[This Transcript is Unedited]
Hubert Humphrey Building,
Room 505A
Washington, D.C.
DR. BLAIR: Welcome to the June 1-2 meeting of the computer-based patient record work group. This work group is within the Subcommittee on Standards and Security, which is within the National Committee on Vital and Health Statistics.
Our work effort continues. We are about to review the sixth and final draft of the report to the Secretary of HHS on uniform data standards for patient medical record information.
The agenda for today as we take it through will wind up covering that report. That has been distributed to all work group members and all staff people. Again, that includes draft 6.1 that we are going to focus on today.
I'm going to make a few comments before we introduce everybody here, just so that there is a little bit of a framework of what we have.
Back at the end of April, we made an attempt to solicit comments and critiques on this report from outside reviewers. During May, we received many comments back, and Margaret Amatayakul wound up pulling together many of these comments and mapping them in a matrix that each of you will see in your packets, and also was distributed to you on Monday electronically. It is an Excel spreadsheet, and it maps all of the comments from each of the individual reviewers, not only against the sections of what had then been draft 5.4, but it also broke it down by topic area. So we got as precise as we could.
Then after those comments were in place, in order to try and help you on the committee here review this efficiently in the limited time we have, Margaret also crafted draft 6.1.
Now, there are some keys to help you understand how that is pulled together. Margaret and I wound up deciding on some wordsmithing, where we felt it would not be too controversial on the suggestions, and it did seem as if there was a number of substantial comments on a point or section. We gave you suggested wording and highlighted that in green on draft 6.1. So we would like you to review that and verify whether you want to accept those changes.
More controversial areas, things where it is not quite so clear, they were highlighted in yellow. There were some additional changes to draft 5.4 which were proofreading and editorial changes from both Susan Bebee and Clauda Tessier. They have been included in, so you may want to carefully read it through. But I think those should not be too much of a problem.
So you can probably see when you look at the spreadsheet, there was a large contribution of very thoughtful comments, insightful comments. I really want to express to the committee appreciation to Margaret Amatayakul for an outstanding job of creating the spreadsheet to help us to be able to assess comments side by side for a particular topic, and then folding these into a draft that should help expedite our review of this process. I really feel like she has done an outstanding job.
Now, maybe we can begin our introductions. I am Jeff Blair, and I am Chair of the work group on CPRs. Maybe we could go around the table here.
DR. COHN: I'm Simon Cohn. I am the National Director for Health Information Policy for Kaiser Permanente, a member of the work group and committee.
DR. MC DONALD: I'm Clem McDonald, a member of the committee and the work group from Indiana University and Regenstrief Institute.
DR. FITZMAURICE: I am Michael Fitzmaurice, Senior Science Advisor for Information Technology from the Agency for Health Care Research and Quality. I am one of the two government liaisons to the committee. I am the co-lead staff of the computer-based patient record working group.
DR. AMATAYAKUL: Margaret Amatayakul. I am an independent consultant and contractor to this committee.
DR. HUMPHREYS: Betsy Humphreys from the National Library of Medicine.
DR. BURKE-BEBEE: Susie Bebee from the National Center for Health Statistics.
DR. FYFFE: Kathleen Fyffe. I am a member of the National Committee and also of this work group. I work for the Health Insurance Association of America.
DR. BLAIR: Do we have other people in attendance, if they could come up to a microphone and introduce themselves? Who is on the phone? Oh, Bill, could you introduce yourself?
(Remarks off the record.)
DR. BLAIR: For other people on the Internet, that was Dr. Bill Yasnoff of the Centers for Disease Control.
Are there other people in the room that might want to come to a microphone to introduce themselves?
DR. SERIKOWSKY: I'm Art Serikowsky from the Center for Devices and Radiological Health of FDA.
DR. BLAIR: Everyone else is shy. Then the thing that I would indicate to you is that what we would like to do is, we would like to address the recommendations section first, and then after that Section 3, which is the overview of standards, and then after that either the executive summary or the introduction, depending on what the committee feels our next priority should be.
With respect to the Section 4, which is our recommendations section, just a couple of words to introduce you to that, because you might see fairly significant changes from our draft 5.4.
We received obviously a lot of critiques and comments and suggestions on this section. One of them was from Dr. Paul Tang that Margaret and I felt gave a very crisp clear revised outline for how we should present the recommendations. So you see that reflected now in the recommendations section, and we folded in a lot of the sub-points into Paul Tang's outline. We hope that you also will find that a little bit more understandable than what we had in 5.4.
Now, one of the other pieces that happened out of that is, because it improved the clarity and flow, it was no longer necessary for us to try to do that by having a separate set of paragraphs which described a selection process. So you will find that that is now missing.
I'd like to at this point -- Dr. Cohn, do you have any other comments? Otherwise, I'll turn it over to Margaret to lead us through.
DR. COHN: No. Why don't we get started with the report?
DR. BLAIR: Okay. Margaret?
DR. AMATAYAKUL: Yes.
DR. BLAIR: Can you lead us through?
DR. AMATAYAKUL: Okay. Do you want me to read from the top of the recommendations?
DR. BLAIR: Yes, because we did a new introduction.
DR. COHN: Margaret, just by way of process, are we going to go through page by page or paragraph by paragraph?
DR. AMATAYAKUL: Paragraph by paragraph.
DR. COHN: Okay, and we are having wordsmithing as well as conceptual issues at the same time?
DR. AMATAYAKUL: Right, yes. What I will also do is, in addition to reading the paragraph, if there is an annotation, I'll explain where the annotation came from, if that would be helpful for you.
Introduction. The National Committee on Vital and Health Statistics, NCVHS, has identified several major impediments --
DR. BLAIR: Can I suggest one thing? Let me just ask, in terms of process and how we step it through, does the work group feel as if we should identify comments that drove us to doing a new section on each stage? Is that going to be helpful to the work group, or should Margaret just go right into the new wordings?
DR. FITZMAURICE: I would suggest that we go right into the new wordings. If anybody asks, they can always get the backup for the new comments.
DR. COHN: Actually, I have no objection with the first paragraph. I am seeing things as we go through, where there are for example places where the change for that would be noted as new wording.
DR. FITZMAURICE: I see some sections deleted or put in another place, and I have some questions about those, too.
DR. COHN: So I'm not sure exactly how to -- I think the recommendations are important enough that other sections, we need not go word by word. But this is only a couple of pages long, and for the benefit of our Internet audience, they might appreciate hearing what the recommendations are.
DR. FITZMAURICE: I'm sorry. I thought you were asking for the backup, that is, who made the comments that led to the changes and recommendations. That is what I was coming at, saying that we would ask if we wanted that information.
DR. BLAIR: That is correct. You are saying no, and I think Simon is also saying no. We just go through it very carefully. Margaret, back to you.
DR. AMATAYAKUL: The National Committee on Vital and Health Statistics has identified several major impediments to improving health care quality and cost and achieving administrative simplification, including the following: Limited interoperability between information systems, lack of comparability in health care data, concerns with the quality of health care data, need to protect the privacy of health information, inconsistencies among state laws relative to medical record information, need for a national health information infrastructure.
There is basically no change from before in there.
DR. COHN: Any comments from anyone? Okay.
DR. AMATAYAKUL: The next paragraph. NCVHS also recognizes the continuing evolution that defines and redefines the content and structure of patient medical record information, PMRI. The most recent example of this evolution is the emergence of web-based personal health records. NCVHS believes that it is important to accelerate the interoperability and comparability of PMRI in a manner that will leave the content and structure of health records flexible to adapt to new medical knowledge, procedures, technologies and public policies.
This paragraph is new, and it is in response to some comments concerning why we didn't address consumer health records and other kinds of things.
DR. BLAIR: Both consumer health records and why we didn't focus on content more. So we thought that this paragraph might be an explanation as to where our focus was and why our focus was that way.
DR. FITZMAURICE: Margaret, does this replace the old paragraph that started out, uniform data standards for patient medical record information?
DR. AMATAYAKUL: Actually, the rest of this introduction section replaces that paragraph. It has got some of the same things, but a little bit more.
DR. FITZMAURICE: That's fine.
DR. MC DONALD: Well, it doesn't mean anything, that first sentence. It is just pablum. So I don't like it for that reason. What is all this stuff? There is a lot of hope by some companies that that is going to be a very popular thing. And some reports I have heard, it isn't. No one wants to spend the time sticking everything into it.
So I think we need to talk about facts and data here.
DR. COHN: I have a more fundamental question. I think it is a good sentence, but I don't think it should be in recommendations. I think it is somewhere in the body of the -- just by way of introduction someplace, that recognizes -- I'm not sure what it is about the recommendation that deserves to be -- about this recognition that needs to be a recommendation.
DR. AMATAYAKUL: It is not a recommendation, it is commentary. So it needs to be someplace else.
DR. COHN: I agree. You agree that it shouldn't be here?
DR. AMATAYAKUL: Yes. It is not a recommendation. It is just commentary.
DR. BLAIR: Consider this, okay? The introduction -- part of what we were thinking of is that there are some people that may go directly to the introduction. So we felt as if a little bit of the thinking behind this should be reflected in there.
Again, this is in response to some critiques and suggestions, so that would be my only suggestion in terms of considering why it is there. Do you still feel like it needs to be in a different section?
DR. MC DONALD: It is sort of a last-minute entry. We had 93 testifiers; it didn't come out from any of that. So it is a point that I think is at least over emphasized, and I don't think it says anything. But I can drop that part of it.
DR. BLAIR: Other thoughts about this?
DR. FITZMAURICE: I guess of the two sentences, I favor the first sentence. Touting the web-based personal health record I do think belongs somewhere else, as one of the technologies that may be emerging. It is not the only technology. Given a choice, if we are going to split hairs, I would perhaps keep the first sentence, but put the second sentence somewhere else, because it is not the only thing that is emerging.
DR. MC DONALD: Is the shaded one the new one?
DR. AMATAYAKUL: No, it's the whole paragraph. The reason I shaded part of it was as an indicator to where something started.
DR. BLAIR: This might help just a little bit. The suggestion that we had was, gee, this report isn't addressing the emerging areas of personal health records. There has been a flurry of conventions and conferences and funding for a lot of these upstart ASPs -- application service providers -- to do these, and many of the traditional vendors have begun to create personal health records.
So it is hard to split off one versus the other. The first sentence is basically acknowledging that there are some new trends. The second sentence is saying why this report is not separately addressing that or separately recognizing that.
DR. KOLODNER: Jeff, this is Ralph Kolodner. That second sentence just says, the most recent example is. It doesn't state that we are not going to address it.
DR. BLAIR: I'm sorry, maybe I am really referring to the third sentence, then.
DR. MC DONALD: Of all the sentences, the third sentence I think is the best. If you could maybe say the same things by saying, for example, a medical procedure such as personal health records.
DR. BLAIR: Clem, what would you suggest we do on this?
DR. MC DONALD: Just that. It's not shaded, and add into it, for example, personal health records at the right place in the sentence; personal health records flexible to adapting medical procedures technologies such as personal health records.
DR. BLAIR: For my benefit, since I can't see it, could you just read me the two -- I gather you are saying there are two sentences we should keep, Clem?
DR. MC DONALD: Well, it is one big sentence. The sentence that I think is pablum is, the NCVHS also recognizes the continual evolution that defines and redefines the content and structure of patient medical record information. The most recent example of this evolution is the emergence of web-based personal health records.
The key thing you are trying to say here is that it is important to let these records talk to each other in some fashion, or let data move around. So the last sentence begins, NCVHS believes that it is important to accelerate the interoperability and comparability of the PMRI in a manner that will leave the capture and structure of the health record flexible to adopt to new medical knowledge, procedures and technologies such as personal health records.
I'm not sure where it really belongs, but you want to say, make it adaptable and find a place to put it in, such as personal health record.
DR. BLAIR: Fine. Does everyone feel comfortable with Clem's modification?
DR. MC DONALD: I just don't know where to put that phrase.
DR. FYFFE: It looks good to me the way Margaret has it.
DR. AMATAYAKUL: I read it, so this paragraph would just simply say, NCVHS believes that it is important to accelerate the interoperability and comparability of PMRI in a manner that will lead the content and structure of health records flexible to adapt to new medical knowledge, procedures, technologies such as personal health records, and public policies.
DR. FYFFE: But it doesn't say anything about the personal health records being web-based. Are we deliberately avoiding that?
DR. BLAIR: No, you can say web-based personal health records for new technologies. How is that?
DR. FYFFE: Thank you, Jeff.
DR. COHN: I am struggling over this one, too. I think there is, if we wordsmith appropriately, something that is nice about the first sentence. I don't like the way it reads right now, but the continuing evolution -- I almost think of it as the dynamic nature of the health care environment that defines and redefines the content and structure of the medical record.
I agree, I don't like a whole sentence on, the focus on web-based personal health records. But I do think we do want to acknowledge that -- and I know understand the point Carol brought up -- that what we are saying is that it isn't a nice evolution; the health care environment is very dynamic right now, and it is going to have a lot to do until all of this stuff eventually gets handled.
By the way, we might consider leaving the first sentence with some modification and go to the third sentence as described there. In the third sentence, which is now the second sentence, I am wondering if there is some wordsmithing -- important to accelerate the interoperability and comparability of PMRI. I'm not sure about accelerating interoperability and comparability.
DR. MC DONALD: Does it not say standards, interoperability of PMRI standards?
DR. COHN: No.
DR. MC DONALD: That's the missing word. We are trying to accelerate the standards.
DR. COHN: No, we are actually trying to accelerate interoperability and comparability. I'm not an English professor, but it isn't good English, something that we are doing there in that piece.
DR. KOLODNER: Foster?
DR. COHN: Maybe accelerate something to improve the interoperability and comparability PMRI. I'm not sure I can wordsmith it on the fly here, but there is something about the verbs and the whatever coming together that --
DR. KOLODNER: Accelerate the infrastructure or the standards?
DR. MC DONALD: This is not the best way to use the committee time.
DR. COHN: I agree. Why don't you note it, and the editors can take care of it.
DR. BLAIR: Okay. Are we ready to go on to our next paragraph then?
DR. COHN: I just have a question here. I had gone through this document assuming that the areas that were bolded were the areas that had changed, and then observing there seem to be lots of other areas, and I am confused. You basically bolded the beginning of areas that changed?
DR. AMATAYAKUL: Yes, for the most part.
DR. COHN: So everything from there on to the end of the section has been changed?
DR. AMATAYAKUL: We had identified that the entire recommendations section had been changed, so we didn't bold the entire section. We bolded the things we thought were most critical to discuss.
DR. COHN: Thank you.
DR. AMATAYAKUL: Because the whole thing has been changed.
DR. COHN: Okay.
DR. BLAIR: I think the way we left this paragraph is that we would keep in the first sentence; we would work to improve it so that it is more readable? So we go to the first to the third sentence and we are deleting the second sentence, is that correct?
DR. COHN: That was my understanding, but I never saw universal agreement.
DR. BLAIR: Does the committee feel comfortable with that? Okay, Margaret, next paragraph.
DR. AMATAYAKUL: This report reflects the belief that significant quality and cost benefits can be achieved in health care, if clinically specific data are captured once at the point of care and derivatives of this data are made available for all legitimate purposes.
In addition, 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.
Furthermore, these recommendations address standards to exchange comparable PMRI seamlessly within a health care enterprise, as well as to share data in a secure manner with those outside the enterprise who have legitimate need for such information.
DR. BLAIR: Comments and critiques on this paragraph?
DR. AMATAYAKUL: We had a couple of people who asked how the report and the recommendations in particular related to the claims attachment standards specifically and all of the rest of HIPAA generally.
DR. BLAIR: As you probably could tell, this paragraph is there -- it was generated because of the comments and critiques where people were winding up wondering where we were coming from and what was our basic intent. So this was to clarify that right in the recommendations section.
DR. COHN: I have a question about the word should. What does that mean in this context? Does that mean the committee will, or is it a statement that this must be -- obviously, this stuff must be consistent, but are we saying this to ourselves, are we saying this as a recommendation to the Secretary? What does that word reference there?
DR. AMATAYAKUL: This is introduction to the recommendations, so it is like a description rather than the recommendation specifically.
DR. COHN: Do we mean then will?
DR. AMATAYAKUL: We could put will.
DR. COHN: That's fine, thank you.
DR. AMATAYAKUL: The last paragraph in this section is, therefore in accordance with the directives in Section 263 of the administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996, HIPAA, and in consideration of industry testimony, the NCVHS makes the following recommendation.
DR. FITZMAURICE: Margaret, it looks like we are making the recommendations and that the guiding principles are the recommendations, the way it is set up here. I don't see a reference to the guiding principles.
DR. AMATAYAKUL: Right. The reference to the guiding principles is in the recommendation. Simon suggested that there be the guiding principles in a box. I think what would be ideal is, when this is printed, that you could have the guiding principles on the left and the first part of the recommendations on the right.
DR. FITZMAURICE: That would be a good presentation format.
DR. AMATAYAKUL: But I can't do that going down.
DR. COHN: So do you want to talk about the first recommendation, and then we'll go to the guiding principles?
DR. AMATAYAKUL: Either way. I think recommendations, then go back to the guiding principles.
DR. COHN: I think the first recommendation is the guiding principles.
DR. AMATAYAKUL: Yes.
DR. COHN: It seems like you ought to review the first paragraph of the recommendations and then we'll go through the guiding principles.
DR. MC DONALD: Could you call out the page number when we get to them?
DR. AMATAYAKUL: The page numbers are not consistent here, Clem, because I had to raise the font and make it bold.
The recommendation section starts out saying B, recommendations. As a result of hearing the testimony, and considering the potential impact of standards required in the administrative simplification provisions of HIPAA, the NCVHS recommends that the Secretary of HHS, one, adopt the guiding principles for selecting PMRI standards, see box, as a criterion to select uniform data standards for patient medical record information.
DR. COHN: Now let's look at the guiding principles.
DR. BLAIR: You want to read through the guiding principles? Would that be helpful, or not necessary?
(Simultaneous discussion.)
DR. AMATAYAKUL: Yes, those are the only changes. Do you want me to read the whole thing?
DR. MC DONALD: Yes, read the whole thing.
DR. AMATAYAKUL: The guiding principles for selecting PMRI standards. The principles proposed below are derived from the guiding principles that were developed to guide choices for the standards to be adopted by the Secretary of HHS, that were published in the Notice of Proposed Rulemaking for administrative and financial transaction standards.
In developing these recommendations and legislative proposals, NCVHS will aim to promote PMRI standards that, one, improve the efficiency and effectiveness of the health system for delivering high quality care; two, meet the data needs of the health community, particularly providers, patients, health plans, clearinghouses and public health organizations; three, bring consistency and uniformity to the uses of the other HIPAA standards and secondarily with other public and private sector health data standards.
DR. FYFFE: What does that mean? Bring consistency and uniformity to the uses of the other HIPAA standards. I should understand that, I think, but I don't.
DR. BLAIR: And again, it was to be consistent with the financial administrative transaction standards, the health claim attachment standards and the codes and identifiers that we anticipate would be regulations prior to the time when PMRI standards are ready. But maybe we need some better wording.
DR. FYFFE: Maybe it is supposed to be, be consistent with.
DR. BLAIR: Be consistent with?
DR. FYFFE: It is not an action, bring consistency.
DR. FITZMAURICE: Having the uniformity of the PMRI standards brings consistency and uniformity to the uses of the other HIPAA standards. Without that, they have their own different data dictionaries, different meanings. This helps to bring uniformity across those standards, and then secondarily other private and public sector health data standards. It is not there yet.
DR. FYFFE: It needs some wordsmithing, Margaret. I'll trust you to do that.
DR. AMATAYAKUL: We actually didn't even look at these, since you all did these many months ago.
DR. COHN: I would even comment that I don't think we actually ever looked at these.
DR. FITZMAURICE: We looked at them in detail -- I read them a year ago.
DR. BLAIR: I think Betsy's suggestion was that it would be clearer if you say, be consistent with.
DR. FYFFE: Yes, but I don't think that is the meaning, based on what Mike just said.
DR. FITZMAURICE: The meaning is that having PMRI standards will help bring consistency to other standards. It is a uniform vocabulary. It is a uniform terminology.
DR. BLAIR: That is a good point.
DR. FYFFE: That is a very good point.
DR. FITZMAURICE: And we are not there yet. Not only the government HIPAA standard, but also the other private sector standards.
DR. FYFFE: So we need to make this clearer.
DR. AMATAYAKUL: Yes.
DR. COHN: So it is, be consistent and uniform with the other HIPAA standards?
DR. FYFFE: No, it isn't.
DR. AMATAYAKUL: It is more than that.
DR. FITZMAURICE: It is to be a tool that brings consistency and uniformity to the uses of the other HIPAA standards.
DR. AMATAYAKUL: Using those words is good.
DR. COHN: How is it going to do that?
DR. FITZMAURICE: It has a reference. You reference the terminology that came out of PMRI standards.
DR. COHN: What if you are not referencing the terminology that came out of PMRI standards?
DR. FITZMAURICE: Then you are rejecting a tool and not bringing uniformity and consistency to what you're doing. Having the PMRI standards will bring uniformity and consistency, but you're right, only if you use them, only if they are used.
DR. COHN: Help me with this one. I don't get a lot of sleep last night, so I am probably a little dull. But --
DR. FITZMAURICE: I didn't get an awful lot, either.
DR. COHN: Yes, okay. But I'm trying to think vis-a-vis the administrative and financial transactions, there are many data sets in those that aren't part of the clinical vocabularies, the medical vocabularies.
DR. FITZMAURICE: That's right.
DR. COHN: Are you suggesting that this recommendation is somehow affecting those to make them all consistent with what we are recommending?
DR. FITZMAURICE: I'm not saying it is going to make 100 percent consistency anywhere. I am saying that having PMRI standards will bring consistency and uniformity to the uses of the other HIPAA standards, and that without them, then you have a separate data dictionary for each standards or each component of the standard. Having PMRI standards gives people a reference point to say, if we are in doubt or if we have two different choices, let's see what the PMRI standards say, let's use that definition. But you are also saying that in many cases, the PMRI standards won't cover the administrative data, that's right.
DR. BLAIR: Could I suggest this? I think that we really have two concepts here. One would be addressed by saying, be consistent with, and the other, maybe we should have an additional guiding principle which articulates what Michael is suggesting. I think we would have great difficulty trying to blend these two concepts into one sentence. They are really two different concepts. Does the work group agree with that?
DR. COHN: Margaret has her hand up.
DR. BLAIR: Yes.
DR. AMATAYAKUL: We already have a recommendation though that identifies the need to be consistent with the meta data registry. So do we really need that in the guiding principles?
DR. COHN: I don't think that being part of the meta data registry has anything to do with consistency, at least as I understand it. To put something in the meta data registry means you send it to the meta data registry; it doesn't mean that you have to --
DR. FITZMAURICE: It doesn't conform with anything.
DR. AMATAYAKUL: It says coordination of data elements among all standards selected for adoption under HIPAA through funding the development and maintenance of an open meta data registry. So the coordination aspect is there.
DR. COHN: I think it is very soft that coordination is likely to be a result of this. I think that is very low level coordination we are talking about, potentially, because a meta data registry doesn't have any enforcement --
DR. FITZMAURICE: It lets you identify gaps, but it doesn't do anything to close the gaps. Most people voluntarily do it.
DR. BLAIR: Are we back then to the notion of having two separate items in the guiding principles then? One that says, be consistent with, and the other one would be maybe what Michael is articulating about promote?
DR. COHN: Margaret is raising her hand again.
DR. AMATAYAKUL: I wonder if we shouldn't then make the recommendation stronger.
DR. MC DONALD: We just talked about consistency with HIPAA as another bullet point. In general recommendations, to be consistent with the other HIPAA standards. So we don't say that again. My inclination, when you have got 12 or 13 bullets and you are trying to make a point, when you can't figure out how to say it, get rid of it. It will come up again. You want people to read this.
DR. AMATAYAKUL: But it is an important principle, isn't it? We have got to have something.
DR. MC DONALD: We say in a separate, outside of this thing bullet that we will be -- not should be -- consistent with the existing HIPAA standards.
DR. FITZMAURICE: You mean outside of the guiding principles?
(Simultaneous discussion.)
DR. FITZMAURICE: It is one of our guiding principles.
DR. AMATAYAKUL: But it seems to me that it is one thing to say as a guiding principle for selecting, we are going to select those standards that are or can be consistent with HIPAA standards,and it is another thing to state that somehow, whatever we select is going to bring consistency. But it seems to me as a selection principle, the issue of bringing consistency to other standards is what we assume will be an effect of adopting PMRI standards. It is not a way of selecting them, whereas some ability to be consistent would be a selecting principle.
DR. FITZMAURICE: But I wouldn't want to tie us to making a change in a PMRI standard that will introduce some inconsistency at first, in the expectation that the other standards will conform to this one.
DR. HUMPHREYS: Then I would say that maybe getting rid of this is good. It seems to me that why we describe why we need PMRI standards, we can somewhere, if it is not already there, insert the point that we actually also need them in order to be sure that there will be greater consistency in the administrative and transaction standards, if that is what we believe will be the outcome of this, rather than making that a selection principle for these. It seems to me that it could bring valid consistency is a reason for adopting them; it is not a way of selecting them.
DR. FITZMAURICE: True, but I think the principles are to give us reasons for selection, and not for telling us how to implement them. So it would seem important to me to -- in our selection we want to bring consistency and uniformity to the uses of not only the other HIPAA standards, but also other private and public health sector standards, that that is why we are doing this.
So it is a guiding principle as why we are choosing --
DR. AMATAYAKUL: All the rest of them are actually characteristics of the standard, in my mind, rather than an effect of adopting them, which is what this sounds like to me, the way you have described it, Mike.
DR. FITZMAURICE: There are others that would also seem to have --
DR. AMATAYAKUL: Maybe we should get rid of those.
DR. MC DONALD: The point is, you are saying these are approved standards, which means we can't go in and muck with them, if you follow the approved rules. The process decides that. So I think we are mixing a little bit what we hope will be the outcome and what the selection process will be.
DR. FITZMAURICE: But a lot of these are tradeoffs. There are many cases where we won't be able to meet all 13 of these criteria, so we are going to have to make tradeoffs.
DR. COHN: We are I think talking about four or five different things at once. I agree with Jeff about this, that it is getting a little bit confusing.
I think issue number one is, do we want to have an item three that says, be consistent and uniform with other HIPAA standards? That is question number one. Question number two has to do with this issue about bringing consistency and uniformity to the other HIPAA standards, which I would observe is more of a concept issue, I think, and a terminology issue, at least as best as I can figure it out. But I can't see coming up with another message format standard is going to be consistency and uniformity to the other HIPAA standards. A code set could help, potentially.
DR. FITZMAURICE: Well, this isn't limited to --
DR. COHN: That's true, but I get a little confused as we start talking about what this really means. So maybe we should divide the question here, and first of all, decide if we are going to have one, and then if we'll have number two. I would propose that we at least have a number three that says, be consistent and uniform with the other HIPAA standards. I think it is probably not bad saying it twice, in the introduction and in the recommendations. So is that okay with everybody?
DR. AMATAYAKUL: Simon, do you want the uses of in there?
DR. COHN: No, just to be consistent and uniform with other HIPAA standards.
DR. BLAIR: Right, and that is a clear statement, that is a guiding principle. Now let's discuss an additional guiding principle that Michael is suggesting, and see the right way to phrase that.
DR. COHN: Where did we lose you, Margaret?
DR. MC DONALD: These are principles for selecting PMRI standards, not principles for making the world better.
DR. BLAIR: That's correct.
DR. AMATAYAKUL: I just wanted to point out that we have that statement.
(Simultaneous discussion.)
DR. COHN: I think this is one of the principles. People are not going to look at the introduction when they are mulling over the principles.
DR. FITZMAURICE: It is a selection principle, it is not all principles.
DR. COHN: Margaret, I specifically had it stop after HIPAA standards. Now, the question is, what do we want to do with this other issue.
DR. BLAIR: I am trying to echo here what I am hearing. I am hearing Betsy and Clem and Simon feel as if the concept that Michael is suggesting really is reflected in other parts of the document, and probably repeatedly so.
DR. HUMPHREYS: I don't know that it is, but I think it should be somewhere else in the document and not here.
DR. FITZMAURICE: And in response to that, I would say that rather than being consistent with the other HIPAA standards, that it would be more important to bring consistency and uniformity to the uses of those other standards, because being consistent with an existing standard that may be deficient in some way, but you then propose a standard that conflicts with it, it may be better to have a conflicting standard. I wouldn't want to rule that out by saying we can't have it, it conflicts with an existing HIPAA standard.
DR. BLAIR: Now, we do talk about coordination and harmonization. There are recommendations for those, and I think also -- is there a guiding principle there that refers to coordination and harmonization?
DR. FITZMAURICE: I just can't recall.
DR. BLAIR: No, there wouldn't be in selection principles.
DR. MC DONALD: Yes, these are selection principles, not our total principles. We've got other principles. We are principle people.
DR. BLAIR: Michael, I think that the thought that I am beginning to derive is that the benefit of consistency I think has more to do with things that we want to achieve, rather than a way of selecting.
Let me ask you this, Michael. If we don't have it in the guiding principles for selection, where is the next place that you want to see this concept expressed?
DR. FITZMAURICE: Whenever a decision is made about what standards we need and should either adopt or should have developed.
DR. BLAIR: But where else in the document?
DR. FITZMAURICE: I don't have any other place. If you would like to delete it, that is all right with me. I think it is an important principle. But even though I stand on that, I certainly bow to the wishes of the other people.
DR. COHN: I always like the term parking lot for certain things as we go through this. It seems like the concept needs to be put in parking lot, and let's figure out where in the recommendations it should as we go through. I'm not sure I see where it is right now, but as we look through we can find a spot.
DR. FITZMAURICE: Yes, let's table it and move on.
DR. COHN: Yes.
DR. AMATAYAKUL: The next guiding principle is four, have low additional standards development and implementation costs relative to the benefits of using PMRI standards.
The next one has been changed. Will be supported by an accredited standards developing organization. Where an accredited standards developing organization does not address a domain, another private or public organization may be selected. All organizations selected to support standards must operate in an open consensus manner and assure continuity and efficient update of the standards over time.
This statement actually was worded -- the original wording was exactly the same as it came from the other standards, the other transaction standards. But we had several comments that expressed concern about private organizations being standards development organizations, so we tried to modify it to address those concerns.
DR. MC DONALD: This is a comment. I think in general, having such a thing is good, but in the law there is a distinction between two kinds of standards that have to be approved, but are not. And this distinction isn't showing up here. So the code standards weren't covered in the same way in the HIPAA law.
The second thing is, consensus and efficiency is often a contradiction, in terms of speed. So I just don't know whether -- you are not going to get efficient update by having a consensus manner, just as a matter of fact.
