN: She is wrong.
PARTICIPANT: It has been changed.
DR. COHN: She is wrong.
DR. FITZMAURICE: I think it is "language".
DR. COHN: She is allowed to make mistakes.
MS. AMATARA: Okay. I was so surprised.
DR. FITZMAURICE: That was a good catch on Jeff's part.
PARTICIPANT: Yes, really.
DR. COHN: So we change terminologies in C, terminologies in C-one, and I think two is fine. Three needs some wordsmithing.
DR. FITZMAURICE: I have a proposed one to insert between two and three for your consideration.
DR. COHN: Let's do three, and then you can put that one in. It basically ¾ probably what we mean here is development and testing by appropriate multi-agency projects.
DR. FITZMAURICE: In the projects?
DR. COHN: You are right, leaving "it" in. Why don't we say, "in appropriate multi-agency projects"? Okay? Okay, what is your new number three?
DR. FITZMAURICE: Bear with me. I would insert, "Developing and testing of quality measures such as are found in AHRQ's National Quality Measures Clearinghouse, clinical practice guidelines such as are found in AHRQ's National Guidelines Clearinghouse, and patient safety measures, for their compatibility with existing and developing clinical vocabularies, code sets and classifications." I could drop those words and just say "clinical terminologies".
DR. COHN: I think you need to get ¾ I did not pick up most of what you said, and I know that Margaret did not.
DR. FITZMAURICE: Developing and testing of quality measures, clinical practice guidelines ¾
DR. COHN: Look up there and see where she has gotten.
DR. FITZMAURICE: Let's see, where are we. Testing of quality measures such as are found in AHRQ's National Quality Measures Clearinghouse, clinical practice guidelines such as are found in AHRQ's National Guidelines Clearinghouse ¾
MS. AMATARA: The same thing as are four in AHRQ?
DR. FITZMAURICE: One of them is the Guidelines Clearinghouse, and the other one is a Quality Measures Clearinghouse.
MS. AMATARA: AHRQ's Quality Measures Clearinghouse?
DR. FITZMAURICE: That is the first one.
MS. AMATARA: What is the second one?
DR. FITZMAURICE: National Guidelines Clearinghouse. That is AHRQ's AAHP and AMA. We can get the specific wording if we need it. It is, "Development and testing of quality measures such as are found in AHRQ's National Quality Measures Clearinghouse comma ¾
MS. AMATARA: Mike, hold on.
DR. COHN: Mike, it sounds like you are wordsmithing. Did you have it there?
DR. FITZMAURICE: I have it right here.
MS. AMATARA: Tell me after the second clearinghouse.
DR. FITZMAURICE: It is hard for me to read the red that is on the board. After the second clearinghouse, "and patient safety measures for their compatibility with existing and developing clinical terminologies."
Very good.
DR. COHN: That needs immediate funding?
DR. FITZMAURICE: Given the pressures on patient safety, given the fact that quality measures are being used, NCQA and others, the faster those are linked with terminologies, the faster patient medical records standards can bring uniformity to the exchange of this information. It would also, we would hope, reduce the cost of getting that information.
DR. COHN: Okay, what do people think of that? Kathleen?
DR. BEBEE: I think it is a very good point. It has to be made.
DR. COHN: Okay.
PARTICIPANT: I would support it.
DR. COHN: I think my only issue is wordsmithing here in the sense that there probably ought to be some way to combine ¾ I guess it does not matter to me which clearinghouses AHRQ has ¾
DR. FITZMAURICE: Don't mention about that. We can ¾
[Simultaneous comments.]
DR. COHN: We can wordsmith that and come up with more of a generic "as found in AHRQ clearinghouses." Yes, that might shorten this a little bit, but I think we can let Margaret do some wordsmithing there but otherwise okay.
Margaret, are you comfortable with that?
MS. AMATARA: Yes.
DR. COHN: Okay. For the next one, under D is coordination of data elements among all standards selected for adoption under HIPAA through funding, one, development and maintenance of an open medical data registry.
PARTICIPANT: I have to go meet my boss.
DR. COHN: Okay. Two, working conferences to harmonize message format and vocabulary standards. Comments? Okay. We pass that.
Ease development and maintenance of reference terminology for drugs and biologics that promote the ability to share clinically significant information. I think we pass that one also.
PARTICIPANT: [Off microphone.] Good compromise.
DR. COHN: Yes. Okay, any final comments on three before we move on to four?
Form needs for each standard recommended by NCVHS, commit funding for A, development of the uniform implementation guide, B, development of conformance testing procedures and selection of performance testing organization ¾ adding an "s" for organizations ¾ ongoing government licensure of those terminologies selected for adoption as PMRI standards so that these code sets, classifications and vocabularies are available for use in the public and private sector at little or no cost.
Comments? Kepa, are you with us still?
DR. ZUBELDIA: Yes, I am here.
DR. COHN: Okay, any comments on four?
DR. ZUBELDIA: No.
DR. BLAIR: I think Kathleen Frawley has tried us. Kathleen, are you with us? No.
DR. COHN: The next one is five, which is promote early adoption of PMRI standards and evaluation of candidates for PMRI through PMRI standards within government programs to provide broadened feedback to the standards development community. These early adoption activities should begin as soon as possible in order to provide information to assist with both the selection of PMRI standards and their official designation as HHS regulations. Huh.
To achieve this, HHS should support the use of PMRI standards according to the following priority. We list three priorities. Then government agencies that may be candidates for early adoption activities include but are not limited to, and there is a list of possible groups there.
Comments?
DR. ZUBELDIA: I have a question. What is the official designation of HHS regulations? What does that mean?
PARTICIPANT: I do not know either.
DR. ZUBELDIA: Is that any different from adoption of standards?
DR. COHN: I am sorry, Kepa, I missed what the question was.
DR. ZUBELDIA: Is that different from adoption of PMRI standards?
DR. COHN: What is different, do you mean the question here?
DR. ZUBELDIA: What is different between a designation as HHS regulation and adoption of PMRI standards?
PARTICIPANT: The second sentence.
DR. COHN: I find that to be an odd sentence myself. So you mean about the selection of the PMRI standards. I think probably we should put a period after the PMRI standards, I would imagine. I think that HHS regulation, how about "the selection and adoption of PMRI standards" as probably a better way to handle that one. Is that okay?
PARTICIPANT: Yes, that is it.
DR. COHN: Get rid of the remaining part there.
DR. ZUBELDIA: You have to remove the word "both".
DR. COHN: You are going to get rid of both the selection and adoption?
DR. ZUBELDIA: It says the selection and the official designation as ¾
DR. COHN: No. What we have now is "provide information to assist with both the selection and adoption of PMRI standards," period.
DR. ZUBELDIA: Okay. That is fine.
DR. COHN: Okay?
DR. ZUBELDIA: Yes.
DR. COHN: Other comments?
DR. BLAIR: Good.
DR. COHN: Okay. Six is "support increases in funding for research, demonstration and evaluation studies to: A, promote data capture systems that can make it faster and more economical to collect clinically specific information once at the point of care and enable derivatives of that data to be used for payment, quality improvement, public health research and other purposes." B is "to undertake basic informatics research on health data representation, data mining methods, work flow efficiency, change management and human-computer interfaces."
DR. ZUBELDIA: I have a problem with the data derivatives.
DR. COHN: Okay.
DR. ZUBELDIA: This looks like a 1984 thing.
DR. COHN: A 1984 thing?
DR. ZUBELDIA: I mean, it is a very, very surveillance type of paragraph.
DR. COHN: Again, are you against all of A or are you against ¾
DR. ZUBELDIA: No, maybe enable anonymized data derivatives or something like that.
DR. COHN: You would not want to anonymize data for payment, I do not think.
DR. ZUBELDIA: I know. That is just ¾
DR. COHN: The concept here is obviously being able to have data captured once and used for multiple purposes.
DR. ZUBELDIA: Yes.
DR. COHN: I mean the ¾
DR. FYFFE: Then just say that, "multiple purposes such as".
DR COHN: "Purposes such as," okay.
DR. FYFFE: Get rid of the word "derivatives".
DR. ZUBELDIA: That is much better.
DR. COHN: Okay. Such as payment.
DR. FYFFE: Yes.
DR. COHN: Okay, good. Thank you, Kepa.
DR. BEBEE: I have a question, too ¾
DR. COHN: Sure.
DR. BEBEE: ¾ about the addition that Mike made. He is not here. I am wondering if it would be best put here since this is dealing with quality and evaluation studies and that kind of thing. The only difference would be, in my mind, it is the place where it is now, it is under the immediate funding.
DR. COHN: Which level of funding is this one?
DR. BEBEE: This comes even below ¾
DR. COHN: Why don't we wait for Mike to come back and ask him that question.
DR. BEBEE: Yes.
DR. COHN: I do not think I can answer that. The question was whether it is already being partially funded and we need to increase it or whether it is not being funded at all.
Okay, now, the next one is "Accelerate the development and implementation of a national health information infrastructure. HHS should work in collaboration with other federal components, state government and the private sector on demonstration and evaluation projects, test beds and/or networks such as the GCPR framework project." My memory had been that was actually C under six. Am I mistaken on that one?
MS. AMATARA: We had it as a separate bullet because it was ¾ when Jim Scanlon came in and he talked about privacy and NHII, we shifted it to a numbered item by itself as it had been before.
DR. COHN: Okay, and that was because?
MS. AMATARA: We had it as a separate numbered item before, and then when Jim came in yesterday, he asked about having a recommendation on privacy and NHII, and we said yes, and he said, "Good."
DR. COHN: Oh, does that mean that it had to be separate recommendation instead of a bullet?
MS. AMATARA: No, it just seemed like it was appropriate because it had been separate before.
DR. COHN: Okay.
MS. AMATARA: But we can make it a "C".
DR. COHN: Do people have an opinion one way or another? I guess I am trying to make these as few as possible, and I am trying to consolidate. Kepa, do you have a comment on this one? Would you rather see it as a separate bullet or a sub-bullet?
DR. ZUBELDIA: I think it is fine the way that it is now.
DR. COHN: Okay. I guess I will leave my comment, and we will leave it there.
Number eight is, "Demonstrate the benefits and measure the costs of using uniform data standards for PMRI. Areas where value may be demonstrated include clinical performance measures, use of practice guidelines, reduction in adverse events, and public health surveillance and intervention. I do not know what it should be, but it sure should not be a full number.
MS. AMATARA: What ¾
DR. COHN: I said I do not know where this should be, but it sure should not be a full bullet on its own sitting out there.
DR. BLAIR: Which one is this?
DR. COHN: It says, "Demonstrate the benefits and measure the costs of using uniform data standards of PMRI. Areas where value may be demonstrated include clinical performance measures, use of practice guidelines, reduction in medical adverse events, and public health surveillance and intervention." My only comment is I do not disagree that it needs to be somewhere, but it is not a full bullet, a full numbered item.
DR. BLAIR: The discussion we had yesterday was that the reason we wanted it as a separate bullet was because there were a number of individuals and special interest groups that were focused on the cost benefit aspect of it. For visibility purposes, we were doing that, and I thought that there was agreement yesterday that we would. Kathleen, do you have a thought on that?
MS. AMATARA: It had been a full bullet item before.
DR. BEBEE: Yes, I am here. I am thinking, Jeff.
DR. COHN: It really seems like it ought to be a part and parcel of one of the other implementation or funding areas.
DR. BEBEE: What about under six?
DR. COHN: I guess I am sort of struck that ¾ once again, Mike, it is my own penchant that we do not come up with 20 recommendations. Since some of these areas are making this argument, we could easily take 3C and blow it up into a full recommendation. It is an important recommendation. By definition of any important recommendation needs to have its own number, we wind up getting into trouble.
DR. BLAIR: Also, while Kathleen is thinking of her thoughts on this, you see, I had basically said the same thing that you said, in discussions with Margaret, and Margaret also pointed out to me some of the sensitivities of this issue. So, Margaret, let me encourage you to say your thoughts on why this is a separate recommendation.
MS. AMATARA: I see it could be maybe under four. There were an awful lot of comments that we got back, I mean, more than just one or two, that there needs to be a study of what this is going to cost, that there needs to be assistance provided so that when an impact study has to be ¾ when an impact analysis has to be given in the NPRM, for instance, there would be something to go on. I think it could go under four.
DR. COHN: Yes, four would be a very appropriate place ¾
DR. BEBEE: Yes, I think four is a good fit.
DR. COHN: ¾ and probably it should be "C" under four with "C" now going to "D".
MS. AMATARA: Okay.
DR. BEBEE: Good show.
DR. COHN: Thank you. Okay, number nine is, "promote United States interest in international health data standards development: A, through HHS participation in international healthcare informatics standards development organizations and B, incorporation with the Secretary and the Department of Commerce to monitor the activity of U.S. health care information system vendors abroad and taking appropriate steps to correct anti-competitive activities that may be based on standards." "May be based on standards." Comments?
As I am reading these things out loud, some things sound right, and some do not, and I am finding the very last part of "B," which is, "anti-competitive activities that may be based on standards" seems relatively awkward. What do we mean by that?
DR. BLAIR: That standards might be used to ¾ well, we ¾
DR. COHN: If they are being used, that is not really part of our problem.
DR. BLAIR: No, no, no. I am using careful words here, that is why the pause.
Dr. COHN: Yes.
DR. BLAIR: The standards may be used to discriminate against American health care information systems, and both vendors and more and more health care delivery systems are also becoming worldwide as well, so it was ¾ we removed the word "discriminate against," you know, so we watered down the phrase. Maybe we watered it down so much that it is not clear what it is saying.
DR. COHN: I think it is more of a wordsmithing issue, probably.
DR. BLAIR: What would you suggest, Simon, in terms ¾
DR. COHN: I do not know.
DR. BLAIR: ¾ of better words?
DR. COHN: [Pausing.] I think we should get rid of that whole area. I would just say basically to correct anti-competitive activities, period, since the first part is basically to promote United State interests in international health data standards development.
DR. BEBEE: Yes, I am not comfortable with the words "correct anti-competitive activities."
DR. COHN: Oh, you want to get rid of that?
DR. BEBEE: Yes.
DR. COHN: So basically, you are saying just change it to, "in cooperation with the Secretary and the Department of Commerce to monitor the activity of U.S. healthcare informatic system vendors abroad," period?
DR. BLAIR: Just leave it at that?
DR. BEBEE: Correct.
DR. BLAIR: How is that?
DR. COHN: Yes, I think that would probably be a little more reasonable. Okay, good.
I guess we have lost number ten there somehow. Okay, ten is, "Encourage enabling legislation for use in the exchange of electronic data including the following." Electronic data. Okay, anyway, "Including the following: A, comprehensive federal privacy and confidentiality legislation issued to insure that all health information in any medium used for any purpose and disclosed to any entity receives equal protection under the law."
What I think is supposed to be B is "establishment of public/private mechanisms to help the health care industry identify and correct vulnerabilities and respond appropriately to privacy and security incidents." And C is "electronic retention of PMRI and acceptance of electronic authentication, visual signature, in a compatible manner across all 50 states."
Now, probably it is electronic something or other. Is it electronic health care data? In the first sentence.
MS. AMATARA: Here?
DR. COHN: No, under ten, the first sentence.
DR. BEBEE: Yes.
DR. COHN: As in electronic health care data or…? Okay. Does anybody have any issues with ¾ I am finding "C" just to be a little awkward in its reading.
MS. AMATARA: Would "retention of electronic PMRI and acceptance of electronic authentication" be better?
DR. COHN: Isn't it retention of PMRI in electronic format or something like that?
MS. AMATARA: That would be fine.
DR. COHN: I am still not sure that is quite the right one. Kepa, can you be helpful on this one at all?
[No response.]
DR. BLAIR: My thoughts were slightly different.
DR. COHN: Okay, go ahead, Jeff.
DR. BLAIR: I do not remember exactly how it is phrased right now, so I am going to talk conceptually, okay. I thought there were three points. One is ¾
DR. COHN: Information.
DR. BLAIR: ¾ state recognition of health care data in electronic form, legal recognition, okay. The second is uniformity in retention among state laws and authentication. Authentication, we think of that as digital signatures. Authentication meaning that you can have information from one state communicated to another state electronically.
DR. COHN: We actually have the electronic authentication already.
DR. BLAIR: Okay, anyway.