DR. BLAIR: Clem, are you saying that what Margaret read to us applies to transaction standards explicitly, but not necessarily to codes?
DR. MC DONALD: I can't remember the wording, but HIPAA does apply -- it has to be an approved or find another way.
DR. AMATAYAKUL: The HIPAA document says, will be supported by the accredited standards developing organization or other private or public organization --
DR. HUMPHREYS: You are talking about the guiding principles, he is talking about the law.
DR. AMATAYAKUL: Oh, got you.
DR. HUMPHREYS: I think.
DR. MC DONALD: So they make a distinction between the largely transaction sort of standards and the code standards for a number of pragmatic reasons. And code standards being adopted purely on consensus is hard, if you have to vote on every word that goes in.
So I think this is a good concept. It's just maybe that those distinctions should be -- and I think the code standards should also have some open public -- I'm not saying that they should be renegades, but open public manner is -- somehow we've got to say open to them, too.
DR. AMATAYAKUL: Should we drop the word consensus?
DR. MC DONALD: Maybe, because the accredited forces that. The ANTI accredited part is going to get tough for organizations like WHO ICD-9. That is what we've got to use.
DR. BLAIR: What if we stated that this -- at the beginning of the sentence, if we just put the word transaction standards?
DR. MC DONALD: You really have a two-step thing. Some of the stuff applies clearly in the law to the transaction standards, not the code standards, or maybe it is that the code standards are carved out.
DR. FYFFE: They are, right.
DR. MC DONALD: But yet, you don't want code standards to be a monopoly company that can just rip off the whole world. There should be some open process to that, too.
DR. FITZMAURICE: Clem, would it help to change the must to a should? All organizations should operate?
DR. HUMPHREYS: I see the issue that Clem is bringing up. It is true that open manner and assure continuity and efficient update affects all of them, but there is the issue which is also related to the update frequency and so forth of cods, which is one reason why they were carved out of the original law, so they wouldn't be stuck with the same update limitations as the other standards, which would make them unworkable soon.
If you dropped consensus here, then you would have a statement that -- if you dropped consensus, you would have a statement that covered all the types of standards.
DR. COHN: If you dropped which statement?
DR. HUMPHREYS: Just dropped the word consensus and say open manner. The process is defined anyway.
DR. BLAIR: That's a good point.
DR. MC DONALD: But can you figure out a way to easily stick in the supplied carveout from the accredited to the code standards?
DR. AMATAYAKUL: It does say where an accredited organization does not address a domain.
DR. MC DONALD: But that's not how the law goes.
DR. COHN: The first sentence seems a little strange to me. I like the way the old version, number five, read. But I also like the last sentence, about an open manner. So the question is, the way number five used to read, which will be supported by accredited standards developing organization or other private or public organization, that will assure continuity and efficient updating of standards over time, solves all the problems we have just been talking about.
I guess I would question in my own mind whether -- not knowing what the future may hold, about whether or not we want to necessarily box ourselves in by saying any potential standard by definition has to be from an accredited --
DR. MC DONALD: I think we should fit within the law, because that is what we are really operating under.
DR. COHN: Number five supports --
DR. MC DONALD: It is almost there. We need to say something slightly different about the things in a code standard.
DR. HUMPHREYS: The other thing is that it seemed to me that what Simon just said solved the problem. If you said will be supported by an accredited standards developing organization or other private or public organization and then leave the last sentence, all organizations selected to support standards must operate in an open manner and assure, that looks like it would cover it.
DR. BLAIR: Let me add one problem to that. I don't have strong feelings about this, because it could be the way Simon just suggested it. However, we had that before, and we did get criticisms from --
DR. HUMPHREYS: We didn't have the second sentence added to it, though.
DR. BLAIR: That is what I'm saying. We added the second sentence to address the concern of folks, where it simply said, accredited or private organizations. So in order to address their concerns that it is not simply one or the other, we added the phrase that said, when an accredited organization does not cover a particular domain, then --
DR. HUMPHREYS: That to me is too restrictive.
DR. MC DONALD: I agree.
DR. HUMPHREYS: It seems to me that if we somehow ended up with an accredited organization who said that they were developing something that was in direct conflict with a direct competitor of the international classification of diseases, we would not want to have an argument about whether we should still be using ICD or not. So that is too restrictive a sentence.
DR. BLAIR: Okay. It seems like it is the consensus of the group that it is too restrictive a sentence, is that correct?
DR. MC DONALD: I'm kind of ambivalent. I don't have the law in front of me, but the law what is said here more or less exactly like that, applying to one subset of the standards domain. Then it says something slightly different about another subset. If we had that phrase, --
DR. COHN: I'll get it here in just a second.
DR. MC DONALD: -- we might be able to be specific this way, but it may just get too complicated, and we'd be better off with a simple sentence.
DR. HUMPHREYS: I think the carveout has more to do with the update process than it does with the organization responsible.
DR. GREBERMAN: I agree with Betsy. MEDRA as a past example wouldn't need the restricted requirement. Also, we are doing a lot with the international communication in terms of harmonization efforts. Clearly, the process will become more consistent with what we would like to see in the future. But right now, there is a lot of international harmonization activities that will be done in an open fashion and still be subject to review.
DR. MC DONALD: Oh, don't get me started on MEDRA.
DR. GREBERMAN: Okay, I'll get off the MEDRA thing, but we are really talking about for the future. There are a lot of international harmonization activities that I think will be very difficult to be boxed in, just like Betsy said for her example.
DR. BLAIR: Simon, did you find --
DR. COHN: Well, it is complex, and that is part of the problem. It says, role of standard setting organizations. Except as provided in paragraph two, any standard adopted under this part -- once again, we will find out if the administrative and financial transaction is identified, shall be a standard that has been developed, adopted or modified by a standard setting organization. Then it says, the Secretary may adopt a standard that is different from any standard developed, adopted or modified by a standard setting organization if the different standard will substantially reduce the administrative costs to health care providers and health plans compared to the alternative, and the standards promulgated in accordance with the rule-making procedures of sub-chapter 3 of Title 5, United States Code.
It says that no standard setting organization --
DR. FYFFE: Speak up, Simon.
DR. COHN: I'm sorry. If no standard setting organization has developed, adopted or modified any standard relating to a standard the Secretary has authorized or required under this part, paragraph i, paragraph one, shall not apply and subsection XF shall apply.
That is for the message format standards. We can go to code sets.
DR. BLAIR: Is that what the heading was about?
DR. COHN: That was actually the -- the standards setting organization is approved standards, where the standards are listed.
DR. KOLODNER: Maybe we can just reference the law.
DR. HUMPHREYS: Look at the way Margaret has it now.
DR. AMATAYAKUL: Let me read it for you, because it is kind of -- will be supported by an accredited standards development organization or other private or public organization that will assure continuity and efficient update of the standard over time. All organizations selected to support standards must operate in an open manner.
DR. COHN: Is that okay? These are principles.
DR. MC DONALD: I understand, but the principle we are imitating is what they said here. It more or less said everything except code standards should be approved when possible, when an organization exists.
DR. HUMPHREYS: I think you are remembering that a little wrong.
DR. AMATAYAKUL: Is that revisionist history there?
DR. MC DONALD: I think that is what that says. SDO is defined as an approved standard.
DR. BLAIR: I have the impression that it was trying to give preference to SDOs that were accredited.
DR. MC DONALD: Definitely.
DR. BLAIR: On the other hand, I thought it was also trying to give latitude, that if a domain wasn't covered by an accredited organization, we have the flexibility to go elsewhere. Is my statement not correct?
DR. MC DONALD: That's correct.
DR. BLAIR: Could we then reflect that in the principle?
DR. COHN: The problem is that that references basically the message format standards. It doesn't reference the code sets, so should we do another one for code sets?
DR. BLAIR: Maybe we have to. Maybe that will fix it. Let's carve it up. Let's do one for terminologies, where we maybe leave it the way we had phrased it, right? And then have another one for code sets.
DR. FITZMAURICE: Why not just reference the law, using this as the opening phrase, and reference the law for the specifics?
DR. BLAIR: I think the law, as you can see when Simon read it, is very difficult to follow. We are referencing something that people who are reading this document are not going to know what this says.
DR. HUMPHREYS: But Clem is right. When you get down to code sets, the --
DR. BLAIR: It is different.
DR. HUMPHREYS: It is very different. It just says you're going to select these things. So it does seem to me that this general principle, going back over the law, I have to agree, it is giving a higher weight to ANTI than is given in the law.
DR. BLAIR: It is an accreditation --
DR. HUMPHREYS: For code sets, which accreditation or standards groups is given a high weight for the rest of the standards.
DR. BLAIR: Could we then go back to the original sentence and just put the word transaction in front of the word standards, and see if that would fix -- then we could leave it just the way we had it.
DR. COHN: Then the question is, what are we going to do for code sets?
DR. BLAIR: I think we have to separately --
DR. COHN: Either that, or do we say this, and then at the end of the sentence put -- make a reference to the subtitle, to the law.
DR. MC DONALD: I think you just put transaction standards, have another one saying code standards will be selected in an open manner according to the --
DR. COHN: You could do that. I'm just saying, there is a way at the end of that first sentence to reference in -- compatible with, as detailed in subtitle F of that first sentence, might handle it.
DR. BLAIR: I responded to Clem's suggestion. I thought that was a neat way to handle it, what Clem had just said.
DR. COHN: Well, should we have two different sets of guiding principles then?
DR. BLAIR: No, no, all the rest apply.
DR. AMATAYAKUL: I am concerned about the use of the term transaction standards, because we have so much confusion. If people read this and thought we were redoing the administrative and financial transactions -- if you want to modify standards, I would suggest you modify it by actually saying message format standards, and then using vocabulary. Again, we have people -- I have had people come up to me and being confused between vocabulary and code set.
DR. COHN: Let me just try this one for just a second here. If we say in the first sentence -- basically, get rid of transactions and just say be supported by whatever, then say, comma, consistent with subtitle F, whatever the public law number is, that would reference you to all of the vagaries of all of this. It might mean that we don't have to spell it out.
DR. MC DONALD: I thought we were almost there.
DR. COHN: Well, we were there for the --
DR. MC DONALD: Let's not quit yet. The minute you start out saying your message format standards will be supported by accredited organizations, the next sentence is fine, format standards must operate in an open and consistent manner, you are substituting in two places, message format standards and --
DR. HUMPHREYS: Where?
DR. MC DONALD: At the very fruit part of the sentence, message format standards will be supported by --
DR. HUMPHREYS: Yes, but now you've got to do it in parallel construction here.
DR. MC DONALD: There is one more place that you need to put it, and I think it works. Then, at the third line before standards, message format standards, then we need one more bullet to say code/vocabulary standards will be selected in an open manner according to the law.
DR. BLAIR: That is clear to me.
DR. COHN: Will be established in an open manner?
DR. HUMPHREYS: They operate based on the fact that they are.
DR. MC DONALD: Consistent with the paragraph referenced in the law.
DR. COHN: So Clem, read this over and see if this is what --
DR. MC DONALD: We need something in front of five, right after the dot five. Message format standards.
DR. COHN: Will be supported by an accredited message format standards development organization or other private or public organization.
DR. MC DONALD: You don't need all that anymore. Where an accredited standard does not address a message format domain, another private or public organization might be selected.
DR. COHN: But there is also the part of the law that says that the Secretary has the right to select another standard if another one is more efficient.
DR. MC DONALD: Yes.
DR. COHN: Are we going to add that, too?
DR. MC DONALD: No.
DR. COHN: How come?
DR. MC DONALD: We can reference the law if you want to get into all that phrasing, but that is really what we are saying. Where an ANTI doesn't exist, --
DR. GREBERMAN: I think it is important at least to have -- for this situation reference the law.
DR. BLAIR: We could still reference the law at the end.
DR. GREBERMAN: I think in the area of the exception, it is useful to have for that exception as you just read it, it was about five words, the Secretary has the right according to the law, or whatever.
DR. AMATAYAKUL: You know what? I think I've got the gist of it. Why don't I wordsmith this and bring it back like this afternoon or tomorrow morning? Would that be okay?
DR. COHN: That's great.
DR. AMATAYAKUL: Okay. Number six. Have timely developmental testing, implementation and updating procedures to achieve benefits faster. Seven. Are vendor neutral and technologically independent of the computer platforms and transmission protocols used in the electronic exchange of PMRI. Eight. Are precise and unambiguous, but as simple as possible. Nine. Keep additional data collection and paperwork burdens on users as low as is feasible. That is not crossed off; the box is just flowing in.
DR. MC DONALD: Could I suggest a slight change? Could you say minimize or keep additional data collection and paperwork burdens to an absolute minimum?
DR. FITZMAURICE: An absolute minimum is zero.
DR. MC DONALD: No, it's like saying what is the most we can -- that would be nice.
DR. FITZMAURICE: But as low as possible kind of says that.
DR. COHN: Somebody observed to me that the concept of paperwork burden in this context is a bit of an oxymoron. Maybe we just want to say keep additional data collection burden on users as low as is feasible.
DR. FITZMAURICE: We think that electronic records are --
DR. COHN: Well, because these are electronic standards generally.
DR. FITZMAURICE: Maybe it is not just paperwork burdens, but all burdens we want to keep low.
DR. MC DONALD: That's all right, I'm not unhappy with this one.
DR. AMATAYAKUL: Now we have, keep additional data collection burdens on users as low as is feasible.
DR. MC DONALD: That's fine.
DR. AMATAYAKUL: Ten. Incorporate flexibility to more easily adapted changes in the health care infrastructure, such as new services, organizations and provider types and changes in information technologies such as new forms of data capture, knowledge representation and information presentation.
Eleven. Are consistent with the characteristics and attributes for clinically specific PMRI terminology. These characteristics and attributes as described in section three have been recognized within several scholarly works in the industry, culminating in an ASTME 2097 standards specification of quality indicators for controlled health vocabularies, unquote.
DR. MC DONALD: There are two issues here. This applies to vocabulary code sets, not to everything, so you might want to clarify that. The second thing is --
DR. AMATAYAKUL: It actually does apply to the other, too.
DR. HUMPHREYS: I would say it does, Clem, because you are saying you want to adopt standards that are consistent with the characteristics and attributes of clinically specific terminologies. So if you have a message format standard that did not allow you to be specific, then it wouldn't be consistent.
DR. MC DONALD: That's okay, I take that back. The other part is, I don't think we are saying what we want to say. What we want to say is the ideal PMRI terminologies. Anything could qualify to be a specific PMRI terminology.
DR. BLAIR: Well, aren't these guiding principles anyway? So we don't think anything is ideal. Nothing is going to meet all of these things.
DR. MC DONALD: The next sentence is talking about the ideal. It is not talking about just any terminology. I would almost worry about having to reference particular documents here, because then it doesn't have the spiffy type --
DR. BLAIR: Could I make an argument for leaving it the way it is, based on this? That is, within the HL-7 vocabulary TC last week, they accepted very close to the same wording that we have here, which is the sense that those ASDM attributes and characteristics would be -- I don't remember whether they use the word principles -- they would be guidelines for the registration of vocabularies that would fit into HL-7.
So I think that at this point, there is a convergence on this notion that the ASTM attributes and characteristics are guidelines. Did I convince you?
DR. MC DONALD: It would be nice if you could say what that meant to the average reader, so they wouldn't have to go get another book.
DR. BLAIR: Tell me again --
DR. MC DONALD: I don't know how we can do it, though.
DR. HUMPHREYS: I don't know how you can, either.
DR. MC DONALD: If you could say they would be non-redundant --
DR. AMATAYAKUL: They can read Section 3.
DR. MC DONALD: Why don't we say that, then?
DR. AMATAYAKUL: We did, as described in Section 3.
DR. MC DONALD: Where?
DR. BLAIR: Section 3 of this report.
DR. MC DONALD: I actually was looking for Section 3. I can't find it. Can you give me the page?
DR. BLAIR: That is the overview of standards section.
DR. MC DONALD: Isn't it a small part of Section 3, three dot something?
DR. AMATAYAKUL: I can put the page number if you would like.
DR. MC DONALD: It is a Section 3 subpart somewhere, or is it in the appendix?
DR. COHN: It is in the main body of the text.
DR. BLAIR: Right, so maybe if we add a page number as well?
DR. MC DONALD: That, or else target it narrower, the subsection.
DR. HUMPHREYS: I actually feel that you could make this shorter by just saying, are consistent with the characteristics and attributes for clinically specific PMRI terminologies, and then just say, as described in Section 3, dot dot dot, and in Section 3 dot dot dot you can make reference to the standard.
DR. MC DONALD: That makes more sense. But isn't it a subpart of Section 3 actually?
(Simultaneous discussion.)
DR. AMATAYAKUL: I'll put a specific reference when I get there.
DR. HUMPHREYS: When we stop editing this document.
DR. AMATAYAKUL: That's right. So we should end it at these characteristics and attributes are described in Section 3, page whatever.
DR. HUMPHREYS: Or even just, as described in, without even a separate sentence.
DR. MC DONALD: Yes.
DR. AMATAYAKUL: Okay. Next one, 12. Are consistent with features and characteristics of data quality as described by the American Health Information Management Association's data quality management model, as described in Section 3, page whatever.
DR. MC DONALD: Where is that? I couldn't find that, either.
DR. COHN: Can I ask a question about the earlier one, just a real quick one? I'm wondering if that in some way handles this issue, about the item number three that we had put in the parking lot. Is this another way to approach that?
DR. FITZMAURICE: A problem with 11 that I have is that it refers to something outside of the guiding principles, so the principles don't stand on themselves. But I don't think it probably does handle it.
If I went back and read through what the ideal characteristics are of the terminologies and other standards that might be adopted under PMRI, it could handle it. I just don't know it. But we would have to start looking through other pages and other documents to find out what our guiding principles are; they don't stand on their own two feet.
DR. COHN: Is there a way to include the standard as an appendix? I don't know how long this particular standard is.
DR. BLAIR: To be honest with you, these documents if I recall were 15 to 20 pages.
DR. MC DONALD: They are copywritten in the charge form.
DR. BLAIR: I think it is going to be so much easier for people to read it the way Margaret has laid it out. She has made it easier to understand. Once you get to it, you can go right down the attributes and characteristics, and you can understand it.
DR. AMATAYAKUL: Maybe we could just say, are consistent with the characteristics and attributes for clinically specific PMRI terminologies, as described in ASTM E-2087, specification of quality indicators for controlled health vocabularies, since that is referencing a specific ANTI standard. Then if we wanted to in parentheses, we could say, for additional information, see Section 3, page whatever.
DR. BLAIR: I would do it the other way around though, because many of the readers that are reading through this thing are going to want to understand what those are right away. It is right there in the overview. I'd point them right there to that, and then in parentheses I would wind up saying, if you want additional information, go to the ASTM standard, which is detailed.
Although Betsy suggested that in the overview where you describe that, you referenced the ASTM standard there, right?
DR. MC DONALD: Yes. Either we're going to say just the one sentence and then refer them to the other part of this document, which does give you some description --
DR. COHN: Leave it at that.
DR. FITZMAURICE: Suppose you dropped the reference to anything outside and simply say, are consistent with nationally recognized desirable characteristics and attributes with clinically specific PMRI terminologies. The nationally recognized means that these change over time, because of technology changes or whatever. You then go to look to see what is nationally recognized.
DR. HUMPHREYS: Yes, but if I'm reading these guidelines and I have this document, I'm with Jeff; I immediately say, what is that? I want a reference to this document I have in my hands, so I go read what these are.
DR. BLAIR: I think that should point directly to the section in the page, in the overview, where we describe what they are. Within that, it also beyond that does give a reference then to the ASTM standard.
DR. COHN: Agreed.
DR. AMATAYAKUL: So it reads, are consistent with the characteristics and attributes for clinically specific PMRI terminologies as described in Section 3, page whatever.
DR. BLAIR: Right.
DR. AMATAYAKUL: Twenty-one, right now.
DR. MC DONALD: I think you should give the subpart, Section 3, something-something, the two pages. The pages get screwed up.
DR. AMATAYAKUL: C-2. Onward. Are consistent with the features and characteristics of data quality as described by data quality management model, as described in section --
DR. MC DONALD: But when I look at this thing, how is that different than in the ASTM? This is just a general overview about how we can think about quality. I'm looking at this figure on page 32. I'd be challenged to know how I use this.
DR. BLAIR: As you are going through selecting?
DR. MC DONALD: Yes.
DR. BLAIR: Well, I'll tell you, Clem, what do you think about this? In the back of my mind, I was envisioning that when we go through the standards selection process, we would be looking at for example message format standards for PMRI. As we looked at those, we would also be reviewing the characteristics and attributes in the HEMA for data quality, and there may be a number of areas where we could ask SDOs to enhance to strengthen the message format standards to include attributes for data quality and data integrity and accountability as a result of those.
That is what was in my mind as how they would be used in the selection process.
DR. COHN: I do have to say that I find the wording that describes the 10 characteristics of data quality more helpful than the management model, but it is probably the same thing.
DR. MC DONALD: Which is it?
DR. COHN: They are one and the same, so --
DR. MC DONALD: Maybe we could say the bullets, then.
DR. HUMPHREYS: And if we do that, then we can do it for number 11. That would address Mike's view that the guidelines stand by themselves. I'm not voting against it.
DR. MC DONALD: I can see how I use them. I can't see how I use this model to pick something. I can see how I'd use this model to think about the problem.
DR. AMATAYAKUL: The model and the 10 definitions go together. We can make them look more physically together.
DR. MC DONALD: You don't need to. The items are what you use to do your checkoff list.
DR. AMATAYAKUL: So do you want to put those items under guiding principle number 12?
DR. MC DONALD: No, I think we could just say, as listed in the bullets under Section 3, third paragraph, whatever it is.
DR. FITZMAURICE: It might not be bad to put them in as bullets.
DR. MC DONALD: Okay.
DR. FITZMAURICE: Then the specific stands by itself. At least, that one does.
DR. AMATAYAKUL: So right after this then, we should delete the reference and list the items.
DR. BLAIR: Does that seem to be the consensus of the work group? Okay.
DR. HUMPHREYS: Now we get to number 13, where I am going to ask your question, what does this mean.
DR. BURKE-BEBEE: Can I ask a question, too? I'm wondering if 18 months to two years or whatever down the road that we look at these guiding principles again and they are outdated because of the specifics that we just put in.
DR. MC DONALD: Are you on number 12 or 13?
DR. HUMPHREYS: Or 11 or 12, or both.
DR. BURKE-BEBEE: I'm talking about 11 and 12, specifically 12.
DR. BLAIR: I think we picked attributes and characteristics that we felt are not -- that are divorced from technology, they are divorced from new medical procedures. We felt that these were things that are not going to be outdated, two, three, four, five years from now. Or am I missing --
DR. MC DONALD: Every now and then, I think it has got a lot of chutzpa in it; we are going to pick this stuff based on these rules, when there is millions of workers out there making decisions every day in the marketplace. We haven't even mentioned market acceptance. I don't think we're that smart, necessarily.
DR. FITZMAURICE: Although we will certainly ask the market for its opinion and its guidance, and we'll have hearings. So the market will get to the table.
DR. MC DONALD: Oh, come on. The market doesn't get to this table. We pick people to come to these table.
DR. FITZMAURICE: And we pick people representative of the market. We offer them the best advice we can, and if the marker doesn't accept it, we will not have done a good job.
DR. MC DONALD: But we can tell what the market forces are. We can actually say that as a criterion. There has been market acceptance. It is not what we hear at this table; you can go out and survey.
DR. BLAIR: I think Clem makes a very important point. I thought that at one point in the guiding principles there was some reflection of marker acceptance, wasn't there?
DR. HUMPHREYS: There was in the original set, wasn't there, for the transaction standards?
DR. FITZMAURICE: Yes, there was. I have a copy of those here, but that is basically the key by which we are measured in the HIPAA transaction standards.
DR. BLAIR: That it would reflect or consider market acceptance?
DR. FITZMAURICE: Yes.
DR. HUMPHREYS: I think of course here, we have a different situation, where there is the feeling that the actual establishing or anointing of a standard will hasten market acceptance, because otherwise, people are standing around saying, I don't want to do this work. This is certainly true of the clinical terminology. I don't want to do this work if I find out that tomorrow afternoon I have to redo it for another standard.
So I'm hearing what you are saying, but I think that you don't -- it seems to me something that makes reference to market acceptance as one of the criteria that should be considered, without saying that if there is no market acceptance, then we can't do anything here.
DR. COHN: Maybe more fundamentally what we are talking about is acceptable, or supported by the health care industry. That is the same thing, except it hasn't been implemented yet.
DR. MC DONALD: No, I think it is two cases. There are things that are there, and you can gauge market acceptance, besides political acceptance. There are things that aren't there, and you can't gauge it; you have to pick something.
DR. FITZMAURICE: Would you agree that it is somewhat a matter of different maturities between the different transaction standards and the PMRI standards? In the case of the PMRI standards, we are not likely to get market acceptance in the first year, second year and so forth, but it is a matter of leadership, to see if we can lead the market.
DR. BLAIR: Clearly for those PMRI standards, in particular transaction standards, where there is some degree of market acceptance already, I think that should be included in among the guiding principles. Margaret, is it possible for you to take a look back and see if we could recapture the guiding principle that referred to market acceptance?
DR. AMATAYAKUL: I'll see what I -- I don't know if I have it with me here today. None of the current versions have market acceptance for this report. I'd have to go back to the one for --
DR. MC DONALD: I think we should clarify what has come out of this discussion. I really meant what the discussion said. That is, when we are choosing standards that are out there, that are in the market, we should consider the market acceptance as a balancing factor in the choices. It is not that we only take things that have been accepted by the market. There are some things that just haven't gotten there yet.
DR. BLAIR: Does this address this point? Can we move on?
DR. AMATAYAKUL: The last one was a suggestion of one of the reviewers, that is, are based on a publicly available set of semantic models of the clinical domain.
DR. HUMPHREYS: Then we might as well go home. We can't select any standard.
DR. MC DONALD: Is this 13?
DR. AMATAYAKUL: Yes.
DR. MC DONALD: Then we can't say it is based on.
DR. COHN: Can you explain both what it means and why it has been put there?
DR. BLAIR: Could I interject a little bit, and then Margaret, you fill in where I have left things off, okay?
There were comments that came out at us from several viewpoints on this. One is the number of folks that were winding up saying we needed to somehow reflect ontological principles for the developing of clinically specific vocabularies. So that was one aspect. Ontological principles of course involve the idea of models, concept models for terminologies.
The other pieces were that there was assertions that we should also somehow recognize -- and this may be getting to your point, Michael, if we recognize the strength that a standard might have, if it is based on a reference information model or other kind of a model that begins to promote consistency, compatibility, greater updatability, there are a lot of strengths that that gives in terms of -- the word that you were thinking of was consistency and compatibility?
DR. FITZMAURICE: Yes.
DR. BLAIR: So at least in my mind, those were the comments we were hearing that caused us to start to try to add this additional principle.
Margaret, what did I leave out?
DR. AMATAYAKUL: I'll just read you -- actually, this is from Woody Bealer. I believe there should be an additional principle or the incorporation of an additional idea into one of the existing principles. I am speaking specifically of the concept of an overall design model to which standards adhere.
I am not arguing for a single model for all standards. Rather, I believe any organization proposing standards should have a published semantic model that it uses to insure the internal consistency and continuity of its standards. Among the current guiding principles, numbers four, eight, 10 and 11 each argue for support of an information model. Nevertheless, I would recommend including an additional principle that expressly calls for the standards to be based on a stable, publicly available set of semantic models of the clinical domain.
DR. BLAIR: It is probably too strong to say based on, but I think we should recognize the value of consistency and compatibility that information models and ontologies can give us.
DR. FITZMAURICE: I think I agree with all of that. It is just that we don't have it yet. So it may be a work in progress or a test to be done, that the NCVHS should investigate and adopt a model. That sounds more like a recommendation. I don't think we have one on which to base a principle.
DR. HUMPHREYS: If you say that you are considering these guidelines, and as we said with the HIPAA standards, it is not necessarily that you are going to find anything that meets all 13 or 10 or whatever. Then to get at that thought, I might say something like, are based on an explicit defensible semantic model of the clinical domain.
I think stable publicly available sounds like these things already exist in some magnificent form, and if they are not there, then every existing standard is deficient, and that would be about the case. Maybe one or two would not be deficient.
DR. BLAIR: Could I add one word to your phrase?
DR. HUMPHREYS: As many as you like, Jeff.
DR. BLAIR: Well, this is not necessarily mutually exclusive from semantic, but what if we said conceptual and/or semantic? No? You don't want to do that?
DR. COHN: I don't know. I'm having a hard time with this whole piece. I find the world of models to be both fascinating and the syntax and semantics of how people even define what a model is I find to be somewhat elusive. So I find myself having some trouble with this one.
DR. HUMPHREYS: Can I just quickly ask a question? You referred earlier, Jeff, to the fact that some of these comments -- or you got comments also from people who were interested in ontological whatever. If there is not some reference to being based on ontologies or something that is comparable to that already in the desirable characteristics for clinical terminology --
DR. BLAIR: Yes, that's true.
DR. HUMPHREYS: So if it is already there, then I think we could leave it out here if we can even figure out a way to do this, so that anyone can understand it.
DR. BLAIR: Let me take that point a little bit further, because when we do look at the characteristics and attributes for selecting terminologies, I think it alludes very strongly to the need for information models for semantic consistency. So maybe we have it covered there.
DR. HUMPHREYS: Boy, that sounds like a great idea, because I think putting it up here is going to elicit a tremendous amount of remarks like we started out this conversation with; what does this mean.
DR. BLAIR: So does that mean we would agree to eliminate adding principle 13?
DR. COHN: Yes.
DR. FITZMAURICE: Yes.
DR. BLAIR: Okay.
DR. MC DONALD: My comment on it is that I think what he says is a good idea in general, but I don't know how to say it in a bullet. I think what will happen will be confusion.
DR. FITZMAURICE: It will be transferable to a recommendation.
DR. MC DONALD: It is just so hard without understanding.
DR. AMATAYAKUL: We tried hard to avoid referencing model within the description, like in Section 3. Would it be appropriate to add some of this information from Woody in that section, just as a discussion point?
DR. MC DONALD: It's hard to get it right. I think you can try, but it is hard to get it right.
DR. HUMPHREYS: The way he expressed it reading the entire thing as opposed to reducing it to a bullet, I think it conveyed more of the real flavor of this point.
DR. AMATAYAKUL: That is why I was wondering, if we actually just put this discussion in the overview section.
DR. FYFFE: I don't think that is a bad idea. I think his point is a good point, and it shouldn't be lost.