DR. COHN: But we somehow messed up the first two pieces, I think. We have retention. We do not have a concept of uniform ¾ we actually do have a compatible manner across all 50 states. We probably do not need electronic here since we are talking about electronic health care data on the top.
MS. AMATARA: We originally had uniform recognition by all states of electronic health record keeping and electronic authentication signatures.
DR. BLAIR: That would be okay with me. We changed it for some reason; I do not know why.
DR. COHN: I think that is ¾ do you want to type that up there so we can just take a look at it for as second.
DR. ZUBELDIA: I am sorry. I was on mute before, so you could not hear me. On the line where it says, "coordinate legislation for use and exchange of clinic data."
DR. COHN: Yes.
DR. ZUBELDIA: I would change that to PMRI.
DR. COHN: So basically electronic PMRI data?
DR. ZUBELDIA: No, "for use and exchange of PMRI."
DR. COHN: Oh.
DR. ZUBELDIA: "Including the following…"
MS. AMATARA: Yes, that is it.
DR. COHN: Thank you!
DR. BEBEE: Good.
DR. COHN: Okay. Great, and then we need to add "electronic" down in "C", or do we want to talk about electronic? Okay, so now our new "C" is "electronic retention".
DR. ZUBELDIA: My fax shows A, C and D.
DR. COHN: Yes, I know.
DR. ZUBELDIA: I would remove "C" completely.
DR. COHN: Oh, you do not like that?
DR. ZUBELDIA: I do not think that it fits here.
DR. BLAIR: What is "C"?
DR. COHN: "C" is the establishment of public/private mechanisms to help the health care industry identify and correct vulnerabilities and respond appropriately to privacy and security incidents.
DR. ZUBELDIA: We are asking for enabling legislation, so I do not know if it fits here.
MS. AMATARA: This was the one that used to be the center.
DR. COHN: We actually pulled back. The original version was describing a center, which we could not say whether it was public or private. I guess it comes down to the people that there is nothing wrong with this one. You are right, it may not be exactly in the right spot, but we seem to be putting privacy and confidentiality and state law stuff. I think it is probably ¾ I mean, as we move more and more into the storage of patient medical record information, I think we need to augment our abilities to support privacy and confidentiality. This, I think, is an example of it.
DR. ZUBELDIA: Maybe. To get back to the original wording and establishing a privacy emergency response team or like the SERT(?) for the internet, or security and privacy emergency response team.
DR. COHN: We actually talked about that some yesterday. Kathleen Fyffe has a comment.
DR. FYFFE: What is the context for this bullet because I thought we already had laws on the books. Am I really lost?
DR. BLAIR: Laws on the books that do what?
DR. FYFFE: That take care of privacy and security problems. Am I really out to lunch on that?
DR. BLAIR: Margaret, could you give us a cogenesis of ¾
[Simultaneous comments.]
DR. FYFFE: Why are you asking for enabling legislation? We have already had legislation.
MS. AMATARA: Oh, you mean up in nine.
[Simultaneous comments.]
MS. AMATARA: We do not have privacy law.
DR. BLAIR: Right.
MS. AMATARA: I mean, it has been stuck in Congress forever, and that is why we ended up with the regulations.
DR. FYFFE: Right.
MS. AMATARA: The notice of proposed rule making practically begs for legislation.
DR. FYFFE: Okay, okay.
MS. AMATARA: So we are sort of just supporting that.
DR. FYFFE: Then let's somehow say that. This thing of a public/private mechanism to help the ¾ I mean, I am wondering if we are saying, okay, we need to establish another association or something. I mean, it is just really odd!
DR. COHN: Well, it was watered down from the previous version. I think my own personal opinion would be that we might just as well, at this point, scrap it. The question got to be, is it a good idea to have something to help. I think the original proposal was a center.
MS. AMATARA: Actually, Kepa had commented on something like SERT, which is a private organization that helps in sort of an emergency response mode when there are computer viruses and things like that. It just sort of alerts everybody that there is this issue.
DR. COHN: But that does not require enabling legislation.
MS. AMATARA: Oh, no.
DR. COHN: That was the issue that this has to do, obviously, with enabling legislation.
MS. AMATARA: Yes, yes.
DR. COHN: If we are talking about something like SERT, then I do not ¾ it does not sound like we need legislation for that.
MS. AMATARA: Maybe nine should be to encourage or support privacy, the concept of privacy in general, without saying legislation, and then "A" is comprehensive federal privacy and confidentiality legislation.
DR. ZUBELDIA: If you want to have something like SERT, I would put it into recommendation four, and that is commit funding for an emergency response center that addresses issues concerning security and privacy of PMRI.
DR. COHN: Why don't we write that down and figure out where it goes. That may actually be ¾
DR. FYFFE: Can somebody give me an example here? Are we talking about a hacker going into a university teaching hospital database or something? I mean, why? I am really losing the point here.
DR. BLAIR: At least the way that I understand it is that right now, if I were to, let's say, all of a sudden I discover that I go around and nobody will hire me. I am beginning ¾ and then I discover that my medical records have been distributed somehow to employers. I have no place to go.
DR. FYFFE: You are talking about employment discrimination. You are not talking about ¾
Dr. BLAIR: Yes, but I have no place to go to wind up ¾ there is no agency, there is no central body, there is no center, there is no recourse that I have to help me correct this problem because ¾ and I think people are worried about it especially since if it is in electronic form, you could have something erroneously or incorrectly in your medical record.
It may be correct; it may not be correct. It may just simply be that I was trying to help my mother who is elderly, and so I wound up going on websites looking for information about Alzheimer's Disease, and therefore I ¾
DR. FYFFE: Pardon me for interrupting. I have a few reactions to that. First of all, there is an office of civil rights, and there is a whole body of law that I think would be applicable. I am not an attorney, but I am just reacting.
The other thing is I thought that the proposed rules for the privacy provisions of HIPAA had provisions for inspection and correction of medical record information.
DR. BLAIR: Only within the provider sector. It is the provider and health plan sector.
DR. COHN: I do not think this has anything to do with the way that we are crafting this with web-based regards. That is not how I read this. Margaret, you had a comment?
MS. AMATARA: Yes. Actually, the proposed privacy rule also does create a sort of federal complaint center where if you have privacy issues, you can bring it to the Federal Government. I think what we were talking about here was is that the most appropriate thing, and what will they do with that, and do you want it to be government. So, I think we were looking at more of a response center to help the industry and potentially be in the private sector as opposed to something that might ultimately cause a provider to have an inspection or something.
DR. COHN: You know, I think we need to decide relatively quickly on this one. This is not something that we should spend the rest of the day talking about. I mean, my own view, based on the fact that I have not heard anything from proponents either clarifying this one or makes it compelling that we ought to take it out. We came to ¾ if people want to bring it up, they can bring it up at the June 24th meeting as should we add this in, and if so, where, but I have not heard any example that has come forward. I have heard of really good private organizations that do not need enabling legislation that do this sort of thing.
DR. BLAIR: Okay.
DR. COHN: So I am all in favor of the idea; I just do not think it should go here. Are we okay with that?
DR. FYFFE: Yes, thank you.
DR. COHN: Okay. So we have now and A and B, one which is privacy and another one which has to do with state law issues. Now, there is one final recommendation that seems to have gotten lost from yesterday.
DR. ZUBELDIA: Simon, may I speak to that.
DR. COHN: Yes.
DR. ZUBELDIA: On "D", is there a reason why the word "uniform" has been dropped from the beginning of that sentence?
DR. COHN: Kepa ¾
DR. ZUBELDIA: It used to read, "uniform recognition by all states of electronic health records," and now it says, "electronic presentation of PMRI." The "uniform," I think, is important.
DR. FYFFE: Yes, it is back. Right there.
DR. COHN: It says, "Uniform recognition by all states of electronic health care record keeping and electronic authentication, parenthesis, signatures."
DR. ZUBELDIA: Yes.
DR. COHN: Is that okay?
DR. ZUBELDIA: But then uniform. Now it says ¾
DR. COHN: We changed it. It now says, "Uniform recognition by all states of electronic health care record keeping and electronic authentication." Is that okay?
DR. ZUBELDIA: If you are going to do that, after record keeping, I would insert a comma and record retention times or PMRI retention times and comma ¾
PARTICIPANT: That is good.
DR. ZUBELDIA: ¾ or retention requirement. Because that retention is a problem.
DR. COHN: Okay, retention requirements.
DR. BLAIR: Just the word "retention". Comma, retention and authentication.
DR. ZUBELDIA: Okay.
DR. COHN: Okay, so it says, "Uniform recognition by all states of electronic health care record keeping, PMRI retention and electronic authentication."
DR. ZUBELDIA: Good.
DR. COHN: I think it still should be PMRI retention requirements.
PARTICIPANT: Yes.
DR. ZUBELDIA: Yes.
DR. BEBEE: We are not saying digital signatures now?
DR. COHN: Oh, yes, it is still there.
MS. AMATARA: I think what happened to it, we actually did take it out on purpose, but maybe we should put it back in. Three, C-1. Three is, "Provide immediate funding if there was government-wide licensure or arrangement for these vocabularies are available for use at little or no cost."
DR. COHN: Yes, but the issue is a different one.
MS. AMATARA: Okay. There is also under 4-C, "ongoing government licensure of those terminologies selected for adoption if PMRI standards so that these code sets, classifications and vocabularies are available for use within the public and private sectors."
DR. COHN: It is still not the same issue.
MS. AMATARA: Okay.
DR. COHN: The issue was that there was a major bullet. Let me see if we can just find it.
MS. AMATARA: Eight.
DR. COHN: It was to provide incentives and promote the equitable distribution of costs for using PMRI standards across all major beneficiaries of PMRI. I do not think that talking about vocabulary licensing is the same.
DR. FITZMAURICE: I think that is right. Yes.
DR. COHN: I do not know the wording that we had on this, but I think it got changed from this one. I think it is an important concept that is different from studies of vocabulary development.
DR. BLAIR: We have vocabulary development subsidized in other recommendations.
DR. COHN: Right. This is just a single bullet without any As or Bs. It is probably number nine with the final remedial legislation being ten.
DR. BLAIR: Good.
MS. AMATARA: You do not want, "This would take the form of"?
DR. BLAIR: We do not need it now.
MS. AMATARA: Okay.
DR. COHN: Right now, it reads, "Provide incentives to promote the equitable distribution of the costs for using PMRI standards among all major beneficiaries of PMRI." Provide incentives. Maybe it is to promote the equitable distribution of costs.
MS. AMATARA: Yes. Yes.
DR. COHN: I do not think that it is to provide incentives to do this.
DR. BLAIR: The reason that we picked that word was, again, there were many testifiers. I can give you some of the names. The word that they were saying was "provide incentives". I am thinking now. The incentives issue was ¾
DR. FYFFE: That was really in the vocabulary.
DR. BLAIR: That was on other issues.
DR. FITZMAURICE: That was for payment for using PMRI standards and putting out data in a uniform manner.
DR. BLAIR: Okay, so yes, let me yield on that. If you would rather have promote instead of provide incentives, that is fine.
[Simultaneous comments.]
DR. BLAIR: I think someone over here said that they would prefer promote?
DR. FYFFE: Yes, promote the equitable distribution is fine. We need to take a five-minute break, though.
DR. BLAIR: I am so glad that you said so.
DR. COHN: I think that we are done with the recommendations, so why don't we take a ten-minute break at this point.
[Brief recess.]
DR. COHN: The next part of the meeting, we are going to basically start off on page one of the document and move through handling any conceptual issues that any of us feel uncomfortable with. I would suggest, in the interest of time and otherwise that we not handle wordsmithing at this moment but that anyone who has any wordsmithing additions or changes, that they be sent separately to Margaret as part of the completion of the final draft. Is everyone okay with that?
DR. BLAIR: Please copy me on what you send to Margaret, although Margaret will share them with me anyway.
DR. COHN: Kepa, are you on the line also at this point?
DR. ZUBELDIA: Yes, I am.
DR. COHN: You are in agreement with that?
DR. ZUBELDIA: Yes.
DR. COHN: Okay. Margaret, I think, is going to have to help us a little bit in terms of moving through this document. I did want to remind everyone that you need to spend about 15 minutes at the end talking about the executive summary. We need to move through this relatively smartly, and I am going to suggest that we focus on those areas that Margaret has identified by bolding that we need to discuss.
We also have just received a seven-page list of comments from Dr. Clement MacDonald on the body of the text. While many of them luckily are wordsmithing changes, I will do my best as we go through, if there are substantive issues, to bring them up and see if we can get them resolved in the context of the meeting, recognizing that I only received these ten minutes ago.
Margaret, do you want to lead us through?
DR. FITZMAURICE: What page are we starting with?
DR. COHN: Page seven.
MS. AMATARA: With the introduction. Section A is purpose and scope, and the highlighted area here, other provisions of administrative simplification addressing administrative and financial transactions, there were comments that asked us to clarify the relationship between PMRI standards and the transaction standards. We attempted to do that there.
DR. COHN: Did you want to read it, or do you want me to read it?
MS. AMATARA: Did you want me to read it? I can read it.
DR. COHN: I think ¾ okay. Other provisions of administrative simplification address administrative and financial transactions and the code sets within them identify our security and privacy. This report addresses standards which may make the content and structure of the patient medical record information more uniform and hence more easily exchanged between computer systems and understood across systems. As a result, PMRI standards will be better able to enhance quality, improve productivity, manage costs and safeguard patient data.
Does anybody have a comment on this one? Is this okay? I am actually fine with it.
DR. BLAIR: Fine.
MS. AMATARA: The next section, B, is intended audience for the report. We did not have any major changes or issues with that.
DR. COHN: Yes, I think the only comment that I would make, and maybe this is wordsmithing. There is a sentence here that says the executive summary is intended to provide a brief overview of the entire report. I thought that since we are in the body of the report, describing what the executive summary is, that is probably unnecessary. That is my own.
DR. BLAIR: The reason that we had it in here was some folks wound up asking us to explain this. There were folks who were saying that they liked it, and they wanted to use it as a primer, as an educational tool. We had thought of having this particular paragraph even before the executive summary to wind up saying what each of the sections is intended to do.
DR. COHN: that is fine. Let's not discuss it today here. It is fine; leave it in. Let's move on.
MS. AMATARA: Section C is background and general rationale. We have the three scenarios and then a summary of those. There were no major comments.
DR. COHN: Kepa?
DR. ZUBELDIA: The second scenario, it says in the second line, the proficiency information system delayed the warning. I would change that from "delayed the warning" to "did not convey the warning" because if they cannot talk to each other, there is no idea of a delay. It is going to be a breakdown of communication.
MS. AMATARA: Good.
DR. ZUBELDIA: Delay conveys the meaning that it happened but later.
DR. COHN: Yes.
MS. AMATARA: Good.
DR. COHN: Kathleen.
DR. BEBEE: That is fine. Thank you.
DR. COHN: To move very quickly, the next line says "insulin." It is really actually serum glucose level.
DR. BEBEE: Glucose level?
DR. COHN: Like blood sugar.
MS. AMATARA: Question number one, how does this report help to address national health care issues, and both John Lumpkin and Barbara Starfield commented that the first sentence was not true. Barbara offered the recommendation to change it to, "Technologically, the health care delivery system in the United States is considered to be among the best in the world." The rest of it is pretty much the same, and then in the second paragraph, she also suggested to address that issue, "However, the U.S. health care delivery system has some complex and serious problems."
DR. COHN: Are we okay with those changes?
DR. FYFFE: One suggestion. I think that the fourth paragraph ¾
DR. COHN: Okay, we have not gotten to that.
DR. FYFFE: "Today, health care information systems…"
DR. COHN: Okay.
DR. FYFFE: Ought to be the first paragraph.
DR. BLAIR: I do not know how to react to it.
DR. FYFFE: The question one says ¾
DR. BLAIR: I do not know what paragraph it is and how it would change the flow of things.
DR. FYFFE: It says, "Question one, how does this report help to address national health care issues?"
DR. BLAIR: Yes.
DR. FYFFE: We go through three paragraphs before we get to the fourth paragraph where we are answering that question.
DR. COHN: Where it says, "Today, health care information systems are beginning to demonstrate ¾
DR. FYFFE: Yes.
DR. COHN: ¾ that they can potentially improve the quality and level costs at the same time. This report recommends standards or actually an approach to standards that contributes not only to the administrative ¾
DR. FYFFE: Right. I think that paragraph should be first, and the other three paragraphs should remain in the sequence that they are in. That is just a suggestion.
Margaret, you can think about that offline, please.
MS. AMATARA: Okay. Actually, that paragraph was added in response to a suggestion that we needed a more definitive answer.
DR. FYFFE: Yes, and so therefore it should go first.
DR. COHN: I think we are all in agreement on that, so, and we are okay with the wording there.
DR. FYFFE: Yes, it is fine. It is just the sequence.
DR. COHN: Okay.
DR. BEBEE: The only comment that I would make just quickly is that there are, I think, eight or nine or ten questions that we keep that same structure. If the answer comes right after the question, we might want to watch that.
DR. COHN: Okay. There are some general questions about restructuring to make it more direct. Agreed.
MS. AMATARA: Suzie, if you would not mind, if you feel like there is a specific place that we are not picking it up, could you mention that.
DR. BEBEE: Okay.
MS. AMATARA: Question two, what has already been done to improve quality and control rising health care costs. There was no change.
Three, how have other sectors of the economy been able to improve quality and control costs. No change basically.
DR. COHN: Actually, Clem had a comment here. I believe. Actually, it is not under three, it is under four, so that is fine. Three will remain unchanged.
MS. AMATARA: Four is, "Why has health care been slower than other industries to implement information infrastructure to improve quality and control costs?" We actually ¾ there was basically one answer to this question, and so we add ¾ originally, and we added ¾ we tried to add several issues saying that there are many factors that have contributed. One is the complexity, two is the lack of commitment, three is behavior modification.
DR. FYFFE: The only question that I had in the first paragraph under four, the last sentence, on line 33, starting with "information technology." I thought that sentence was awkward. It may not be to other. "Information technology has yet been able to fully convert natural language to discrete, codifiable data elements and link data elements with their inherent relationship to one another."
MS. AMATARA: Yes, I think it meant to say, "information technology has not yet been able to."
DR. BLAIR: Right.
DR. COHN: Forgot the "no" there. Okay, Clem is actually making the comment here about the fact that he wonders ¾ he does not feel this is quite fair. I almost think he is maybe adding an issue that has to do about the fact that health care is so labor intensive and resistant to replacement of people by automation and therefore some of the benefits that drove other industries may be less so in health care. I think we can ¾ it brings more of an additional piece that we could add.
MS. AMATARA: I will try to incorporate some of that.
DR. COHN: I think the concept there is probably just an additional piece there to observe that is probably another reason why things have been slower.
MS. AMATARA: Okay. Question number five is, "How do standards for patient medical record information fit within a national health information infrastructure?"
DR. COHN: Unchanged.
MS. AMATARA: That is unchanged. Six what are the consequences of not having complete and comprehensive standards for PMRI?" We had a question under where it says, "The lack of interoperability and comparability of health care data makes it difficult to measure quality and therefore impacts the ability to improve clinical processes." One of the reviewers challenged us to justify this statement. We did not quite know what to do.
DR. COHN: Actually, though, I think that there are ¾ let's see if there was another
PARTICIPANT: [Comment off microphone.]
DR. FITZMAURICE: We could put in there. It makes it difficult to aggregate quality measures. It makes it difficult to aggregate quality measures and therefore impacts the ability to improve clinical process. How can you compare best practices when you cannot add things together to get a best practice?
MS. AMATARA: That is good. That may help. I hope.
DR. COHN: Yes, I guess the other piece, isn't there something here about the ability to support? I mean, it is beyond the measurement of quality. There is a whole bunch of information system stuff like where we are entering in all of this, and decision support, and error. Not error reporting but error detection, that we are not somehow mentioning in any bullet.
DR. BLAIR: In the benefits, we listed those. That long list of, "What are the benefits?"
DR. COHN: Right. Maybe it should be there. I was just thinking about consequences of not having complete and comprehensive standards, I think, makes it more difficult to implement the systems to actually improve the quality of care in addition to just measuring quality. That was really what I saw there, so I think there needs to be a little note that it is improving quality as well as measuring quality.
MS. AMATARA: Okay, got you.
DR. BLAIR: Good.
DR. COHN: Otherwise [pause].
MS. AMATARA: Question number seven is, "Why is it taking so long to develop and implement complete and comprehensive standards for PMRI?" This was the area that yesterday Clem ¾
DR. ZUBELDIA: Can we go back to question six for a minute.
DR. COHN: Yes.
DR. ZUBELDIA: It is on page 11, line 3. "Integrate these systems in a timely and low cost manner, avoiding customization of interfaces and facilitating the translation and mapping of data." I would like to not facilitate the translation but remove the need for translation and mapping of data.
DR. COHN: Oh, very good.
DR. BLAIR: Remove the need for translation?
DR. ZUBELDIA: Yes.
DR. COHN: Great. Is everybody okay with that?
Dr. BLAIR: I am not real sure because if we wind up having clinically specific data dictionaries, aren't we translating text into code? The computer would change text into code, or am I missing what you are saying?
DR. ZUBELDIA: Let me state it a little different. Avoiding customization of interfaces ¾
DR. BLAIR: Oh! You are on the interfaces.
DR. ZUBELDIA: Yes. Avoid customization of interfaces and the need for translating and mapping data.
DR. BLAIR: Okay.
DR. COHN: Okay, good.
MS. AMATARA: Okay, section seven had this paragraph that we had started talking about yesterday with Clem's concerns. I did make ¾ I tried to make some changes ¾
DR. FYFFE: The question.
MS. AMATARA: ¾ with question seven. Clem was concerned ¾
DR. FYFFE: No, no, we need to read the question.
MS. AMATARA: Oh, I am sorry. "Why is it taking so long to develop and implement complete and comprehensive standards for PMRI?" Clem had concerns about paragraph three. What do you think of this? "Many observers have noted that the healthcare delivery system appears to place a higher priority on acquiring information systems for reimbursement than systems that support quality of care. There are several reasons for this. First, the standardization of information required for the claims process was easier to automate than standardizing information for the clinical process.
Second, standards for supporting clinical processes have not been universally developed or applied. Then you go down to lack of investment in health care information systems is further impacted by the fact that many of those who benefit by these systems do not share in the cost of implementing and using them, et cetera.
DR. COHN: I think that is very good. Very good.
DR. BLAIR: Yes.
MS. AMATARA: Eight. What other issues should be considered? No changes there.
DR. FYFFE: Hang on a second, please. I did not understand. What issues should be considered? What other issues about what? Maybe the question needs to be expanded a little bit.
DR. BLAIR: They are related to PMRI, I guess.
DR. FYFFE: I read the question, and I read the answer, and I said, I am not sure that ¾ I do not know if the answer has responded to the question because I am not sure what the question was.
DR. BLAIR: Maybe it is what other issues related to PMRI.
DR. COHN: Actually, the answer has to do with the National Health Information Infrastructure.
DR. BLAIR: I am sorry.
DR. COHN: So, and that is what the answer is. It sounds like the question needs to be rewritten.
DR. FYFFE: Correct.
DR. ZUBELDIA: I have another issue that is not the NHII that would fit here. Another issue is the lack of uniform privacy protections for PMRI and the lack of widely implemented security mechanisms. The administrative provisions of HIPAA in these two areas are good although incomplete step in the right direction to correct this deficiency.
MS. AMATARA: Could you ask him to repeat the second one?
DR. COHN: I think you are going to have to restate this. Do you have it written down, Kepa?
DR. ZUBELDIA: Yes, I have it written down. I sent it in an email. Another issue is the lack of uniform privacy protections for PMRI and the lack of widely-implemented security mechanisms.
DR. COHN: What answer do we have for that?
DR. ZUBELDIA: The administrative provisions of HIPAA in these two areas are a good, although incomplete, step in the right direction to correct this deficiency.
DR. COHN: I think that sounds good to me. Does anybody ¾ that is all that you have? That is actually a short answer.
DR. ZUBELDIA: That is all I have, yes.
DR. COHN: That is great. I am all in favor of brevity on this. Are we okay with that? That actually probably helps provide a segue into the development to the recommendation on privacy and confidentiality.
MS. AMATARA: Could you repeat the last?
DR. COHN: He sent it by email to you.
MS. AMATARA: Okay, good.
DR. COHN: He actually already did, I believe, so you should have it.
DR. ZUBELDIA: I sent it by email. Initially, I had put it in question number four, but I think it fits here better than question number four.
DR. COHN: Okay, so we have two issues. One of them is the NIAA and the other answer has to do with privacy and confidentiality. Okay. But we still need to see if that is the right question here and whether we want to even break that one out as another bulleted question. The privacy one might be important enough to be another number itself.
DR. FYFFE: I agree with that. That is fine.
DR. COHN: Yes, okay. Margaret, if I am going too fast for you?
MS. AMATARA: No, I am fine.
DR. COHN: Okay, so number nine is, "What benefits can we expect when standards for PMRI facilitate a health information infrastructure?" I think we all have had wordsmithing on this, I bet. If we have not, we should. Anything substantive on this one?
MS. AMATARA: The very last paragraph.
DR. COHN: That was moved. Do you want to go down to that?
MS. AMATARA: There is, "These and many other examples in peer-reviewed medical literature lead us to the conclusion that information systems have the potential to both improve the quality and lower the cost of health care." One of the reviewers suggested that the examples and this statement may lead one to believe that maybe standards are not needed after all. We did not quite feel that way, but we wanted to bring that to your attention.
DR. FYFFE: It would defeat our purpose here?
MS. AMATARA: Yes.
DR. COHN: Well, no, I think there maybe wants to be another sentence that would say that, "These examples, however, are isolated in large part because of a lack of standards." I think that is a final.
DR. FYFFE: Yes, I think one thing we can do on line two of page 13. It says, "However, there are many examples." I would simply delete the word "many" and just say, "There are examples of pioneering efforts."
DR. COHN: So basically these and other examples?
DR. FYFFE: I would just get rid of the word "many" on both line 2 and on line 23.
DR. COHN: Okay. Is that okay?
DR. FYFFE: I think that helps.
MS. AMATARA: Okay, summary of general rationale. It was suggested by one of the reviewers ¾
DR. COHN: Get rid of it.
MS. AMATARA: No, I am sorry, ten is okay. It is "D". I am jumping ahead. She suggested that the focus areas were no longer kind of that structure anymore, so we just took it out. Is that okay?
DR. COHN: Great.
PARTICIPANTS: Fine.
MS. AMATARA: Process of studying issues and making recommendations then, pretty much we left that intact. Okay?
DR. COHN: Okay.
MS. AMATARA: Onward? Overview. Section A is PMRI standards concepts, PMRI, electronic exchange, uniform data, and health information infrastructure. Simon, your reviewer had a note that in section four, health information infrastructure, with the sentence, "A radiologist may conduct a teleradiology consult with another radiologist in another country." He said that was illegal.
DR. COHN: That is actually not illegal, but it is in a different state.
MS. AMATARA: Should we just take that example out?
DR. COHN: No, actually, I think the example is fine.
MS. AMATARA: Okay.
DR. COHN: My understanding is it is a misreading of the regulation when I saw that note. The illegality has to do with a state in which you are not licensed. I think that internationally ¾
[Simultaneous comments.]
PARTICIPANT: I know it occurs.
PARTICIPANT: Oh, yes!
DR. COHN: I guess another nation could decide that it is illegal, but there is not anything, just per se, illegal about that, and it is done in many environments. It gets a little more tricky in the United States when you are reading x-rays in California for x-rays done in Missouri or whatever.
DR. BLAIR: Isn't this an example of what we might have in the future rather than what we ¾ what was the context of that example?
MS. AMATARA: I think it is okay, Jeff, actually. Simon had a reviewer, and I was just responding to that.
"B" is evolution of health care informatics standards. Let's look at one. Did Clem have comments on one, Simon?
DR. COHN: Around evolution?
PARTICIPANT: Yes, he does.
DR. COHN: Yes, he has a number of comments having to do with, I think, the history which I think we need ¾ this actually is the right page. For a long time, he was not putting the right pages on. I think he has some changes to the history that I think we should just basically accept. It is talking about the fact that there really was not a whole lot of formal activity until the mid-1980s. When you get into terminologies, we have very difficult situations about what is a standard and what is not.
MS. AMATARA: Should I just kind of read it and see where ¾
DR. COHN: Yes. I do not think there is anything there that we need to be voting on per se, but these are just some factual things that we need to somehow incorporate in there.
MS. AMATARA: Okay. Number two, standards development organizations.
DR. COHN: Actually, he had some comments about ¾ right above two where this issue of having standards, have dominant vendors and all of this stuff where there is ¾ my note was that I had basically agreed with his comments without reading his comments. [Laughing.]
MS. AMATARA: Was this the one that starts out "Last three lines at top of page"?
DR. COHN: Yes. Yes, but I think it is a question of just another view of why we have been sort of slow on standards, so I think it would probably be incorporated as it is appropriate. All of you have Dr. MacDonald's notes, and we are sort of looking through here. I think that could be incorporated without too much trouble. It may not all be incorporated, but some of it would be incorporated.
MS. AMATARA: Okay. Number two, standards development organizations. Yesterday, Clem suggested that we take some of the content from section D, which starts on page 28, and move it to under two. We discussed how that could cause some problems. I have not, but I will add a few sentences to this paragraph and explain a little bit more about the specific SDOs. Hopefully that will help.
DR. COHN: That would be great.
MS. AMATARA: Next question. Mike gave me a correction. It is 1991 instead of 1992 for NCHISB.
DR. FITZMAURICE: On the last sentence, where it says, "Still the state of health care informatics standards remains complex." I would say, "and underdeveloped" because it is not the complexity that is so much the problem as it is underdeveloped. There is much more work to be done.
MS. AMATARA: So, take out "complex"?
DR. FITZMAURICE: In addition to complex, I would put "and underdeveloped."
DR. COHN: It is already there.
MS. AMATARA: It is already there.
DR. FITZMAURICE: It is? Whoops! I am reading off of my old one. Never mind!
MS. AMATARA: We anticipate your every need.
DR. FITZMAURICE: If that were only the case. I am sorry, I was reading from my version four.
MS. AMATARA: In "C", overview of data standards issues, we had one reviewer who suggested that we bring the definition of interoperability and also in the next section for comparability, bring the definition up front.
DR. COHN: I think that is fine. Does anybody have any objection to that? I thought it made that a lot clearer.
MS. AMATARA: Good. Now we have standards ¾
DR. ZUBELDIA: On that section of page 19, line 3, 'creating semantics sufficient to improve operability." The first line says, "Message format standards have operated at the functional level of interoperability." I think it is better to say at the level of functional interoperability because you just described what functional interoperability is.
DR. COHN: Where are you referencing?
DR. FYFFE: Page 19, line 3.
DR. ZUBELDIA: On 19, line 3.
DR. COHN: Page 19, line 3. That is fine. We have a lot of things on 18, too. So you wanted to make a change to the ¾ this is a wordsmithing issue.
DR. ZUBELDIA: It is the level of functional interoperability.
DR. COHN: Fine. There are a number of ¾actually, let me make a comment about page 18. Clem, Dr. MacDonald, made a number of comments which I think he actually has wording about why the optionality exists. His point is that the optionality has a lot to do with the variability in workflow, et cetera, et cetera, and I think these are additional musings why the optionality has existed. I think we could probably put most of his comments ¾ for example, he talks about changing line 17 on page 18 where it says, "The principle reasons for this optionality are to accommodate the extreme variability of work flow and availability of information in a health care setting." It gives an example. I am not sure if that is the principle reason, but it is one reason or an additional reason.
DR. BLAIR: Part of my thinking is that it is giving all of these reasons why optionality is there, and I sort of feel like all of that may be true, but does a reader need to understand all of those things to be able to understand that we need to reduce that to make standards interoperable and what we need to do on that? I mean, is it really helping to have that explanation in there?
Dr. COHN: He actually explained other reasons for the options, so I think this becomes another reason.
MS. AMATARA: Simon.
DR. COHN: Yes.
MS. AMATARA: The way I read Clem's comment, I think you are looking so you could change the sentence beginning on line 17, "The principle reasons for optionality are to accommodate the extreme variability of work flow and availability in a given health care setting."
DR. COHN: It would be just another reason.
MS. AMATARA: It is a second reason.
DR. COHN: Yes, another reason.