DR. BLAIR: I think all of us think it is a good point, but the area of information models -- the best paper I've seen recently was one Stan Huff did in January on information models. In an attempt to wind up giving definitions to what is the difference between a reference information model, a reference model and a data model and an information model and all these things, it is so fluid right now that I think that almost anything we would attempt to say would be a target for people to pick at it.
DR. HUMPHREYS: Well, maybe you could take a look.
DR. COHN: So Margaret, what were you proposing?
DR. AMATAYAKUL: We worked very hard to avoid referencing models, because it was so confusing.
DR. COHN: And I support that.
DR. AMATAYAKUL: I only was offering --
DR. HUMPHREYS: But you don't really want to offer, so don't do it.
DR. AMATAYAKUL: Okay.
DR. COHN: I think in for a penny, in for a pound.
DR. BLAIR: Yes, I think we are hearing thanks, but no thanks.
DR. AMATAYAKUL: Thank you.
DR. COHN: So I guess we are done with this, with the exception of trying to figure out how to wordsmith that earlier bullet, which you are going to come back with this afternoon.
DR. HUMPHREYS: No, three and five.
DR. AMATAYAKUL: And also the market acceptance.
DR. COHN: Other than that one piece, we are done with this section.
DR. AMATAYAKUL: Right.
DR. FYFFE: Good time for a break.
(Brief recess.)
DR. BLAIR: Margaret, are you ready to continue on our recommendations?
DR. AMATAYAKUL: Yes.
DR. BLAIR: I think we have covered recommendation number one. We are going on to number two, is that right?
DR. AMATAYAKUL: Yes. Number two is to direct NCVHS to select uniform data standards for PMRI, according to the criteria in the guiding principles for selecting PMRI standards. Where standards do not exist or are still under development, the NCVHS would identify mechanisms to accelerate the development of those standards.
The NCVHS will recommend specific standards for adoption and appropriate mechanisms to accelerate standards within 18 months following the Secretary's acceptance of this report.
The reason I highlighted this last sentence is that several -- many, many of the expert reviewers commented that they thought the original time line was quite aggressive.
DR. BLAIR: Actually, it was 12. There were people who said, why didn't you pick them already, and we didn't feel like we had a mandate for that. Comments, critiques, thoughts on recommendation two?
DR. HUMPHREYS: If we are going to say the NCVHS will recommend, should we in the previous sentence say where standards do not exist or are still under development, the NCVHS will identify mechanisms? It sounds funky to have would in one sentence and will in the next one.
DR. COHN: Let me make one general comment and then a specific comment. I'm sorry that Dr. McDonald isn't back in the room, but we were asked by the people on the Internet that we make sure that we give everybody a chance to talk, and not all talk at the same time. I know we got very excited during the first session, and I think we found it difficult to capture the words with people talking on top of each other. So just a process comment.
Now, talking about number two, I guess I had made a recommendation earlier about either identifying or staging identification, that the first set would be out in 18 months. That is one way to handle this, that we would come up with some recommendations, but not all of the recommendations. But even that may be too aggressive. We may just want to get rid of the time frame on here, period.
DR. BLAIR: Is that not in there? Is the wording not in recommendation two, that the first set would be --
DR. AMATAYAKUL: In recommendation number four, we added the point of a series of final rules to suggest a staging. But we didn't put that in number two. We could.
DR. HUMPHREYS: Just amend it to say, will recommend the first set of --
DR. COHN: Yes, because I think this is going to be an ongoing effort. I think at least in my view, it isn't like we are going to come out with this in 18 months and then be done forever, no further standard is needed.
DR. BLAIR: The work group feels comfortable with that modification?
DR. AMATAYAKUL: I think I had used the first of a series. Would that be okay, Betsy?
DR. HUMPHREYS: That's fine. Would it be better to put number four up underneath too?
DR. BLAIR: Well, there was originally, back six drafts before -- not that many, but we actually did have -- and I think what you are referring to on four is the actual adoption. We did, and then some people wound up thinking that recommendation three wouldn't begin until after the rules -- all the standards were adopted. That is the reason that we spaced it the way we did, but if that creates confusion -- we tried a reference back and forth, referencing back to two, to try to make the connection. But maybe we want to discuss that, to see if we still didn't do a good job on that.
DR. COHN: Maybe rather than the first of a series of specific standards, which tends to communicate to me that we are going to come up with one standard recommendation in 18 months. Maybe it is the first set of specific standards.
DR. BLAIR: Yes.
DR. AMATAYAKUL: Can we make that same change in four then, too?
DR. COHN: Sure.
DR. HUMPHREYS: I don't know that they have to be parallel. It looks right in four. They don't exactly say the same thing.
DR. BLAIR: Simon, would you accept that? Betsy just made a comment. Did you hear that?
DR. COHN: Yes, which was number four. We haven't gotten to four yet, so we can take a look at it. Dr. McDonald, we are just finishing up two. Do you want to take a look at it?
DR. MC DONALD: Okay.
DR. COHN: The only question is, are we talking about 18 months or two years? I am looking at the numbers of the subcommittee and work group at this point. Is everyone okay with the 18 months? Miss Fyffe?
DR. FYFFE: Ambitious.
DR. COHN: Can we do it, or do we need to say 24 months?
DR. FITZMAURICE: I go along with Kathleen. It is ambitious. But if we don't set time limits, --
DR. HUMPHREYS: Look at it this way, too. This is just the recommendation to the Secretary. Then we all know that it takes a little while if we want to translate any of this into rules. So maybe we shouldn't allow this first thing to be too long.
DR. BLAIR: Yes, some people looked at this and wound up saying, gee, it is going to be three years before the rules are out, and then they are going to start implementing it.
The other piece is, we also wound up saying the first set would be 18 months, so --
DR. COHN: What we have in 18 months is the first set.
DR. BLAIR: Is the first set.
DR. COHN: Okay. I just wanted to make sure that there is a willingness on the part of the work group to meet those deadlines.
DR. BLAIR: Now we are committed. We are bought in.
DR. AMATAYAKUL: Number three. Number three has several parts to it. I'll go through each part. Provide funding to accelerate the development of uniform data standards. This should take the form of support for A, government participation in standards development, one, as members of health care informatics standards development organizations, two, as a departmental member of the American National Standards Institute health care informatics standards board.
DR. COHN: I think it ought to say uniform data standards for PMRI in the beginning.
DR. AMATAYAKUL: Up here?
DR. HUMPHREYS: Development of?
DR. COHN: Yes, development of, at the beginning of the first sentence.
DR. BLAIR: Ready to go on?
DR. AMATAYAKUL: B, broader participation of expert representation in standards development, one, through outreach and demonstration projects to those groups typically under represented in the standards process, for example, clinicians from small provider organizations, physicians from subspecialty groups and nursing and allied health professionals, two, to encourage standards developing organizations to make greater use of the Internet to solicit comments and conduct balloting, and three, through making existing government teleconferencing facilities available to standards development organizations.
DR. BLAIR: Comments?
DR. MC DONALD: I think it may beg the question a bit about who is under represented. It might be better if we could be more vague and say, those who might be under represented.
DR. AMATAYAKUL: Yes. The reason we even added that was somebody else too was represented.
DR. MC DONALD: I think in some areas you do have some of those groups represented.
DR. AMATAYAKUL: So you suggest we say those who may be under represented include --
DR. MC DONALD: No, no, no. What I am really suggesting is, we are making an assertion that these are typically under represented. I don't think we know that uniformly. It would be safer to say to those groups who may be under represented instead of typically under represented.
DR. AMATAYAKUL: Instead of typically?
DR. MC DONALD: Yes.
DR. AMATAYAKUL: Then would you want to leave the parentheses in?
DR. MC DONALD: Sure.
DR. COHN: Other comments on this one?
DR. FITZMAURICE: On B3, making existing government teleconferencing facilities available to standards development organizations, I would strike teleconferencing. If the government is to support standards, I would make rooms available, whatever facilities they might have, and I wouldn't just restrict it to the teleconferencing facilities.
DR. MC DONALD: I don't disagree with that, but you maybe don't want to take out teleconferencing.
DR. FITZMAURICE: Including teleconferencing.
DR. BLAIR: Facilities such as or including?
DR. FITZMAURICE: Including.
DR. COHN: I'm still looking at the first one in the examples given, which has to do with the throughout reach and demonstration projects to those groups, who may be under represented in the standards process, I am actually trying to think in my own mind of the value of specifying certain groups and not specifying other groups.
My own view would be just to take out the EG. But is there an issue or a rationale behind it?
DR. BLAIR: It would be fine with me if we took out the EG. The reason that we had put it in was, we had a comment or critique that asked us to give examples of who we were referring to when we referred to under represented groups.
DR. COHN: My judgment on this one would be that it doesn't add anything to the recommendation. If we invite people to focus in on which groups it is and how come they are not included, I think each standards developing organization may discover as they evaluate its participation that there are groups that are under represented that need to be there. It will probably vary by standards development organization and activity.
DR. BLAIR: Is there consensus that we delete what is in parentheses? Hearing no objection -- Clem, is that all right with you?
DR. FITZMAURICE: With regard to that same B1, do outreach and demonstration projects, I am hard pressed to describe a demonstration project to a group that may not typically be involved in the standards process. We may want to get them involved, but I'm not sure what a demonstration project would be. Does someone have something in mind on that?
DR. COHN: You mean, as opposed to outreach?
DR. FITZMAURICE: I think I know what outreach is. That is, do whatever you can to get them to the meeting and get them participating in the standards development process. I'm not sure what the demonstration project would be.
DR. HUMPHREYS: The demonstration of how their business and interest is being terribly impacted, and they better get into the room.
DR. FITZMAURICE: I can understand that, but that is not typically what we mean by demonstration. I agree with that, Betsy.
DR. AMATAYAKUL: I think Betsy characterized it pretty well. I think basically people were saying let's not forget these kinds of folks and see whether the standards work in their environment or not.
DR. HUMPHREYS: So you might actually fund a group that doesn't usually participate to do a test implementation to find out whether you have inadvertent --
DR. FITZMAURICE: How divergent they are from the main. I'll agree with that.
DR. COHN: Maybe rather than demonstration, maybe it is other projects.
DR. FITZMAURICE: But that gets so vague.
DR. COHN: Well, demonstration is pretty vague.
DR. BLAIR: One of the other phrases that was considered was proof of concept.
DR. FITZMAURICE: I think that is worse than demonstration.
DR. BLAIR: That is worse than demonstration?
DR. FITZMAURICE: Yes.
DR. MC DONALD: If you can't defend it, get rid of it.
DR. FITZMAURICE: Outreach could include demonstration. It could include everything. So I would be in favor of deleting demonstration.
DR. BLAIR: If we delete the word, what is left in the sentence?
DR. AMATAYAKUL: Through outreach projects to those groups who may be under represented in the standards process.
DR. MC DONALD: Sounds good to me.
DR. FITZMAURICE: And that could include demonstration. I am not ruling those out, particularly the way Betsy described it.
DR. COHN: Other comments on this area?
DR. HUMPHREYS: This next section C got strangely convoluted.
DR. FITZMAURICE: I thought that might be the case.
DR. AMATAYAKUL: Let me read it.
DR. HUMPHREYS: Things got pulled apart in a very interesting way.
DR. AMATAYAKUL: C says, enhancement and maintenance of the unified medical language system used in the medi thesaurus, through support for the National Library of Medicine, the Agency for Health Care Research and Quality, two, through encouragement of vocabulary developers to embody enhanced mapping capabilities among and between medical vocabularies and between the medical vocabularies and the more general statistical classifications and reimbursement code sets, designated in the HIPAA standards for financial administrative transactions.
DR. BLAIR: I don't disagree with any of that there, except I think it is too narrow, by putting the enhancement and maintenance of UMLS as the guiding sentence.
DR. HUMPHREYS: Yes, I think there are a couple of things. The ordering principle that was brought up before when Jeff said that putting -- people got the impression that we weren't going to work on these immediate activities until after we had promulgated the rules, so you move that around.
I really feel that we want to have something that is a little more general about what we want the government to do right now to promote clinical vocabularies. One of the bullets to me is the second one, to promote the coordination, but the more important bullet in my view is to have this report reflect that the committee, if it does, thinks that it is a good idea to proceed with some of these government-wide licensing and up-front support mechanisms for clinical terminologies. And to move that up earlier so that it doesn't look like we are waiting for 18 months for the recommendations and then we are going to do this kind of thing, but we get support for doing it right away.
DR. COHN: The question would be whether or not we want to somehow at the beginning of three make a comment like, provide immediate funding, and then have the things here that need to be immediately funded, rather than trying to put a combination of things that don't need immediate funding and other things that may need funding for two years. So we may want to -- we can try that one on for size and see how that fits.
DR. FITZMAURICE: I have a question about the enhancement and maintenance of the UMLS and the two bullets that come before it. I would make a general category, and I would make the funding for enhancement and maintenance of UMLS to be a subcategory.
DR. HUMPHREYS: Yes. In fact, I had proposed something like having there be a bullet at -- I mean, a number at the level of B, but C, if the committee wanted to put it here. So you are going up to the top of this recommendation. So it says, this should take the form of support for, and when you get down to C it would say, ongoing maintenance, enhancement and distribution of clinical vocabularies useful in PMRI, probably, or something like that.
DR. FITZMAURICE: And stick the word application in there, then I agree with Betsy.
DR. HUMPHREYS: And then have some other bullets, which I had done a little bit of drafting on some of this. I don't know whether that is something -- in PMRI applications, you wanted maintenance, distribution and application?
DR. FITZMAURICE: Yes, I wanted under the application of PMRI.
DR. HUMPHREYS: Although if we put the application there, then this also moves -- does this mean that you are in essence saying we should put recommendation six up front here, too?
DR. FITZMAURICE: Let me see what six is.
DR. HUMPHREYS: The recommendation six is the one that said demonstrate the benefits and costs of using uniform data standards for PMRI.
DR. FITZMAURICE: I would leave that for a later discussion. I wouldn't move it up yet. But I am thinking in terms of continuity between -- you get a technician working in the office who is using terminology, you've got access to guidelines, you've got access to the medical literature, you've got development of medical knowledge. Our agencies play complementary roles throughout all of that, so that is why I put the application in there, to stress that continuum.
So it might be, for example, application for how do you get information for quality improvement measures as well as, how do you link to particular sets of medical knowledge of journal articles.
DR. BLAIR: Could I just step back? Margaret, have you -- I wanted to give her a little time because I think she is reformatting recommendation three along the lines of what you were suggesting, Betsy. I was just waiting to see the next draft.
DR. HUMPHREYS: You have had most of this wording already.
DR. AMATAYAKUL: Yes, actually I do.
DR. FITZMAURICE: She is reformatting part C under Section 3, under recommendation 3.
DR. AMATAYAKUL: Can we go back up just for one minute to the, provide immediate funding? Would you want to say provide funding prior to NCVHS making its final recommendations, being a little bit more specific?
DR. FITZMAURICE: I don't think so. That is a burden on NCVHS on timeliness.
DR. COHN: I think it is either an issue there or related to C, and I think you are talking about something which I am little concerned about. It sounds like we are off doing things that haven't been identified as standards or potential standards, or just out there doing stuff.
DR. AMATAYAKUL: Are you talking about C?
DR. COHN: Yes, C.
DR. AMATAYAKUL: The way it has been changed?
DR. COHN: Maybe you can read the first part there.
DR. AMATAYAKUL: Sure. Provide immediate funding to accelerate the development of uniform data standards for PMRI. This should take the form of support for maintenance, enhancement, distribution and application of clinical vocabularies useful in PMRI.
DR. COHN: I have a question there, since we are talking about things having to do with standards and moving towards standards, and this seems to be a completely different thought here. So we are talking about these things as having potential value as standards.
DR. FITZMAURICE: I think you're right. I think it is not only the development of standards, but it is also talking about the application of standards.
DR. COHN: Yes, but these aren't standards necessarily that we are talking about. This is where I am coming to on that. I think what we are trying to do is to get these things distributed, applied, tested, evaluated, see if they are potential for standards.
DR. FITZMAURICE: I think you're right.
DR. COHN: And we need to do a lot of this stuff to make that happen.
DR. HUMPHREYS: Maybe what you want to say, maintenance of clinical vocabularies with strong potential as PMRI standards, or something like that, that indicates --
DR. MC DONALD: Maybe it is there, but we had an additional sentence related to that, that referenced that the intent was to make standards available at little or no cost. Is that still there?
DR. HUMPHREYS: That is still there. It goes -- did you get this far? Margaret didn't get that far.
DR. AMATAYAKUL: Down here?
DR. HUMPHREYS: What I'm saying is, you didn't read that part.
DR. AMATAYAKUL: Oh no, I didn't read it yet. Maintenance, enhancement, distribution and application of clinical vocabularies with potential for PMRI standards.
DR. HUMPHREYS: That's the wrong wording, I'm sorry, but something like that.
DR. AMATAYAKUL: We'll put something together.
DR. FITZMAURICE: Deployment and evaluation.
DR. AMATAYAKUL: Through government-wide licensure or comparable arrangements, so these vocabularies are available for use at little or no cost. Two, through continued development of the National Library of Medicine's unified medical library system, MLS, to embody enhanced capabilities among and between medical vocabularies and between medical vocabularies and the more general statistical classification and reimbursement code sets, designated in the HIPAA standards for financial and administrative transactions.
DR. COHN: I am persuaded as I look at this that number six somehow needs to be part of this.
DR. BLAIR: What is number six?
DR. COHN: Number six is, demonstrate the benefits and costs of using uniform data standards for PMRI, research and demonstration projects should be funded to measure the added value of using PMRI standards. And there are a couple of examples. Maybe it isn't six, but it seems to me that there is a research and evaluation piece that needs to be here that isn't.
DR. BLAIR: Let me just add this, because Margaret and I discussed this quite a bit. We had thought about, do we fold six into three, which is what you were just suggesting. I think there were two elements. One was that there were several people that were explicitly concerned about business case issues and costs and for visibility purposes, that was one reason to look at it as an independent recommendation.
The other reason was that it was a different type of research that was involved here. Margaret, maybe you can elaborate on that, because I feel like we could go either way, but I just want to make sure that these thoughts were considered in the work group. Margaret, you had some other reasons why you felt that six should be separate.
DR. AMATAYAKUL: Well, there were several people who commented that we should not forget to determine what it would cost to implement these standards, do an impact study, as is typical for these proposed rules.
However, we worried that if we put that up in three and that occurring before four, which is occurring before the final rules, that it could take forever and you would never get final rules out. So we felt concerned about constraining the time frame to wait for these studies to be done.
DR. COHN: Maybe I'm mistaken, but I thought that any notice of proposed rule as well as the final rule needed to have a cost benefit.
DR. AMATAYAKUL: Yes, but they don't always have a cost benefit as a result of a formal study.
DR. FITZMAURICE: If their effect is over $100 million, then they need to have an impact statement, the regulation has to have an impact statement.
DR. COHN: Mike, what is your judgment about the impact of these standards that we may be getting into? I would think that they would be $100 million.
DR. FITZMAURICE: I would guess if it is a broadly scoped PMRI standard that is put out in regulation, that when they come to write that regulation. They would have to look at whatever information is available on the costs and the benefits.
If you look through the HIPAA transactions, you see that it was a very hard find.
DR. HUMPHREYS: I think that actually, I am persuaded by having it separate so that it can show later. If we wanted to factor in some other type of more short-term research here, maybe we could figure out a way to word that. The fact is, if you haven't accelerated the development and you haven't made them available so people can implement them, at least those who want to in circumstances, then you haven't promoted that, then you are in a very bad way in terms of attempting to do any rational impact statement.
In the case of impact on the administrative transactions, there at the very least was real data about the existing mass electronic interchange of these data, administrative data, on which to base some rational cost estimate. We don't necessarily have this over here, so I think that putting the research and the costs a little lower in the process, after we have sufficient adoption of something that begins to look like these standards, so that we can do the cost analysis, makes more sense.
DR. COHN: It seems to be an ordering of things, though, that you would be favoring the implementation of a standard that had uncertain benefits and uncertain costs.
DR. HUMPHREYS: Maybe it is the wording that we have here, because I know when we have thought about this before, there is obviously an assumption, strong among some of us, that this will have major benefits and will not increase costs, but over time perhaps will have the opposite view of costs.
But in order to prove that, you have to have an existing group of people who are using this to a great enough an extent to make that case. If you are required to do the research before you can do the activities to promote sufficient use to make the case, then we are just running around in circles.
DR. COHN: That is true, but I think one of the things that one would want to do immediately is to fund the demonstration projects or research. You wouldn't want to wait until it had gotten out before doing research or -- you might not want to wait for the results.
DR. HUMPHREYS: Then you have to perhaps reduce -- you have to change the wording of six, which seems like, what we need research to demonstrate the costs and benefits of doing this. That is a different type of research than trying to get broader adoption and see what the benefits are, so that we can then do a more reasonable, broader scale thing, and then look at the cost issue.
DR. BLAIR: So you are saying, if we move it up, it would be more like an impact statement, which is require anyway by the Office of Management and Budget.
DR. HUMPHREYS: The next recommendation deals with having the government being an early adopter to provide data. So maybe that covers also some of what you are interested in, Simon.
DR. MC DONALD: I think there are two sets of issues here. Firstly, having stable standards to be used when one would use a code is different than saying one must code everything that one says. That is where the costs will go. So there is a little bit of a tangle here. I think a lot of this is enabling, and doesn't by itself say cost.
If you are going to use this as a code, use this code, it probably will be welcome, but if you say you now must change your policy and your procedures, your work load, your employment level, et cetera, because you are going to code more, --
DR. HUMPHREYS: Clem, you remind me then of some of our earlier laying out and discussion of these issues. We discussed explicitly I think that there was great value in saying, here are standards that are supported, that cover these activities that are non-duplicative. If you are going to code or to capture clinical data in a controlled fashion, for goodness sakes, use these standards, independent of a much later step, where we have demonstrated value, cost benefit, et cetera, and we actually have the government say, okay, everybody, you will actually use these, you have to use them for at least these certain data elements or these certain transactions.
I really think that what we are trying to do with this -- or what I would like to see us trying to do with this number two is essentially accelerate the position where, if people really want to use these control vocabularies or the more specific HL-7 standards or whatever, they are all trying to use the same ones, so that we are building up a -- but that is -- but we do need to do the cost benefit before the federal government says, okay, everybody from sea to shining sea, use these tomorrow for everything, or even for this subset of activities.
DR. BLAIR: Would it be okay from a process standpoint -- would you feel okay with this if we focus on completing recommendation three first, and then when we get down to six, we could consider whether or not that could be folded into --
DR. COHN: Sure, that would be fine. I would want to make one change to see in that case, which would be somehow that we add testing as one of the verbs -- I'm trying to think if it is a verb or not. We have maintenance, enhancement, distribution and application, and it seems like we ought to provide immediate funding also for testing of these things. Maybe it is in pilot testing. That might meet my needs.
DR. HUMPHREYS: Just use testing, I think. Let's not have an argument about whether a large-scale test is a pilot or not, if we need a large-scale test.
DR. COHN: Okay.
DR. AMATAYAKUL: So it reads, maintenance, enhancement, distribution --
DR. BLAIR: Could you start so that I can get it in context? Are you able to now read three with all of the sub-items all together?
DR. AMATAYAKUL: Okay. Three is, provide immediate funding to accelerate the development of uniform data standards for PMRI. This should take the form of support for -- and the first one is A, government participation in standards development with its two sub-bullets. Do you want me to read those?
DR. BLAIR: Yes, please.
DR. AMATAYAKUL: One, as members of health care informatics standards development organizations, two, as a departmental member of the American National Standards Institute Health Care Informatics Standards Board. B, broader participation of expert representation in standards development, one, through outreach projects to those groups who may be under represented in the standards process, two, through encouraging standards development organizations to make greater use of the Internet to solicit comments and conduct balloting and three, through making existing government facilities, including teleconferencing available to standards development organizations.
C, maintenance, enhancement, distribution, testing and application of clinical vocabularies with potential for PMRI standards.
DR. BLAIR: Is there a verb in front of maintenance?
DR. AMATAYAKUL: No.
DR. HUMPHREYS: It is up at the top. This should take the form of support for.
DR. BLAIR: For, I'm sorry. Then read C again.
DR. AMATAYAKUL: Maintenance, enhancement, distribution, testing and application of clinical vocabularies which have the potential to be PMRI standards. Then one, through government-wide licensure or comparable arrangements, so these vocabularies are available for use at little or no cost, and two, through continued development of the National Library of Medicine's UMLF 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.
DR. COHN: Everybody okay with that so far? Great.
DR. FITZMAURICE: I guess I would like to see something there for other uses than just the administrative transactions, things dealing with what AHRQ deals with -- quality, guidelines or linkage with guidelines at least. I'm not sure exactly how to say it. Can I just reserve a time tomorrow just for an insert?
DR. AMATAYAKUL: Would that hold it for now?
DR. FITZMAURICE: Sure.
DR. AMATAYAKUL: I'll just add it in other uses at the end.
DR. FITZMAURICE: Okay.
DR. AMATAYAKUL: D then, which is, this should take the form of support for, D is development of a uniform implementation guide for each standard.
DR. COHN: The only question I have here now, I am all in favor of that, except that it doesn't quite follow. We have talked about immediate funding to accelerate the development of uniform data standards. I think you need to identify the standard first, before we can have them develop a uniform implementation guide.
DR. BLAIR: That is correct. So maybe that is development of implementation guides for each standard that has been selected as a PMRI standard.
DR. COHN: I think this one maybe needs to be under another piece, which is something that occurs after we make recommendations of --
DR. KOLODNER: And particularly because this doesn't accelerate the development of the standard. It is really the next step of -- once you have the standard, it is the implementation in other --
DR. BLAIR: That is correct. Maybe this -- do you think that this could be subsets under four, maybe, recommendation four?
DR. AMATAYAKUL: No. That is the notice of proposed rulemaking.
DR. COHN: Maybe it is five.
DR. AMATAYAKUL: Would you want to make this as a separate bullet as four? And then renumber the rest, four becomes five, et cetera?
DR. BLAIR: I think the next one after this is also going to be the demonstration test, which has the same problem that Simon just indicated on this one. So it is the next two. Both of them would be prefaced by, once PMRI standards are selected, then both of these things apply.
DR. HUMPHREYS: The thing is, if we include Simon's wording, provide immediate funding and include A, B, C, move D, E, F, which are the ones that seem to relate to the standards that would have proposed by NCVHS, probably leave in G, which is the one about the drug reference terminology, then maybe you could move three lower in the process without confusing people, because it is going to say, provide immediate funding after you go through these other steps. Maybe the fact that you are saying provide immediate funding for these means you don't have to rely so much on the order. I don't know.
DR. COHN: Let's try to separate what is now versus what is delayed, and then figure out where it goes after that.
DR. FERRANS: It makes sense for recommendations, adopt the guiding principles, direct the NCVHS, provide immediate funding for, and then provide future funding -- or upon selection of standards provide funding for implementation guide A, implementation guide B, conformance testing and C, interoperability or whatever, coordination of data elements.
DR. BLAIR: Right. I think the only point was that those items have to fall beyond what is now recommendation four, is that correct?
DR. AMATAYAKUL: No.
DR. BLAIR: No? They wouldn't? All right.
DR. KOLODNER: And I think that at least given the experience that we had with HIPAA for such things as the implementation guide, where the funding for that was accomplished by multiple agencies pitching in money because there was no single responsibility, that it is immediate funding and commitment for the followup funding, so that you are not stuck part way through. But you understand that when you bite off this piece, you are committing to the rest of that funding.
DR. BLAIR: Margaret, are you already in the process of creating a separate bullet for us to --
DR. AMATAYAKUL: Yes. I don't know if this wording is good, but I put A, B and C as we just discussed under the immediate funding, and then kept the drug reference terminology under that immediate funding.
DR. BLAIR: That became D?
DR. AMATAYAKUL: That became D, and now I have got a four that says, commit funding for subsequent development of. Then it would be A, a uniform implementation guide for each standard --
DR. HUMPHREYS: For each standard recommended?
DR. AMATAYAKUL: Right.
DR. FERRANS: And that actually should come before the final rules. During the comment period, people will say there is no implementation guide, how are we going to do this.
DR. COHN: I think what happens is that we should make a recommendation, then this happens, then it goes into the notice of proposed rules.
DR. HUMPHREYS: But let's get back to this position that four now says, okay -- not the new four, the old four, where we are now down to where we were going to issue PMRI standards within 18 months after the acceptance of the recommendations. That it seems to me does not get at the issue of doing the assessment of when it makes sense to actually require these as national standards.
That seems to be missing. We had it in an earlier version. Here it is saying, 18 months from now we are all going to be ready to issue standards.
DR. BLAIR: I think it is 18 months after the Secretary approves this report, we should -- the NCVHS should recommend standards. Then it would take another 18 months to produce the MPRN and issue rules.
DR. HUMPHREYS: I understand, but there is nothing in this recommendation that had the flavor of some of the earlier recommendations that said that the timing for release of these rules and for the requirement to implement the standard should be based on an assessment of the readiness of the industry and the field to implement standards down at this clinical level, and the costs and the benefit piece of it, like where should we mandate these for use and what other types of data, maybe it is not cost effective to mandate use. We just seem to be directly saying, issue the rules on this timetable. Some of the earlier versions couched this with an assessment of both readiness of the field and some of this research that showed for what data elements and transactions do we really need to have standards at this level of clinical specificity.
DR. BLAIR: Could I piggyback your thought with a few other points? It sounds like -- and I now we would be moving on now to this particular recommendation which had been number four, it sounds like from what you are saying, that it should reference number one, readiness, number two, maybe that is where the business case issue would fold in, with the Office of Management and Budget having to do the impact statement, that that would fall in there. Is that what you're saying?
DR. HUMPHREYS: That's right. We seem to have lost a few of those points in this version.
DR. BLAIR: Are we throwing too much at Margaret all at once here?
DR. AMATAYAKUL: I'm trying to figure out where this should go, because in number two, we do have where standards do not exist or are still under development, NCVHS will identify mechanisms to accelerate the development, and maybe it is there that we should talk about --
DR. HUMPHREYS: Oh, I see. When you say that the NCVHS will recommend the first set of specific standards for adoption, maybe you could there reference based on readiness and some of these other issues. So the Secretary doesn't get a recommendation theoretically unless the NCVHS feels that this is a standard that could be implemented.
DR. BLAIR: One other thought, though. I think -- could I suggest that a better place to put that in terms of based on the readiness, is that we make sure that that thought is in the guiding principles? I think we are getting to that thought, including in the guiding principles, when we say market acceptance as well?
DR. HUMPHREYS: I think that I would agree with you that the market acceptance would be there. But I think that since people may read these recommendations and say they are crazy, we are not going to be ready for this for years or whatever, that actually written in one of the recommendations there should be something about readiness. I think people may not go back and read your principles before they dash off the irate comment.
DR. BLAIR: Okay.
DR. COHN: This isn't on standards readiness, it is actually on industry readiness. As I am looking at this one, I have a question. It says, the NCVHS will recommend the first set of specific standards based on industry readiness for adoption, and appropriate mechanisms to accelerate standards within 18 months.
I am worried about that, and appropriate mechanisms to accelerate standards, when what we are talking about is, recommend the first set of specific standards within 18 months.
DR. AMATAYAKUL: Because we have already said the NCVHS will identify mechanisms to accelerate the development. Maybe we don't need this here.
DR. COHN: I also think we are beginning to recommend some immediate steps that need to be happening, so this is already occurring right now.
DR. AMATAYAKUL: So this then reads, the NCVHS will recommend -- well, let me read the whole thing. Direct NCVHS to select uniform data standards for PMRI according to the criterion, the guiding principles for selecting PMRI standards, where standards do not exist or are still under development, the NCVHS will identify mechanisms to accelerate the development of those standards. The NCVHS will recommend the first set of specific standards based on industry readiness for adoption within 18 months following the Secretary's acceptance of this report.
DR. FITZMAURICE: Should the second sentence, where the standards do not exist, should that come after the NCVHS will recommend? In other words, they select the standards, they recommend the first ones, and then if the standards don't exist.
DR. MC DONALD: I'm just wondering whether we want to put the qualification of waiting until it is accepted, in case it is not accepted quickly. We have already been charged to do this by law.
DR. FITZMAURICE: Certainly to study.
DR. MC DONALD: I don't know if it is good or bad, but you hate to have to do this -- with the election and all in the next nine months.
DR. COHN: The question is, I think the Secretary's acceptance of the report as you hand the Secretary the report --
DR. FITZMAURICE: That is the delivery of the report.
DR. COHN: What does accepting the report mean?
DR. FITZMAURICE: if that is what you mean by acceptance, why don't you just say delivery of the report?
DR. COHN: I think that is what we are talking about.
DR. FITZMAURICE: That is what is in your control.
DR. COHN: Yes, otherwise this could be a multi-year project.
DR. BLAIR: I thought we used the word acceptance where she accepted the recommendations, as opposed to the document.
DR. AMATAYAKUL: No, that was in four. This is in two.
DR. MC DONALD: This is to the people who are more expert on what really goes on. I don't know whether it is routinely accepted or whether it may be delayed for nine months. I kind of think we have the right to try to do this by what we already have in our package.
DR. AMATAYAKUL: So the NCVHS will recommend the first set of specific standards based on industry readiness for adoption within 18 months following delivery of this report.
DR. MC DONALD: If that is okay.
DR. FITZMAURICE: It is better to say delivery. That is something you can affect, you can cause to happen.
DR. KOLODNER: So we are making a recommendation which if she doesn't do, we are going to do anyhow.
DR. MC DONALD: For a certain part of it. We are talking about recommending certain ones, and then we have asked them to do other things.
DR. COHN: My expectation of this report is that she would have it delivered, she would read it. If we need to wait for a letter from the Secretary saying thank you for the report, or I accept your report, is that what we need to wait for?
DR. FITZMAURICE: Rob's point would be that NCVHS is an advisory committee to the Secretary, so the Secretary can take your advice or can not take your advice. So at the borderline, are you saying, we now want to become an office that has this ongoing responsibility? Then the question is, did Congress charge NCVHS with having this ongoing responsibility.
DR. HUMPHREYS: But you could say that if you are going to just make recommendations to her and you are just telling her, in another 18 months we are coming back at you with another set of recommendations, the NCVHS is empowered to provide recommendations. I believe they can do that whenever they want to.
So that isn't the same thing as whether the Secretary agrees that she is going to provide immediate funding or she is going to promulgate standards or whatever. But you are just saying, we are going to send you some more advice.
DR. KOLODNER: But look at number two. Number two independent of this recommendation is, direct NCVHS to select the standard.
DR. HUMPHREYS: Oh, I see what you mean.
DR. KOLODNER: So we can go on, and even if it takes nine months, it doesn't mean we can't get started. We can deliver it within 18 months. If she takes 17 months, we may deliver one month after she accepts the report. But the point is that this is a recommendation, for her to direct us to do this. For us to say we are going to do it within 18 months -- why make a recommendation? Why not just say, this is what we are planning to do?
DR. BLAIR: We can fix this two ways. We can either leave it like it is by saying we are going to wait until you tell us to do it, or we could take out the direction and make this more of an announcement, that this is the first set of recommendations, we'll make another set.
DR. KOLODNER: Is there any reason we need the Secretary to direct us to do this? Is there any reason we can't just do it?
DR. BLAIR: Let me just explain how we wound up with the wording. I believe it was Bill Yasnoff that felt as if the authority that we had wasn't as definitive as the authority we had to set the financial and administrative transactions. He thought that this would reinforce our authority to move forward on this area. So that was the reason that we did that.
Now, maybe Bill is not the ultimate authority to guide us in how we should proceed here.
DR. KOLODNER: Does the Secretary have the authority to direct us how to do this, or is this something that requires --
DR. FITZMAURICE: The Secretary could certainly direct you to make recommendations in a particular area. You consume resources. The Secretary could also withdraw resource support for particular things that the Secretary doesn't like.
DR. HUMPHREYS: I guess the question here is, it seems to me this is more of a -- we know what we would like to have happen, and maybe this is a matter where John and Jim Scanlon should work out what is in line with what the NCVHS has done in the past and seems to make sense here.
My feeling is, if you ended up in a hiatus situation where there was no one to accept the report or whatever, or no acknowledgement of it, probably the committee could continue, based on the fact that they are assuming that it would be accepted.
DR. COHN: I agree with you. If we got a letter back from the Secretary saying thank you for the report, what do we do?
DR. FITZMAURICE: Proceed.
DR. COHN: Is that acceptance?
DR. KOLODNER: We are making a set of recommendations. We expect that -- isn't there a standard procedure of accepting or not accepting the recommendations, and then there is followup action?
DR. HUMPHREYS: Not really.
DR. FITZMAURICE: You can accept the package that contains the recommendations, and you can look them over and decide what you want to do within the department forever.
DR. FERRANS: I know it still says that the Secretary should direct, but another way to say it, rather than the Secretary's acceptance of the report at the delivery, but the delivery of this report I thought was something specified in HIPAA, four years past the enactment of the legislation. So if there could be some reference to following fulfillment of this -- I don't know how to say it, but find the fulfillment of this requirement of HIPAA, which is the -- I don't know how HIPAA reads or what does it say, the NCVHS shall issue the report no later --
DR. FITZMAURICE: Shall make recommendations and legislative proposals no later than four years after the date of --
DR. FERRANS: Yes, something along those lines, because then we are hitting the milestone whether or not we get an acknowledgement or not.
DR. FITZMAURICE: Further work will depend on the agenda that NCVHS wants to set for itself and acceptance for that agenda by the Office of the Secretary. So what we are doing is placing this on the agenda.
DR. KOLODNER: But then what we can say is, unless directed otherwise, this is what we intend to do. It is not a recommendation; we are just planning on meeting.
DR. HUMPHREYS: That seems to me like that goes in a cover letter, that we are planning on proceeding with this, are very interested in hearing your comments. The committee is excited about moving forward and we are doing it.
DR. BLAIR: But even if it goes in the cover letter, don't we need to correct that item that says, -- what does it say?
DR. AMATAYAKUL: Direct the NCVHS to select uniform data standards.
DR. HUMPHREYS: I really do feel that --
DR. BLAIR: Is that wording right?
DR. HUMPHREYS: -- it is probably better to ask some other people, Jim and some others.
DR. BLAIR: Okay, let's make a notation to ask Scanlon and Braithewaite. We'll have the full committee meeting also to help us with that in three weeks.
DR. AMATAYAKUL: Can we ask them before?
DR. COHN: Yes. This needs to be part of the final -- how we are doing it. So we'll mark this as getting some sort of secondary comment or input on the wording.
DR. BLAIR: Yes. Now, do we have a new recommendation that you carved out of the items from recommendation three?
DR. AMATAYAKUL: Okay, recommendation three. Provide immediate funding to accelerate the development of uniform data standards for PMRI. This should take the form of support for A, government participation in standards development as members of SDOs and as departmental NCHS ISB, B, broader participation of expert representation in standards development, one, through outreach project --
DR. BLAIR: Margaret, I was really asking whether you had crafted a new recommendation which had pulled out what had been items D, E and F.
DR. AMATAYAKUL: That has now become number four. For each standard recommended by NCVHS, commit funding for subsequent A, development of a uniform implementation guide, B, development of conformance testing procedures and selection of conformance testing organization or organizations, and C, coordination of data elements among all standards selected for adoption under HIPAA through funding, one, the development and maintenance of an open data registry and two, working conferences to harmonize message format and vocabulary standards.
DR. HUMPHREYS: G sounds like it is an immediate action item.
DR. COHN: Yes, I think I would put that in the higher --
DR. HUMPHREYS: The one about the HIPAA transaction elements I think goes up in the previous one.
DR. AMATAYAKUL: This one, coordination?
DR. BLAIR: What had been G and what you moved down there to be C, which was the funding for the data registry and workshops. I think that is what you were referring to. That should be moved back up under immediate funding.
DR. COHN: I would probably put because as a new D and have that other one be E.
DR. BLAIR: Right.
DR. AMATAYAKUL: 3D is coordination of data elements and 3E is development and ongoing maintenance of the drug reference terminology, and then four has --
DR. MC DONALD: I want to come back to the E before we leave that, though.
DR. AMATAYAKUL: Okay. Four then is, for each standard recommended by NCVHS, commit funding for each subsequent development of implementation guide, development of conformance testing procedures and selection of performance testing organization.
DR. FITZMAURICE: You may want to say, for each standard recommended by NCVHS and adopted by the Secretary.
DR. COHN: Well, that is a little late. We say adopts it after it goes through the final rule.
DR. FITZMAURICE: There is a timing problem with that. If the Secretary doesn't adopt these standards or has no intention to, then I'm not sure you want to make a recommendation.
DR. HUMPHREYS: No harm in having a guide for it.
DR. FITZMAURICE: That's right, and the budget process will take care of it whether it is desirable or not, have no fear.
DR. COHN: Should we go back to that E then, or do we want to go to D now and talk about D first? D hasn't been discussed, I don't think.
DR. AMATAYAKUL: D is coordination of data elements among all standards selected for adoption or HIPAA through funding, one, the development and maintenance of an open meta data registry and two, working conferences to harmonize message format and vocabulary standards.
DR. MC DONALD: It is kind of like God and motherhood, so it sounds evil to say anything negative about that. But my belief is that that won't do any good, that we will have people ship in stuff, it will get stuck into a file by someone who doesn't know anything about the content, no one will ever talk about what they really mean by it, and you will never know whether they are the same or not.
What you would like to get into if you could, but it may be too hard, is to try to suggest that we encourage the use of the same code systems when the contents are the same. It is harder to say, but something more specific, and the same representation. So you would represent dates the same, you would represent -- if you had a choice of six elements, those would be the same six elements.
DR. HUMPHREYS: But doesn't two get at that?
DR. MC DONALD: That does more than the other, but -- I'm not against it. I just think what will happen with number one is, we will have this huge file that just accumulates all the parts with the different standards.
DR. BLAIR: I think what you are saying, Clem, is that there is an opportunity for either lack of focus or for waste or for ineffectiveness if that is not done properly and if it is not done in a manner that is coordinated with the rest of the SDOs and all.
DR. MC DONALD: No, I'm saying something different. I am saying we can't just fund the development of a meta data and get anything out of it. What we are going to have to do is to say something more globally, develop mechanisms to maximize the commonality or the re-use of -- I can't say it well.
DR. BLAIR: My inclination at this stage, Clem, would be to leave it there. There already is the USIC meta data registry that is being developed, not only with an array of seven different SDOs, but also with -- I believe there are four different government agencies that are participating in that.
DR. MC DONALD: That is the reason why it gives me lack of faith.
DR. COHN: Maybe I should make this comment then. I think what you are talking about is the time and the way we influence some of these things has to do around the selection of the public airing process. If that is an issue regarding the standard, then the NCVHS does have some ability to say, you've got a pretty good standard here, but we can't accept it because all your data elements are off the map. You need to go and think about that stuff and come back to us with your next version of the standard.
So that is an opportunity to do what you're saying. This I think -- we can argue about whether it is going to be effective or not, but I agree that it is a good idea. I can't think of any reason not to support this and be hopeful that it will have some effect. If nothing else, it will assist us in identifying if things are --
DR. MC DONALD: We had the opportunity in this committee to review the comparisons that were made 18 months ago, a database built up by the department, which showed X12 compared with some other variables. We never did. You and I walked in the street and talked about how that would take 25 more months of looking at.
I just think that we are kidding ourselves. I don't think there is anything evil about it. But no one really knows what an open meta data registry is. There is no incentives to do the deep heavy work, and there is a lot of -- what I really worry is, people will think they understand it, when they won't. I just worry that we are going to pretend like we have done something, and I don't think we will. But it has got motherhood, so I can't oppose it.
DR. COHN: Good, so you're voting for it. Margaret?
DR. AMATAYAKUL: In the recommendation, the way this was stated previously, would it help at all to add -- we had the phrase potentially based on the ISO 1179 standard for meta data, to move towards consistency in data element names and definitions in all standards adopted under HIPAA administrative simplification. Would that phrase help?
DR. MC DONALD: No, I think I am satisfied.
DR. BLAIR: Just leave it the way it is.
DR. KOLODNER: There is one other change in three that I would suggest. I am looking down at five where we cite the GCPR framework project.
DR. COHN: We're dealing with D and then we're going to go to E.
DR. KOLODNER: Well, but up at C, in terms of mechanisms for 3C, we have two mechanisms there in terms of how we have said how we do mechanism enhancement distribution, testing, application. One being the government wide licensure and the other being UMLS. But I think a third one is government wide or multi-agency projects, such as GCPR.
I think that we need to at least list that there as well, because that does extend into new areas where there aren't modeling, but in conjunction with other standards development organizations. So that way, we are not doing a government only, but a multi agency collaborative projects in conjunction with data standards.
DR. COHN: I am losing what this looks like. Can you go up to the C part there and see if this makes any sense?
DR. KOLODNER: Maintenance, enhancement, distribution, testing and application of clinical vocabularies. GCPR at least in the vocabulary area is building on the models that --
(Simultaneous discussion.)
DR. KOLODNER: But if you look at GCPR, it is that infrastructure, so it is actually saying, we don't have a standard in area X or something, and how can we get together, infuse resources across agencies, gather staff, generate a first cut, then work with the appropriate standards groups.
DR. COHN: I sort of understand what you're saying. It is just that this doesn't say that. What this is talking about is immediate funding of multi-agency projects such as the GCPR framework project. I'm not sure that what we are talking about here is an effort focused on maintenance, enhancement, distribution, testing and application of clinical vocabularies. So if there was a project or a piece within that that needs to be funded or support to do that, that is fine. But what you are describing here is that we ought to be supporting immediate funding of the GCPR framework project, which is much beyond what you are describing, at least I believe.
DR. KOLODNER: As of the end of this calendar year, the technical infrastructure -- the routers and the hardware and the protocols will be in place sufficiently that we will be able to say what we need to do, is to model and develop the vocabularies and the modeling in any of the pigmented areas that have to do with clinical vocabularies.
So they could support these areas, which provides that enhancement and then testing in the real world.
DR. BLAIR: Could you give some suggested wording to Margaret?
DR. FERRANS: Through applicable portions of multi-agency projects, which then narrows it down to the vocabulary piece.
DR. BLAIR: Say that again?
DR. FERRANS: Applicable portions of multi-agency projects.
DR. AMATAYAKUL: Do you want on clinical vocabularies or no?
DR. KOLODNER: I think that is supplied by what Steve says.
DR. AMATAYAKUL: So this would read, through applicable portions of multi-agency projects such as in a GCPR framework project and in conjunction with standards development organizations?
DR. FITZMAURICE: Should probably drop the in after such as.
DR. KOLODNER: I would drop the and following in conjunction, just say in conjunction with.
DR. COHN: Great, thank you. On to E.
DR. BLAIR: Read E.
DR. AMATAYAKUL: E is developing and ongoing maintenance of a drug reference terminology that promotes the ability to share clinically specific drug information, that is, dose, route, frequency, strength, chemical composition, et cetera.
We have highlighted drug information just to note that we wanted to define clinically specific and wanted to verify that those things in the parentheses were appropriate.
DR. BLAIR: Is it Mel that had a -- yes.
DR. GREBERMAN: First I'll introduce my colleagues here who participated in the comments FDA submitted, and many others are interested in the output that we have from this meeting.
But we would like specifically for this point expand it to go beyond drugs to include the broader area of medical products, and I will suggest a wording: development and ongoing maintenance of a medical products reference terminology that promotes the ability to share clinically relevant information related to medical products, including drugs, biologics and devices.
For example, here we get back to the specific issue you suggested. For example, the drug reference terminology should facilitate the sharing of information on dose and the other things that were in parentheses.
DR. AMATAYAKUL: Would you read the last part one more time, Mel? After including drugs, biologicals.
DR. GREBERMAN: We use biologics and devices.
DR. BLAIR: Mel, question. I think it would be very helpful to do this addition. My only concern is, could we do it as separate items, so that we are not mixing the need for clinically specific drug vocabularies with the other valid need for vocabularies that cover supplies? Could we make that as an addition, but make it as an independent addition?
DR. GREBERMAN: I'm not sure.
DR. MC DONALD: I have a deeper question about that. I guess I'll be blunt. This sounds like the standardization by MEDRA or through MEDRA.
DR. GREBERMAN: We're not dealing with MEDRA in this --
DR. MC DONALD: It sounds like it.
DR. GREBERMAN: Not at all.
DR. MC DONALD: It sounds like it could be the whole darn report. The words you use here could say, standardize everything in health care.
DR. GREBERMAN: We start off with drugs. I think it is important to recognize that there are other medical products for which this needs to be done, and getting greyer areas that -- I just want to comment on one thing. I'm not talking about just supplies; I'm talking about medical devices.
DR. HUMPHREYS: But the thing that is interesting there, it seems to me, Mel, is that if I am correct, I am aware of what I think is a very good international effort on devices, which essentially is hoping to base a new terminology on the existing pretty excellent work done at ECRI with the universal device nomenclature system. Is that correct? Or are you talking about a third thing? Because if you are, then I have a real objection.
DR. HANSEL: I'm involved in that process. I think there are two elements. What ECRI has gives you groupings of devices, but it doesn't get you down to specific devices. The equivalent of the universal drug code is the universal product number, which I believe is becoming more utilized in the device arena, primarily at this point, in conjunction with expendables, but with the hospitals' concerns about monitoring, maintenance and corrective actions by companies on capital equipment. We anticipate that it is likely that the universal product numbering for medical devices will eventually be utilized by industry on all devices.
DR. HUMPHREYS: But as I see it, I feel that if you are over on the drug side, people say, yes, we have the NDC codes, but we can't connect this back to something which is more clinically meaningful, that describes purpose, function, dose, whatever it is.
On the device side, we are in the exact other position. In many ways, the ECRI UMNDS does provide a very, very nice categorization, but it doesn't go all the way down to the individual number.
DR. HANSEL: That's correct.
DR. HUMPHREYS: So the work that needs to be done to solve these two problems is different work, and I think maybe it would be better to divide them out, because the whole process of how you would move ahead on the one is different from the other.
DR. HANSEL: Well, I won't get into whether they should be separate or combined, but I think it is important to include more than just drugs, and looking at the need to come up with systems of being able to exchange --
DR. HUMPHREYS: I agree with you on that. I just think that from the point of view of the NCVHS going back to all the testimony on this issue, this drug thing here, because people heard a lot of written testimony about the problem of this clinically specific drug information. That is why this recommendation is here, so it may be advisable to have a recommendation that is recognizable to the people who recommended very strongly that the government do something in that area, and somehow incorporate this new idea in a way that doesn't make it difficult for people to recognize the previous idea.
DR. FYFFE: I don't presume to know much about this particular area, but my reaction is that I don't understand why this is in the scope of our report.
DR. COHN: You mean the drug or the medical product reference terminology?
DR. FYFFE: The medical product reference terminology. Aren't we getting down to a level of detail that isn't really appropriate here? Maybe I really don't know what I'm talking about.
DR. GREBERMAN: They didn't come out much in the discussion, I agree. It is obviously how much of a voltage you deliver and how much -- they are similar issues in terms of medical products and how we use them. Clearly, the gray area between medical devices and drugs and biologics is getting grayer in many ways as technology evolves.
I don't think -- first of all, it doesn't deal with process. It talks about a product. I think for the future, it is important to recognize that gray area. I think we can emphasize the statement. For example, we can hit the drug ones specifically as an example. That could even be the first one you recommend, if you want to do prioritization.
DR. HUMPHREYS: Can I ask this question? What is the FDA planning to do? Is the FDA planning to move ahead on this thing? Is this a very good idea which needs support, in terms of going down to the UPN -- which needs support and potentially additional funding, so it should be recognized here to get that?
I think people have an idea of how they might proceed on the drug part.
(Simultaneous discussion.)
DR. HANSEL: VA is looking at the need to go down the same road that DoD has gone down, of requiring UPNs as part of their procurement and inventorying process. We have been looking at the FDA going down to what we call model level listing, which is the equivalent of what drugs does with the universal product codes.
However, the number of devices that are in the marketplace are really very large compared to that of drugs, and there is concern in our agency that there is a need for essentially the commercial third party environment to be capturing all that individual information, that it would be very difficult and cost prohibitive for FDA to gather all this data and keep it current.
We anticipate that this will become data that will be maintained, like the drug information is maintained to support various bar coding systems and point of sale and various EDI transaction exchanges. So we are studying the matter, but the magnitude of the number of individual devices out there is so large compared to drugs that there is the concern about cost.
DR. MC DONALD: I've got three thoughts. If you are saying you want a universal product identifier, say it and don't leave it vague. But then I don't know that this is still necessarily a part of this, because that activity is ongoing in the industry at large.
The second part is that four or five years ago, there was a very strong switch in government sentiment that the standards activities would be -- the center of gravity would be in the private sector. The only government agency that I know that -- except in one area, has been very resistant to participating in this area is FDA. In fact, what I worry most about is, this will give the center of gravity the wrong place again, and the FDA will do one more new standard which will create great havoc in the care environment, when the care environment might be using SNOMED for defining clinical realities, and a whole different code, say MEDRA, comes out of FDA out of the blue.
It will get even worse if you decide to define the attributes that went along with these. What this thing was talking about was the codes that go into the frequency, strength, chemical composition, are already being developed in a consensus standard organization, and that sounds like the other thing you like to do.
So I think really, the camel instead of putting its head under the tent should join the groups that are doing this and let it come from them, rather than letting them have their own leadership ship in this. That is what worries me most about this, that you will end up --
DR. HANSEL: I was involved in the MEDRA activity. MEDRA does not get into product.
DR. MC DONALD: If all you're saying is you want to have a universal product code, that is fine. We should say that. We should describe a universal product code that would be used across industry in health care, et cetera, et cetera. But it wouldn't be FDA specific, or anything specific to drugs. It could be sheets and other things.
DR. GREBERMAN: It doesn't say that.
DR. MC DONALD: This is a quite different proposal. If you are saying you want to have a universal product code, fine, that's good, say that. Don't get tangled up with this thing about, you're building data structures and you're going to fill in the blanks on how you record data about these things. because that will cause problems with the industry which is collecting data for other purposes.
DR. GREBERMAN: (Comments off mike.) One of the activities is the development and maintenance of this nomenclature.
DR. FERRANS: Mel, let me see if I can suggest a solution here. Along the lines of the principle that the immediate funding in placing the drug information was the result of direct testimony, and people were saying this is something that is urgently needed, and we want to break this out, we have broken it out in every instance of the report, we tried to achieve what you are doing.
Under number two, the last sentence in number two, where we talk about where standards do not exist or are still under development, if we had something in parentheses, putting including biologics and devices, -- no? If we make some reference, because what they are really talking about is a standard that doesn't exist.
DR. MC DONALD: It depends on what they are talking about. I don't think we know.
DR. COHN: What you're saying is, you don't want it here.
DR. FERRANS: I'm saying I don't want it with the drugs, because that was something that people said this was an urgent need. But if this is an issue that we should look at, we should somehow put it on the schedule, apply the guiding principles and see how it falls in.
DR. BLAIR: Let me see how I could characterize this in a constructive manner. I think that the idea of a universal product number is a good idea. I think that having identifier codes for medical devices is a good idea. If we want to discuss a reference to that in the recommendations which would support those, I think that that is a subject that I think we could reasonably discuss as adding those to the recommendations.
The piece that I feel that you are hearing people feel very uncomfortable with, and I think almost everyone on the committee has expressed discomfort with, is the idea that universal product codes are somehow addressing the need for clinically specific drug vocabularies to help in the patient care process.
If you are willing to separate that out, I think that there is an opportunity for us to wind up putting it in an appropriate independent place among the recommendations. That is my comment.
DR. COHN: I think you are echoing first of all that we need to divide these issues. Am I hearing anybody disagreeing that they are separate issues?
DR. MC DONALD: I'm not sure. I have no clear idea what they intend. That is my problem. If it is just a universal product code, I think that is a great idea, and we can say that generally. It doesn't have to even be very specific.
DR. COHN: Would you want that under E, or is it a different --
DR. MC DONALD: I don't know what it is.
DR. GREBERMAN: Can I try clarifying? Clem's specific question was not just for the universal product code. Probably that would be part of it, but basically -- remember, we are doing a lot with reporting adverse events. Those issues are clinically relevant, and we need to be able to link the product, the devices, as an example, with what happens in the real world. So that is why I think there are very similar parallels.
DR. MC DONALD: But that is exactly the part that I am against. Let me explain. The universal product code I think is a no-brainer. That is an ongoing activity in the industry, to get the one universal product code for all products. So we could support that. I think everyone could support that enthusiastically.
You are saying, you are going to build new data structures, conceptualizations, fields, to deal with stuff independent of how the industry collects that data in the hospital and in the clinics. That is what I worry about. That is what I think you shouldn't be doing.
DR. GREBERMAN: Well, I don't say who is doing this in the statement.
DR. MC DONALD: I know.
DR. BLAIR: I think Clem's point is very, very critical, because if you look at the entire thrust of this report, it is very much focused on how do you collect data that is part of the normal patient care process, which is not disruptive, not an independent information gathering activity, and then you use derivatives of that information to support all the other uses. That is a principle that underlies this report.
DR. GREBERMAN: And my point is, this is no different from that. Maybe I'm not making the point, but basically we are talking about clinically relevant data and how we collect it, and how that can be used to determine when problems occur.
I'm not talking about different data. I'm not talking about new words, new phrases. But wouldn't it be nice if the agency could be able to use that data effectively from the clinical environment. We could even link those things to problems that occur with devices, just as the big issue came up with drugs. I think there is less of an issue with drugs than biologics, because that includes blood, blood products, vaccines, genetic material. So I think the word drugs was meant to include perhaps a broader thing. Maybe biologics helps that, but if we want a separate sentence, in addition, to deal with devices, I think it is still relevant clinically.
DR. COHN: Can I make a comment here? I am actually very uncomfortable with this conversation. I think we are mixing and matching.
I fundamentally support the idea of a drug reference terminology, among other things because we heard extensive testimony on it. We understand the issue and we crafted a recommendation. This is something where I had to look very hard at previous testimony in order to understand the issue. We did not hold hearings on the UPNs extensively, UCRI briefly. This is an area where I think it might have a lot of merit, we might want to hold hearings on it.
DR. HUMPHREYS: The other thing is that we have to remember that we did hear about UPNs in the HIPAA environment. We had interest among Congress and among other constituents coming forward. We explicitly asked people on the administrative transactions what they thought about UPNs and what they thought should happen in the future. In the end, this will be a great idea, but it is much too early to proceed with it.
That of course doesn't preclude there being a recommendation from the NCVHS that we should move forward to do something to push this along. It doesn't preclude that. But the use of these UPNs will not only impact patient medical record information; it will definitely slop back over into the administrative standards, because the comments we heard there is, yes, when this is far enough along, there will be cases where administrative transactions should also include these. It is just that we are not there yet. And of course, nobody was estimating when we would be there.
DR. COHN: And I guess what I am saying here is that I can support unambiguously the drug piece. The other piece is something where -- we are going to be doing discussions on codes later on this year and into next, and maybe it is the time to revisit this issue, recognizing it as an independent issue, as opposed to trying to add it in, and almost describe it at the last minute as a recommendation here.
DR. GREBERMAN: -- hear about the biologics, though.
DR. COHN: That is an intermediate question. I am trying to think what you mean by biologics.
DR. GREBERMAN: Vaccines, blood, blood products, genetic material.
DR. COHN: Mike is raising his hand.
DR. FITZMAURICE: I support what Mel is bringing up to us. I think putting it in strengthens the report. What strengthens it is, I don't hear people saying these things don't need to be enumerated, coded. I hear them saying that here is an agency that doesn't always operate in an open process. Putting them in the report ties them with the guiding principles for developing PMRI standards. So someone who develops the standards for these things that don't have standards right now would be obliged to look at the guiding principles. By not mentioning it, we leave an arena that is entirely uncovered by the report.
So I support with Mel putting them in the report. I support linking them with the guiding principles. We would not expect them to be developed in the cover of night and sprung internationally without prior knowledge of the standard developing organizations.
DR. BLAIR: I'm not sure that this recommendation -- let's just see how people react to this. If we were to add -- and I'm not exactly sure whether it is under this recommendation. We have recommendations where we wind up indicating fundings to do research and to study, remember?
DR. AMATAYAKUL: Yes.
DR. BLAIR: Underneath that in the appropriate location, if we were to indicate that there is a recommendation that funding be available to study identifiers -- I think you called them uniform product identifiers, such as medical devices and biomedics, so that they could work cooperatively, harmoniously with other PMRI standards, something like that, is that getting at the kind of -- no? I hear uncomfortableness on that.
DR. COHN: There are a lot of things going on in this area.
DR. MC DONALD: The product code thing is a no-brainer. Somehow we've got to get to one. But there is a lot of energy behind it, so the study thing is right. The real issue about putting in a recommendation in particular, what we are really saying here is, you want to develop a system that will assist adverse drug reporting, which is good and right and proper. It is just, why do we pick that out and not outcomes management and all the other things that have similar exact issues related to them?
Now, we did talk about those things in the body of the report in bullets, and we could easily add in discussion about adverse drug reporting and -- I think the real word is product experience reporting, which is one of the better euphemisms in the universe. So we could have the product experience reporting section described in more explicit detail as examples of the benefits of the standards, and with the assumption that we will make these things all harmonize, too.