DR. BLAIR: My thought was there are some of those reasons that are not going to be addressed by standards, at least not PMRI standards. They are going to have to be addressed by the standardization of clinical processes. That is beyond the scope of what we are trying to get into here, so that is why I was asking, is it useful to go into those things? Maybe you feel like it is needed for balance, in which case, okay, but I am wondering if it is tangential or distracting to the thought track.
DR. COHN: We are talking about one sentence, and I ¾
MS. AMATARA: I think he makes a good point.
DR. BLAIR: Okay. Go do it.
MS. AMATARA: I will not change it right this minute. I will work ¾
DR. COHN: Yes, I think something around, though, that it is not just the issue of ¾ I mean, it is a complex set of issues. Of course, we are all in agreement that it has costs that are probably unnecessary at this point. There are other ways around standards to develop that and produce it.
DR. FITZMAURICE: The way that I read it, Clem is referring specifically to here is why you put the information at this point in work process and you may put it in another point in the work process, and that is why it may not be available, but in the message standards format, it may be that the order in a particular format that is an extreme is different. You have to jiggle it around in the message format standard to make things fit together, which is maybe a separate standards issue than why is a variable there or not there. When you are configuring something from one information system to another and you are trying to get the message format the same, you may have to translate it because one system has a different string than another system has a string.
DR. COHN: Right.
DR. FITZMAURICE: It is entirely a product of whether you have the blood information upon admission or later on in the course of the stay.
DR. BLAIR: It seems like everybody who has read it seems to think that it is a good idea to add it, so go ahead and do that.
DR. COHN: I have this other comment here which has to do with line 18. I think it is line 18 where he says, "This optionality can require costly custom programming." He writes, "But the larger problems are deviant implementation of the standard to violate the letter or the intent of the standard and enormous variability of vocabulary.
I do not know. I think that is another problem also. I think we need to somehow note that. I mean, we sort of cover that a little bit, I think, but I do not think that it is in line 18.
I guess I would think that we need to let Margaret sort of figure out how she wants ¾ what of this can be put in that does not ¾
DR. FYFFE: Send us an email.
DR. COHN: Yes, I mean, we have to have a conference call on a couple of pieces around here to resolve a couple of Clem's comments. This one is just a complex area.
The one point that I would make about the paragraph on page 18, line 14 through 27, is that I think we need ¾ if we can get this right, much of this actually can go up into the executive summary. I think that this is actually the business case that we have been sort of searching for around why this is all-important. I do not think you want to necessarily put all of it in, but this is the clearest articulation in this whole paper of why it is important. I would just recommend that we ¾ I starred this area.
MS. AMATARA: Got it. He has other stuff about conformance testing and ¾
DR. COHN: He thinks that that is a very good idea.
MS. AMATARA: Can we go on?
DR. COHN: Yes.
MS. AMATARA: Under greater semantic precision to improve interoperability, we had another comment with regard to message format standards developers are beginning to coordinate with terminology standards developers. Message format standards developers are beginning to coordinate with terminology standards developers to specify the content of the message and make the message format standards interoperable at the semantic level.
I think it was actually Suzie who had a question about including content developers, DCCs. I think I saw an email, but I am not sure if I understood.
DR. COHN: What are DCCs?
DR. BEBEE: The data content committees. I was just thinking ¾
DR. COHN: Oh.
DR. BLAIR: NUBC and NUCC.
DR. BEBEE: Yes, just in the spirit ¾
DR. COHN: I am sorry. I am getting just the acronyms. What part of the NUBC?
DR. BEBEE: The MOU signers.
DR. FYFFE: Just in the spirit of the MOU and that idea coming together. That is the only point that I had ¾
DR. COHN: So you would want to add the data content committees.
DR. BLAIR: The only thing is, consider. That tends to be ¾ and I am not intimately involved with NUCC and NUBC. The impression that I had is that they tend to focus on claims and billing, and we are focusing on patient medical record information. I think that there is ¾
PARTICIPANT: A reason.
DR. COHN: That is actually a good point. Kathleen, do you have a comment? You are a member of the data content committee also.
DR. FYFFE: They focus on claims and billing, but guess what, they use information from the medical record to do the billing and prepare the claims.
DR. BLAIR: Yes, but aren't they kind of like a secondary user, so to speak? Whatever. Maybe you can see your way to include them.
DR. COHN: I think the only question that I would have here is, to my knowledge, and Kathleen, you are a member of more of these committees than I am, but Marjorie is also a member of the Data Content Committee. Are any of the Data Content Committee meetings beginning to coordinate with terminology standard developers to specify the content of the message and make the message format standards interoperable? I do not think so. They may plan to do that at some point.
DR. FYFFE: Yes.
DR. COHN: I do not know of any example where that is happening right now.
DR. BEBEE: I think we should drop the ¾
DR. ZUBELDIA: I think that they are focusing strictly on administrative transactions like Jeff is saying. I do not think that they have the expertise on PMRI either.
DR. FYFFE: No.
DR. COHN: Let's accept this one without the addition of data content committees.
MS. AMATARA: Okay. The next section is addressing gaps, inconsistencies, is about the same. Then comparability. Again, we moved the definition up. Is that okay?
DR. COHN: We agreed on that one already.
MS. AMATARA: In terminology concepts, we had a question about the use of the term "terminology," and we did not actually change the definition but just wanted to verify.
DR. COHN: I am fine with it. I mean, if we start changing it, we have to change the entire document. Does anybody have a problem with the definition of terminology?
DR. BEBEE: No, but is there some reason why it is two places?
MS. AMATARA: Two places?
DR. FYFFE: Yes. If you look at line 9 and line 27, it is repeated.
DR. BEBEE: That is okay if that is the intent.
DR. COHN: Actually, I think it is okay.
MS. AMATARA: It is partially repeated. It is just the way the term ¾ just highlighting the way the term is used. It seemed to be confusing to people, so we kind of wanted to make sure that they understood that we were using it a certain way in this report.
DR. FYFFE: Margaret, if you could just take a look at that terminology concepts section because it is just a bit awkward. What technology is considered to be. It just seems a little awkward, that is all.
MS. AMATARA: Okay.
DR. COHN: That is a wording issue.
DR. FYFFE: Yes.
DR. COHN: Okay. Everything will be looked at for wording issues.
MS. AMATARA: Vocabulary characteristics and attributes. That is a summary of the ASTM standard. Then we had, in addition to the ASTM standards, we said vocabularies to become national standards should also possess the following traits. Some of these traits are in the building principles, but the one in particular that one reviewer commented on was where we say that they must be maintained on an ongoing basis, and there is maintenance in the standard up above, so suggested that we drop that.
DR. COHN: It is interesting. Somebody else, actually Dr. MacDonald, said to get rid of the self-sustaining bullet.
MS. AMATARA: I think that might be a good idea because, I mean, technology neutral, self-sustaining and maintenance is in the standard. Technology neutral is in the guiding principles. We have all of these things somewhere else, basically.
DR. COHN: Should we get rid of the entire area?
MS. AMATARA: Oh, yes.
DR. ZUBELDIA: I also vote for getting rid of the self-sustaining.
DR. COHN: Okay, but I think that we are talking about getting rid of the entire area here with lines 23 through 38.
DR. ZUBELDIA: If we do not, I also would like to get rid of the last bullet. Process controls. I am not sure what that means.
DR. COHN: Yes, I actually had a question there myself. Okay, I think we are moving towards getting rid of those 11 lines. Is everyone okay? Some nodding. Going, going, gone. Okay.
DR. FITZMAURICE: I would like to move up to the structure of the vocabulary model, starting at line 8. There is a lack of parallel structure in the second sentence of it reading, "The goals of the model include, one, the ability to combine atomic concepts into composite concepts of various types; two, that content can be normalized.
PARTICIPANT: Yes.
DR. FITZMAURICE: People do not know what "normalized" means.
DR. COHN: Let me make a general comment here because I think that we need to go back and look at this area, or Margaret needs to try to make it a little more understandable. I do not think that it is just the structure. I think that each of these needs to be somehow ¾ I mean ¾
DR. AMATARA: It needs to be less technical language.
[Simultaneous comments.]
DR. COHN: ¾ area. We could potentially expand this or make it a little bit more understandable since it is part of the guiding principles. We are referencing this. We do not want to include the ASTM document as part of this. So, I think we have a little responsibility to explain to people what we mean by general characteristics. What sort of general characteristics need to be there, what sort of structure characteristics need to be there, what sort of maintenance needs to be there, and what sort of evaluation. Once again, a relatively brief format.
MS. AMATARA: Can it be the whole page?
DR. COHN: Yes, it could be a whole page.
MS. AMATARA: Thank you.
DR. COHN: Is that okay with everybody?
DR. FYFFE: It is fine. Thank you, Simon.
DR. BLAIR: Margaret, do you remember yesterday I was talking about the section that I thought was ¾ this was the section.
[Simultaneous comments.]
MS. AMATARA: Okay, good.
DR. COHN: -- describe what it is describing.
MS. AMATARA: Yes, it was really ¾ I mean, this is dense stuff.
DR. COHN: Agreed. We need to humanize it a little bit.
DR. FYFFE: I am not going to say that we need to dummy it down.
[Laughter.]
DR. COHN: We do not need to dummy it down.
Okay, so everyone is okay with that, and it is once again one of those areas that we will probably review during a conference call.
Anything else here? Let's see, Clem, on page 22 on line 7 through 10, thought that this was not a very good example which had to do with vital signs and not knowing people had vital signs.
DR. FYFFE: I agree.
DR. COHN: The question is, does anybody have a better example?
MS. AMATARA: This is actually the example that the joint commission represented and used in his testimony.
PARTICIPANT: Oh, my!
MS. AMATARA: That is why I chose it [laughing].
DR. COHN: Unless we come up with something that is really much better. Kathleen, do you have a better example?
DR. FYFFE: The joint commission. Oh, my.
MS. AMATARA: That could be one.
DR. COHN: This actually is a relatively complex issue because some people take blood pressure standing and others take them sitting. Other people take them standing and sitting.
DR. FYFFE: It is a technique. I mean, it is ¾
DR. COHN: It gets to be an impression ¾ I mean, if your general process in the office is that you are doing vital signs when the patient is already standing, the vital signs they are taking, other people do it when they are sitting. It seems to be not quite the same thing.
DR. ZUBELDIA: Maybe a simpler one is to use the clinical pathology profile.
DR. COHN: That is a simpler one?
DR. ZUBELDIA: Maybe.
PARTICIPANT: [Laughing.]
DR. ZUBELDIA: What is included in one of those profiles.
PARTICIPANT: [Off microphone.] It is not that simple.
DR. COHN: A clinical pathology ¾ what is that?
DR. ZUBELDIA: What used to be SMA-20. What is SMA-20.
DR. FITZMAURICE: What is a SMACK-10(?) or a SMACK-12.
DR. COHN: HCFA is made for standardization of that. I do not think that we want to go there. For the moment, if anybody has an idea, they can send it tomorrow, but I do not think we want everybody's time right now trying to figure out an example. This is our default unless we can come up with a better one that we can send to Margaret and during the conference call we say it is a much better example.
DR. ZUBELDIA: Yes.
MS. AMATARA: All right. We are moving down to number three, data quality, data accountability and data integrity.
DR. FITZMAURICE: Before we get there, do you have something that you wanted to bring in, Simon, before we got there?
DR. COHN: Yes, I actually just wanted to make one comment, a note that I had made about ¾ on line 17 where it says, "However, the parsing methodologies which are dependent upon a reference terminology are under development without a single standard methodology yet existing. See line 17 through 19?
DR. FITZMAURICE: Yes.
DR. COHN: The issue, though, is that there is not a standard terminology or a standard reference vocabulary. Underline these things. It is sort of like, furthermore, there is not even a standard reference terminology. That, to me, is a big issue. It is not the standard methodology about parsing. We should make that ¾ because that is obviously one of the issues we have been discussing.
DR. FITZMAURICE: I marked that same thing. I am not sure that I would say very much under development. Either something is or is not. What we might say is in early development.
DR. COHN: There is no standard, approved standard, as a reference terminology ¾
DR. FITZMAURICE: Okay, that will cover it.
DR. COHN: ¾ for these to be based. Maybe that is what we need to say.
DR. BLAIR: Could I? Either one, but I kind of like Michael ¾ sorry. I kind of like Michael's stage that it is early development. What do you think, no?
MS. AMATARA: What line are you looking at, Mike?
DR. FITZMAURICE: Line 20. It says, "However, parsing methodologies are very much under development." I would say, "in early development," and limited by what Simon said. There is no reference terminology; there is no standard.
DR. COHN: Yes. There is no standard reference terminology.
DR. BLAIR: Does that nail it from both sides?
DR. COHN: Yes, I think it does. I think it does. Good.
MS. AMATARA: I am sorry, but because I do not have line numbers on here because they have been changed with the side of the text ¾
DR. FITZMAURICE: The paragraph begins, "One solution to the data capture challenge ¾
MS. AMATARA: Yes.
DR. FITZMAURICE: Then about a little bit more than half way down, it starts with "however".
MS. AMATARA: Okay.
DR. FITZMAURICE: Parsing methodologies are in early development and limited by the life of the reference terminology standard.
MS. AMATARA: Am I in the right place, Mike? Could you look?
DR. FITZMAURICE: Yes, uh-huh. I am looking for the "however."
MS. AMATARA: However, the parsing methodologies, which are dependent upon a reference vocabulary, are in early development.
DR. FITZMAURICE: Yes, early development and are limited because there is no standard reference vocabulary.
DR. BLAIR: Reference terminology? Reference ¾
DR. FITZMAURICE: Terminology.
DR. BLAIR: Should we say "yet"?
MS. AMATARA: Yet existing.
DR. BLAIR: Yet existing.
DR. COHN: Okay. On from here. Mike, you had an issue on three? Three is data quality, data accountability and data integrity.
DR. FITZMAURICE: Under that first paragraph, a second critical function of PMRI usually in aggregate form. I would take out the aggregate form because in many cases, an aggregated data is needed for looking at things like best practices. You do not have to identify the individual observations, but you need to look at the individual observations and not have them aggregated.
MS. AMATARA: Data quality.
DR. COHN: Mike, is this something that you can put in offline?
DR. FITZMAURICE: Sure, just strike out the "usually in aggregate form." Take that out.
MS. AMATARA: I did that.
DR. FITZMAURICE: Okay.
DR. COHN: Okay. Now, in this one, I think we are on ¾
MS. AMATARA: We had the identifiers here.
DR. COHN: Yes, we probably just need to see where we are with that one.
MS. AMATARA: What we have so far is we changed ¾
DR. COHN: Yes, Kepa and Kathleen, we are on page 23 starting with line 33, which is this issue of the identifiers. Are you ¾
DR. ZUBELDIA: ¾ amendments?
DR. COHN: Yes, we actually had some ¾ she should read, unless you have the updated versions, which I do not think that you do.
MS. AMATARA: No.
DR. COHN: Why don't you just read what we are sort of dealing with right now.
MS. AMATARA: Lack of ability to uniquely identify patients because each provider creates its own patient medical record identifier system and maintains its own master patient index. Patients have different identifiers at each location where they have received care. This makes it very difficult to seize the exchange data when authorized among providers.
Additionally, different master patient indexes and for the sign identifiers often collect different information making it difficult to map identifiers. For instance, one system may capture patient name, address, telephone number and date of birth. Another system may substitute Social Security number for date of birth, not capture telephone number but capture mother's maiden name.
Sometimes, patients get assigned several different numbers by one provider such as when a patient has a name change or uses a nickname on a subsequent visit. This can result in loss of data for patient care purposes. It constrains the ability to exchange data across providers for continuity of care.
As providers merge and consolidate, there is a huge cost of merging master patient indexes into an enterprise-wise master person index due to the lack of a unique patient identifier. While there are benefits to a unique patient identifier, the availability of standards for master person indexes, while less efficient, may also contribute to data quality. The rest of the paragraph is deleted.
DR. COHN: I am actually wondering whether even that sentence, the last one that you read, may need to be deleted, too. I am not sure there is light of day here. I am not sure that that adds a lot. I think what we are doing is addressing ¾ noting the issue as opposed to necessarily giving the solution here, is that not right?
MS. AMATARA: Right.
DR. COHN: So if we just basically make the statement that this is the problem, I think we sort of let the reader make the conclusion.
DR. BLAIR: The only thing that I might add, Simon, I do not have a personal feeling on this but just reflecting comments that we have received. There were several people who seemed to want us to include some mention of master person index as a balance to a reference. In other words, yes, it is an issue, but it may not be a "do or die," so to speak. It may not be a "show stopper," so to speak. We did get suggestions asking us to do that.
DR. COHN: Maybe the answer to this one is even being more minimal. We could say, "As providers merge and consolidate, there is a huge cost of merging master patient indexes into an enterprise master patient index," then period.
MS. AMATARA: Yes.
DR. COHN: Kepa, you have some comments, too.
DR. ZUBELDIA: On the use of master patient index, I think that it a provider-created master patient index, a provider-created patient index, when you have sources of identifiers from multiple sources, then you would have a master patient index.
DR. COHN: Correct.
DR. ZUBELDIA: So on line 34, it says, "Each provider creates his own patient medical record identifier and thus his own patient index." Scratch out "master".
DR. COHN: Ah! Okay, good.
DR ZUBELDIA: Two lines below that ¾
DR. COHN: Hang on. It is the third line, Margaret. It is basically its own patient index. Get rid of "master".
DR. ZUBELDIA: Patient index. Two lines below that, it says, "Additionally, different master patient index systems." Scratch "master patient index." Additionally, different systems that have sign identifiers.
DR. COHN: Okay, so get rid of "master" there also.
DR. ZUBELDIA: Get rid of "master patient index," all three.
DR. FYFFE: Say, "Additionally, different systems that assign identifiers."
DR. ZUBELDIA: Then go down to what was line 44.
DR. COHN: Kepa, you have to realize that Margaret does not have the line numbers. You have to tell us how far.
DR. ZUBELDIA: "As providers merge and consolidate, there is a huge cost of merging patient indexes into an enterprise-wide master patient index."
DR. FYFFE: Take "master" out of there.
DR. ZUBELDIA: So, scratch out "master" in the first one.
DR. BLAIR: But you are retaining "master" in the very last part of the last sentence.
DR. COHN: You know what he is talking about. There is a huge cost of merging patient indexes into an enterprise-wide ¾ one line up from where you are, Margaret.
DR. BLAIR: Yes.
MS. AMATARA: What does he want to do here?
DR. COHN: He wants to go to the first master, right where you have it right there. Get rid of that "master" so it says, "merging patient indexes into an enterprise-wide master patient index."
DR. ZUBELDIA: That might clarify the fact that the master patient index is the one that aggregates multiple identifiers and can be used to ¾
DR. COHN: Agreed, Kepa. Now, Kathleen has a comment and then Margaret has a comment.
DR. FYFFE: Margaret, could you please note, and I do not know if everyone is going to agree to this, but the description of this problem is so important that it should be highlighted in the executive summary just the way that it is. I mean, after all, Congress said, "You cannot spend any more funding on a unique patient identifier, and this is a very, very big problem. I would just lift the paragraph and put it into the executive summary so when the executive summary takes on a life of its own, and it will, that will be highlighted.
DR. COHN: Great, thank you. Margaret, do you have a comment?
MS. AMATARA: Just a question. We have used the term "master" ¾ we have used the term "person index" in referring to "enterprise-wide." Master person index tends to be the more preferred term lately. Is that confusing to people?
DR. COHN: I will leave that up to you. I mean, you just need to make it consistent.
MS. AMATARA: But individual organizations that have patient indexes that are now merged into master person indexes. Is the terminology being used.
DR. ZUBELDIA: I would use "master patient index."
DR. FYFFE: Yes, I would use "patient." I would not use "person."
MS. AMATARA: That is fine. I think that is clear.
DR. BEBEE: Did we want to recognize that Clem had comments about two other previous bulleted items?
DR. COHN: Which ones are you referring to?
DR. BEBEE: Line 6 on page 23 about the narrative data. He said that it took a negative approach, and he wanted to eliminate the limitations of current classification systems, line 27, completely.
MS. AMATARA: He wants to eliminate both of those bullets?
DR. BEBEE: No, the first one on line six that I referred to about narrative data. He says that it is a negative statement.
PARTICIPANTS: [Comments off microphone.]
DR. BEBEE: He says, "Some may read into this intention to forbid the use of narrative text. It would be impossible." I agree with that. He also wants to eliminate the chunk of 27 through 31, which I do not agree with.
DR. COHN: Which is limitations of current classification. You do not agree with his taking it out, or you do not agree with ¾
DR. BEBEE: I do not agree with it being deleted.
DR. COHN: The question first of all, then, is do we get rid of this unstructured data. Is that a data quality problem that we want to highlight.
DR. BEBEE: He just says it appears like we want to get rid of text narrative data.
MS. AMATARA: Maybe we should say, "Narrative data are sometimes necessary but must be recognized as not readily retrievable."
DR. COHN: That is great.
[Simultaneous comments.]
DR. BEBEE: That would resolve that one.
DR. COHN: The next one is the limitation of current classification. Why did he want to get rid of this limitations of current classification systems?
DR. BEBEE: Yes, I do not understand what his reasoning is either. "We cannot be asking the providers to capture additional interpretations, calculations, when they can and should be derived from the primary data that the provider will capture. Arguing for direct capture and recording of information that can be computed or derived from more raw data is now what we want to do, so I would eliminate this chunk, too."
DR. COHN: No, actually, I think it should be left there.
DR. BLAIR: I do, too.
DR. COHN: I think he is off point on that one.
DR. FYFFE: I disagree with Clem also.
DR. COHN: Okay.
DR. FYFFE: Let's just leave it the way that it is.
DR. COHN: Great. So, I think we are on to ¾
MS. AMATARA: Data accountability and integrity.
DR. BEBEE: The only comment that I had about the data accountability in reference to the conversation and discussion we had about devices and in line four, it refers to, I guess, what is the device.
DR. BLAIR: Could you read where line four is?
DR. BEBEE: It says, "Data accountability refers to identifying the health care party, i.e. individuals, organizations, business units or agent, e.g. software, device, instrument, monitor."
DR. COHN: What is the problem with that?
DR. BEBEE: I do not have a problem with it, but I was just wondering if we would be consistent with the discussion that we had yesterday about devices and should there be more stated there than just device.
DR. COHN: No. I do not think so, anyway. Since we deferred that discussion for this report, I do not think it is appropriate to put it in.
I would make a comment on we were talking about a unique provider identifier. We probably ought to acknowledge that that is already going to be happening under HIPAA.
DR. FYFFE: Is it?
DR. COHN: National provider ID? Sure.
DR. BLAIR: Provider ID is.
DR. BEBEE: Yes, provider.
DR. COHN: They are waiting for the final reg to come out on that one.
DR. FYFFE: That is all it is going to take. I'm sorry.
DR. COHN: I do not know how to respond to that.
DR. FITZMAURICE: I have a question on the last ¾
DR. COHN: I think it is not even as required; I think it is provided for under the administrative.
DR. FITZMAURICE: That is a good way to phrase it. On the last sentence of that paragraph, "Evidence of accountability does not persist through the life of the data making auto-mobility of data content difficult or impossible." It does not seem to be very hard to audit data content. It is either there or it is not there. Maybe we want to say something else.
MS. AMATARA: No, I think what he is saying is that because the audit trail often times is not retained for a long period of time, it is difficult to determine who wrote or who reviewed or whatever the data content.
DR. FITZMAURICE: I will buy that. I do not think this says it.
DR. BLAIR: Let me just ¾ it is 11:54. Kathleen Frawley has not joined us, is that right, on the telephone? We do have a bare quorum here, but Kepa, will you be able to stay on for another hour?
DR. ZUBELDIA: Yes, I will.
DR. BLAIR: So that we can include you in a vote?
DR. ZUBELDIA: Yes, I will.
DR. BLAIR: Thank you.
DR. FYFFE: Yes, I am here for another hour, too.
DR. COHN: Yes, I think we are all here for another hour, and then we are done. We do need to spend a little time on the ¾
DR. BLAIR: The executive summary.
DR. COHN: No, we need to spend a little time on what is happening in July and October, so we will be seeing them show up, Bill and Karen, in a little while. I think we will go through this. Let's continue through.
Okay, so I think if we have ¾
DR. FITZMAURICE: If we can just take up data content, that might fix it. We are auditing who did it not of what the content of the data are.
MS. AMATARA: Okay.
DR. COHN: Okay, great. Anything else on page 24?
MS. AMATARA: Yes. We have ¾ under "Other issues, privacy, confidentiality and security," we had a change there to provide more balance. There is widespread public concern that PMRI in electronic form may compromise an individual's privacy by reducing his confidentiality. Many health care professionals share this concern. On the other hand, many believe that the existence of electronic security tools will protect the confidentiality of PMRI even better than in their current paper form."
DR. COHN: That is fine.
DR. FITZMAURICE: Yes.
MS. AMATARA: Then the one below it, "To support the uniformity and efficiency of privacy protection across the U.S., it is strongly desirable that this legislation establish a standard that would be uniform across all states," as opposed to "preempt."
DR. COHN: That is fine.
DR. FYFFE: That is good.
DR. FITZMAURICE: Yes.
DR. BEBEE: Yes. Very good.
MS. AMATARA: Then the very last paragraph in this section on the next page, "Finally, information systems vendors," and Clem ¾
DR. COHN: I do not see a note from him on this page.
MS. AMATARA: Yesterday, Clem commented. I made a note.
DR. BEBEE: It is there. Page 25, third full paragraph. "As it stands, the statement about European directives does not fit. I would be inclined to eliminate."
DR. COHN: Actually, I would agree with that. I do not know what that has to do with this here.
DR. BLAIR: What is Clem's comment?
DR. COHN: His comment is that the European directive for data security ¾ we talked about this yesterday.
DR. BLAIR: Yes.
DR. COHN: And I think that none of us could figure out what this paragraph was doing in this piece. I think we commented on that yesterday. I thought we had already ¾
DR. FYFFE: Yes, Mike had.
DR. COHN: ¾ sort of agreed to remove this paragraph.
DR. BLAIR: Michael, are you here?
DR. FITZMAURICE: Yes, I am here. I am trying to remember what we discussed about that. It is certainly something that people who deal with international ¾ their own workers and exchange of medical information have to do with what is required in other countries.
MS. AMATARA: I made a note to myself that we said this supports the need for privacy, but we do not have anything to harmonize with.
DR. FITZMAURICE: That is right. That is the point. It is that other people have privacy directives, privacy laws; we do not. So, we cannot harmonize with what we have; we do not have anything. It is an issue for us, and therefore it strengthens our recommendation that we need legislation for privacy. That is the link that I made.
DR. COHN: I think there are enough other reasons why we need privacy and confidentiality. I do not think this is a document where we need to make a case that there needs to be privacy and confidentiality legislation.
DR. FITZMAURICE: That is fine.
DR. COHN: if that is the argument here, I do not think that it needs to be there. Any other comments?
DR. FYFFE: Agreed. Drop it.
DR. COHN: I think the only other question that I have, two paragraphs before, where we talk about business partners, there is, "A significant privacy concern is potential for unauthorized disclosure of data by business partners that provide services to the health care organizations." I thought that was actually part of the privacy NPRM. Am I wrong about that?
MS. AMATARA: No. That is right.
DR. COHN: So why are we ¾ I am just trying to think.
MS. AMATARA: Just to strengthen the need for privacy legislation because the business partners are not covered except through a business partner agreement, so if we have privacy law, they would be covered or hopefully they would be covered.
DR. FITZMAURICE: Within the privacy law, yes.
MS. AMATARA: Right.
DR. BEBEE: Directly instead of indirectly ¾
MS. AMATARA: Indirectly, yes.
DR. COHN: Okay, that is fine.
DR. FITZMAURICE: You keep that out of civil courts since you probably ¾
DR. COHN: In that case, that is fine. Let's move on. Diverse state laws. Page 25.
MS. AMATARA: We did not have anything.
DR. COHN: I do not see anything here. Does anybody have any comment?
DR. ZUBELDIA: On page 26, line 5.
DR, COHN: Okay.
DR. ZUBELDIA: It says, "May render electronic signatures illegal." I would say "invalid" instead of illegal.
DR. COHN: Great.
DR. BLAIR: Invalid.
DR. FYFFE: Substitute the word "invalid" for "illegal."
DR. COHN: Anything else on that section?
DR. BEBEE: Are we still on page 26?
DR. COHN: Yes. We are moving down to business case for standards development now.
DR. BEBEE: No. I was down there already.
DR. COHN: You were there already, okay.
MS. AMATARA: Clem had a comment yesterday in the last paragraph in this section. "In addition to inconsistent representation," he said he was concerned about the reference to supporting travel by U.S. subject matter experts.
DR. COHN: Where is that?
MS. AMATARA: "In addition to inconsistent representation." This is on page 27, line 7 through 13. He said, "In addition to inconsistent representation of U.S. standards development activities, U.S. representation in international standards PMRI development process is impaired by lack of funding to support travel by U.S. subject matter experts." He said he thought that suggests ¾ even though we do not have it in the recommendations, he suggested that this was sort of encouraging this funding.
PARTICIPANT: Yes.
DR> COHN: We did take that off as a recommendation, so it is probably a little odd making this comment if we are not going to make a recommendation around it.
DR. FYFFE: Delete it.
DR. COHN: I am trying to think, does that whole paragraph need deleting or?
MS. AMATARA: The last sentence supports the recommendation that we have about competing in the ¾
DR. FITZMAURICE: Competition.
MS. AMATARA: Yes.
[Simultaneous comments.]
DR. COHN: Do you want to basically get rid of the concept or the issue about lack of funding, U.S. subject matter experts?
DR. FITZMAURICE: You could say just "lack of representation" and not attribute it to funding.
DR. COHN: Okay. Lack of representation. Okay, get rid of "lack of representation".
DR. BLAIR: Was he saying to get rid of it? I think Michael was suggesting to reword it.
DR. COHN: She took out too much. I am saying get rid of the lack of funding and say basically it is a lack of representation by U.S. subject matter representatives.
MS. AMATARA: So you want to keep this part in?
DR. COHN: Yes. We just want to say "by a lack of representation by".
DR. FITZMAURICE: Yes.
DR. COHN: Actually, the last line on page ¾ are we okay there?
MS. AMATARA: And then delete the rest of this sentence?
DR. COHN: No.
DR. FITZMAURICE: No, because it ties in with the Department of Commerce.
DR. COHN: Up a little higher, I mean before this, there was a comment that Clem made where it says, "Many testifiers identified the level of participation in the standards development process by both professionals and vendors is insufficient to accelerate the development of PMRI standards." He thought we should remove the word "vendor" from that line. He thought that there were probably enough vendors around.
DR. BLAIR: I really do not agree with him.
DR. COHN: You disagree?
DR. BLAIR: No, I really do disagree, yes, because we have heard that as a concern. Especially we hear it from the concerns from small entities, whether they are small ambulatory focused physicians and care givers to small vendors, so I feel like ¾
MS. AMATARA: I would also note that it is particularly true of PMRI standards because I am heading up a subcommittee on ASTM, and there are no vendors, and I cry for them.
[Sounds of telephone connection.]
DR. COHN: Did we just get somebody else on? Kathleen, are you there?
DR. GREBERMAN: Mel Greberman.
DR. COHN: Oh, Mel, hi. We are on page 26 of the review.
DR. GREBERMAN: Thank you.
DR. COHN: We will leave that, leave the vendors alone. On to page ¾
MS. AMATARA: We are on national health information infrastructure. This is on page 27.
DR. COHN: I think the business case for standards development is okay. National health information infrastructure. Is there anything here? I am going through Clem's notes.
DR. BEBEE: No, he does not have anything until page 30, I think.
DR. COHN: I am okay with ¾
DR. BEBEE: Except back on page 26 on line 38 where it says, "Although definitive business case does not exist," he wanted it changed to, "Although a proven business case does not exist."
DR. COHN: Fine.
DR. BEBEE: Just something simple.
DR. COHN: I believe you can make that change. I consider that to be wordsmithing mode. Okay, so we have agreed to the national health information infrastructure piece.
MS. AMATARA: Under data elements to produce PMRI content, we had the reviewers express an issue that we addressed.
DR. COHN: Margaret, you need to get close to the microphone.
MS. AMATARA: I will in a second. Data elements within this mid-level content area have begun to be defined in the financial and administrative transactions standards. There was concern again that there needed to be an understanding of how PMRI related to the transactions standards and especially the claims attachments.
DR. COHN: Do you want to read this piece.