DR. GREBERMAN: I was just using that as an example. Clearly, I think it could be used in terms of -- that we use the same terminology in clinical trials. They are basically clinical studies. That would be helpful to us, too.
I'm just using that as an example of medical products and the things that are clinically associated with them.
DR. MC DONALD: But this is true -- the web is seamless. We all use the same terminology in Xray reporting and laboratory reporting and in blood pressure measurements and allergy reporting and all these other things.
So I don't think there is any contradiction or disagreement. It is just, why are we singling out one agency to have this particular thing in the recommendations?
DR. GREBERMAN: The agency brought it up. I think the issues of biologics and devices are relevant to the whole sector of health care, not just the federal government, and not just drugs.
Now, if we want to have the drugs as an individual bullet, I would suggest also having biologics added in that, because -- and we could put perhaps in addition a separate statement about devices that would cover some of the issues. I have no problem with that.
DR. MC DONALD: But you have a universal product code for drugs. NDC has got a few little flaws around the edges, but for practical purposes it is UPC, it is at that level of granularity. What we don't have, except maybe in the industry -- I don't want to say that we don't and no one in the universe has, but there certainly isn't a universally accepted generic drug name code, plus more, which they are talking about in here, and biologics would be happy to add that to it. But you're talking about a UPC code at the same level of NDC code. So why don't you just extend it? You don't even have to talk to us.
DR. GREBERMAN: How does that deal with the issue -- the comparable things for --
DR. MC DONALD: That is the part I don't want you in. You are going to end up with your own unique standard.
DR. GREBERMAN: We didn't say we. As Mike said, this gets it into the open process.
DR. MC DONALD: It is in the open process. This kind of conceptualization is there.
DR. COHN: Let's just step back for a second here and look and see if we can come to some agreement on what we need to do. We can certainly spend the next two days talking and arguing about this one. I am getting a little confused myself even on what we are arguing about.
Now, I guess what I am hearing -- I think what I am sensing is that we can divide the topic a little bit. The drugs and biologics could be in one category, and medical devices could be in another.
DR. GREBERMAN: We can come up with the wording.
DR. COHN: Are we okay with this old D, new E as written here?
DR. BLAIR: I'm a little concerned about adding the biologics to the drugs on that bullet. I do feel as if that bullet is created to explicitly address an issue that has been referenced to us.
I would feel okay if we did invoke and include the thoughts that are being suggested by the representatives of the FDA in a separate line item, and then we could put biologics, we could put medical devices or not, and we could even include -- maybe it is even two separate bullets. Maybe it is one bullet with a universal product number that includes biologics and drugs, and that is one piece, but the other piece would be the separate issue of medical devices.
DR. COHN: Let's find out how we want to divide this issue, first of all. I suggested drugs and biologics together; you are saying keep them separate. Margaret has a comment now.
DR. AMATAYAKUL: I probably am much like Kathleen in terms of my information about drugs and all. But I have the feeling and the sense that drugs and biologics go together. I would keep them together. I think the devices probably do need to be separate from that.
DR. COHN: Are people comfortable with that? Let's first of all figure out how to put them together.
DR. FERRANS: It reflects the reality of the merger of the two.
DR. BLAIR: We would just be adding biologics to the wording that we now have for that recommendation. Then we are going to have a second recommendation to address the broader issue of --
DR. COHN: Let's go through this recommendation with the biologics. Maybe you can read it.
DR. AMATAYAKUL: What I have, I just added in biologics; development and ongoing maintenance of a drug and biologics reference terminology that promotes the ability to share clinically specific drugs/biologics information. Maybe it would be better worded, development and ongoing maintenance of a reference terminology for drugs and biologics that promotes the ability to share clinically specific information. Would that be okay?
DR. GREBERMAN: Yes.
DR. AMATAYAKUL: And do we need this parentheses, yes or no?
DR. MC DONALD: I think I'd take it out.
DR. GREBERMAN: Several people had asked what do you really mean. I think examples of clinical information include --
DR. MC DONALD: This was not intended at the product level. I hope you understood that.
DR. BLAIR: And I really feel like we need to have what is in parentheses there, so that it is very clear that it is not talking about what is at the product level.
DR. MC DONALD: No, no, that won't help. What we are really talking about is the names of these.
DR. BLAIR: It has administration, dose, frequency. That is not at the product level.
DR. COHN: I hear 180 degrees --
DR. HUMPHREYS: If you leave it in, you have to say EG.
DR. AMATAYAKUL: We do have it in the body of the report.
DR. MC DONALD: What is causing confusion here is that these things are not drugs. It implies we are talking about the codes for frequency. It does get very confounded in terms of what we really mean. If we are talking about a reference terminology for drugs and biologics, that is fairly clear. People might want to build these codes up, but I think we are just going to end up, everybody putting all their work into this bullet, like we are having here.
DR. AMATAYAKUL: What I think might be helpful for people who didn't understand this is, in the overview section, there is a specific place where we repeat this, that is, dose, frequency, et cetera. If maybe you could just look at that and see if --
DR. MC DONALD: I still think it is going to cause confusion.
DR. AMATAYAKUL: But not in the recommendation, but in the body of the report, to provide further explanation. I think it would be useful.
DR. BLAIR: Is there a feeling in the work group, do we keep it in or take it out?
DR. MC DONALD: I vote for taking it out. What you are talking about, you are trying to make a name for a drug. It is not the product level, that is very granular, and it is not just penicillin B, because the dosing -- how it is given makes a difference in the physiologic response. It is at the ordering level where things get tangled into that, is what this is going after. I think it is very hard to say this without thinking you are building the database of an order.
DR. FITZMAURICE: You mean a generic name for the drug you are prescribing, so that any number of manufacturers can be used to fill that particular name of a drug.
DR. KOLODNER: But it is more than that, because the chemical composition doesn't necessarily -- it isn't necessarily in the drug ordering level. So you have got some things that are at the drug order level, you've got some things that are not at the drug ordering level. Unless you put something in that covers both, you are not going to get across that it is not any one of those, it is at all of those.
DR. FERRANS: Somehow, I think that we will be able to let them know when we go through the rulemaking process or whatever what we mean by this. I don't think it is that critically important that we specify it is a drug reference terminology.
Perhaps one thing we might want to do is put in the glossary of terms drug reference terminology, put down what we think that means, and just leave it like that.
DR. COHN: Okay. So we are all in favor at this point?
DR. MC DONALD: What is crossed out?
DR. COHN: Dose, route, frequency, strength, chemical composition. Now, let's talk specifically about the issue of medical devices. Is that something that means funding, or do we need to revisit at a hearing this year the issue of where we are at in relationship to universal product numbers and all of this. It is more of a question that we need to come to a recommendation.
I ask that question, because if indeed it is the latter, we will have a hearing this year, and we can elicit comment on that. If it is not something that is developed at all that needs funding to make it happen, then that is another issue.
(Simultaneous discussion.)
DR. COHN: Then I think we'll take that under advisement. But we are planning on going into code sets later in the year and into next year, so I think it is a very appropriate time to revisit what was a recommendation a couple of years ago.
DR. FITZMAURICE: I think the important thing is to mention it, so that it is known to fall under the domain of what NCVHS would be considering. So making a recommendation for the hearing, we'll do that.
DR. COHN: Is the recommendation here?
DR. FITZMAURICE: We recommend that a hearing be held next year.
DR. MC DONALD: But we haven't gotten any of this granular detail. There are lots of other issues that we haven't touched. We haven't even distinguished between -- there is the product advocation which says this is the kind of thing made, and then there is also the internal serial number, manufacturer's serial number, which says this particular instance of this product -- these are all these things we are just lumping together. I don't think we should be singling out at such an intense level. New devices is everything in the universe. It is really like saying the world. It is everything.
DR. CHANKOWSKY: I just want to mention one thing. This is Art Chankowsky from the Center for Devices. I hear you talking about medical devices as replacement body parts or hardware. Medical devices today are becoming competitive with drugs, for example, for the treatment of anti-tachycardia. Rather than use a drug, we are finding that certain types of pacemakers and defibrillators are better for equivalent therapy for drugs.
So we are talking about the same issues that is being cited here and talked about that you have with drugs being applied to medical devices. As the technology evolves, this will become more of an issue. So we are talking about -- what are the ways we are talking about these things.
DR. BLAIR: Are you able to return with us right after lunch? It sounds like there are a number of folks that feel there is a need for a break at this point. Can you return right after lunch?
DR. COHN: Well, we need the answer right now, that this not be in the recommendation if there is someplace to put in the body of the text the notation that we need to be evaluating this further, that's fine, or we can just keep it mentally as one of the issues that when we start getting into codes, we will have a hearing on. But I don't think it should fit in the recommendation that the NCVHS will study UPNs later this year.
DR. BLAIR: Kathleen, are you here?
DR. COHN: She's not here.
DR. BLAIR: What I'm hearing is what everybody seems to be agreeing on.
DR. AMATAYAKUL: One or two people made a suggestion to update the NCVHS work plan which is in one of the appendices. You might want to just add some of this to the work plan for your next year.
DR. BLAIR: The work plan doesn't go past where we are now. I see what you're saying.
DR. AMATAYAKUL: Just as a place to put it.
DR. COHN: Yes. Should we break for lunch at this point?
DR. BLAIR: What time is it now?
DR. COHN: It's 12:40.
DR. BLAIR: And we return from lunch at 1:30.
(The meeting recessed for lunch at 12:40 p.m., to reconvene at 1:30 p.m.)
DR. BLAIR: Can everybody take their seats, please? Is Margaret here?
DR. AMATAYAKUL: I'm here.
DR. BLAIR: Are we ready to convene on our next recommendation? Margaret, why don't I let you proceed?
DR. AMATAYAKUL: Okay. We are on recommendation number -- what is now number five, which was previously number four. That is, issue a notice of proposed rulemaking to gather comments and publish the first of a series of final rules for PMRI standards within 18 months after acceptance of the NCVHS recommendation for the selection of PMRI standards.
Recommendation number two. Require implementation of the PMRI standards within the time frames recommended by the NCVHS.
DR. BLAIR: Any comments or concerns? I don't hear any.
DR. AMATAYAKUL: The difference between what we had before and this is that we have split up, so that there is the notice of proposed rulemaking within 18 months, that is separate now from the implementation requirement, which NCVHS would recommend time frames for.
DR. FITZMAURICE: So as I understand this, Margaret, you require implementation of the PMRI standards within the time frame as recommended by the NCVHS. Those time frames will be given at the time NCVHS makes its recommendations, not at this time.
DR. AMATAYAKUL: Right.
DR. COHN: Do we need to say anything in our earlier recommendation when we are talking about the things we are sending to the Secretary? Instead of a set of standards, do we need to say something about, and recommended implementation time frames? Not here, but in -- what is it, two or three?
DR. AMATAYAKUL: Two. Let's see what two looks like. We could say NCVHS will recommend the first set of specific standards and their implementation time frames, based on industry readiness.
DR. BLAIR: If you didn't have the word there, just and implementation time frames.
DR. AMATAYAKUL: The NCVHS will recommend the first set of specific standards and implementation time frames based on industry readiness for adoption within 18 months following delivery of this report.
DR. BURKE-BEBEE: Do you think you ought to put the within 18 months up after the recommend? Because it gets a little bit confusing.
DR. BLAIR: Right, too many ideas in there now. People are going to wind up, what does the 18 months refer to. So maybe you have to do it in two sentences now.
DR. FITZMAURICE: I think Susie's suggestion was good. Put the 18 months so that it appears more directly to modify when NCVHS will recommend.
DR. BLAIR: Okay.
DR. BURKE-BEBEE: I don't think that will be too long once you see it, Jeff.
DR. AMATAYAKUL: The NCVHS will recommend within 18 months following delivery of this report the first set of specific standards and implementation time frames based on industry readiness for adoption.
DR. FITZMAURICE: It's awkward.
DR. BLAIR: Let me ask you this. Do we --
DR. AMATAYAKUL: We could say the NCVHS will make recommendations for standards within 18 months following delivery of this report. The recommendations will include implementation time frames.
DR. BLAIR: And the recommendations will be based on industry readiness and will include implementation time frames.
DR. COHN: Actually, we can say take into consideration industry reediness.
DR. BLAIR: That's it, take into consideration. On the first part of that sentence, did we lose the wording where we were saying we were going to make recommendations for specific NCVHS standards? Is that still there?
DR. AMATAYAKUL: No, that is still there.
DR. AMATAYAKUL: So this now reads --
DR. COHN: These recommendations will include implementation in time frames taking into account industry readiness for adoption.
DR. AMATAYAKUL: Okay. So the whole thing reads, direct the NCVHS to select uniform data standards for PMRI according to the criteria in the guiding principles for selecting PMRI standards. The NCVHS will recommend the first set of specific standards within 18 months following the Secretary's acceptance of this report. These recommendations will include implementation time frame, taking into account industry readiness for adoption. Where standards do not exist or are still under development, the NCVHS will identify mechanisms to accelerate the development of those standards.
DR. BLAIR: Good.
DR. BURKE-BEBEE: The first set of specific standards leaves me wondering, are there going to be more referred to in this report. I understand the idea of the 18 months and only being able to start someplace, but I don't get that feel in this couple of sentences. It leaves me with what are the first set of standards and then what is the second, what is the third.
DR. AMATAYAKUL: Would it be better to say the NCVHS will recommend a first set of specific standards?
DR. COHN: Yes.
DR. BURKE-BEBEE: I think maybe initial.
DR. AMATAYAKUL: The initial set.
DR. BURKE-BEBEE: Because then I'm not left with, what are they.
DR. COHN: I'm still not sure about the last sentence, where it says where standards do not exist and are still under development, the NCVHS will identify mechanisms to accelerate the development of these standards. Is that necessary anymore? I'm trying to remember if we had talked about that and actually taken it out already once. Maybe I'm mistaken.
I thought what we were doing here is, below that number three making recommendations to accelerate the development.
DR. BURKE-BEBEE: I think it is good where it is.
DR. FITZMAURICE: NCVHS identify not only standards to be implemented, but also gaps where there are no standards. So maybe there is a sub-bullet on number two that starts to take into account that second sentence.
DR. COHN: Where gaps are identified? Where gaps in standards are identified, the NCVHS may identify the mechanisms to accelerate the development.
DR. FITZMAURICE: Yes, something like that. It makes it complete without giving it the same force as what is above it.
DR. BLAIR: If we start getting into gaps, then there are gaps, there are overlaps. I am inclined to leave it the way it is.
DR. COHN: Right now we have changed it a little bit, where it says standards do not exist or are still under development, the NCVHS may identify mechanisms to accelerate the development of those standards.
DR. AMATAYAKUL: Then we probably in new five don't need this last sentence.
DR. COHN: No, actually we still do. We are making recommendations, and then this is saying that we want her to --
DR. BLAIR: So what does five say now?
DR. AMATAYAKUL: Issue a notice of proposed rulemaking, gather comments and publish the first of a series of the final rules for PMRI standards within 18 months after acceptance of the NCVHS recommendation for the selection of PMRI standards.
Recommendation number two. Require implementation of the PMRI standards within the time frames recommended by the NCVHS.
DR. BURKE-BEBEE: What confuses me here is, is this 18 months different than the other 18 months?
DR. FITZMAURICE: Yes, it is another 18 months.
DR. BURKE-BEBEE: I know that, but it doesn't sound clear when you refer back to number two. When I read that, it makes me feel as though it is the same.
DR. AMATAYAKUL: And you know what? We took out acceptance of recommendations. We said delivery of the report.
DR. COHN: Well, this is different. Here we are talking about after we make this next set of recommendations, she needs to accept those recommendations before she does any of the rest of this stuff. So I think acceptance is actually the right word here.
DR. AMATAYAKUL: That's right, because there could be a gap between the delivery of the report in 18 months, and then there could be another big gap --
DR. FITZMAURICE: Between the recommendations for the initial set and the Secretary's acceptance of that initial set.
DR. COHN: The issue here is as to the NCVHS recommendations for the selection of PMRI standards. And representing recommendation two, basically these are not recommendations for the selection; these are the initial set of standards,
DR. BLAIR: Right, regulations.
DR. COHN: -- of standards recommended. So that needs to be somehow reworded, because right now it sounds like this document.
DR. BLAIR: What we did was, we wanted to tie back the reference point to recommendation two, but Susie observed that some people may wind up reading that -- if they are not reading the full sentence, they are focusing on the 18 months and not seeing what the difference is.
What if we -- in the way we refer to recommendation two, read me the phrase that precedes where we refer to recommendation two.
DR. AMATAYAKUL: For the selection of PMRI standards? The whole sentence is, issue a notice of proposed rulemaking, gather comments, and publish the first of a series of final rules of PMRI standards within 18 months after acceptance of the NCVHS recommendations.
DR. BLAIR: Recommendations which were set forth in recommendation two. Does that help?
DR. FITZMAURICE: I might be comfortable if we called them the initial set of something, where we used initial set.
DR. BLAIR: So you have the same words there?
DR. FITZMAURICE: Yes, so they know what is being recommended.
DR. BLAIR: Susie, does that help?
DR. BURKE-BEBEE: Yes.
DR. AMATAYAKUL: Within 18 months after acceptance of the NCVHS recommendations which were set forth in the initial set of recommendations.
DR. FITZMAURICE: The acceptance of the initial set of NCVHS recommendations, or the initial set of PMRI standards recommended by NCVHS.
DR. AMATAYAKUL: Mike, I'm sorry -- right here, or someplace else?
DR. FITZMAURICE: We are using the same words we used up in number two. In number two, we said we are going to make an initial set of recommendations. Here we are saying we want to publish within 18 months the MPRM following the Secretary's acceptance of that initial set of recommendations. So it is whatever words we used up in number two, I don't have them in front of me, but it would be up above there. Initial set of specific standards, that's it. When the Secretary accepts that initial set of specific standards, we would hope from acceptance to publication of the final rule is 18 months.
DR. AMATAYAKUL: Okay. The first of a series of final rules for PMRI standards within 18 months after acceptance of the NCVHS recommendations which were set forth in the initial set of specific recommendations.
DR. COHN: I don't know why -- which were set forth, I don't think any of that is needed.
DR. FITZMAURICE: Recommendations of the initial set of specific standards.
DR. COHN: So maybe it is on the initial set or for the initial set.
DR. FITZMAURICE: Or NCVHS recommended initial set of specific standards. Then take out the NCVHS recommendations above. So we have acceptance of the recommended.
DR. AMATAYAKUL: Issue a notice of proposed rulemaking, gather comments and publish the first of a series of final rules for PMRI standards within 18 months after acceptance of the NCVHS recommended initial set of specific standards.
DR. FITZMAURICE: Put a hyphen between NCVHS and recommended. Does that look okay to everybody?
DR. COHN: Yes.
DR. MC DONALD: Are we calling them everywhere the initial set of specific standards?
DR. FITZMAURICE: That is what we called them in the second recommendation.
DR. COHN: The last sentence, we probably want to require implementation of these PMRI standards, rather than these.
DR. BLAIR: Shall we move on?
DR. AMATAYAKUL: Six. Promote early adoption of 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.
To achieve this, HHS should support use of PMRI standards according to the following priority. Within government projects such as the GCPR framework project, within government agency programs that deliver health care services, within federally funded clinical research, where applicable. We added where applicable because some people said it would be difficult for everything to be required.
DR. GREBERMAN: I'd like to suggest a slight change in wording in the second bullet. Clearly, I think as we have at the bottom, given the items that come after that, HCFA and FDA ought to be in that. But since neither of us deliver health care services directly, I think maybe wording, programs that deliver or have an impact on health care services. It is a slight change, but --
DR. AMATAYAKUL: And then add FDA or -- they are down there already?
DR. MC DONALD: We could be more specific and have program requirements, too. That is really the key thing.
DR. GREBERMAN: -- because clearly we are working voluntarily with distance learning and other groups.
DR. BLAIR: The thought that was trying to be communicated here was that before agencies that use the data can obtain the clinically specific data, you have to have providers that are capturing that data. So the intent of this was -- because we had gotten criticized on the previous set of recommendations that we had, when we wound up listing agencies that use the data. So we tried to be very clear to try to prioritize this in terms of those agencies that capture the data first, versus those that use the captured data.
DR. AMATAYAKUL: But we do have HCFA and FDA in this list that follows.
DR. FITZMAURICE: I do like Clem's suggestion about, those that have a reporting requirement, because all government agencies, at least in HHS, you would expect to have an impact on health care services.
DR. COHN: I'm not sure that we actually need to do any of this, since we are already listing the FDA and HCFA at the bottom. So if we listed them explicitly, we might say, they are already included, but they are included explicitly, so I don't see what --
DR. GREBERMAN: I guess it was the wording, because it didn't make sense.
DR. FITZMAURICE: Some agencies don't deliver health care, but they have an impact.
DR. COHN: That's true. I was going to add a fourth bullet, which says other sanctioned activities by application or something like that. Well, forget it. Looking at this, it doesn't make any sense. Anyway, do we need that there particularly?
DR. BLAIR: Do we need what?
DR. COHN: The additional wording there, those that have a reporting requirement or have an impact on health care services.
DR. BURKE-BEBEE: I don't think it hurts.
DR. COHN: We need the bullet then.
DR. FITZMAURICE: I wouldn't do both. It just goes on too long. Impact is one of those words that editors are always supposed to expunge from a document. I guess it is not a verb, so it is okay.
DR. AMATAYAKUL: Is it on, or those that have --
DR. COHN: Let me ask you what you mean by government agency programs that deliver health care services? Are you referring to Medicare or are you referring to the VA?
DR. GREBERMAN: We were thinking of VA health service, the Department of Defense Health Affairs. All of those deliver health care services. They capture data, patient data. That is what we were thinking of.
DR. MC DONALD: So what you are really saying is those that give care or else require caregivers to report to them.
DR. COHN: If anything, it should be a separate bullet. I think there is a significant difference between delivery of health care versus reporting requirements. I'm not even sure that it needs to be specified, but --
DR. MC DONALD: We might be better off going back to the original sentence, because no one really cares that much about these details, do they? Or do we?
DR. GREBERMAN: It does look like all the others are excluded.
DR. AMATAYAKUL: Do you want to take this out? Is that what you're saying?
DR. MC DONALD: No, I think we should leave that. The last bullet, you would say those that require caregivers to report to them. That is actually the most severe -- that is the toughest one, to me.
DR. BLAIR: So you're saying that phrase we would delete, is that what you're saying?
DR. MC DONALD: I'm trying to just get to closure.
DR. COHN: It says, by federal government agencies that are involved or --
DR. MC DONALD: The trick is, they are asking for clinical data from the institution, so the institution is going to have to send it to them in the standard way. That is why we ended up where we are.
DR. AMATAYAKUL: I think since this is supposed to be the early adoption, and you say federal government agencies that have reporting requirements, that is going to be everybody in the country. So I don't think that is what you want for early adopters.
DR. FITZMAURICE: It may be easier for them to be early adopters, if it is just a matter of specifying the paper reporting requirements.
DR. AMATAYAKUL: The whole world?
DR. FITZMAURICE: No, the specific reporting programs. Your whole program -- you do it for a portion of your program. They should start working it into their programs.
DR. MC DONALD: There is no easy way to say that with the structure we have here now. I think somebody needs to propose something, to say that it is a formal proposal and in writing, because we are not doing well in a group edit.
There was discussion of this at a previous meeting. We deliberately wanted to make a hierarchy. That really reflects it. And the FDA is involved in research, so that covers them.
DR. FITZMAURICE: We could take out that deliver health care services and simply say within government agency programs. Let the programs decide where to begin implementing this. Some early implementation should start within government agency programs, not just those that deliver health care services.
DR. MC DONALD: But patient care and medical data. This whole thing is all qualified by patient medical record data.
DR. AMATAYAKUL: I think though if you leave it broad, somebody could interpret that the early adopters should be anybody that has to report to Medicare.
DR. FITZMAURICE: They are not going to enforce it where the burden is so great. They are not going to take our recommendations as a mandate. On the other hand, we don't want people yelling at the report because they think we are.
DR. COHN: We do mention HCFA at the bottom there.
DR. AMATAYAKUL: Maybe we should take HCFA out.
DR. FITZMAURICE: No, no, no. HCFA does some things internally that would make sense, but I think we have covered it.
DR. COHN: You think we are okay just leaving it alone?
DR. FITZMAURICE: I think we're better off than spending the whole day at it.
DR. GREBERMAN: I assume federal funded clinical research, that was both intramural and extramural. Maybe a slight modification was federally funded clinical research and evaluation.
DR. BURKE-BEBEE: And I have a question. Where it says promote early adoption of PMRI standards within government programs, since the programs are -- as Mike, you said, maybe -- we are addressing maybe part of the overall program. Is the early adoption supposed to be outside of these two 18 month periods? That may be an ideal world, but in the real world, as this is evolving like it is for transactions, there are people who are already getting ready before it is published. So what do we mean by that?
DR. FITZMAURICE: We mean as soon as they can, which would include the examples that you brought up, even before it becomes mandatory.
DR. BURKE-BEBEE: So this is to mean before the two 18 month periods that we referred to.
DR. BLAIR: Maybe and maybe not. That is why we didn't specify it. If some can actually get started after the first 18 months and start then, great. Others may not be able to until later.
DR. COHN: We were talking about vocabularies likely to be used, talk about terminologies likely to become PMRI standards. I forget where we commented about that.
DR. BLAIR: Candidate. PMRI standards -- Maybe the phrase is PMRI standards that are candidates for selection or adoption?
DR. FITZMAURICE: When we were talking earlier, we mentioned clinical vocabularies which have the potential to be PMRI standards.
DR. COHN: Yes, talking about standards and --
DR. FITZMAURICE: Those that have the potential to be standards.
DR. BLAIR: There you go, yes.
DR. AMATAYAKUL: Mike, is that what you just said?
DR. COHN: We are talking about two different things. One is to promote early adoption of PMRI standards as well as evaluate experience with candidates --
DR. FITZMAURICE: For PMRI standards.
DR. COHN: Oh, we just lost what we had there.
DR. AMATAYAKUL: You want what I had back?
DR. COHN: Yes, let's see.
DR. FITZMAURICE: Promote early adoption of PMRI standards and promote --
DR. COHN: And gain experience.
DR. FITZMAURICE: -- experience and early evaluation, maybe, of candidates for PMRI standards.
DR. BLAIR: Susie, is this addressing your thoughts?
DR. BURKE-BEBEE: I'm looking.
DR. FITZMAURICE: Gaining experience with -- I would put with after experience.
DR. AMATAYAKUL: So it would read, promote early adoption of PMRI standards and gain experience with and early evaluation of candidates for PMRI standards within government programs to provide broadened feedback to the standards development community.
DR. FITZMAURICE: We've got promote, modify, early adoption and early evaluation, but it doesn't modify gain experience with.
DR. AMATAYAKUL: Do we need this, in early experience and evaluation?
DR. COHN: We're talking about candidates.
DR. FITZMAURICE: They need to be evaluated.
DR. BLAIR: And evaluate candidates. Just have evaluate candidates.
DR. FITZMAURICE: Promote early adoption of PMRI standards and evaluation of candidates for PMRI standards within government programs.
DR. COHN: I think it needs to be wordsmithed a little bit more, but I don't want to take the committee's time to do that. But I think it has the idea, talking about early adoption of PMRI standards as well as taking the lead on these candidates, to figure out whether they should be PMRI standards.
DR. BURKE-BEBEE: I think that works. It fits right into that feedback part. Then the next sentence talks about adopting as soon as possible. So I think that works.
DR. AMATAYAKUL: Government agencies that may be candidates for this support include the National Cancer Institute, Centers for Disease Control and Prevention, Agency for Health Care Research and Quality, Indian Health Service as an HHS participant in the GCPR framework project, Health Care Financing Administration and the Food and Drug Administration. I think we actually had a question as to whether that was the complete list, and is there any order that we need to put these in. Is there some sort of better order alphabetically?
DR. MC DONALD: What is the reference? What is to be ordered? I'm not following.
DR. AMATAYAKUL: National Cancer Institute, Centers for Disease Control, Agency --
DR. COHN: Margaret, I think I would let you as editor figure out that. I might say with these government agencies that might be candidates for support include but are not limited to.
DR. MC DONALD: The first sentence starts out, promote early adoption by et cetera, et cetera. There is no word support to link these concepts together. That is, we didn't say anything about support up there, so now you are using the word support up there, you are using promote. Are you saying that agencies should support the funding for this? Aren't they the ones that should adopt?
DR. COHN: Use the PMRI standards. There is no funding here at all.
DR. MC DONALD: What you are really saying, you want these candidates to be candidates for early adoption.
DR. COHN: Maybe six is fund activities to promote early adoption.
DR. FITZMAURICE: That implies that the department gives money to the agencies and that generally doesn't happen. Agencies submit their budgets up through the department. So the agency may support their budget requests.
DR. MC DONALD: What we are trying to do is be more specific about what we said in the paragraph above. When we change all the verbs and all the relationships, it is not going to be clear that that is what we are saying. What we are saying above is that the government should support the early adoption by adopting it in their programs. We use that same phraseology in the next paragraph. Candidates for adopting in their programs are set up for the support -- and then the rest of it is all the same.
(Simultaneous discussion.)
DR. MC DONALD: We can still say may be candidates, but it is not -- the word support is what I am griping about.
DR. AMATAYAKUL: We don't have support in there.
DR. MC DONALD: Down under the three bullets? Under A.
DR. AMATAYAKUL: We haven't gotten to A yet.
DR. COHN: No, we are in the paragraph above A.
DR. MC DONALD: Never mind, sorry. I'm reading off my paper.
DR. COHN: Government agencies that may be candidates for adoption activity?
DR. MC DONALD: That's fine. I'm happy.
DR. COHN: I have a question about the word priority. I'm not sure what that word means exactly. Is it a hierarchy or is it a sequence?
DR. MC DONALD: Are you referring to the priority that we would expect the early adopters to be caregivers or providers first and then users of the data second?
DR. COHN: It says, to achieve this, HHS should support use of the PMRI standards according to the following priority, within government projects, within government agency programs and within federally funded clinical research. I'm not sure --
DR. FITZMAURICE: What is the basis for assigning those priorities.
DR. BLAIR: I think there was another part to that first phrase, within government programs that deliver care.
DR. MC DONALD: What we meant was in that order, that is, don't leap into the big ones right away.
DR. BLAIR: Yes, it is in that order.
DR. MC DONALD: I don't think we were trying to be real specific.
DR. COHN: So priority isn't the right word, but I don't know what is. So maybe the editors can figure out a better way to be --
DR. MC DONALD: We were trying to be vague.
DR. COHN: Okay, that's fine.