MS. AMATARA: We added this piece at the end of the data elements to produce PMRI content. "Data elements within this mid-level content area have begun to be defined in the financial and administrative transactions standards and will continue to be defined as claims attachment standards are developed. Definitions of data elements for clinical data and their sources are being defined within message format and medical terminology development activities. The standards for PMRI that will result from the recommendations in this report should be consistent and compatible with the administrative and financial transaction standards including the claims attachment standards."
DR. COHN: You know, I almost agree with that. I think that there is a slightly different context, though. This work will accelerate the work on the claims attachment standards because this is the entrance of the claims attachment.
DR. BLAIR: I think that is a very good addition.
MS. AMATARA: Should accelerate?
DR. COHN: I think basically the recommendations will be consistent and compatible and will actually accelerate the claims.
DR. BLAIR: Say "and accelerate." Keep what you have but just add.
DR. COHN: I think it is at the very end there where it says, "including the claims attachment." We say "and accelerate the claims attachment standard." The expansion, I guess, is really what we are saying.
DR. BEBEE: You are really changing the meaning.
MS. AMATARA: Yes.
DR. BLAIR: It is a different thought. You may want to do it as a separate sentence. I do not know. Maybe it is too many thoughts in one sentence.
MS. AMATARA: The standards for PMRI that will result from the recommendations report will be consistent and compatible with the administrative and financial transactions standards and will accelerate ¾
DR. BLAIR: And this should accelerate, yes.
DR. COHN: I guess in addition.
DR. BLAIR: I would make that a separate sentence.
DR. FYFFE: Should they be consistent with the claims attachment standards have been developed? Of course, they have not been promulgated. I mean, that was the thought that was here.
DR. COHN: Yes, and accelerate the further development rather than expansion.
DR. FYFFE: Yes.
DR. BEBEE: I was not sure that I understood the levels either from this paragraph.
DR. FITZMAURICE: Do you mean the levels of granularity?
DR. BEBEE: I understand what that all means but ¾
DR. FITZMAURICE: Or the question about the contrast?
DR. BEBEE: The granularity is at the lowest level, and then you go to the other end of the spectrum, and then all at once you have the trend or the attachment at the mid-level. I just ¾ is that the way that this is describing it? I was not sure of ¾
DR. COHN: Maybe the concept is a little wrong here. We talked earlier about data collected once and used for multiple purposes and aggregated. Is that not what we are really talking about here?
DR. FITZMAURICE: I am not sure because we talked about, on one hand, at the lowest level of granularity, data elements. Then at the other end of the spectrum are broad data sets as opposed to, I would phrase it as broadly defined data elements. Are we talking about the granularity of the data? Or are we talking about the number of elements that we have? What is a broad data set?
DR. BEBEE: I think that the concept is there. I just did not get it from ¾
DR. FITZMAURICE: What is the opposite of low level of granularity? What is a high level of granularity? For me, that is a broadly defined data element not a broad data set.
DR. COHN: My sense on this one is that this is another area that we are going to need to re-review. I mean, I agree with everyone that this does not quite do it. I am just trying to think, can we give Margaret ¾
DR. FITZMAURICE: I think Margaret has it.
DR. COHN: ¾ some guidance to ¾
DR. FITZMAURICE: I think Margaret has it.
DR. COHN: Broadly defined data elements? Okay, that does sound better already. Maybe we are okay there then.
MS. AMATARA: I will look at the whole paragraph again a little bit more.
DR. COHN: Okay, great. Are we okay with this then?
DR. FITZMAURICE: Yes.
DR. BEBEE: Yes.
DR. COHN: Okay.
DR. ZUBELDIA: I have an addition or a change on page 27, line 35 to 43, that paragraph. I went through this ¾
DR. COHN: Yes, we are at this part. You are back to a previous issue. Go ahead.
DR. ZUBELDIA: There is a Big Brother aspect to this. I would like to kill it. Let me suggest a couple of changes. On the third line.
DR. COHN: The third line of what?
DR. ZUBELDIA: I am sorry, line 37.
DR. FYFFE: What is the beginning of the paragraph.
DR. BLAIR: Could you read it because when you refer to lines, then I am completely lost.
DR. ZUBELDIA: Sorry, Jeff. Public health needs PMRI to monitor the health status of the population, create public health programs to improve health status and to manage health studies of our communities. PMRI, in its new virtual form, would provide a longitudinal view of data, to identify factors that affect population health at all life cycle stages. I would like to add the word "anonymized" before data. So, it "would provide a longitudinal view of anonymized data to identify factors…"
DR. COHN: Okay.
DR. BEBEE: That is good.
DR. ZUBELDIA: Then on the next sentence, "That extraction would not require manual abstraction." I would change that to "manual intervention" or "manual interaction" or something other than abstraction. Abstraction sounds like you are taking data out.
Then on the last sentence, "Data in electronic form may be de-identified or made anonymous, further protecting the confidentiality of community health services." I would add the word "easily" before "de-identified" so that it reads, "Data in electronic form may be easily de-identified or made anonymous."
DR. COHN: We are fine with all of that, I think.
DR. FITZMAURICE: Could I suggest on that last sentence. Protecting the confidentiality of people who receive community health services. It is not the services that we are holding confidential, it is the people, the identity of the people.
DR. COHN: [Comment off microphone.]
DR. FYFFE: What? I do not think it is that easy to de-identify data always.
DR. ZUBELDIA: But it is easier to identify electronic data than it would be paper data. That is one of the advantages of the PMRI.
MS. AMATARA: More easily?
DR. COHN: It could be more easily de-identified?
DR. ZUBELDIA: Well ¾
DR. BEBEE: Kepa, I think it should be modified with the word "more". It should be "more easily."
DR. ZUBELDIA: Or maybe "easier to de-identify or made anonymous."
DR. BEBEE: Okay.
DR. COHN: I think we are okay here. All right, anything else, Kepa, on that?
DR. ZUBELDIA: No, that is it.
DR. COHN: Okay, we are on to current status of data standards, page 28. Am I going too quickly for you, Kepa?
DR. ZUBELDIA: No, you are fine.
MS. AMATARA: I just want to point out here. I did not mark it because it is in the diagram, but in the diagram, Figure 1, message format domain areas, NCPDP sent me a note. I just want to make sure that we are okay. The connection between, on the right-hand side of the diagram, between billing and payers, we added NCPDP. Between the pharmacy benefits managers and the community pharmacies, we removed X-12-N.
PARTICIPANT: Okay.
DR. COHN: I agree. Kepa, do you agree with that?
DR. ZUBELDIA: Not really because they do get the 835s with X-12. They bill auxiliary pharmacy, PME equipment and things like that used in X-12.
DR. COHN: Is that to the payers or is that to the pharmacy benefit managers?
DR. BEBEE: They are the community pharmacies.
DR. ZUBELDIA: It goes from the community pharmacies to the payers. It is a line that is not represented here. It normally goes to a PDM.
DR. COHN: Oh, does it, so we should put it back in then.
DR. ZUBELDIA: Yes.
DR. COHN: Okay. So we are going to stick X-12 back in there.
MS. AMATARA: But the addition of NCPDP billing the payers is okay?
DR. FITZMAURICE: Yes. It has to be.
DR. ZUBELDIA: Yes.
DR. COHN: [Pausing.] Excuse me. Okay, on to medical terminologies.
DR. FITZMAURICE: In the second sentence there, recognizing it, it does not say who is recognizing it.
MS. AMATARA: I know.
Dr. FITZMAURICE: I would suggest, "NCHS believes that," so that NCVHS is the one that is recognizing it. I would put that after "implemented." "Recognizing that medical terminologies need more development and testing that they can be widely implemented," I would insert, "NCVHS believes that," and then continue, "development, maintenance and use of clinically-specific terminologies that provide a suitable basis for standardization should be accelerated."
MS. AMATARA: Wait a second. I lost my cursor.
DR. COHN: Did everybody hear that? I do not know that we need to write that up there. If you have it written down, this is wordsmithing stuff.
DR. BEBEE: IF you could send an email to Margaret.
DR. COHN: I agree with you that what you did sounds better. I do not think that it changes the wording at all
MS. AMATARA: I am sorry, but I have lost my cursor, and I need to take a minute.
[Brief pause.]
DR. COHN: We have some substantive areas on page 30.
DR. GREBERMAN: This is Mel. I was going to check. I talked to the folks at the FDA this morning. I obviously did not get in there for other, urgent reasons. I did not know whether Randy Levin had talked to Margaret any and whether Margaret has gotten the latest version for the NBC material.
MS. AMATARA: He did talk to me. He said he was going to fax us something, but we have not received it yet.
DR. COHN: Mel, we are going to wind up having a conference call, I am sure, in the next week to deal with things that we cannot. There will be outstanding items, I would suspect.
DR. GREBERMAN: Okay, fine.
DR. COHN: Hopefully a brief one.
DR. GREBERMAN: [Laughing.] Hope springs eternal.
DR. COHN: Yes, I know. Are you into the medical terminology? I know that you wanted to be ¾
DR. AMATARA: Mike, you were going to send me something for this, is that what you are going to do?
DR. COHN: Yes, we are onto the next thing.
DR. FITZMAURICE: I think you deleted the last half of that sentence.
MS. AMATARA: I deleted what, this?
DR. FITZMAURICE: This is recognizing.
DR. GREBERMAN: Where are you looking now?
MS. AMATARA: This is not a complete sentence.
DR. FITZMAURICE: I think what happened was it got deleted, the last half of that sentence. We will just note that.
DR. COHN: You have the new sentence there, right?
DR. FITZMAURICE: Yes.
DR. COHN: We are now moving on to page 30 which is ¾ and I think there is an area here that you wanted to get some input on?
MS. AMATARA: Yes. Two changes. The one in green was the one to address the FDA's question as to how the NDC does not support specific requirements for patient care. We made those changes there in the green. However, it should be noted that there is a need for multiple domain coverage but that all terminologies need to converge. What may not be apparent from the diagram is the variation in specificity or gaps that need to be addressed. Also, there are some areas of content coverage where the need for greater specificity and harmonization are more acute than others. For example, the need for harmonization of terminologies in a drugs area is very acute. I am sorry. This comment was made that why did we highlight the drug areas as more acute when, from the diagram, it appears that everything is. We wanted to emphasize that.
The one in yellow is the one not designed to support more specific requirements for patient care. Example, dose ¾
DR. COHN: Mel has, I think, wording for that.
DR. GREBERMAN: I think what will happen, there are some errors in that statement. I think what I would like to do is maybe when we get that conference ¾ after we get that material from them, maybe decide how to handle that.
DR. COHN: Okay, that sounds fine, so we will defer that area. My only comment on the green area is that it should be need for coverage for multiple domains. The second line in the green says, "multiple domain coverage." I think it should be, "coverage of multiple domains." It is a little bit of wordsmithing that sort of changes the meaning slightly.
DR. GREBERMAN: I guess after we have a chance to review what the NBC really does, you might want to wordsmith some of the latter part of it, too, but still give some idea that we have to do something. I think we can handle that later.
DR. COHN: That is fine. Since you do not have it, there is no way for us to deal with that right now.
DR. GREBERMAN: I appreciate that.
DR. COHN: The next part is data quality, data accountability and data integrity.
Kepa, do you have anything else?
[Simultaneous comments.]
DR. ZUBELDIA: That same paragraph, the last sentence says, "This will become even more acute with the use of HIPAA transaction standards and code sets that eliminate the use of J-codes." Since we were instrumental in killing the J-codes, I would remove that sentence.
DR. COHN: Huh.
[Brief silence.]
DR. FITZMAURICE: Moving J-codes into a drug classification system ¾
[Simultaneous comments.]
DR. ZUBELDIA: ¾ recommended that the J-codes be eliminated and replaced with NBC.
DR. COHN: Right but ¾
DR. ZUBELDIA: Over my objections, if you remember that.
DR. COHN: Actually, I think the word "acute" is probably not the right word. I think it is more of an issue.
DR. ZUBELDIA: We are the ones who recommended removal of the J-codes. Now we are saying here, oh, wait a minute, did we make a mistake here?
DR. COHN: I am not sure that I read this that way. It is really more that there needs to be some things done.
DR. ZUBELDIA: Maybe more urgent.
DR. COHN: That may be okay. It actually has an even more urgent issue.
MS. AMATARA: Should I say ¾
DR. COHN: I guess the question is, first of all, do we even want to have that there?
DR. FITZMAURICE: A lot of the J-codes are incompatible with other states to begin with, so I am not sure that their elimination is going to make this more acute. It may force an addition to coding systems, but at last that addition will be uniform across 50 states.
DR. FYFFE: Do we need to mention J-codes at all?
DR. COHN: Yes, maybe we should just ¾ I mean, Kepa is saying to get rid of the sentence.
DR. FITZMAURICE: I would favor that, too.
DR. COHN: I think at this point, I would favor that also. We are not ¾
DR. FYFFE: Delete it.
DR. BLAIR: Concur.
DR. COHN: Okay. Anything else, Kepa, in that section?
DR. ZUBELDIA: No.
DR. GREBERMAN: I had another comment, but I guess I will see how the other thing comes along and how to incorporate it. Laden Hansel had suggested some changes in the figure two with that section with some word changes in the related reference to figure two.
DR. COHN: Does this have to do with the MDC?
DR. GREBERMAN: No, it has to do with another code, not with the MDC. He was going to suggest another code where we have that figure, where it says, "other codes, health language center."
DR. COHN: Yes?
DR. GREBERMAN: He wanted to suggest adding UCC/HIBCC universal product number.
DR. COHN: Is everybody okay with that?
DR. FYFFE: That is fine.
DR. BLAIR: Fine.
DR. FITZMAURICE: Fine.
MS. AMATARA: UCC-slash?
DR. GREBERMAN: I guess the ¾
MS. AMATARA: Mel, could you repeat that UCC-slash-what?
DR. GREBERMAN: H-I-B-C-C universal product number.
MS. AMATARA: Gotcha.
DR. ZUBELDIA: UCC/HIBCC.
MS. AMATARA: Just HIBCC?
DR. BLAIR: No, UCC/HIBCC is what he suggested, although it is one in the same.
DR. COHN: No.
DR. GREBERMAN: If you just want to put UPN, that is fine, too, and then we can define what that is.
DR. BLAIR: That is fine.
MS. AMATARA: UPN?
DR. COHN: Universal product number.
DR. GREBERMAN: Instead of spelling it out. He was going to basically put a sentence in that said what that was.
DR. COHN: That is in the appendix, yes. If you want to provide something for the appendix, we will put it there.
DR. GREBERMAN: Yes, sure.
DR. COHN: Okay.
MS. AMATARA: Simon?
DR. COHN: Yes.
MS. AMATARA: Betsy gave me a chance to the diagram also. Should I tell you about it?
DR. BLAIR: They are some good changes.
DR. COHN: Very quickly.
MS. AMATARA: She asterisked all of the codes that were in the UMLS and put a footnote to say, "Four-year partially included in the UMLS medical thesaurus(?) as of March 1, 2000, and she removed UMLS from the center circle.
DR. COHN: Oh.
DR. BLAIR: She also had a title for that. She modified that as well.
MS. AMATARA: Instead of "Coordination/Convergence," she took "Coordination" off.
DR. BLAIR: Just "Convergence" only.
DR. COHN: Oh, okay.
DR. FYFFE: I do not have a problem with that.
DR. BLAIR: That is good. Is she saying, "Unified Medical Library System" or language? Or did she not reference that?
DR. COHN: Let's move on, Jeff. Data quality, data accountability and data integrity. That is page 31. Let me see if ¾
DR. ZUBELDIA: While you are thinking, Margaret, on that diagram, if you could change the yellow arrow to maybe purple or something that would print darker.
DR. COHN: I do not think she knows what you mean, but I am sure she will figure that out.
DR. FITZMAURICE: Figure three.
DR. ZUBELDIA: Figure three.
DR. FITZMAURICE: The bottom right-hand arrow. The color does not print out well.
DR. COHN: Clem makes ¾ lines 31 through 38. You know, I have problems with the data quality, data accountability and data integrity area. I think it has to do with the fact that it appears to me that there is a fair amount of redundancy with earlier comments about data quality, data accountability and data integrity. I found myself ¾ I guess I am just trying to figure out what ¾ I sort of wonder what the whole point of this part is. I specifically find myself questioning the second and third paragraph.
MS. AMATARA: This is the status of data quality as opposed to what the issues were from before.
DR. FITZMAURICE: I think also, too, it does not flow as data quality, accountability and integrity in the paragraphs. I see integrity at line 32. It is the fifth paragraph down. I saw data quality somewhere else, oh, right below it, principles of data quality. It is not in the order that the title has.
DR. COHN: That might help. If you could do that, if you could identify which of these are data quality, which are data accountability, and which ones are data integrity, that would be useful.
MS. AMATARA: I can do that.
DR. COHN: Can you do that? Okay. Maybe that would be ¾
MS. AMATARA: What about those two paragraphs? Do you want to ¾
DR. COHN: Since I do not know what they refer to, it is hard.
MS. AMATARA: How about I take a look at it, and you can send me a note or something offline.
DR. COHN: Okay. Did anybody have a comment on this, or did everybody else think it was okay?
PARTICIPANT: It is fine.
DR. FITZMAURICE: I thought there was duplication but not exact duplication.
PARTICIPANT: I feel a little bit like Julie come lately, but I was back on the previous page, on page 30. Did you incorporate these suggestions from Clem?
DR. COHN: Page 30. Calling it message specific codes as opposed to the message related codes?
DR. FYFFE: I do not think that we discussed that.
PARTICIPANT: Actually, it is the 33rd line from the top of the page. That is where it starts, I guess.
DR. FYFFE: Yes, we did address that.
PARTICIPANT: But not the diagram.
DR. FYFFE: Right.
DR. COHN: We handled lines ¾ he did not support 10 through 14, but I think we thought it was fine.
PARTICIPANT: Yes.
PARTICIPANT: Yes.
DR. COHN: Then he just wanted to change the top box. Rather than "message related codes," he wanted to call it, "message specific codes." Is that right?
DR. FYFFE: He wanted to change med-rah(?) was the other thing, I think, was the other thing.
DR. COHN: He had a comment about, "When I reviewed it, med-rah did not contain any drug codes." Indeed, the planning book said they did not even try to define drug codes because each country has its own MBC like code. Med-rah is really a pretty broad vocabulary. It probably belongs under clinically specific codes.
DR. BLAIR: Clinically-specific codes?
DR. COHN: That is what Clem said. I would defer that question to Mel. Mel, are you still on the line?
DR. GREBERMAN: I did not hear a little of the discussion, though?
DR. COHN: What?
DR. GREBERMAN: Could you repeat that? I could not hear very clearly.
DR. COHN: The issue was that ¾ this is not going to be decided now, but Dr. MacDonald felt that med-rah was not a drug code but it was a clinically-specific code because it really does not have any drug information in it. There are no drugs in it.
DR. GREBERMAN: Obviously, I would have to get some clarification from the people who know it better than I do.
DR. BLAIR: Yes, that surprises me.
DR. GREBERMAN: He also says that he has not looked at it in a few years.
DR. BLAIR: Yes.
DR. COHN: Can you get a comment for us? Can you get a response for us?
DR. BLAIR: Yes, I think we also might want to have input from Chris Chute on that as well.
DR. GREBERMAN: I think we have it now. Is it somewhere in there?
DR. COHN: It is under drugs.
DR. GREBERMAN: I see, okay.
DR. COHN: It is really an adverse reporting system, so it may not actually have a whole lot of ¾
[Simultaneous comments.]
DR. BLAIR: I would put it under the other areas because I do not hear that it is either clinically specific. I agree with Simon that it is more of an adverse reporting system and that it should be ¾
DR. COHN: Let's stick it under other codes then.
DR. BLAIR: -- others for the other codes.
DR. COHN: That is a great solution. Why don't we do that then.
DR. GREBERMAN: That sounds reasonable to me, but I will see if there are any problems.
DR. COHN: Just check, but I think that is our solution there.
DR. BEBEE: One last thing from Clem is he has pretty much on these two paragraphs about page 31, line 36 and 37. He has given a commentary and feels that he has some rewording if we are interested in getting it from him.
DR. COHN: I think he is talking about the issues of going to five digit ICD codes.
DR. BEBEE: And some other comments.
DR. BLAIR: I am wondering if we need to get into that kind of detail because, you know, I do not know if the report is going to concentrate too much on the idea of focusing on ¾ I think we are just taking ICD and CPT codes as givens. Right?
DR. COHN: Yes. I do not think that ¾ I mean, he has written elsewhere about the issues that he has with ICD and other classifications and requirements to go with the levels.
DR. BLAIR: I think whatever thoughts we had with respect to the need for clinically specific PMRI codes, we have been able to make that. I do not know if we need to go into more detail on ICD and CPT. Do you, Margaret?
DR. COHN: He actually had a removing the sentence which is really ¾ he said, remove the sentence, but you should not use the broad classifications to support diagnoses because this precludes the use of a patient ¾ here is the sentence. "They should not use broad classifications to support patients diagnoses and/or document interventions.
DR. BEBEE: And if you look above that where he said he would rather say ¾ in another area, be able to use the most precise terms that apply to clinical circumstances and express them from a clinician's vernacular.
DR. BLAIR: I do not disagree with what he is saying, and I do not really ¾ if you feel like it helps the report to include that, that is fine. I just do not know ¾ it seems to be more elaboration of points that we have already made, I think.
MS. AMATARA: I could also reference his editorial.
DR. COHN: there is nothing here to reference in terms of ¾
MS. AMATARA: no, but I could make this change he is suggesting and then reference his editorial as a source.
DR. BEBEE: It seems to be ¾ I do not know if all of these points are all together relevant to what is here.
DR. COHN: You know, I have a feeling that we are going to need to look at data quality, data accountability and data integrity again because it needs to be reorganized. I think maybe after the reorganization, some of us pulling it out should become clear. I am not sure the issue of going down to a five-digit ICD is pertinent to the discussion of data quality, data accountability and data integrity.
I do think that the issue of using something that is more specific so that a physician can go to the right level of specificity is probably something that ought to be referenced here. That is actually the value of a clinical terminology as opposed to a broad classification. If that is not clear, you ought to make that somehow clearer here. I think that is really probably the issue and probably really is, in some ways, what Clem's five-digit ICD issue really is.
Is it possible? Is this something that you can look at and reformat a little bit? We will put this on the list of things to look at when you go around this?
Is there anything? We are on to page 32, which is the data quality ¾
DR. FYFFE: Simon, it is 20 minutes until 1:00.
DR. COHN: Yes. We are on the last page, I think.
DR. FITZMAURICE: Kepa does not like the color for warehousing, right, Kepa?
DR. COHN: I think the rest of this in terms of the quality management model is fine.
DR. ZUBELDIA: It is not that I do not like the color; it does not print well.
DR. BLAIR: Let me ask you. Do we really have a vote that is necessary by the workgroup to bring this forward to the NCVHS?
DR. COHN: we need a vote accepting it.
DR. BLAIR: I mean by the subcommittee?
DR. COHN: Yes.
DR. BLAIR: My thought, to be honest with you, is I think they are going to cut off that thing at 1:00.
DR. COHN: That is why we are going to finish this up and talk about the executive summary for a minute, decide whether it is going to be included or not, and then we are going to restart the subcommittee and take a vote on this because we have another 20 minutes.
DR. COHN: Okay, so everybody is fine with the last page. Now, shall we talk for just a minute or two about the executive summary.
DR. FYFFE: Please.
DR. COHN: In my view, the executive summary is another, if I can find it at this point. We have obviously already identified some areas that need to be in the executive summary. I apologize that I cannot even find my executive summary anymore. Here we go.
I would first of all comment that ¾ gosh, obviously, I think it needs a fair amount of wordsmithing changes that we can handle offline. My feeling is that the executive summary is not adequate and needs a fair amount of changing.
DR. FYFFE: We revised the body of the report; therefore, we have to revise the executive summary.
DR. COHN: Exactly.
DR. MAC DONALD: [Via telephone.] One additional small point related to the executive summary. We talked about the IOM studies, but since then, the quick group has responded to that. I do not know if we want to reference that in addition.
DR. COHN: Not if we are not referencing the body of the report.
DR. MAC DONALD: Well, is the IOM study in the body of the report?
DR. COHN: That is a good question. Maybe I am mistaken on that, that we can reference things.
MS. AMATARA: Do you mean that to err is human is referenced in the body of the report as well.
DR. FYFFE: Yes.
DR. COHN: I would say, at this point, unless it has some major pertinence to the call for action, and if it does, then you should forward it to ¾
DR. MAC DONALD: It has a major call for action in terms of what the various federal agencies are committing to doing something in terms of errors and some of which will certainly have an impact on these issues. That would be the only reason. I wish there was a fast way of putting that in.
MS. AMATARA: Can you send me that, Clem?
DR. MAC DONALD: I can give you the website, and that may help in terms of defining whether it makes sense.
DR. COHN: Okay.
DR. MAC DONALD: It is W-W-W-Dot-Q-U-I-C-Dot-Gov. That has the report that was the response to the President's directive to do something about this. Then I could talk to all of you about it later.
DR. COHN: Exactly, okay. The one area that you had asked questions about, about whether we were going to add internal and external exchange of PMRI.
MS. AMATARA: Yes, there were ¾
DR. COHN: I did not think that it was necessary.
MS. AMATARA: There were a number of commenters who asked, would you please clarify. Does this mean ¾
DR. COHN: Couldn't we have that in the body of the text? I mean, I do not think that it needs to be in the executive summary. Is that in the body of the text?
MS. AMATARA: These were commenters representing major professional organizations. Therefore, we thought it might be appropriate to be sure that it is clarified.
DR. FYFFE: What page are you on?
DR. COHN: Page four. The first page of the executive summary.
MS. AMATARA: There was a question as to, does the Secretary have the authority to regulate standards for internal exchange of PMRI, and does this really pertain only to patient medical record information that may be exchanged in transaction standards.
DR. COHN: Is that a different question than what you are addressing here?
MS. AMATARA: I mean, the discussion was internal/external.
DR. COHN: I know, but what you are asking now is whether the Secretary has authority to do it as opposed to what the report focuses on.
MS. AMATARA: The issue is both. The question was, does the Secretary have the authority to do that and therefore should the report address this or not.
DR. FYFFE: Well, if we are going to open up this Pandora's box, we ought t have ¾
DR. BLAIR: What is this? I am sorry. I am unable ¾
DR. COHN: This is internal and external.
DR. BLAIR: Internal and external what?
MS. AMATARA: Exchange of PMRI.
DR. BEBEE: Exchange of PMRI within an institution, between institutions.
DR. FYFFE: If we open up this Pandora's box in the executive summary, we have to add at least an explanation of a paragraph or two in the report, right?
DR. BLAIR: Is the problem that systems are not compatible?
MS. AMATARA: No, it is one of authority.
DR. COHN: That is a different issue than what is up here.
DR. FITZMAURICE: I do not know if that is an information system issue except as you have to maybe determine that you exchange only information with like authorities. Maybe there should be a classification of authorities. I guess I do not understand what the problem is.
MS. AMATARA: The question was, Clarify if this report applies to transfer of information or internal uses only, and then the question went on to ask about the authority of the Secretary.
DR. FITZMAURICE: It is going to apply to all exchanges of information.
DR. FYFFE: I sense that the person who made this comment used this issue as almost a showstopper issue in terms of our report.
MS. AMATARA: There were two people who commented. Two groups.
DR. FYFFE: Actually, they bring up a very, very good point.
Ms. AMATARA: There were two groups. One said, Note, no federal law requires medical record standards. Does HIPAA model for transaction standards extend to intra-enterprise? Then the other group was, Clarify if it applies to transfer of information or internal uses only?
DR. FITZMAURICE: Do you mean if the Secretary adopts PMRI standards, does it apply to everybody or does it apply just to government people? Is that basically it?
[Simultaneous comments.]
DR. FYFFE: That is one part of it.
MS. AMATARA: That is part of it.
DR. COHN: Does it only apply if I am sending a claims attachment, or does it apply to my lab system to my EDP system.
DR. FYFFE: You look at the combinations, permutations, and hybrid organizations out there. We really get into quite an issue here.
DR. BLAIR: Why would it be any different than the covered entities that were described earlier in the HIPAA administrative simplifications which is providers, health plans and clearinghouses?
DR. BEBEE: So is that what we need to say?
DR. FITZMAURICE: The question is, does HIPAA give the authority for the Secretary to set PMRI standards?
MS. AMATARA: Let me read this one paragraph to you quickly. It is important to note that NCVHS's responsibilities on the issue of PMRI are fundamentally different from than those for HIPAA administrative transactions. There is no federal legislation requiring implementation of medical records standards. In fact, it is not at all clear if the HIPAA model for administrative transaction standards, which is intended to address inter-enterprise communication, is very applicable to medical records standards that involve a large intra-enterprise focus. This should be stated in the executive summary and in the recommendations section of the report.
Then the other one was, NCVHS should clarify whether its recommendations are intended to address transfer of information from one party to another, trading partners, or whether they also apply to organizations' internal PMRI uses.
DR. FITZMAURICE: Okay, I am starting to understand that, but that only talks about violations and enforcement. If there is no violation and no enforcement specified, then what ¾ they might use something else.
Dr. FYFFE: They are talking about applicability.
DR. FITZMAURICE: They should be applicable in all circumstances, whether it is internal or external.
DR. FYFFE: But see, the commenter questions that.
DR. FITZMAURICE: I think the commenter is questioning the authority to make somebody do something not just whether the standards are applicable.
DR. BLAIR: My understanding is that the administrative simplification provisions simply indicate that the NCVHS is to make these recommendations.
DR. FYFFE: Right.
DR. BLAIR: So this report is in the law. As to whether or not the Secretary chooses to go further than that, then that might be ¾
DR. FITZMAURICE: I think Jeff has it right on the button.
DR. FYFFE: Yes. Okay, Jeff, thank you.
DR. COHN: Okay, so I guess we are persuaded that we actually have to put something in here. I guess my own wordsmithing on this issue is that we say both for internal use and external exchange of PMRI.
DR. FITZMAURICE: I am not sure that we even have to get into that issue.
DR. COHN: You want to just sort of get ¾ okay, go ahead, Mike.
DR. FITZMAURICE: Just not address it. It is an issue only when you decide how you are going to promulgate these standards ¾
DR. BLAIR: The standards, and I really think ¾
DR. FITZMAURICE: ¾ and whom you are going to make abide by them.
DR. BLAIR: Yes, I do not think ¾ to be honest with you, I think it is within our scope to make these, the report and the recommendations. The issue that this individual is raising goes beyond this report, and I think that we should not address it.
PARTICIPANT: Yes. I think that is right.
DR. FYFFE: Okay, so we should delete the words "internal and external."
DR. BLAIR: Internal and external.
DR. COHN: So we are in agreement on that then, good.
DR. MAYES: Did you keep this recommendation about that following the secretary's acceptance of the NCVHS recommendations, the NCVHS is prepared to assist the HSS?
DR. BLAIR: We did change that wording, yes.
DR. MAYES: Because that implies that it will move. We are proposing that it will move ¾
DR. BLAIR: We made it very much more general. I do not know whether Margaret can quickly get that, but yes.
DR. COHN: We will share that with you, but not in the next 15 minutes.
[Simultaneous comments.]
DR. COHN: I guess the question is, what else needs to be ¾ there are a couple of other highlighted areas here, none of which is basically wordsmithing changes. My own view is obviously that the recommendations need to be overhauled. That goes without saying since we changed the recommendations.
DR. FITZMAURICE: Extensively in the executive summary.
DR. COHN: And they need to be able to stand on their own.
DR. FYFFE: Just to clarify, Simon, the recommendations within the executive summary need to be overhauled because of the recommendations in the report.
DR. COHN: Were overhauled, yes. And they need to be able to stand on their own.
DR. FYFFE: Correct.
DR. COHN: We cannot talk about guiding principles unless we have the guiding principles example.
DR. BLAIR: What about Bill Braithwaite's recommendations that we really need to keep this executive summary within two pages?
DR. COHN: That is fine. If the recommendations, however, do not make any sense, then the whole report does not make any sense.
MS. AMATARA: Simon, how would we word the first ¾
DR. COHN: I do not know. We will not decide that in the next 15 minutes.
DR. BEBEE: I do not agree that it needs to be two pages.
DR. FYFFE: Neither do I. You are talking about a 60-page report here.
DR. COHN: Yes, I think that it needs to be as long as it needs to be.
DR. FYFFE: No more than four pages, maybe.