DR. AMATAYAKUL: A, study and promote data capture systems that can make it faster and more economical to collect clinically specific information at the point of care. The intent of these studies is to find ways to improve the ability to capture clinically specific information, once at the point of care, and enable derivatives of that data to be used for payment, public health research and other purposes.
DR. FITZMAURICE: I would suggest, after payment, put in quality improvement.
DR. COHN: I have a problem with this whole area, in the sense that we are changing concepts mid-recommendation. The first parts are having to do with promoting early use. I don't think there is any funding here at all, and suddenly we're talking about what sounds like a set of funding issues. Am I missing something?
DR. FERRANS: I thought this was a totally separate area. This is an area that is saying, these are some basic questions that were brought up by testifiers, basic research, that impede the adoption of standards, the user interface for data capture issues, and that we should fund those. But it is completely separate from the issue of funding, early adoption and government implementation projects.
DR. MC DONALD: So it is a new item called research support.
DR. FERRANS: Yes.
DR. COHN: That is probably six, actually, research and demonstration.
DR. AMATAYAKUL: The intent of these, A, B and C, was to describe the type of early adoption activities and the feedback. That was the intent.
DR. FERRANS: But I think that the early adoption -- for example, and very specific to this, the GCPR project is not focused at all on data capture issues; it is on interoperability, data exchange between federal agencies. So they don't live in the application layer, so to speak. I think this applies more under the -- this is the concept of government supported research to advance the field.
DR. BLAIR: Do we even need this? Do we need this phrase? We have already got the recommendation saying to support early adoption.
DR. FITZMAURICE: It may be a separate recommendation, a research recommendation, as Clem suggested.
DR. FERRANS: We certainly have basis in the testimony, that people said you need to do this, you need to do that, and by the way, you need to fund basic health care informatics research in such areas as --
DR. BLAIR: So this is a separate recommendation, is what you're saying?
DR. FERRANS: I think so.
DR. COHN: I think it used to be. So I think what we are saying here is that the committee identified a number of basic issues that cut across many of the standards that need to be addressed. And certainly A and B are there. I'm not sure what C is all about, but we can get to that.
DR. FITZMAURICE: The demonstration, that is a research demonstration.
DR. FERRANS: Margaret, can I also suggest that half of that paragraph that you are doing is redundant? That make it faster and more economical to collect specifically clinical information for the purposes of payment, health quality and public health research?
DR. MC DONALD: How do you mean? This thing is trying to make the point that we have heard many times. We want to make it so that you collect it once and it gets split out among these other things.
DR. FERRANS: I was just going to leave in at the point of care. It is just repeating, capture the clinically -- at the point of care and enable derivatives, like that.
DR. AMATAYAKUL: This would be number seven then, study and promote capture systems that can make it faster and more economical to collect clinically specific information at the point of care and enable derivatives of that data to be used for payment, quality improvement and public health research and other purposes.
DR. BLAIR: I didn't hear the word once at the point of care. Once at the point of care?
DR. AMATAYAKUL: We'll stick once at the point of care in.
DR. COHN: My feeling is, both seven and eight are really an A and B of something.
DR. BLAIR: Yes.
DR. COHN: What is the topic? Areas that need research?
DR. FITZMAURICE: Support research, demonstration and evaluation studies, period.
DR. FERRANS: Mike, I have a question for you. When we use the words support research, what does that mean in the budget allocation process?
DR. FITZMAURICE: It most directly means support through a grant mechanism. It could be interpreted to extend to contract mechanism. In a broader sense it could mean intramural research, but most directly it means support through a grant mechanism.
DR. FERRANS: I think what I meant to say is, does this mean take existing research dollars and shift them to this, find new money, or --
DR. FITZMAURICE: It means take whatever research dollars you have.
DR. FERRANS: Is that what the committee -- and I am asking the members -- is that what the committee is recommending, or are we saying that we should augment the amount of money, and is that even something appropriate to recommend? I don't know.
DR. FITZMAURICE: It can take two years to initiate a new program. You put it into a proposed budget, and then a year goes by and you put it into a recommended budget, and then gets passed by the Congress.
DR. FERRANS: I just want to make sure we are clear. Forget about what the wording is up there. What do we really want the Secretary to do? Do we want to increase the level of informatics research? Do we want the current level to focus on this? This is something that Betsy educated me on, when people put some of these things forth. That must means that sometimes they oppose -- it de-emphasizes other programs that they consider to be worthy. So the intent is good, but --
DR. FITZMAURICE: Since we are in a lot of different government agencies, we think that this should be a high priority, but we are not in a position to judge what should be given a lower priority in each agency that might do this kind of work. But we are saying, as a recommendation of the national committee, we think this is of high priority and it should be done.
DR. COHN: I think we mean fund, not support, first of all. The question is whether we want to add something about the nature of the funding.
DR. FERRANS: I just don't know.
DR. FITZMAURICE: Support increase in funding for it? Does that get the sense of what you are trying to say, Rich?
DR. FERRANS: If there was consensus -- that was my recommendation, that whatever -- the more increases there are, then the more new -- I am fairly familiar with the current programs.
DR. AMATAYAKUL: So seven 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, one, at the point of care, and enable derivatives of that data to be used for payment, quality improvement, public health, research and other purposes, and B, basic health care informatics research on health data representation, data mining methods, work flow efficiency, change management and human-computer interfaces.
DR. FITZMAURICE: I might put, at the beginning it would be undertake, so that everything starts with a verb.
DR. AMATAYAKUL: So up above seven, the sentence preceding seven is gone then. We are not making this a part of the previous --
DR. FITZMAURICE: Right.
DR. FERRANS: So on six, this support should be stricken.
DR. BURKE-BEBEE: This support should, on the right-hand bottom of your screen.
DR. AMATAYAKUL: This here?
(Simultaneous discussion.)
DR. AMATAYAKUL: Got you. Then we have this hanging thing, provide leadership and funding to accelerate the development, implementation and education of a national health information infrastructure. HHS should work in collaboration with other federal departments and the private sector on demonstration projects, test beds and/or networks such as the GCPR framework project.
DR. FITZMAURICE: I would add in there evaluations somewhere.
DR. FERRANS: May I also add in that unless there are specific directions sometimes, the federal government has trouble working with state governments. There is the idea of federal departments -- I was hoping to say federal, state and private. I know North Carolina has a big initiative.
DR. FITZMAURICE: Federal departments, state governments and the private sector?
DR. FERRANS: I don't want them left out because they weren't specifically mentioned.
DR. MC DONALD: I think that is a good one. I have had a lot of experience working with state governments, and it has worked out very well for both.
DR. COHN: I'm going to make a comment here that sounds very much like Clem's comment about, it is hard to argue about this one because it is like Mom and apple pie. I might have more understanding if I could figure out what you mean by national health information infrastructure, since the early definitions seem to include all the previous eight recommendations. I understand the new standards are a key part of that infrastructure, so -- what exactly are we talking about here? Are we talking about funding the T1 lines? What exactly are we talking about here that we haven't been doing already? Maybe you could elucidate that or clarify that for me. It is hard to argue against.
DR. FITZMAURICE: Since a lot of this is about interoperability and comparability of data, I would envision that providing this leadership and funding would illustrate interoperability of health systems at these different levels, and also the comparability of data at the different levels, that is, between federal departments and the state governments, between both of those and the private sector. I don't want to draw a million lines between each entity, but we are promoting interoperability and comparability of data.
DR. COHN: If this is a research agenda then, why don't we stick it under number eight?
DR. FERRANS: I agree. I think that is a very good idea. One example I was going to give you, Simon, and your point is well taken about the HII definition in NCVHS and how it doesn't encompass everything. Also, the biomedical applications in the next generation Internet, which is an NLM led project. That is the kind of thing where you are saying this is something going to lead towards interoperability, has relevance with standards, is funded in different places. Then there are all these other projects that are similar to that all over the map.
DR. GREBERMAN: Those deal with potential cost issues though or reimbursement issues. For example, the legislation that facilitates the use of telemedicine in remote areas by reducing barriers because of cost. I wasn't sure whether that was included in this context or not.
DR. AMATAYAKUL: We have a definition for national health information infrastructure in the glossary.
DR. COHN: Right, it includes everything else that we have been talking about, that was the point. So I was just trying to figure out how this was different than the other seven recommendations. That was really the question.
I'm happy with the way you have described it. I would speak against it as a main recommendation, but it is fine as a C someplace.
DR. FITZMAURICE: Margaret, under C, is there an extra departments after state government, or is that deleted
DR. AMATAYAKUL: This one is deleted. But Mike, this word evaluations that you asked to have added, it doesn't seem --
DR. FITZMAURICE: Well, we do have evaluation up above. I'm just thinking, demonstration projects, maybe demonstration and evaluation projects. Just to have something in there that we are not seeing what we are getting for our money. That is fine.
DR. AMATAYAKUL: Is that better?
DR. FITZMAURICE: Yes.
DR. BLAIR: Can I ask a question about the word evaluation? One of the things that makes me a little nervous about that particular word is, I am concerned that people will feel like we have to evaluate that before standards are implemented. I wanted to make sure that that was not what was being thought of here.
DR. FITZMAURICE: Jeff, I don't think that it does. It talks about working with the federal, state and private sector on demonstration and evaluation projects. So it is all one phrase, and test beds, other networks. I don't get the sense -- and others jump in if they think that I am wrong -- I don't get the sense that it says hold up everything until we can evaluate these projects.
DR. GREBERMAN: It is a minor point. Should it be departments working with science and technology policy, R&D, et cetera?
DR. FITZMAURICE: I don't think it does. OSTP would be the oversight. Whatever we are doing with their framework --
DR. GREBERMAN: Departments just might mean like the Department of Defense, the Department of Veterans Affairs, et cetera. It's just the wording, that's all.
DR. FERRANS: I think all this is saying is, let's help develop the NHII. I think it is fairly innocent by itself.
DR. AMATAYAKUL: But Mike, if you have got accelerate the development implementation and evaluation of a national health information infrastructure, do you mean evaluation here by projects as well? Isn't that understood?
DR. FITZMAURICE: It could be. I'm not strongly wedded to it. I don't want to have the sense that we are putting these projects out there and not evaluating the projects or the test beds or the networks.
DR. COHN: When we say accelerate the development, implementation and evaluation of an NHII, we should accelerate the development and implementation of an NHII, and then go around where you talk about work in collaboration and do demonstration and evaluation of test beds.
DR. FITZMAURICE: That's a good suggestion, yes.
DR. AMATAYAKUL: So the whole thing reads, accelerate the development and implementation of a national health information infrastructure. HHS should work in collaboration with other federal components, state governments and the private sector on demonstration and evaluation projects, test beds and/or networks such as the GCPR framework project.
DR. COHN: Sounds good.
DR. AMATAYAKUL: We are now on 10. Ten was six. I'm not sure I have my numbering right. I think this is nine.
(Simultaneous discussion.)
DR. AMATAYAKUL: It's a new number. Don't worry about what number it is.
DR. MC DONALD: This is another one of the research projects, though.
DR. AMATAYAKUL: No, this is a new separate --
DR. MC DONALD: No, it is, because we didn't have a separate one before. But now we have made a separate one for research projects, and this is probably D under that.
DR. AMATAYAKUL: Oh, you want to make this D?
DR. MC DONALD: We may have some overlap.
DR. FERRANS: That might actually be even a higher priority.
DR. COHN: Maybe that is an A.
DR. FERRANS: Yes, I was just going to say.
DR. AMATAYAKUL: Okay.
DR. MC DONALD: There is one tiny wordsmithing. You are saying, demonstrate the benefits and the costs. I think you want to demonstrate the benefits and measure the costs.
DR. COHN: Thank you.
DR. FITZMAURICE: Or measure both of them.
DR. MC DONALD: You are not going to demonstrate the costs.
DR. COHN: Do you want to read that paragraph?
DR. AMATAYAKUL: This paragraph says, demonstrate the benefits and measure the costs of using uniform data standards for PMRI. Research and demonstration projects should be funded to measure the added value for use of PMRI standards. Areas where value may be demonstrated include clinical performance measurement, use of practice guidelines, reduction in medical adverse events and public health surveillance and intervention.
DR. COHN: Let's put that as A for the area before.
DR. AMATAYAKUL: I'll move it later.
DR. BLAIR: Mike actually had a better way to say that beginning part. Do you want to do that?
DR. FITZMAURICE: Al;l I said was, quantify the benefits and costs. But I don't know that I like your way better than my own.
DR. BLAIR: I liked the demonstrate the benefits and measure the costs.
DR. FITZMAURICE: I like that, too.
DR. AMATAYAKUL: The next major item, new number, whatever it is, is, promote enabling legislation for use and exchange of electronic data, including the following. A, comprehensive federal privacy and confidentiality legislation. This should insure that all health information in any medium used for any purpose and disclosed to any entity receives equal protection under law, and that individuals have private right of action under such law.
DR. FERRANS: General question. Should this be promote enabling legislation? We don't want to say proposed. It comes from somewhere, and when it comes, you should promote it. What are we asking? If we think it should propose, it should be very specific.
DR. FITZMAURICE: The Secretary can through the Administration propose legislation and usually find a friendly Congressman to introduce it.
DR. FERRANS: Absolutely.
DR. BLAIR: Yes, but are we asking them to propose new legislation? I thought that what we are saying here is, we want t he Secretary to support many of the enabling legislation that protect the privacy and confidentiality of health records.
DR. FITZMAURICE: I think Jeff has a good point. If something exists there that the Secretary can support, the Secretary should support that, rather than proposing her own legislation.
DR. BLAIR: It has been six years they have been trying to get some legislation through. I feel like we don't want to ask her to propose something new. They couldn't even get the things that she proposed two years ago.
DR. FERRANS: I don't want to wordsmith it to death. Should it be strongly support?
DR. BLAIR: Yes.
DR. FERRANS: We want the bar to be high on this, as far as -- strongly support enabling legislation.
DR. FITZMAURICE: Support strongly, starting with verbs.
DR. MC DONALD: Getting into the next two sections, I would suggest we not be so specific, because the different legislation that might pass, you basically might get them into conflict, but what is going to pass. For example, the right of private action is a very controversial issue, and depending on how it is written and how it is specified, it could be very expensive. It might even stop the whole process.
DR. FERRANS: I don't even know what it means, so --
DR. MC DONALD: It means you can sue for anything you want.
DR. FERRANS: Because somebody releases information about you, you can sue because you're harmed.
DR. BLAIR: I think the key thing is, we want the Secretary to support legislation that will strengthen privacy and confidentiality of health care information, and we say that.
DR. MC DONALD: If we go into details, then we write the legislation, and we want to let the Congress do that.
DR. AMATAYAKUL: So we have, support strongly enabling legislation for use in exchange of electronic data, including the following. Then just A, comprehensive federal privacy and confidentiality legislation?
DR. FITZMAURICE: We don't have to say including the following.
DR. MC DONALD: I think you want to say comprehensive federal legislation somewhere.
DR. FERRANS: No, B is the center for health care privacy and security. That is the B.
DR. FITZMAURICE: Oh, we do want to keep that.
DR. MC DONALD: I'm not sure we want to keep that, either. That is part of the legislation. Isn't that part of the privacy legislation?
DR. BLAIR: That may be a new proposal. That is possible. I like that idea.
DR. FITZMAURICE: I actually like it, too.
DR. MC DONALD: Just beware. One other privacy legislation that was put under the FBI, I tell you, I want to quit practice if I've got to worry about the FBI if I make a mistake.
DR. FERRANS: Amen.
(Simultaneous discussion.)
DR. AMATAYAKUL: -- federal privacy and confidentiality legislation. This should insure that all health information in any medium used for any purpose and disclosed to any entity receive equal protection under law, period. Then we have a B, establishment of a center for health care privacy and security. This should help the health care industry identify and correct vulnerabilities and respond appropriately to privacy and security incidents. This center would develop privacy and security training, produce model contract provisions, research causes of privacy and confidentiality violations, continually monitor violations, privacy legislation and regulation, and issue periodic reports.
There is also a C under here, uniform recognition by all states of electronic health recordkeeping and electronic authentication signatures.
DR. FITZMAURICE: Could I ask a question about B, the establishment of a center for health care privacy and security? We envision this being a federal center or an institute in the private sector somewhere, maybe with some federal funding.
DR. AMATAYAKUL: I actually saw it like CERT.
DR. FITZMAURICE: Like what?
DR. AMATAYAKUL: CERT, out of Carnegie Mellon.
DR. FITZMAURICE: So it would be a private center funded?
DR. MC DONALD: This thing could be a monster or a great thing. There are certain countries in the Middle East that have police to make sure you don't do anything wrong, and this could be like that. I am a little nervous about how this is constructed, especially having seen legislation that --
DR. FERRANS: What I don't want it to be is a regulatory agency, where health care institutions spend months preparing documentation that they are in compliance with huge manuals of checklists, rather than going about the business of taking care of patients.
DR. BLAIR: Margaret, how did you envision this entity? Would it be responded to people who complained? But the people wouldn't know that they had their health care violated.
DR. AMATAYAKUL: I saw it like CERT. I saw it as a private organization that would be a place for people to go to report that there are issues with respect to privacy and would provide training and all these other things that are listed here.
DR. MC DONALD: Continuing monitoring violations suggests a regulatory role.
DR. FITZMAURICE: We might take that out.
DR. MC DONALD: A private organization that would actually make it easier for people to implement privacy properly.
DR. FITZMAURICE: One might measure the costs and the benefits and say, you are spending $20,000 to protect 20 cents worth of data with this rule, but here is another rule, that you are overlooking something that needs to be protected, some kind of independent advice.
DR. COHN: So we need federal enabling legislation for the private sector for health care privacy and security?
DR. MC DONALD: Good point. What is the sentiment of the group, though? You want it as a federal regulatory agency or you want it as a --
DR. AMATAYAKUL: The other thing I was responding to, I know, when I put this in initially was the center that they are creating in response to the IOM patient safety.
DR. COHN: Do you want to call it public-private center? Are there such things?
DR. FERRANS: Where did this come from again?
(Simultaneous discussion.)
DR. AMATAYAKUL: I put it in. We can take it out just as easily as we put it in.
DR. FITZMAURICE: One might argue that some already exist, like Georgetown University as a center.
DR. MC DONALD: The other part of it is, there is a whole other report coming out on privacy, so I think we should take a strong stand that we want federal legislation for privacy. I think the second D is important for all this to work, and this middle one as a very specific mechanism, depending on where you think the problem is.
DR. AMATAYAKUL: Do you want to take this out?
DR. MC DONALD: If you put it in and it didn't come from testimony, yes.
DR. FITZMAURICE: It's an idea. If the committee has that as an idea, the committee can discuss it.
DR. COHN: The question is, if it is private, it doesn't need federal enabling legislation, and if it is public, then what exactly are we having to do? My own feeling generally is that these recommendations are getting to be a little long. I think about the rule of three, and we have gone three times three now. So I think we definitely need a recommendation on privacy, but I would think of something short and succinct as opposed to long with multiple bullets.
If you want to make an argument about it being a public center that needs to be federally funded, then it should be in here. If it is going to be private, it shouldn't be here.
DR. BLAIR: Maybe it is quasi.
DR. COHN: Is it public-private?
DR. BLAIR: Public-private, yes.
DR. FITZMAURICE: These things have a way of getting legs of their own that are not always in the best interest of the whole nation. They can get captured by one viewpoint or another viewpoint, if there is no governance to keep a balance in them.
DR. BLAIR: Clem, your point is correct; there could be some time in the future abuse, but I think for us to say we are not going to try to do something good because in the future it might be abused --
DR. MC DONALD: I'm saying we have to be minimalists. We shouldn't be building things just because it might do good. We don't have that much money, time or energy in the country.
DR. FERRANS: Here is the issue, Clem. If I think out the scenarios on either side, it might turn into something like the privacy seals of approval that have lost all credibility on the Internet. On the other hand, if it is so enamored with privacy that it does it at the expense of any use of information for large databases, and then that sets up a thing with people doing public health research, it could go any way.
It is not clear to me. I'm kind of ambivalent now, the more I think about it.
DR. MC DONALD: We have got a very long set of recommendations. People are going to get tired by the time they get this --
DR. GREBERMAN: Just as a suggestion, if you want to have it as a placeholder to modify it a little bit, if you don't want to drop it entirely, which is okay with me too, but if you want to keep it as a placeholder, establishment of public-private mechanisms to help the health care industry identify, as a second sentence, and leave it at that without the details.
DR. FITZMAURICE: Perfect.
DR. AMATAYAKUL: And end there? Public health record, keeping an electronic authentication of signatures.
DR. FERRANS: I have a question on this one. I thought that there was some sentiment not just about uniform recognition of electronic health recordkeeping, but also uniformity of, because recognition is saying yes, this is a valid record, but uniformity would imply things like, you should keep it X number of years.
DR. FITZMAURICE: Uniform requirements across all states? Would that fit the bill?
DR. FERRANS: I thought there was sentiment -- when we looked at the state laws issue, I thought there was more sentiment about bringing more uniformity towards requirements, rather than just recognition that this is a legal document. That is a no-brainer.
DR. BLAIR: So let's separate them out into two separate things. One is the recognition of health records in electronic form. A second point is that state standards for health records be consistent.
DR. FITZMAURICE: It is hard to recommend to the states that their standards be consistent. We are recommending to the Secretary legislation that will result in uniform --
DR. BLAIR: Maybe we should say, instead of that their regulations be consistent, that we state that state regulations should not impede electronic transfer of health records? No, some people are going to jump out on that one. We don't want to say that. The uniformity of --
DR. FERRANS: What about uniformity by all states of electronic health recordkeeping and electronic authentication?
DR. BLAIR: I think we only want the uniformity to the extent to which it enables sharing of health data.
DR. FERRANS: That is a good way to put it. If we add that onto the sentence, to the extent that it promotes, so that there is a purpose to the uniformity, rather than a single federal standard for everything.
DR. BLAIR: To the extent that it enables electronic data sharing.
DR. FITZMAURICE: If we go back to the beginning of this, it says promote enabling legislation for use in exchange of electronic data, including the following. So that would be including uniformity across all states of electronic recordkeeping requirements?
DR. BLAIR: That is too broad a statement, though. That is why I was trying to say, let's break it up into the specific things we could agree with. The first thing we could agree with is state recognition of PMRI in electronic form. That is one thing we want. The second thing is state regulations that enable electronic sharing.
DR. FERRANS: I'll give you a perfect example of electronic authentications. If I am in California and my records are here in Maryland, and Maryland will not accept a digital certificate, signed document that is an authorization for a release of records, then we are going to have to fax it or send a letter or do something else. But if that facilitates the electronic interchange --
DR. AMATAYAKUL: Originally we had, HHS should promote legislative initiatives that enable electronic retention of PMRI, and acceptance of electronic signatures to authenticate PMRI in all 50 states. This is intended to promote the electronic exchange of PMRI that will contribute to administrative simplification.
DR. BLAIR: That's fine.
DR. GREBERMAN: Do we get into electronic signatures elsewhere?
DR. BLAIR: No, not in the recommendations.
DR. GREBERMAN: I guess there is one point that I would like to ask us to think about. I don't know how much detail we want to get into in this, but one of the points that she made was, electronic records should have an audit trail that automatically records a created record and modify it, when and what modifications were made.
This gets us into some practical issues. I wasn't sure what we were expecting in terms of the system when we talked about electronic identification or signatures.
DR. BLAIR: Audit trails are both in the proposed legislation and in the regulations.
DR. FITZMAURICE: I would leave that as a detail of the regulation.
DR. GREBERMAN: I was bringing it up in that context. I guess we can deal with it later.
DR. FITZMAURICE: I would go with just uniformity and acceptance of electronic PMRI for legal purposes across all states, and for uniformity in the use of digital signatures across all states.
DR. AMATAYAKUL: I'm sorry, Mike, what are you saying?
DR. FITZMAURICE: I would go for uniformity across all states in two things, the acceptability of electronic PMRI and in the application of digital signatures or electronic signatures.
DR. AMATAYAKUL: Uniformity across all 50 states in the electronic retention of PMRI and acceptance of electronic signatures?
DR. FITZMAURICE: Yes.
DR. AMATAYAKUL: Do you want this extra phrase, this is intended to promote the electronic exchange of PMRI that will contribute to administrative simplification?
DR. FITZMAURICE: It kind of goes without saying. It is why we're doing a lot of this. It doesn't hurt, it doesn't help.
DR. FERRANS: I don't want to beat this to death, but I thought the electronic signatures piece was in the security NPRM that is about to be finalized. I'm already thinking this is covered, and why are we asking to promote legislation.
DR. BLAIR: This was consistency in state laws. That is what this was.
DR. AMATAYAKUL: And electronic signatures being taken out.
DR. COHN: And we'll be holding hearings on this in the fall, so it doesn't need to be -- my understanding of the digital signature is that it is the digital signature for the covered transactions.
DR. FERRANS: Oh, it is just for the covered transactions.
DR. BLAIR: Right, and this is for PMRI.
DR. FERRANS: Is this a covered transaction?
DR. COHN: If it was going to be part of the security regs, then it should cover --
DR. BLAIR: But it's not. They have had to table that, so I really feel like it is important for us to mention support for this.
DR. FERRANS: If it is tabled, it is highly relevant to what we are doing.
DR. BLAIR: Right, it was pulled out. The electronic signatures was separated from security.
DR. COHN: That is because things weren't ready, not that they weren't interested in moving forward on it.
DR. BLAIR: That's true.
DR. COHN: Jeff, the question is though, right here we are saying there needs to be legislation. We are going to be holding hearings on it, probably this October, here. So the question is, if it is already covered by legislation, let's not waste the states' regulation.
DR. BLAIR: I think this was getting at a different point. My thought is that this was getting at the issue -- because remember, one of our focus areas in the report was how inconsistent state laws impeded the transfer of PMRI. So that is what I believe this recommendation is addressing, is that the areas in which inconsistent state laws are impeding the transfer of PMRI, and the lack of consistent state law on PMRI is one of them.
DR. AMATAYAKUL: We have already got some states that are creating electronic signature laws, because they know that the federal law is not going to be real quick. So then we are going to have, starting all over again, all these different laws.
DR. COHN: It actually just pulled out the electronic signature part of the Kennedy-Kassebaum bill. It describes it only with respect to the transactions referred to in the subsection A. So it makes sense to include this.
DR. FITZMAURICE: In place of electronic, I would substitute digital. I hate to embed existing technology in it, but electronic signature could be a picture.
DR. BLAIR: That is a good technical correction. I agree, digital signatures. Margaret, I thought we put in the word authentication, we want consistent authentication, parentheses, i.e., digital signatures.
DR. AMATAYAKUL: Well, we had that in the new one. I just took the old ones, so acceptance of authentication, and then in parentheses we'll put digital signatures?
DR. BLAIR: Yes.
DR. COHN: Do you want to read it?
DR. AMATAYAKUL: Uniformity across all 50 states in electronic retention of PMRI and acceptance of authentication of digital signatures. This is intended to promote the electronic exchange of PMRI that will contribute to administrative simplification.
DR. FITZMAURICE: Could you back up just a bit to the same one? Uniformity in electronic retention. We would also want to say what recognition was meaning to connote, namely, acceptance as a legal document.
DR. BLAIR: I do think we have picked that up, because we have added authentication. The authentication authenticates it as a legal document as well as authenticating the individual signing it.
DR. FITZMAURICE: Maybe acceptance of electronic authentication.
DR. AMATAYAKUL: Digital signatures.
DR. BLAIR: Am I wrong, Michael, in covering what you were trying to say?
DR. FITZMAURICE: You can store electronically the PMRI, but we still want to have a paper record.
DR. AMATAYAKUL: But it says acceptance of electronic authentication.
DR. FERRANS: Can we take out electronic?
DR. AMATAYAKUL: Here?
DR. FERRANS: On both of them.
DR. FITZMAURICE: Then I would take digital signatures out of parentheses so they know clearly what we mean.
DR. FERRANS: No, no, no. Should it be electronic retention of PMRI?
DR. FITZMAURICE: Yes, I think so. We want to specify that.
DR. BLAIR: I think you also want electronic authorization.
DR. FITZMAURICE: Maybe uniformity across all 50 states in acceptance of electronic retention and acceptance of electronic authentication.
DR. AMATAYAKUL: Uniform across all 50 states and acceptance of electronic retention of PMRI and electronic authentication. No.
DR. FITZMAURICE: Get rid of acceptance of.
DR. AMATAYAKUL: I think uniformity across all 50 states of electronic retention of PMRI and acceptance of.
DR. BLAIR: Why don't you say of electronic health records including retention and authentication, parentheses, digital signatures?
DR. AMATAYAKUL: Electronic health record? I don't think -- we didn't use that before, no.
DR. COHN: I think we've gotten pretty close. I would ask you to do wordsmithing --
DR. FITZMAURICE: Maybe wordsmithing is doing nothing.
DR. COHN: Yes.
DR. AMATAYAKUL: Can we take a two-minute break, please?
DR. COHN: How about a 10-minute break?
(Brief recess.)
DR. BLAIR: Shall we convene?
DR. AMATAYAKUL: Whatever number this is next is, provide incentives to promote the equitable distribution of the costs for using PMRI standards among all major beneficiaries of PMRI. This may take the form of A, government licensure of those vocabularies selected for adoption, so that these vocabularies are available for use at little or no cost, B, private sector incentives such as payor and researcher reimbursement of providers for use of clinically specific data.
DR. BLAIR: And in this case, A has been moved up so that it is now part of three, right?
DR. AMATAYAKUL: Right.
DR. BLAIR: In addition, Bill Yasnoff gave us some new wording for B.
DR. FERRANS: Why is it payor reimbursement? Isn't it provider reimbursement?
DR. COHN: Where are you looking at?
DR. FERRANS: B, payor and researcher reimbursement. The payors don't get reimbursed, they do the reimbursing. I think it is provider reimbursement.
DR. BLAIR: We have a rewording of this anyway from Bill Yasnoff.
DR. COHN: Let's see what we've got here.
DR. AMATAYAKUL: What he had was -- let me just read this. This may take the form of reimbursement incentives for improved quality of care, including documentation and reporting requirements designed to provide advantages for the use of PMRI.
DR. COHN: I really must be very dense. I'm not understanding that.
DR. BLAIR: This replaces B.
DR. COHN: I know. I just don't understand what the sentence is, though.
DR. FITZMAURICE: Does that mean, if you are a provider of care and your patients get better faster, let's say, so you have an improved quality of care, you get paid more?
DR. BLAIR: No. I think what he is saying is -- remember, this is under the recommendation to have additional incentives to improve quality of care. So he is tying this very specifically to that by saying that the payors should put in place incentives for quality as well as cost.
DR. FITZMAURICE: Nice, but how does that relate to PMRI standards?
DR. FERRANS: I think it should be something like reimbursement centers for use of PMRI in documentation, or to improve the quality of documentation or something like that. Selected PMRI standards.
DR. COHN: If we have gotten rid of A, we need to make sure under two that that is really covered. Was the piece that we already put in around the vocabularies, does that fully cover A?
DR. FERRANS: That is what I was talking about earlier today.
DR. COHN: I was just wondering if it was really covered or not, or just partially covered.
DR. FITZMAURICE: I just don't know what we are aiming for.
DR. AMATAYAKUL: Maintenance, enhancement, distribution, testing, application of clinical vocabularies which have the potential to be PMRI standards for government licensure or comparable arrangements so these vocabularies are available for use at little or no cost.
DR. FERRANS: That sounds like it is a federal initiative to underwrite vocabularies for the federal government. I think that is what I was --
DR. COHN: I think this was is actually a little different.
DR. BLAIR: So we need this in addition to what we had up there?
DR. COHN: Yes. That was part of the question of whether or not we needed an A and B to begin with.
DR. BLAIR: Yes. Good catch, Simon. So we are going to leave A in, and we're going to go on to discussing B now?
DR. COHN: Right.
DR. AMATAYAKUL: So we're going to leave A in here?
DR. BLAIR: Yes, because this is under the topic of incentives. With respect to B, did you want to read Bill Yasnoff's statement again?
DR. AMATAYAKUL: Sure. Let me read the intro. This will provide incentives to promote the equitable distribution of the costs for using PMRI standards among all major beneficiaries of PMRI. This may take the form of -- and then B would be reimbursement incentives for improved quality of care, including documentation and reporting requirements designed to provide advantages for the use of PMRI standards.
DR. FITZMAURICE: I don't understand that. I don't know who is getting paid and what they are getting paid for.
DR. FERRANS: People are getting incentivized for improved quality of care according to how it is constructed.
DR. FITZMAURICE: I can see paying for PMRI data that improves the quality of care.
DR. FERRANS: Reimbursement incentives for use of PMRI standards in documentation and reporting in order to improve the clinical specificity or quality or something like that.
DR. BLAIR: Maybe I ought to step back. Prior to his recommendation, if you go back to document 5.4, he felt uncomfortable with -- we struggled with this quite a bit, where we had B and then we had already eliminated C, which wound up saying what you just said, Michael, which is that the secondary uses of data would pay for the data. He indicated there was widespread concern and objection within the Centers for Disease Control that they might have to pay for data. So he was trying to give an alternative to us.
DR. FITZMAURICE: Data aren't free.
DR. COHN: In the old version it says HHS should also encourage the private sector to adopt such incentives. Incentives would include having payors and researchers fairly compensate providers for the use of clinically specific data.
I have a note here. I'm a little confused on how to handle this one. It isn't just private payors. There is a large payor that sits in the middle of this room, which isn't here today, that happens to be a federal payor, that we would also want to see have this applied to.
I guess the issue is that payors and researchers -- the question is, are we talking about PMRI or are we talking about in electronic formats? Maybe payors and researchers should increase reimbursement for services whenever data is substantially or completely in electronic format. That isn't quite what we are talking about.
DR. FERRANS: I thought this was going to be some kind of demonstration or research project. When we originally started talking about this, we said, hey, wouldn't it be nice if we tried some kind of -- if you document and report in SNOMED or in whatever, instead of just using CPT or other billing and reporting code sets that have less clinical specificity, we will pay you a little more. We wanted to provide some encouragement, some incentives, rather than, just do this.
DR. FITZMAURICE: If I can just elaborate a little bit on what Richard said, it is essentially, if providers supply the data that makes the system more efficient or delivery higher quality of care, then the provider should be paid for improving the system, for supplying the tools that improve the system, i.e., the better patient medical record information.
DR. FERRANS: Let me see if I can construct it a different way. If HCFA is looking at quality of care issues using vocabularies that lose a certain percentage of the clinical detail and there is an option to have people report in things that have more clinical specificity, more detail, so that they can look at issues of quality and outcomes and things like that, and people ought to be incentivized to do that. But I didn't think we were going to recommend that uniformly. I thought we were going to -- they were going to test out this notion in some controlled sort of fashion. I didn't think there was any evidence or body of literature to say people ought to have the option to document in whatever format and get paid more.
DR. BLAIR: I have fought long and hard to try to keep the notion of these incentives in to be fair to those testifiers that said we need to have incentives. I think we have struggled now for months to try to craft a recommendation where we could do that.
At this stage and at this time, I'm afraid that -- and especially in my conversation with Bill Yasnoff, he made several points that I felt I could not ignore. The points that he made was that if we improve the quality of care, providers benefit from that directly, because they are chosen by health plans, they wind up competing better, they wind up reducing their own costs. So providers benefit inherently by improving quality. I think we are going to wind up having tremendous difficulty getting support for being able to charge payors and researchers for data.
I think at this stage, my inclination is to let this one go.
DR. MC DONALD: I had interpreted this as the issue that -- leaving out the specificity, but the person who has to get into the electronic side of the clinical data has to do all the work and doesn't get any gain. So the feds get a gain by having cheaper quality review, the payors have a gain by having more stuff coming electronically, all these other people that are going to have gains out of it, the public health departments have gains by getting the data for communicable diseases. So the costs are on the wrong end of the stick. I thought there were going to be some general incentives for using the standards to accelerate it, but in proportion to some benefits to the larger players who get the gain.
DR. COHN: I also thought that. I think we have seen over and over again on these things that the benefits -- indeed, we see this in administrative simplification. The benefits of adopting PDI or anything else do not apply equally to all the players. Electronic data interchange benefits the payors a lot more than it does the providers. In the long run, providers would do well, but still not as well as the payors.
So the question is, how do we make this more equitable?
DR. BLAIR: And nobody has been able to craft a way to do that.
DR. COHN: One option here is to stay away from the specifics, where we say provide incentives to promote the equitable distribution of the costs for using PMRI standards among all the major beneficiaries of PMRI, and stop there.
DR. FITZMAURICE: That is what I'd do.
DR. BLAIR: Fine.
DR. COHN: And just leave it as a single sentence, recognizing that we couldn't come to the specifics.
DR. FERRANS: Although I like the vocabulary licensure.
DR. COHN: Let's see if we can stick that somewhere else. Maybe this somehow gets involved back into 3D or whatever, as part of that piece, because 3D almost covers it. It just doesn't quite.
DR. FERRANS: I don't even think that the availability at little or no cost is not an equitable distribution of the cost. It is lowering a barrier of adoption of PMRI standards.
DR. BLAIR: Right.
DR. COHN: So it should be in three.
DR. BLAIR: Why can't we leave A underneath there? It is B that I was saying that I couldn't find a way to craft B, where we could get support for it.
DR. COHN: Let's see if we can put the A somewhere else.
PARTICIPANT: May I make a comment on A?
DR. COHN: Sure. Come to a microphone.
PARTICIPANT: In looking at A, I wish Kathleen Frawley were here, because this is also a legal question. When I look at A, one of the things that comes to mind is the concern over the situation we have with the CPT codes and the copyright granted to the AMA rather than the government, rather than HCFA retaining the copyright on that, which has jacked up the cost of that to providers. It is also a very sore point to many providers.
So I have a question and a comment. My question is, government licensures -- I'd like to see that paragraph stand in there, stand alone, but just specifically head off a repeat of the CPT. My question is, does licensure -- is that the appropriate legal terminology or would it be licensure/copyright? Are the vocabularies considered copyrightable? Because the government could -- de facto, the government has licensed CPT code, but the AMA holds the copyright.
DR. MC DONALD: The government can't hold copyright. This gets complicated. What you want is free for the users.
PARTICIPANT: So can you get that stronger, so that we can't have a repeat of the CPT, where a non-government organization is charging and making money off of a required or recommended --
DR. FITZMAURICE: This is intended to head that off. You want to keep A, though.
DR. COHN: But I think A needs to be somewhere else.
DR. BLAIR: We already have a variation of A in three, so it is now in two places anyway.
DR. COHN: I think we can do a little bit of wordsmithing on three.
DR. MC DONALD: It is well under the equitable thing, because it really does spread the cost.
DR. COHN: But in three we already have a discussion around -- under 3D, we have government-wide licensure or comparable arrangements of these vocabularies available for use at little or no cost. The only issue here had to do with vocabularies which had the potential to be PMRI standards.
DR. MC DONALD: I agree. Then you can make it more simple by getting rid of that one.
DR. BLAIR: So what are we doing on this now?
DR. MC DONALD: Get rid of A and B.
DR. COHN: Get rid of A and B, but somehow -- the concept here that isn't in 3D or 3C has to do with the vocabularies that are selected for adoption as opposed to potential. That is what the difference is here.
DR. FERRANS: So that should actually go into four, which is provide funding in the future for.
DR. COHN: That is an interesting idea.
DR. FERRANS: To say, when a vocabulary is selected, then commit funding for insuring that it is available to all at little or no cost.
DR. BLAIR: Right.
DR. FERRANS: Bingo. We have laid out the benefit to those who would have their standards selected.
DR. FITZMAURICE: When you say vocabularies, do you also mean code sets?
DR. BLAIR: Vocabularies include code sets. That is the way we defined them.
DR. AMATAYAKUL: We should say terminologies if we mean code sets.
DR. BLAIR: Margaret, were you able to grab onto Richard's suggestion?
DR. AMATAYAKUL: So under four, we have for each standard recommended by NCVHS, commit funding for subsequent, A is development of implementation guide, B, development of conformance testing procedures and then C would be --
DR. COHN: In the case of terminologies?
DR. AMATAYAKUL: Government licensure of those terminologies selected for adoption.
DR. BLAIR: Right, as PMRI standards.
DR. FITZMAURICE: So that these vocabularies and code sets?
DR. COHN: These terminologies.
DR. AMATAYAKUL: Terminologies includes code sets such as CPT, ICD, as well as vocabularies such as SNOMED, et cetera.
DR. MC DONALD: You had distinguished those two things as different kinds of creatures? They both have codes and names on them.
DR. AMATAYAKUL: Look at page --
DR. MC DONALD: I read that. I know both of them intimately, and I think of them as the same things. You've got codes and names in both of them. Just for the record, there is no vocabularies except MEDRA that doesn't have a code in it, and there are no codes that don't have names in them.
DR. AMATAYAKUL: I know. We are using the term terminology to describe classification systems that include codes, the big bucket, as well as vocabularies that don't have big bucket.
DR. FITZMAURICE: Would it be clearer to replace the second terminologies so that these vocabularies and code sets are available?
DR. AMATAYAKUL: So it reads for each standard recommended by NCVHS, commit funding for subsequent government licensure of those terminologies selected for adoption as PMRI standards, so that these code sets, classifications and vocabularies are available for use at little or no costs.
DR. FERRANS: I want to get into a couple of issues with this language just to make sure we're clear. When we talk about -- someone might read this and think it is available for use, but if the government is licensing it, who is it available to. So if we would want to be specific there, we would say government licensure, so it is available in both the public and the private sectors. So I would want to add that.
The other thing is, getting back to the testimony, there was discussion -- rather than necessarily licensure, the idea of underwriting costs of development and maintenance as an alternative to licensure. I don't know whether we want to get into that specific detail.
DR. COHN: I think it is the same thing.
DR. MC DONALD: We're using the same wording in the front.
DR. AMATAYAKUL: So it reads government licensure of those terminologies selected for adoption in PMRI standards with these code sets, classifications and vocabularies are available for us in the public and private sectors at little or no cost.
DR. COHN: Good. So are we done with the recommendations?
DR. BLAIR: No, we've got more recommendations.
DR. AMATAYAKUL: The last one is, facilitate protection of United States interests in international standards development, A, through HHS participation in international health care informatics and standards development organizations, B, in cooperation with the Secretary of the Department of Commerce through monitoring 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.
DR. FITZMAURICE: I would suggest taking out protection of and just say facilitate United States interests. Protection sounds like we're the big bad guys, ugly Americans, coming in to protect our interests.
DR. BLAIR: I thought it was the other way around. I thought it was European vendors and nations that feel like they are having difficulty competing with U.S. vendors and software companies, and erecting standards as barriers. So I felt the protection was on their side.
DR. FITZMAURICE: If they read this recommendation, they may take offense at it, whereas our intent is to facilitate our interest. That could be advocacy as well as protection.
DR. BLAIR: The only thing is, you're worry about their interpretation.
DR. FITZMAURICE: No, I'm worried about the interpretation of the man on the street, who will look at this and say, is this a protectionism mechanism of the United States, that we are going to go into all these other standards development activities internationally and weigh in heavily?
DR. GREBERMAN: I guess I would like to see a more positive view, too. I think clearly from a policy standpoint, the government is promoting international harmonization, and trying to insure coordination with the international standards community of its activities.
DR. MC DONALD: I would go in the other direction and say, most of these companies would plead for you to stay out of their way and not be helpful. So I think that that is really begging the question. We have done very well in the U.S. for all these years in international standards without having special legislative interventions.
DR. FITZMAURICE: This doesn't call for legislative intervention.
DR. MC DONALD: I know, but why does poor health care need the help when the companies that are competing internationally very successfully are not asking for this kind of help. So you've got Microsoft and Sun and Ford and Chrysler -- I guess that is a German company now, and General Motors, and it goes on down the line, and oil companies, and Halburton. It seems out of place to me.
DR. SCANLON: I do have some examples of where companies did come to us for help, because in some countries there were some standards being developed that were clearly meant to preclude -- I'd like to say a little more positive word here, but I can come up with examples that -- we got past it by working with the trade associations and with both sides of the Pacific, in this case.
DR. BLAIR: Can you suggest some wording or something?
DR. FERRANS: I was just going to say, I certainly don't want the word protection, since most Europeans feel they need protections from our concept of privacy.
DR. BLAIR: So Michael's suggestion on rewording then? Is that what we are converging towards?
DR. FITZMAURICE: Just take out protection of and say facilitate United States interests in international -- I would insert data standards development, as opposed to all standards development.
DR. BLAIR: Simon in saying, promote U.S. interests.
DR. FITZMAURICE: Okay, sure, promote, advocate. I wouldn't vote against that.
DR. MC DONALD: In reference to this, in the body of the text there is still text that says, fund people going to international meetings. I thought we expressed interest in taking that out in a previous meeting.
DR. COHN: I didn't realize it was still there. We'll go back and check that in just a minute.
DR. BLAIR: Could you tell Margaret specifically where that is?
DR. COHN: Let's finish this first and then we'll deal with that.
DR. AMATAYAKUL: So it now reads, promote United States interests in international data standards development.
DR. FITZMAURICE: Maybe health data.
DR. COHN: Is that A or B?
DR. AMATAYAKUL: This is our main bullet, our main point, main number. Then, through HHS participation in institution health care informatics standards development organizations. Clem, is that what you're -- and then in cooperation with the Secretary of the Department of Commerce, monitoring the activity of the U.S. health care information system vendors abroad and taking appropriate steps to correct anti-competitive activities that may be based on standards.
DR. COHN: I think it's fine. It should not be the first recommendation and it definitely shouldn't be the last.
DR. AMATAYAKUL: This is the last.
DR. COHN: It shouldn't be the last. It should be hidden somewhere in the middle. I think people remember the first and last recommendation, and I don't think this is worthy of either significant comment or being pointed out as --
DR. AMATAYAKUL: Second to the last?
DR. COHN: Maybe that's it. So I think we're finished. Jim Scanlon has now joined us. Jim, did you have any comments?
DR. SCANLON: No, I'll just pick up where we are.
DR. COHN: We had a question. It had to do with recommendation two, which is --
DR. BLAIR: Maybe you have to read one first.
DR. COHN: One was, adopt guiding principles that we have talked about as a criteria for selecting uniform data standards for PMRI. Then number two would say, the Secretary to direct the NCVHS to select uniform data standards for PMRI according to the criteria of these guiding principles. Then it says, the NCVHS will recommend an initial set of specific standards that in 18 months, following the Secretary's acceptance of this report.
Now, the questions we have have to do with -- in terms of the process of this report being delivered, whether it would be an actual acceptance by the Secretary, will we expect to see anything from the Secretary, should we describe this as the Secretary's receipt of this report?
DR. SCANLON: There is no such thing as an acceptance, so there will be an acknowledgement, and then there will be a look at all of the recommendations and other issues in the report. Let's see what the word would be.
DR. COHN: Acknowledgement of this report?
DR. SCANLON: Yes, because the Secretary clearly will get the report and probably shortly thereafter thank the committee and say I am not going to circulate it for policy review within HHS, where there will be a much more detailed look at the recommendations and the framework. That could take a long time. You don't necessarily want to wait until then. But you are looking for some sort of a go-ahead, clearly. Maybe we should put a conditional kind of a sentence here.
DR. FITZMAURICE: You mean something like, if you don't object 18 months following delivery of these recommendations to you, we plan to also deliver something else to you?
DR. SCANLON: Well, a little more diplomatically. I'd say with your agreement or something like that.
(Simultaneous discussion.)
DR. FERRANS: The reason we asked the Secretary to direct, we felt HIPAA was less clear about whether the NCVHS had the authority to go ahead and start selecting PMRI standards. But if the Secretary directed the NCVHS to do so, then certainly they would.
DR. COHN: But then there is the reality of the fact that we are not likely to hear anything directly back. So if we set this up in a way that we are waiting for Secretarial action -- this may be something that you want to talk to others.
DR. SCANLON: Yes, let me see about the right wording. I don't think it changes the reality of the situation. We are in a little different territory here with the PMRI standards than we were with administrative simplification standards. I don't know to what extent there may be existing standards or to what extent consensus may exist on some of the PMRI data standards, as they did on the administrative simplification standards.
So that whole process may or may not be the right model. I think the idea of identifying consensus, if it exists, or to the extent that there are existing standards, and the NCVHS identifying that consensus in existing standards clearly is quite consistent with the rest of HIPAA.
The whole approach in the earlier part of HIPAA was the idea of industry consensus identifying consensus and then the NCVHS acting as the forum to hear all this, balance and then make recommendations. Is there a parallel situation in the area of PMRI, or is NCVHS -- my only worry here is that NCVHS may be looking like it is putting itself into a position that does not fit with the model in the rest of HIPAA.
DR. BLAIR: Let me ask you this, because there is something that we would like to be able to get from the Secretary. The administrative simplification provisions simply made a general statement that we were to study uniform data standards and make recommendations and legislative proposals, whereas for financial and administrative transactions, it said that we were to select claims attachments, referrals, eligibility, enrollments, da da da. In this case, because it is not as proscriptive and definitive, somebody might be able to argue, if we wind up selecting both message format standards and vocabularies, that somebody would say, well, it didn't say anything about vocabularies, or it didn't say anything about vocabularies for drug codes, picking at it because it didn't explicitly give us directions.
So the thinking that we had would be that it would give us a little greater authority, if the Secretary came back to us and said, yes, go ahead and select the standards. On the other hand, if you know that that is going to delay us by many months before we get such a directive, then what is your guidance?
DR. FITZMAURICE: We are also coming up to a particularly sensitive time when the Secretary may receive this, and then in a couple of months you may have a new Secretary, and the education process is going to take a long time.
DR. SCANLON: You are proposing that the NCVHS be directed or otherwise designated to pay the role of the convener, or the forum in which the candidates for PMRI standards is considered as well.
DR. BLAIR: A little more authority. The law already says we should do that, but in such a general way.
DR. FITZMAURICE: We are proposing an agenda item for the committee, and this is it.
DR. BLAIR: I don't think I have that much trouble with the word direct, although I guess my problem was a little bit more with the -- I would feel more comfortable with the recommendation that indicated that the NCVHS would identify and make recommendations for -- identify candidate standards and make recommendations for.
The way it is written now, it almost gives you a government role to select uniform data standards. I think if you make recommendations for, it wouldn't be quite like the committee is actually selecting.
I don't know if I have trouble -- I'll talk to my colleagues. I don't think I necessarily have trouble with the word direct. She could actually do that in a letter or something like that, or she could direct the committee to do that.
DR. COHN: I think there is a fair amount of authority that already exists. There are obviously things that are strictly financial and then there are certain things that are strictly clinical. But then there are a whole bunch of things that are financial and administrative.
There is a piece here that talks about other financial and administrative transactions deemed appropriate by the Secretary. So there are a whole bunch of areas which there probably is consensus on already, that may fit into things that aren't really financial, probably in many ways are administrative, that aren't listed already, that begin to get into some of the PMRI standards.
Now, they don't include everything. So we might get additional authority to go into those areas, but likely those are more frontier areas, anyhow.
DR. SCANLON: We might not have the authority, either, that's the thing. I think in that residual class of HIPAA standards that you described, Simon, there is that category for other financial transactions to ask the Secretary to designate. To the extent that the new standards here would be reasonably subsumed under that classification, I think we could simply use that authority.
To the extent that there is a whole new class of clinical data standards that doesn't fit under the residual authority, then we, even HHS, may need some additional authority, or maybe we can put it as one of the HIPAA standards.
But I don't see any problem with offering the NCVHS as the forum in which the process takes place, of identifying these potential additional standards and having some assessment of them, and then making recommendations to HHS for what they may be. Then the actual formal process begins of a proposed rule, if that is the case. There may be other models, for example, where something less than a regulation may do the trick in this area, I don't know. There may be a voluntary -- this may be a more suitable area where a different kind of model may fit, or we simply have to go the whole regulation route again, and we need proposed rules and so on.
But the way it was phrased, it almost looked like the NCVHS was going to initiate that formal process in terms of selecting. I don't think you want to -- not only will you get other subsets, but you'll put yourselves in a position of just --
DR. BLAIR: The recommendation four does assume that the NPRM process will follow after the recommendations. The key thing is that word direct, direct the NCVHS to do this. Should we have that word? We are waiting for her to direct us.
DR. SCANLON: And if you don't, you're stopped if you don't get something formally from her. Let's see if there is a way.
DR. AMATAYAKUL: Would it be appropriate to say accept the recommendations from the NCVHS for the selection of uniform data standards?
DR. SCANLON: No, you can't tell her to accept recommendations. Consider; that's her thing. If you say direct, you almost have to wait for a formal go-ahead, and that may or may not happen for a variety of reasons. If we can say that the committee will proceed to this step and make recommendations --
DR. FERRANS: Consider and uniform data standards that the NCVHS will recommend according to the guiding principles. So we are going to go ahead and go through and use the guiding principles that we have asked her to adopt, go through the process, make the recommendations, and then I guess her consideration would be to consider it and then if it is affirmative, then it would begin the rulemaking process or something like that? I don't know.
DR. SCANLON: If that is the conclusion. It assumes you are going to go ahead and carry out this step anyway.
DR. FITZMAURICE: One could put in there, recommend to the Secretary, permit the NCVHS to make recommendations. So there has to be a negative, you have to be denied permission to do it.
DR. SCANLON: But without a time frame, that is the same as direct. By when? I see exactly the issue.
DR. FERRANS: What if we said -- does the Secretary propose the rules in the NPRM?
DR. SCANLON: Yes.
DR. FERRANS: What if number two was, propose rules for PMRI standards based upon the NCVHS recommendations. So we are going to go through and make the recommendations and we are asking you to propose rules based on our recommendations. Because in the end, we're going to do that anyway. In number four, we are going to say, please propose rules on the things that we selected. So what if we say, we are going to go through the selection process, and our recommendation to you is, if we have selected something, please propose a rule around it? We are just not asking for permission to make the recommendations, to go through the process and make the recommendations. Does that make sense?
DR. FITZMAURICE: You might say, consider proposing a rule.
DR. BLAIR: It occurs to me that the corner we painted ourselves into in this room is broader than just recommendation two with direct, because even recommendation one says that she should accept the guiding principles as the criteria. So it sounds to me like we have been heading down this path long enough that we have pretty much framed all of our recommendations from the standpoint that we want her authority to continue forward.
DR. SCANLON: I'm less concerned about the first one, though, Jeff, because I think that is a legitimate recommendation. There is an existing set of principles, you are asking her to adopt those as we proceed to the PMRI standards. That is an action that can be worked upon. That to me is legitimate.
The thing is, your next step -- the NCVHS wants to actually proceed to the next step of serving as the forum where the work on standards or PMRI could actually take place. Then based on that assessment and so on, you would make recommendations to HHS, to the Secretary. That point is fine.
My only worry is, if you phrase the recommendation in a way that requires her to act, otherwise you don't have permission to act. For a variety of reasons, you may or may not ever get a directive to go in that way. It may be better just to -- diplomatically, you never tell the recipient of your recommendations that they should or they shouldn't. There are a lot of reasons why things would be done or not done, but you certainly ask them to consider the recommendations, and you say what the recommendations are.
This is more for a process, to have the NCVHS undertake a process. Designate the NCVHS or -- but again, that would require a letter or some -- I think the Department would be favorable towards that, but it would have to actually be in the form of a letter.
DR. COHN: How about this one? Consider forthcoming recommendations to be made by the NCVHS?
DR. FITZMAURICE: For adoption under HIPAA?
DR. SCANLON: In the text preceding the recommendation, is there a discussion that the NCVHS, consistent with its role in HIPAA, will continue to serve as the forum and a bridge and so on for identifying -- and then you say, then the recommendation is -- you are saying what you would do consistent with your role in HIPAA, and then you are asking the Secretary to consider the resulting recommendations, and let's see how it -- consider forthcoming recommendations for the selection of --
DR. FERRANS: That is where we have the problem. The problem that we had was that we originally had in the document, we are recommending that the NCVHS do things. That is kind of silly, so let's take that out and let's just recommend things to the Secretary. But then since we need her approval to act, we painted ourselves in the corner. So I think what we need to do is to break this out into two areas, say here is what we are going to do, and then based on that, here is what we recommend the Secretary consider.
So we will adopt these guiding principles, we will go through this process to select standards. We recommend that you A, take our recommendations and consider them for rules and B, provide funding for the following.
DR. BLAIR: I felt like Simon's recommendation really got us out of the corner, because instead of asking the Secretary to direct us to do, he is saying, change that so that it reads, consider the recommendation for the selection of standards that we will send to you in 18 months. I think that works, actually.
DR. SCANLON: That way, the committee can proceed with the evaluation process.
DR. BLAIR: Yes. Then when it reaches the recommendation, then we've got the process. In the administrative simplification standards, we used the term adoption rather than selection. Obviously there was a selection process as well, but that only applies if there are existing standards -- you only can adopt existing standards. Are we probably moving in an area now where adoption is not the word?
DR. SCANLON: No, adoption is still there, but it is in the next phase. This is where the NCVHS selects those PMRI standards that we would recommend for adoption.
DR. FERRANS: Then you're right. It should -- there in that sentence the way it is constructed, recommendations made by the NCVHS for the adoption, because we have already done the selection, so now we are making the recommendation for adoption.
DR. COHN: I think probably adoption is the right word there.
DR. FERRANS: So what we may want to say in the subsequent sentence is, the NCVHS will select and recommend an initial set of specific standards.
DR. BLAIR: Select and recommend?
DR. FERRANS: Yes, so select PMRI standards --
DR. SCANLON: You're probably going to evaluate too. That is one of the roles that the NCVHS can play. If more than one, this group better than others can do that process. But it might be something like identify, evaluate and recommend. Those are the things the committee does very well in a balanced way.
DR. AMATAYAKUL: And where it says the Secretary's delivery of this report, do we mean delivery?
DR. FERRANS: The completion of this report or the publication?
DR. SCANLON: Submission.
DR. BLAIR: I think that gets us out of the box and it doesn't slow down the committee. If I thought we were going to get a lot of arguments about the role, then we would have to be more careful. But I think no one is arguing. I just don't want us to get hung up on having to get literally a letter that says, I have received your report and I order you to do this or not.
DR. COHN: Just a little bit more wordsmithing. It should say, consider forthcoming recommendations to be made by. Otherwise, I think that looks good.
(Simultaneous discussion.)
DR. FERRANS: It almost makes sense to put that right next to -- so it looks sequential.
DR. FITZMAURICE: Once you make recommendations to the Secretary, then it is up to the Secretary as to what to do with it. It is hard to tell her to propose a rule.
DR. SCANLON: That would be your recommendation.
DR. FERRANS: If we said in that earlier one, please consider our recommendations, and then after that say something like, issue a notice for the ones that you agree to adopt or whatever. We suddenly jump into funding, and then we go into notice of proposed rulemaking.
DR. COHN: Let's take a look at two again. I'm wondering if five is even necessary.
DR. FITZMAURICE: I don't think it is necessary.
DR. BLAIR: I think five is necessary because of the time frame.
DR. COHN: I don't think it is appropriate for us to tell the Secretary that she needs to do this in 18 months. I don't think that is a necessary piece of our recommendations. Maybe I'm wrong about that one, but I'm just looking at the way the stream is going right now.
DR. FITZMAURICE: One could do that in a letter of transmission, that this needs to be done now, or this needs to take two years to happen. Different standards may take a different time frame.
DR. COHN: It is a question more about whether we are telling the Secretary that we want her to do the final rule within 18 months after receipt. It seems a little -- as I am looking at it right now, it seems a little odd.
DR. BLAIR: I think one of the reasons that we had thought of putting that in is because the audience for this is broader than just the Secretary. For those people that read it -- there were people who were not distinguishing between the recommendations from the NCVHS in the final rule. So that was why we put that in there.
DR. COHN: Maybe what we need to say under two then is, upon receipt of our recommendations, we urge a speedy review or something like that, and prompt development of a proposed rule.
DR. FERRANS: That would be great. Just so we know how the process goes.
DR. COHN: Upon your receipt of these recommendations, we would urge --
DR. BLAIR: A creation of an NPRM and further evaluations. There is going to be a whole separate period for other people to comment their concerns about what we have recommended.
DR. COHN: I think we urge, basically.
DR. FERRANS: We urge beginning the NPRM process, so people know what that means.
DR. BLAIR: Well, the rulemaking process.
DR. AMATAYAKUL: What would you like?
DR. BLAIR: Maybe we could say something like, we encourage or support the issuance of a notice of proposed rulemaking to get additional comments before the regulation is finally issued.
DR. COHN: I think you have to do that.
DR. BLAIR: But at least that is here for non-government people to see that that would happen.
DR. FERRANS: The NPRM followed by an appropriate comment period prior to the issuing of final rules.
DR. BLAIR: That is part of the process. I think all you want to see here is that you recommend that she initiate --
DR. FERRANS: I'm just thinking about the broader audience, again.
DR. SCANLON: But even there, you want to say that she initiate the rulemaking process to adopt these standards promptly. If you have a time line, it would be fine. The rulemaking implies all of the things that -- it would be the NPRM plus the comments.
DR. BLAIR: It does to her. My concern was many folks who are outside of the government who would be very fearful that these were about to be enacted without an opportunity for them to comment and express their concerns.
DR. FERRANS: Margaret put it in parentheses. She put rulemaking process issued and then parentheses, issuance of NPRM, comment period and final rule, closed parentheses.