DR. BEBEE: Yes, I agree with that.
DR. COHN: Truthfully, I do not know how to handle number one. We may have to replicate the guiding principles in the executive summary, for all I know, as a final page.
I think we have ¾ there is probably, from my view, I mean, I am just sort of taking everybody's comments, and I know we are getting close here. I think probably the areas that we brought up talking about the business case and the important issues obviously need to be in a section. I do not know if it is major findings or whatever, but that needs to be worked on.
Now, let me just ask before we reconvene as the subcommittee for standards and security. Kepa, you are still there, right?
DR. ZUBELDIA: I am.
DR. COHN: The question is, can we vote on this today, and what should the vote be if we can? It is clear that there area number of areas that need to be fixed. Are we interested in basically giving this to the subcommittee as a vote that with all of the changes being made that we intend ¾
DR. FYFFE: What subcommittee are we moving it to?
DR. COHN: Standards and security, which we have a quorum of and which it needs to pass out of the subcommittee to go to the full committee. Do we want to consider bringing it up to them with the idea being pending all of the acceptance for moving to the full committee ¾
DR. FYFFE: It is substantially ¾ in a substantially drafted form at this point, yes.
DR. COHN: In that case, recognizing that we have 12 minutes left, with the deference of the workgroup, let's reconvene as the Subcommittee for Standards and Security. We now obviously have a quorum of that subcommittee since the members are the same for the work group.
Would somebody like to put on the table the motion that we, with changes to be made, that we approve the forwarding of this document to the national committee for consideration at the June meeting?
DR. FYFFE: So moved.
DR. COHN: Is there a second?
DR. BLAIR: Second.
[Upon a voice vote, the motion carried.]
DR. COHN: Okay, so we have a quorum all supporting that. This obviously means that there still needs to be a fair amount of redrafting work done, and before we adjourn ¾
DR. FYFFE: I just call that editorial work, right?
DR. COHN: Yes, a fair amount of editorial work between now and then, and we probably will need to schedule a conference call to review some of that within about the next week.
DR. BLAIR: Now that we are here, should we pick a time when we will do that?
DR. COHN: Yes. Within the next 11 minutes, we have a couple of things to do. We need to schedule that. I do not know if Marjorie wants to make a couple of comments.
DR. BLAIR: You had given us a deadline of the 9th to get this thing distributed to the full NCVHS committee, and I am wondering, could you give us any more latitude than that because it is going to really be hard.
DR. MAYES: If the idea is that the committee should get it for the meeting.
DR. BLAIR: normally.
DR. MAYES: The meeting is the 20th/21st, so the 9th actually is not even two weeks before, right?
MS. AMATARA: Jeff, it has to be the 9th because I am not available the following week.
DR. MAYES: It will be a busy seven days.
DR. BLAIR: Tough week.
DR. COHN: Actually, we will be in Chicago on the 7th. Do you want to propose an end of the day meeting on the 7th, end of the day Chicago time, around 5:00 Chicago time on the 7th?
DR. GREBERMAN: What time are you suggesting?
DR. COHN: Actually, I have a 6:00 flight. How about 12:00 noon Chicago time on the 7th which would be 1:00 east coast time? Does that work for people? Kepa, are you available?
DR. ZUBELDIA: That is fine with me.
[Comments off microphone.]
DR. FITZMAURICE: What day is June 7th, Simon?
DR. COHN: It is Wednesday, June 7th. It is the date of the HISB meeting in Chicago.
DR. FYFFE: You are just going to have to break out of X-12 for an hour.
[Discussion off microphone.]
DR. COHN: I think that is set, and we will arrange a conference call number.
DR. FYFFE: So that is 1:00 p.m. east coast time on Wednesday, June 7th.
DR. COHN: that is right, or 12:00 noon Central Standard, Central Daylight time. That has been scheduled. Now, I wanted to talk ¾
DR. FYFFE: Another version ¾ excuse me, but another version is going to be distributed then to discuss at that time?
DR. MAYES: No, the polished version.
DR. COHN: The more polished version, yes, along with all of the editorial issues that we needed additional information which to resolve.
DR. FYFFE: I meant that there will be a document distributed prior to that call.
DR. COHN: Exactly. That will be, I think, our final opportunity to ¾
DR. FYFFE: That is going to be draft number seven, is that right?
DR. COHN: Yes, I think we will remove the word "final" from it this time. I think that is bad luck.
PARTICIPANT: Could you send that to me as well, please?
DR. COHN: Yes. We will make sure that gets forwarded to you.
Let me just make also a couple of comments on subcommittee business. First of all, at the full meeting of the NCVHS, I think we will have about an hour on the second day to basically deal with whatever changes or comments come out of our first day meeting. I think that we have an 8:00 meeting, so we just need to be aware of that.
DR. FYFFE: Speak up a little bit please?
DR. COHN: At the full committee meeting, we are scheduled an hour in the morning on the 21st for the subcommittee and workgroup to deal with whatever changes, fixes, whatever need to occur based on comment input on the 20th.
DR. FYFFE: Are both of these days of meetings up in Maryland?
DR. COHN: They are here.
DR. MAYES: No, none of them are in Maryland.
DR. COHN: They are here. This is the NCVHS.
DR. MAYES: The 20th and 21st.
DR. FYFFE: Then what is this invitation for some kind of symposium or something?
[Simultaneous discussion.]
DR. MAYES: The 50th anniversary symposium is at the National Academy of Sciences, which is just down the block here.
DR. FYFFE: Which is in the District of Columbia?
DR. MAYES: It is definitely in the District of Columbia. The meetings are all here at the Humphrey Building. We are meeting here the morning of the 20th; adjourning at 11:30 to go to the symposium; coming back here the morning of the 21st. From 8:00 to 9:00, the Subcommittee on Standards and Security is meeting.
DR. COHN: That is right. Thank you.
DR. FYFFE: Forgive me.
DR. COHN: So this would be an opportunity to make any corrections based on the input from the full committee on the first day when this will be presented.
To go forward into the future, you know there is life beyond these recommendations. I know it is hard to believe. So, July 13 and 14 are the next hearing dates, which will be in Washington. We will be, at that point, talking about tracking implementation. We will get some testifiers and some people from WEDI, hopefully Faulkner and Gray and others about the issues around tracking implementation. We will be looking at early implementation issues and in general looking at what people have done already to be implementing the HIPAA standards. We will be talking about some of the code set issues related to the implementation, about local code sets going away and things like this potentially.
DR. BEBEE: That is going to be July?
DR. COHN: That is July.
DR. BEBEE: Local codes.
DR. FYFFE: Thursday and Friday, July 13 and 14.
DR. COHN: That is right.
DR. BEBEE: Is there one of those days that is designated for the local code discussion?
DR. COHN: It has not been ¾ this is a question of when the testifiers are available, and we have not started calling them yet.
DR. MAYES: I assume you are going to be talking about the September meeting also?
DR. COHN: Oh, probably.
DR. MAYES: At that point ¾ or the panel for the September national committee meeting on code sets.
DR. COHN: I was not clear whether we were going to be doing the code set panel in September or November.
DR. MAYES: Oh, okay. I thought you had said that you wanted it in September, but I think November might be better.
DR. COHN: Yes, I think November might be better, too, for a number of reasons. We will talk about what we are going to be doing in September.
The next dates for hearings that you need to be aware of and write down, because you have not written this down before because we are announcing it today, are October 26 and 27. That will be the next set of formal, two-day hearings. This will be looking at issues having to do with the mandate of looking at changes to the standards that are being implemented. We will be looking also at the issue of digital signature since, as we know, that was a standard that has been deferred. We will hold some hearings around the digital signature to see if that is appropriate.
Certainly based on our conversations yesterday, we will begin to get into the issues around some of the code sets as in device code sets. We will talk about devices, code sets for devices, and sort of see where we are since they were mentioned in the initial NPRM as being an area that we needed to watch, but at least as of a few years ago were not really quite ready to be a standard. That becomes another part of that activity.
DR. GREBERMAN: I am sorry. I was not clear when you said the dates. October what again? I am sorry.
DR. COHN: October 26 and 27.
DR. GREBERMAN: October 26 and 27. Who will be handling who is going to be invited for the digital signature portion of it?
DR. COHN: You can certainly talk to me if you would like or Karen Trudell or Bill Braithwaite.
DR. GREBERMAN: Somebody from our agency might want to really participate in that. You know that we sent in a lot of material on that.
DR. COHN: And we are certainly inviting you to talk about medical devices, too.
DR. GREBERMAN: I appreciate that. Who shall I coordinate the medical device with? Should I talk to you, Simon, then?
DR. COHN: Yes, you can talk to me and just email me and cc Bill Braithwaite and Karen Trudell. That would be great.
Now, actually, unfortunately, the computer is not up anymore, so I do not know if we are still before 1:00 or not.
DR. FYFFE: It is 1:00.
DR. COHN: Marjorie, do you have a comment or two?
DR. MAYES: Two would be all that we have time for.
DR. COHN: That would be fine.
DR. MAYES: I was asked by Bill Braithwaite and Karen Trudell to give you an update on the NPRMs or the rule making process, so I will do that. The transaction code set reg is still targeted for June 30th though there remains an issue about ¾
DR. BLAIR: Financial administrative ¾
DR. MAYES: ¾ the paperwork reduction act, whether OMB must clear the standards. NCVHS's recommendations or comments on the rules supported the department's position that these would not require OMB clearance.
The National Provider Identifier is moving along. The final reg, although there are again some issues that OGC has raised, the general counsel, about whom we can require to get an identifier. We are still hoping to get the rule published this year.
Employer ID, we are making a few changes in those rules.
DR. ZUBELDIA: Marjorie, you said it would or would not be published this year?
DR. MAYES: Excuse me, what?
DR. BLAIR: The provider identifier.
DR. MAYES: The provider identifier, we are still hoping to get the final rule published this year. We are making a few revisions to the employer ID, but I think that should be back in the department for clearance in the next few weeks. Still requiring aligning the security regs with ¾
DR. BLAIR: Does that mean that it would be ¾ when you say "for clearance," in the next few weeks, does that mean that it will become a rule in the next few weeks?
DR. MAYES: No, no. It should be nothing to prevent it from being finalized.
DR. FITZMAURICE: It goes through agency clearance again?
DR. MAYES: Apparently. There are still a number of issues to be worked out in aligning privacy and security rules. We expect these to be resolved as the privacy rule moves toward its final form. We hope that the privacy rule and intend that it will be finalized by the end of the year, but there are approximately 150,000 comments. There are 50,000 separate pieces of mail with each one having an average of three comments in it so that it is quite time consuming, as you can imagine.
DR. FITZMAURICE: I missed that. Is that the security will be out of the end of the year or we hope the privacy will be out by the end of the year or both?
DR. MAYES: Privacy also.
DR. FITZMAURICE: Are they wired together or can they be done separately?
DR. MAYES: I do not know whether they are going to be issued at the same time, but we cannot really apparently finalize the security rule until we have done all of the alignment with the privacy rule, so it does require the privacy rule to be pretty close to finalized as well.
The plan ID is moving along. Hopefully we will be in formal clearance by mid-summer. The attachment standards are on hold until the transactions and code sets are being ¾ are promulgated. Once that rule is published, we will revise the claims attachment NPRM to align it with final decisions made on the transactions standards.
DR. BLAIR: So let me see if I understand. The claim attachments to NPRM probably will not be issued until after the financial administrative transactions.
DR. MAYES: It could not be.
[Simultaneous comments.]
DR. BLAIR: --before data security. I'm sorry.
DR. MAYES: No, it could be before security, I would think. It cannot be issued until the final transaction. I think it was in pretty good shape when it went ¾ you know, the last time it went through clearance. It depends on what changes have to be made based on the final transaction rule.
We have removed the naming of a digital signature standard from the security rule. NISB is still monitoring the development of technology in this area and is waiting for some industry consensus to develop before naming a standard. I hope that we are going to have at least a brief presentation on this topic at the June national committee meeting.
There is a line here that says, "Please let me know if you have any questions," but I am deleting that.
[Laughter.]
In consideration of the time.
DR. COHN: Oh, well. Does anybody have any burning questions?
DR. FYFFE: Yes, I just have one request. When this update is given, can we focus on when the NPRMs or final rules is going to be published in the Federal Register? That is the point at which the public has the opportunity to look at it. When you start talking about internal clearances and OMB and everything else, it just gets very confusing.
DR. MAYES: The problem is that those are the processes that you have to go through in order to publish it.
DR. FITZMAURICE: Those are the milestones.
DR. FYFFE: Yes.
DR. FITZMAURICE: It gives people a sense of how far it is in the department, has it gone to OMB yet.
DR. MAYES: If it has not even gotten through departmental clearance, you know that it is going to be probably several months.
DR. FYFFE: Maybe you could add that in the explanation. You also should include the expected or projected date that it will be published in the Federal Register because that is the most important thing. It can hash around forever in the catacombs of the Federal Government, but until it gets into the Federal Register, it is not official.
DR. MAYES: Where that was provided to me, I did provide it.
DR. FYFFE: Okay. Thanks, Marjorie.
DR. COHN: I would say probably just somewhat editorially that I think the HHS is probably a little gun shy at this point in coming up with dates only because I think we have missed a number of them already. A point that was not missed on us, and I think resulted in that letter to the Secretary at the last NCVHS meeting.
DR> FYFFE: In my mind ¾ and I do not know if this interpretation is correct. In my mind, we are still on track for NPRMs and final regs to be published in the Federal Register in the year 2000.
DR. COHN: Yes. I would say furthermore that it would be very awkward for us to have hearings on early implementation and implementation issues if we do not have a final reg on the transactions prior to July 15th.
DR. MAYES: And that we do hope to have.
DR. COHN: Yes. So, sometimes doing things like this does provide some additional activity.
Now, with that, are there any questions about the activities of the subcommittee or otherwise over the next couple of months? Are there any other issues that we need to be dealing with at this point? We have the conference call set up. We have a major deliverable for June. We have some things set up for the rest of the year. Certainly I would ask for all of your inputs into people, the right people, for the various panels and hearings that we are going to be putting together. We have created, I think, a list. If any of you have suggestions, I would welcome them. We have already elicited from some of you suggestions and thoughts. Obviously, otherwise, we will proceed ahead. Any final comments?
DR. MAYES: I do not know that it is at all needed, but you are not planning to have a conference call prior ¾ we are going to have the conference call about the PMRI this coming week?
DR. COHN: Yes.
DR. MAYES: And then there will not be another conference call prior to the July 13 and 14 meeting?
DR. COHN: Never say never, but hopefully not.
DR. MAYES: Okay.
DR. ZUBELDIA: Marjorie, I have a question on the provider ID. Is HCFA coming up with the registry?
DR. MAYES: It is what?
DR. ZUBELDIA: Is HCFA coming up with the registry for the providers?
DR. MAYES: Is HCFA coming up with the registry?
DR. BLAIR: You are talking about the medi-data(?) registry?
[Simultaneous comments.]
DR. ZUBELDIA: Provider ID rules.
DR. COHN: National provider ID. I think you may have to ask Karen Trudell that. My understanding was that they were taking responsibility for the development of the registry, development and maintenance, but that may not happen.
DR. FYFFE: There is no money.
DR. MAYES: Actually, there has been some progress there, I think, but it is ¾ HCFA will be deciding ¾ this will not answer your question but address your question. HCFA will be deciding shortly whether development and operation of the national provider system will be done in house or contracted out, but I think there has been some clarification that it can be supported by HCFA if funds are available.
DR. COHN: So the intent is still to have them take responsibility for funding that?
DR. MAYES: Either in house or contracted out.
DR. FITZMAURICE: I do not see any legislation or any budget documents that say that HCFA has been told to do this.
DR. FYFFE: Let's not go down that path.
DR. COHN: Let's defer this conversation. We will have a formal briefing at the June full session, and potentially we may have some more information at that point. At least we can ask the question. I know that Marjorie does not have all of the answers to this area, but this is ¾
DR. MAYES: That is fine.
DR. COHN: She is the wrong arm at HHS to really address this.
Now, with that, are we okay to adjourn? Kepa, do you have any other comments?
DR. ZUBELDIA: No. That is it.
DR. COHN: I want to thank you all for a very hard day and a half. We really appreciate everyone's contribution. Obviously, we have a conference call in about a week.
[Whereupon, at 1:15 p.m., the meeting was adjourned.]