DR. COHN: Do you want to read the sentence? It is getting real close.
DR. AMATAYAKUL: There seems to be -- we need an end. We need a time frame at the end. Upon your receipt of these recommendations, we encourage the initiation of the rulemaking process, i.e., issuance of an NPRM -- I'll spell that out -- comment period and final rule, closed paren, to adopt these standards.
DR. COHN: How about, we urge the prompt initiation?
DR. BURKE-BEBEE: We said up above the time frames taking into account. Is that what you're talking about, Margaret?
DR. AMATAYAKUL: This 18 months is the time --
DR. BLAIR: That is the NCVHS self-imposed --
DR. FERRANS: It is actually in there now. We're saying it is going to depend on each one. So I don't think we need to specify 18 or 24 months.
DR. BLAIR: Right, so the only time frame in there that we would reference is our self-imposed deadline of 18 months. The other thing is, Margaret, maybe we could refer to the issuance of appropriate NPRMs, plural, so we're not saying just one.
DR. AMATAYAKUL: Okay. If we are going to delete recommendation five as a result of this, the one thing people stressed was the need for a realistic implementation time frame, because they were worried that the traditional two years is not going to be enough. Should we say --
DR. COHN: Isn't that up there, two sentences before what you have?
DR. BURKE-BEBEE: These recommendations would include, blah blah blah, taking into account industry readiness.
DR. AMATAYAKUL: Okay, got you.
DR. FERRANS: I think we're there.
DR. BLAIR: It doesn't mean anybody is going to agree with us tomorrow, but I think this helps us through.
DR. BURKE-BEBEE: Then we eliminate number five?
DR. COHN: I suspected what we will do is to see this version cleaned up tomorrow just for a final look-through. But I would say, we probably need to get on to the rest of the document, lest we have to make reservations for Saturday or Sunday. Is everybody okay with this at this point?
DR. AMATAYAKUL: I suggested that I'll send this by e-mail to Mike, and Mike will print it out for you tomorrow morning.
DR. SCANLON: Just to raise one question, because it will probably come up in the full committee. Is there a recommendation dealing with privacy?
DR. BLAIR: There is.
DR. SCANLON: You're way ahead of me.
DR. BLAIR: And there is also a supporting recommendation that indicates support for NHII activities as well.
DR. SCANLON: Excellent.
DR. COHN: Any other questions before we move on to other areas?
(Simultaneous discussion.)
DR. COHN: Margaret, if I could ask, does it make more sense to start here or to start at page one and work our way through, without reading the whole thing?
DR. AMATAYAKUL: It's up to you guys.
DR. MC DONALD: I was just trying to figure out how I can convey some of the things I'm worried about, giving the reality that we're writing a lot of them here.
DR. COHN: What would be most helpful in terms of eliciting your comments?
DR. MC DONALD: Well, I've got some little tiny edits. You're missing some words here that are just typos. I don't think that needs to be dealt with formally, but there are some systematic things I'd like to talk about. Like, all the references to the studies that show the benefits of health care are all references to CPRI conference proceedings, which is good because it is very thorough, but no one can get to those. I would think it would be more appropriate to -- most of those have direct references as well, to have both of them on there, so you could have a direct reference that someone could look up, because they can find at least the abstract under PUBMED, if not the whole text under OPED or whatever they happen to have.
DR. AMATAYAKUL: Clem, when did you last look? They are now referenced under McGraw-Hill.
DR. MC DONALD: Is that a search engine?
DR. AMATAYAKUL: No, McGraw-Hill is a publishing house. They are now publishing them. Should I put the McGraw-Hill reference?
DR. MC DONALD: No, that's not my point. It is not a medline journal, the one it is published in. It is an obscure, small proceedings. I love being in it, but if an average guy wants to find the whole reference to any one of these discussions in the CPRI thing, they have got to write -- no?
DR. AMATAYAKUL: No. That is why I mentioned they are now being published by McGraw-Hill.
DR. MC DONALD: Yes, but you're not going to find them in your local library. You're not going to find them in Medline.
DR. AMATAYAKUL: You should.
DR. COHN: The question is, are they on Medline. So we need to identify whether they are or not.
DR. MC DONALD: I don't think they are. In general, when you cite some event, you cite the paper in JAMA or New England Journal, not some summary thing. So I don't think it is wrong to cite both, but I think we could easily put in the citation that people could get to directly.
The second thing is an organizational thing. You start out talking about standards under -- you talk about ANSI and then you talk about -- there is a place where you talk about standards organizations in one small paragraph under B. Then you get back to describing in some detail what they have done under D, which is 16 pages later. It seems to me that people would have a much better idea of what you are talking about in the following discussions if you gave them something concrete to chew on, like you do very well under Section D.
DR. AMATAYAKUL: D or B?
DR. MC DONALD: D as in David.
DR. AMATAYAKUL: Could you identify the page number you're looking at?
DR. MC DONALD: Under Section B, you set out health care informatics standards history. That is number one.
DR. AMATAYAKUL: That's page 16, right?
DR. MC DONALD: Yes, but all that is is a paragraph, just saying something like that exists. Section 3, you say accreditation and coordination, talking about ANSI, and then it is not until page 28 where you get some detail about what you mean by under the current status. Here you start with what the names of these things are, what they are doing, what they have done. It seems like that page and a half or two pages would be best under two, or somewhere in this first Section B.
DR. AMATAYAKUL: So it's D from page 28 should be --
DR. MC DONALD: I think that content could be a sub-header in this B. You're calling it evolution of health informatics standards, but it is really the first introduction to the standards business. Then you get to page 28 before you find out what the product of these has been and who they are.
DR. AMATAYAKUL: We actually tried to reverse B and D once before, because Simon said the same thing.
DR. MC DONALD: I'm worried about those 16 pages in between.
DR. AMATAYAKUL: No, basically we just brought D forward. We can try that again. The problem we had was that they needed -- we felt like we needed to either reword the whole thing or people weren't understanding what the issues were that the standards addressed.
DR. MC DONALD: I think if you said -- forget D, don't call it D; B one, two, and you could either have it three and make accountability of ANSI four, and you would have to reword a little bit D, saying these are the groups and this is what they have done.
DR. AMATAYAKUL: Got you.
DR. MC DONALD: I don't think you have to reorganize much.
DR. AMATAYAKUL: So you are talking about page 28 through 32, stick in at page 17.
DR. BLAIR: Just a consideration, because I am trying to remember why it wound up that way. If I recall, we juggled this around several times. Somebody had asked us, what is B and C, because I think B and C weren't in there before, and they were moved in there because somebody asked us to put them before D.
DR. AMATAYAKUL: The sequence currently is A, which is PMRI standards concepts, some definitions of terms. Then we have B, evolution of health care informatics standards, and we have some history, what the SDOs are and accountability. Then we have C, overview of data standards issues, which is the interoperability, comparability, et cetera. Then we have D, which is the current status of data standards, saying what data standards address those issues.
DR. MC DONALD: I would say D, 28 through the top of 31.
DR. BLAIR: You've got to have D after C, because C says the issues and D says how do you address those issues, right?
DR. MC DONALD: As a plain old reader, the hardest, most tiresome reading is C. It goes on and on about things that the average person doesn't know how to connect those words to, and there is nothing concrete to attach them to. So I would actually try to squeeze C a little bit anyway.
But what you're saying is, we're talking about something nobody knows about, and then you say, this is what it is, and you give them some real examples.
DR. BLAIR: What about this? B is history, is the evolution.
DR. MC DONALD: That is how it is labelled.
DR. BLAIR: Right, so if you move B to the end, I can see how that could be moved to the end.
DR. AMATAYAKUL: We had it at the end originally, and people thought it should be moved up.
DR. MC DONALD: I think B is fine. Here is one little paragraph, standards organization. It is not naming a single one of them, nothing to anchor to, no examples. Then you go, here is the group that controls all these standards organizations, then you go into the more theoretical things, important things, I'm not denying it. It is just that they seem to tightly, naturally connected.
DR. AMATAYAKUL: What if under B2, standards development organizations, we cover the applicable standards development organizations, what they are, and then do C, overview of data standards issues, and then conclude with D, that is the status of the standards. Would that help?
DR. MC DONALD: I think your labels aren't necessarily saying what you are doing. You say history of, then you talk about ANSI is this thing. It is not an historical thing, it is what it is. You are talking about standards organizations and this is what they are. Then you say progress in, and all you're doing is saying who is doing what. I think the content is fine. Your labels are forcing you to do things that aren't necessarily realistic. Give examples right away. You don't wait until Chapter 10 to give the first example. This is what is talking about what is going on.
DR. COHN: As I look through this, I had earlier on suggested that you talk about what is going on and then you talk about the issues.
DR. MC DONALD: That was what was going on. I'm talking about what are these things you're talking about, what do they do.
DR. COHN: And we came to the realization that the way -- probably these things are misnamed, but in reality this current status of data standards is a mish-mash of what these groups are plus the issues they are facing. I think what Margaret is saying is, maybe there is some way to pull the background, listing the names of the data standards organizations up probably under two. And unfortunately we don't do quite the same thing with the code sets.
DR. BLAIR: We got a lot of feedback on this section. In general, did people have difficulty with this section?
DR. AMATAYAKUL: A major difficulty was, I think people that weren't clear about what interoperability and comparability was, so we reversed the paragraphs so that instead of giving an example and then a definition, we gave a definition, then we gave an example. But otherwise, we really didn't have -- it was only one person that made comments about the overview of standards, and that was to define interoperability and comparability up front, and to document better why drug technologies were so critical, versus all the others, because she thought the whole thing was critical.
DR. COHN: I wonder if there really is an issue here.
DR. AMATAYAKUL: Then we had Bob Gelman, who wanted us to make sure we had both sides of the issues addressed.
DR. BLAIR: Part of the reason that I am a little concerned, we do have some real hard issues that we need to make sure we get into the report to change it around, but we had a lot of folks that said, we are very positive about -- because they used this as a learning process, they called it a primer, all that stuff. I am just a little concerned, because as soon as you start to move around a whole lot of paragraphs and sections, you have breakage and you have disconnects.
DR. MC DONALD: That may be. But I think if you look at it more severely, you've got the section D -- each of these sections are very nice, I'm not criticizing the sections -- it talks about the message standards. It is a nice summary, it flows well, I can't find any words to twist around on the vocabulary. So the third thing, you get into something that isn't a standard thing, it is data quality, data accountability and data integrity. It is not a group, it is not an organization. It is more like the stuff under Section C, where you are talking in general about issues and problems and things you want to match standards up against.
So you've got this big split between real things at the beginning and this hint that there are some standards organizations, seven lines, you never say a word about them or what they do, and then you go into things that are issues and principles and guidance. Then you go into this Section D, which gives you some of the concrete things, and then it goes back into principles and guidance and approaches.
So from that perspective -- and each of those sections reads okay. It seems like you could say, this is the standard world, this is what is going on, not in terms of today or yesterday. Or if you want to, you say this is what it has been and this is what is, and then go into the more general stuff.
DR. BLAIR: Do you understand that well enough to be able to make those changes tonight and get this folded into a new document for tomorrow with all the other changes?
DR. MC DONALD: I can see that would be a problem.
DR. AMATAYAKUL: I think recommendations are absolutely critical. I guess I am still struggling a little bit -- I appreciate that Section B2 has standards development organizations and doesn't have a lot, and it doesn't name them and so on. Maybe we could add a little bit there to overcome that.
But the issue I am having is that when you get to Section D, message format standards -- let me just read the first phrase. Today, message format standards have been developed in the private sector to address interoperability. If we don't tell people what interoperability is, they don't know what message format standards are. So it is like, which one do you put first? Do you tell them about message format standards that they address in interoperability and then you have to define interoperability? Do you know what I mean?
DR. MC DONALD: Yes, but I would just take that sentence out; standards have been developed in these areas.
DR. COHN: I should just make a comment here, and it is just my own thinking on this one. I am obviously looking at the fact that this has to be voted on at the end of June.
DR. FITZMAURICE: Voted on tomorrow morning to go to the work group.
DR. COHN: Exactly, voted on tomorrow morning to go on to the group. They need a couple of weeks to have it in advance, because you don't bring this in three days before a meeting. Everybody has had a chance -- the whole committee has received an earlier version of this. I think they are expecting evolutionary changes, probably not something that is a complete revolutionary change.
I think your ideas are good. I tried myself to do exactly what you are describing. I think we need to be rational at this point and realize that there are subject areas that are a problem we need to deal with. If the organization is a problem but the information in here is fine, which I think you are probably saying it is; you just don't like the organization, we probably ought to defer that, unless it is so critical that it is a showstopper. I don't think what you are saying is a showstopper. You're saying it is something that is a bother and you would like to see it better for your document.
DR. MC DONALD: No. The effect it has, I read through the beginning part and I think we're in deep trouble, nothing is going on. Then I get to this beautiful list of all this stuff that is going on, and I have a reversible opinion. Maybe you don't want to have that.
DR. FITZMAURICE: If you read it first and then went through all the problems you might say, oh my gosh, we're nowhere.
DR. BLAIR: Can I suggest, Clem, that we try to capture all the other concerns that you have?
DR. MC DONALD: There are a number of them, and some of them I've written down. Some of them are factual and some are --
DR. COHN: Would it be useful for us to spend a couple of minutes going page by page?
DR. MC DONALD: Some are just some better words.
DR. AMATAYAKUL: And you'll send me those, Clem?
DR. MC DONALD: Yes.
DR. AMATAYAKUL: Tonight.
DR. MC DONALD: If I can print it off, I will.
DR. AMATAYAKUL: How about tomorrow morning?
DR. MC DONALD: I can do that.
DR. COHN: And Clem, I do have a couple of substantive issues I want to bring up that I would like your comment on, but why don't we let you go through page by page and see what --
DR. MC DONALD: The statement about why we don't have standards, where is that one? There is one that starts out as a question, what page is that on?
DR. BURKE-BEBEE: Are those back in the introduction?
DR. AMATAYAKUL: That would be between pages eight and 12.
DR. MC DONALD: The paragraph under four, starting at line 37, page nine, a second issue in the lack of commitment of public health care, this is not going to make the health care industry want to embrace us. We are saying in two places that they really are more interested in money than quality.
Firstly, I don't think it is really true, that that is the explanation for why we don't have them. So the only sentence I think is true -- and I'm not even sure it is, is the middle sentence that says, it is hard to develop -- lack of commitment on the part of health care to advance the technology -- I'm sorry, that is not the one I'm objecting to.
DR. BLAIR: Is it lack of commitment or lack of incentives?
DR. MC DONALD: It is further down.
DR. COHN: Is it 11, why is it taking so long to develop and implement --
DR. MC DONALD: That's the one, yes. It is on line 32 on page 11. This has two fairly accusatory statements, even though they have been softened a bit. Many observers noted the health care delivery system appears to have placed a higher priority on the standards for reimbursement than on standards that could address the quality of care. That is accusatory. The second sentence is also, government, payors, employees and individuals have had more difficulty creating incentives for improving the quality of care than for improving reimbursement processes.
I don't think this persuades anyone. It just goes along with the general nasty feelings about health care. You could get the other side cheering it on, but I don't know that it helps us at all, trying to get cooperation and support from the health care industry. I don't really think that is the reason why we don't have them.
Now, there is the statement in between, that it is easier to do these other standards. But actually, X12 didn't have any more penetration than HL-7 in hospitals at the time before this all started. NCFA's standard did, because it was do or die. You sent in your bills electronically, or you didn't get paid. They had no choice. So that was like 80 percent penetration, so in that sense one could say that there was better penetration, but not in the voluntary standards.
But I don't knew what this is getting us, why do we want to say this, when I don't think we can find data that says this is true, and secondly, it is not going to create friendly feelings in the health care industry.
DR. BLAIR: I think testifiers were telling us that they felt that we should attempt in this report to see if there was something we could do to create incentives for quality, because we heard often in the testimony that the incentives that are in place are for data for the reimbursement process.
DR. MC DONALD: But it offends me, because I spent 12 years learning how to give quality care, and now it is hitting me over the head all day, every day. We stayed up 30 hours, because we weren't supposed to go home until that patient was well. I don't know any other industry that requires their trainees to do that kind of stuff.
So the implication here is that there is no interest in quality. The other side of it is, Floyd Brennan wrote in his recent New England Journal, pointed out that the measures we have had in the area of health care that we are watching over time, it is getting better. The year 2010 healthy people report showed a remarkable improvement in life span in the last 10 years. So that is quality.
DR. BLAIR: I think we have changed this two or three times, because I know that you were concerned about this. But the people that were saying this, I think every single one of them was a physician, active in patient care, and they were winding up saying this is the struggle that they have, that they are struggling with the fact that, in order for them to get paid they have to have this data, but on the other hand, there are fewer incentives in place for them to demonstrate whether or not the care they are giving is -- and they didn't like that. They were unhappy about that.
So I guess I didn't feel from the standpoint of being accusatory, because it was the physicians that were saying this, to say let's create different incentives.
DR. MC DONALD: Or you could say, let's create incentives to invest in things that are expensive and difficult. But to say that the implication is that they aren't interested in quality is pejorative, and it gets us nothing in terms of getting --
DR. BLAIR: I would agree with you. What you exact said is that they are not interested in quality, but I don't think that we say that anymore.
DR. MC DONALD: It says the health care delivery systems appear to have placed a higher priority on standards necessary to facilitate reimbursement than those that could address quality of care.
DR. BLAIR: Is that not a --
DR. MC DONALD: Personally, I don't think it is true. If you look at the hospital industry and you look at the standards that are running in that hospital, they are mostly not billing standards.
DR. BLAIR: My feeling is that I really want to accommodate you. On the other hand, I am concerned that if we yank that out, that there are so many people that have said that to us, that I feel like we're going to hear, what happened to this, this was a major concern. I think you know the names of so many of the physicians --
DR. MC DONALD: Frankly, I don't remember it being said this way at the hearings I was at, but we all had it in our heads.
DR. FERRANS: Perhaps the observation is about health care information systems in general, rather than the standards themselves. I remember a humorous episode where I took a number of foreign dignitaries to tour information systems at a major academic hospital, and at the end -- they were Russian and they knew very little about health care. They said, it looks like 90 percent of your computers are all about billing. I said, I think you're right.
DR. BLAIR: What did we put in place first? The claims and reimbursement codes, because they were more mature and we could wind up moving forward on those. We have to really struggle for standards of patient --
DR. MC DONALD: We could rephrase this then. We could say, the government seems to be more interested in billing issues than quality issues, and I wouldn't feel as offended, but someone else would.
I don't know if you realize, we have some challenges in this. Some in the health care industry aren't happy with the standard business, for whatever reason. If we lay this thing out within the first front end, we are just joining in the beat them over the head business. I think it hurts our chances to have this embraced.
So I'm not saying this so much from the point of view of my personal --
DR. BLAIR: What if we preface that sentence by saying, many clinicians complained that they felt that the health care delivery system did this? Would that help?
DR. MC DONALD: No. We don't have any kind of samples.
DR. COHN: I had two comments here. I was wishing mightily that we could remove the whole paragraph. This may be an option. I think the problem that I am having -- and I agree with some of the other people -- first of all, I'm not sure this is from the health care delivery system or whether it is the HIPAA legislation, which is really the question here. We can point to the HIPAA legislation as already mandating reimbursement coding systems and transactions and now moving on PMRI. So that doesn't point the finger much at anybody.
Now, the other piece that I have a little trouble with is all of the stuff around PMRI standards and quality of care and you aren't doing PMRI standards, therefore you aren't delivering good care, and you need incentives to get you to deliver good care, when really what we are talking about is PMRI standards to help support care. I'm just wondering if we are making a mistake jumping too far into the quality of care issues and the incentives for quality of care, and if we had good incentives for quality of care, that would push us into PMRI standards. If we toned that down a little bit, that might actually make for a reasonable paragraph. Because it really is true that the legislation -- we have already gone through the first set of standards, and they are all financially oriented.
DR. BLAIR: But even John Lumpkin wound up saying he wants this report to focus on patient care and quality of care, and that that is the reason that we are putting forth PMRI standards, and how do we make that case without pointing out these things.
DR. MC DONALD: I don't think there is any contradiction that we can do better.
DR. COHN: Are there other places that we talk about PMRI standards in relation to quality of care?
DR. MC DONALD: It is a theme all the way through.
DR. COHN: That's fine. Then I'm just not sure that we need to have it in this paragraph. At this point, you're talking about quality of care incentives, PMRI standards, it is all getting mish-mashed. I put some questions myself in this paragraph, because I came away feeling like I had been attacked as one who practices clinical medicine, that somehow I wasn't delivering good care, and is there something wrong with me, and that somehow, the government needed to come out with stronger incentives and rules, regulations or whatever. Some days I feel that is definitely the case, but I'm not sure that we necessarily want to recommend that.
DR. AMATAYAKUL: I was just going to suggest, would it be -- going on Rich's theme, many observers have noted that our health care delivery -- our health information systems appear to be more focused on reimbursement than on PMRI standards.
DR. MC DONALD: The parallel is not systems and standards, it is systems and other systems. It is billing systems rather than billing systems.
DR. BLAIR: Could you try that, Simon?
DR. COHN: Yes, that would be an alternative way. We are talking about toning this down.
DR. MC DONALD: But then you're not making the quality contrast. It is care system versus billing systems.
DR. BLAIR: This was one of the links in the chain that led to the fact that if we do have clinically specific PMRI standards, it would enable the ability to measure quality, improve clinical processes, improve outcomes.
DR. MC DONALD: I agree with all that. This particular thing is saying we haven't done it because we don't care about quality, we care about reimbursement.
DR. BLAIR: If Margaret makes that change, would that help?
DR. MC DONALD: I don't know. There are a couple of places she would have to make changes, not just that first sentence.
DR. FITZMAURICE: The chain of logic seems to be that out there, there appears to be a lot of financial and billing systems and fewer clinical information systems. Over the past decade or whatever period, a lot of literature has suggested that use of clinical data systems can improve quality, do this, that and the other thing. In order to facilitate this renewed interest, adoption of PMRI standards are necessary to facilitate the systems to go out -- I don't know if that would be another way to put it.
DR. MC DONALD: I think we might have said that, but I would be happy with that. This particular paragraph is not going to make it easy to get the political support we want.
DR. COHN: Let's just take a look here and see if we can do this. So information for reimbursement systems that address -- or support quality of care as opposed to address quality of care. More recently -- here are several reasons for this. I think the reasons -- the first reason is fine. The first reason is standardization of information required for the claims process was easier to automate than standardizing information for the clinical processes. I think we all agree with that.
Secondly, there is a problem here, government, payors, employers and individuals have more difficulty creating incentives for improving -- I think you're going to have more difficulty measuring what the metrics are. That to me is --
DR. BLAIR: Can we say more difficulty measuring instead of creating incentives?
DR. COHN: Let's see if that helps.
DR. FERRANS: One thing to say is that the standards haven't been there to support the systems. That has been the classic reason for not purchasing systems, has been, when the standard is there, then we'll look at it.
DR. MC DONALD: I'm going to have to leave very shortly. There are two other things I could mention, and then you can discuss them.
This is on page 25, the paragraph just before diverse state laws. This seems like a non sequitur. Finally, because the European directive -- I don't know how that flows, other issues. It is a true statement, but information systems vendors have been engaged in international commerce and are increasingly under pressure to demonstrate compliance with the European directive for data security. That is true, but how does that connect to standards here? So what? Does that mean we use their security thing? What does that really imply? If we make standards, how does that help it?
DR. AMATAYAKUL: I think this supports the recommendations that we had about international standards, in other words, monitoring international standards --
DR. MC DONALD: But it is not in that section. You have a section on that that says, we've got to -- on page 27, we say it has been impaired by lack of funding to support travel by U.S. subject matter experts, which is what I thought we were getting out of that. If you are going to say something, it is just out of place. Maybe it belongs, but so what? What happens when we do what, and how does that relate to it? Does that make us do something or does that make us want to do something different?
So I would take that out, or else make a structure out of it, say, because of this, we need to change them or we need to be just like them.
DR. FITZMAURICE: I think in this section it does talk about other issues, this section on privacy, confidentiality and security, and anybody who is dealing beyond our borders and dealing with Europe is faced with the European privacy directive. But I guess your point is, will PMRI standards help us deal with that, and the answer is, probably not.
DR. MC DONALD: You may have a point. The only reason it fits here is that it is something about security, but it --
DR. FITZMAURICE: But it does support that we have to have federal privacy legislation.
DR. MC DONALD: Why? If it doesn't agree with this directive, it could be -- it almost suggests we should do it the same way.
DR. FITZMAURICE: Yes, because we don't have anything to say they should be compliant with us. We don't have anything.
DR. MC DONALD: If you could get that into that, and if we had appropriate security things, this might no longer be a problem.
DR. FITZMAURICE: We can at least harmonize. We can't harmonize with something because we don't have anything to harmonize with.
DR. MC DONALD: That's all. I will get you something by morning.
DR. BLAIR: Is that going to give you enough time to distribute to those folks that have to vote? Clem, tomorrow Kathleen Frawley will call in and Kepa would call in with his vote on it. We were hoping to be able to get them to document tonight, so that they could look at it. So how could you do it if it is tomorrow morning? You wouldn't have time to get them to Kepa and Kathleen.
DR. MC DONALD: Are we going to revise again at the May meeting?
DR. COHN: Yes.
(Discussion off the record.)
DR. COHN: I was just going to bring up my favorite issue, which is this lack of unique identifiers for patients on page 23. I thought having Dr. McDonald here for this discussion might be useful and interesting.
I found myself looking at this area and -- this is in the area of data quality, data accountability and data integrity. We were making what appeared to me to be a full court press on the need for the unique identifier.
DR. BLAIR: Are you for it or against it?
DR. COHN: I think it is too strong and it needs to be toned down. To me, the issue here was not lack of a unique identifier for patients, but the inability to uniquely identify patients. I think there is a difference here. I think there are a number of ways you could deal with that issue. A unique identifier is one set of solutions -- I just thought that we needed to somehow pull ourselves back from --
DR. MC DONALD: What I like is having a significant sized bullet discussing it, because the rest of it becomes mythic. If we say we're going to do all this, except for the one thing we need, we're not going to talk about. But if you turn it the way you did it, and we can still say these same criticisms, that right now we have multiple identifiers, we have mixed up this, different names, and we can leave out the hot button issue.
DR. AMATAYAKUL: So should we change this to lack of ability to uniquely identify patients?
DR. COHN: Yes.
DR. AMATAYAKUL: Then the rest can stay?
DR. FERRANS: Is it impossible or very difficult? Who argued for that, do you remember, Margaret?
DR. AMATAYAKUL: We had several testifiers that said, please be sure to include unique identifiers in here.
DR. MC DONALD: I think it is right to discuss the issue strongly, because everything else is so dependent on it.
DR. AMATAYAKUL: But we didn't make any recommendations.
DR. COHN: I think we are saying rather than impossible, it is difficult. I think I agree with you about the different master patient index systems.
I guess I'm fundamentally fine with most of what you have there, but it seems to me that there is a spectrum of things that we need to be looking at. One is improving master patient index capabilities and agreeing on standards for that, or going to unique identifiers.
DR. FERRANS: The part that is highlighted in green doesn't make sense. Others believe -- ?
DR. AMATAYAKUL: This was an attempt to address both sides of the coin, that there are people who believe that a unique identifier is very bad and others believe it would help.
DR. FERRANS: Do people say it would contribute -- I am one of those people who believe theoretically that it could contribute to improve, but since it is not obvious to the reader why, there probably should be in my opinion a brief explanation of that. Let's educate people as to why anyone would make what seems to be a contradictory statement.
DR. AMATAYAKUL: Does the part after the green help?
(Discussion off the record.)
DR. COHN: To me, the issue here is that the only solution being offered is a unique patient identifier, which I think is a long stretch under the data quality argument. It seems to me that we want to be able to better uniquely identify patients, and we want to have better master patient indexes, or we want to have a unique patient identifier. Both of them are possible. So I'm not sure whether I'm only barking up one tree on this one, especially if some of the examples you are giving are as bad for unique patient identifiers, since you can get unique patient identifiers every bit as you can get multiple individual identifiers. There is nothing about the unique patient identifier -- it doesn't mean if I change my name and go someplace else, they won't give me a new identifier.
DR. AMATAYAKUL: Simon, you're probably looking at the wrong person to ask.
DR. COHN: What I'm thinking is, whereas ideally a unique patient identifier is a wonderful choice, we should also comment that much work can also be done in improving master patient indexes, and that that would do much to improve data quality. I guess that is the issue that I had with this, that it only seems to be one solution to this discussion.
DR. FERRANS: Margaret, in answer to your previous question about, does the part after the green help, I think it is a fairly marginal argument. That is my problem with it. I think here, you're saying many people believe that it would improve privacy, but the two reasons given I don't think really support the argument that strongly compared to peoples' fears. So it may not prove convincing.
DR. COHN: The point I made to Jeff when I was reviewing this was, I had to look at what the previous positions were of the NCVHS on the unique patient identifier. But I don't think as a committee we have come out quite so unambiguously in favor of a unique patient identifier. It has been a little more couched.
DR. BLAIR: It wasn't whether we came out in favor or not of the UPI. It was whether we came out for the social security as a way or some other methodology as a way. So I don't think it was -- I think that we were called for by HIPAA to be able to make recommendations on it, but nevertheless, my thought is that the point you made just a little bit ago, which is the balance to wind up -- Margaret, and Simon, see if you agree with this, I'm trying to paraphrase what you just said, that while we could make a statement indicating the benefits of having a unique patient identifier, that is obviously the most desirable option, falling short of that, or failing that, that the availability of master person indices, while less efficient, still does afford us many benefits to be able to improve data quality and all. What was the phrase? I'm trying to paraphrase what you said.
DR. COHN: Right, probably improve data quality. Maybe availability and focus on improvements.
DR. BLAIR: Margaret, I don't want to completely undercut the thought that you had there.
DR. AMATAYAKUL: While there are benefits to a unique patient identifier, the availability of master person indexes, while less efficient, may also contribute to availability and focus on improvements.
DR. COHN: I think it is contribute to data quality.
DR. AMATAYAKUL: While there are benefits to the unique patient identifier, the availability of standards for master person indexes, while less efficient, may also contribute to data quality. Then take this sentence -- delete this. Actually, we could delete to the end.
DR. COHN: I think so. We're going to have to look at it tomorrow. I think we're all fading out at this point.
DR. BLAIR: Thank you, everyone, for this tremendous review, and especially again to Margaret for enabling us to go through this in an orderly manner.
DR. AMATAYAKUL: Thank you, Jeff.
DR. COHN: See you at 8:30.
(The meeting adjourned at 5:15 p.m., to reconvene Friday, June 2, 2000 at 8:30 a.m.)