Department of Health and Human Services

MR. BLAIR: Welcome to the joint meeting of the Workgroup on Computer-based Patient Records, and the Subcommittee on Standards and Privacy, which is a subcommittee within the National Committee on Vital and Health Statistics.

I know that we're running late, but it took us a little bit of time with the weather to be able to pull everything together here. So we are about to convene.

The first thing that we will do is introduce those of us that are here. I'm Jeff Blair, chair of the CPR Workgroup.

Dr. Cohn.

DR. COHN: Simon Cohn. I'm the national director for Kaiser Permanente, a member of the workgroup, and chair the Subcommittee on Standards and Security for the NCVHS.

DR. ZUBELDIA: I'm Kepa Zubeldia, vice president of the ENVOY Corporation, and member of the workgroup.

DR. KOLODNER: I'm Rob Kolodner. I'm associate chief information officer for Veterans Health Administration from the VA, and staff to the workgroup.

[Dr. Clement McDonald is participating via teleconference.]

DR. MC DONALD: Clem McDonald.

MR. BLAIR: Clem is with Regenstrief Hospital, and he is a member of the committee.

Margaret?

DR. ZUBELDIA: Margaret is busy trying to work the projector.

MR. BLAIR: On her behalf, Margaret Amatayakul is the person that is heading up the writing of the report to the secretary.

Is there anyone else here that is part of government staff?

DR. FITZMAURICE: How about Michael Fitzmaurice. I'm senior science advisor for information technology at the Agency for Health Care Research and Quality, liaison to the national Committee, and the lead staff on the computer-based patient record working group of the Subcommittee on Standards and Security.

Agenda Item: Review Agenda - Mr. Blair, Chair

MR. BLAIR: Let me just briefly give you an introduction to the agenda today. For those of you who are listening on the Internet, you probably are aware of this or have seen the agenda, but for those who may not have, let me just indicate that the focus today is for us to review the revised updates to the first draft of the report to the secretary on standards for patient medical record information.

Margaret Amatayakul is in the process now of setting up the projector so that that will step through that. While we are awaiting to do that --

DR. FITZMAURICE: You might want to have the visitors introduce themselves, Jeff.

MR. BLAIR: Yes, Simon was just mentioning that to me. How about the visitors, could you please maybe step up to a microphone and please introduce yourselves.

[Introductions were made around the room.]

MR. BLAIR: In our December meeting everyone that was here wound up going through anything that might be a conflict of interest or perceived conflict of interest in terms of affiliations or relationships either with standards organizations or terminology organizations or professional societies or funding for projects or anything. We missed you at that time to be able to do that. So if this is not a good time for you to do that, then we'll wait.

DR. MC DONALD: If you can hear me, I can say things.

MR. BLAIR: We can hear you very well actually.

DR. MC DONALD: I'm director of the Regenstrief Institute at the Indiana University School of Medicine. I'm chairman of the LOINC Committee, which doesn't charge anything for anything. I'm a chair of one of the working groups in HL7, but not an officer. We have funding from Shared Medical Systems in part for some of our development. We have federal grants of many kinds. I think that probably covers it.

MR. BLAIR: Thank you, Clem. I think that that kind of covers it.

Margaret, are you at a stage where you are ready at this point?

MS. AMATAYAKUL: About one more minute.

MR. BLAIR: Does everyone here on the committee have a hard copy of the latest draft of the report? Okay, then I think at this point I might draw your attention to the outline for the report to the secretary. I'll just generally step you through it. Of course it begins with an executive summary, which we will be pulling together after we pretty much agree on the content of the rest of the report. So you don't have content for the executive summary at this point.

The next section is the introduction, which has within it the mission, the purpose, the scope, the background, the general rationale, a summary of the focus areas. You can see all the things that are in that section.

Then we go onto a third and a fourth section. Rather than my articulating it from memory, which is not as perfect as what you have in front of you, let me just solicit, are there any observations, comments on the utility of the outline for the report at this point? Does anybody have any concerns about whether that outline is a good outline to help us achieve our purpose for the report?

DR. FITZMAURICE: Looks fine to me, Jeff.

DR. MC DONALD: Outline for ethics? I couldn't hear what you were saying.

MR. BLAIR: Clem, I was asking from people if the outline for the report, the table of contents for the report, do you feel comfortable with that table of contents, the outline for the report?

DR. MC DONALD: Well, sure.

MR. BLAIR: Okay. I think that we then all seem to feel comfortable with that. Margaret, do you still need some more time?

MS. AMATAYAKUL: We're just adjusting the lights so you can see it, but I'm set otherwise.

MR. BLAIR: All right. Well, I think Margaret is close to being able to help us step through the report. So we may have to wait just a little bit.

MS. AMATAYAKUL: I think we're okay.

MR. BLAIR: Okay.

MS. AMATAYAKUL: Jeff, what do you want me to do, go to each change?

MR. BLAIR: Yes, if you could lead us through. Why don't I do it this way, to try to set it up for you to take us through a little bit. On December 9 and the 10th a little bit we basically went through an outline for what would be in this first draft. Margaret and I pulled together this first draft by the end of December. It was electronically distributed, and Margaret wound up getting that out to everybody so that we could review it by phone on January 10.

We have got a lot of good feedback and comments and critiques back, both during that conference call on the 10th and afterwards. And so Margaret has tried to fold in the additional comments and critiques into the report. So this is kind of a revised first draft of the report.

I think at this stage maybe Margaret if you could just take us through the changes and suggestions.

DR. COHN: Actually, if I can make a suggestion. Actually, I would like to go through page by page, paragraph by paragraph, recognizing that this has been a substantial change from previous versions. We have talked about it in the conference call, but at that time we were not getting to the level of paragraph by paragraph comments.

So Margaret, if it's okay with you, and it would probably make things easier for Dr. McDonald, since he is on the conference call, if we just handled things literally paragraph by paragraph.

MS. AMATAYAKUL: And I would also mention that Stan Griffith sent comments to me, and I have got his comments here as well. So I'll try to track those for you too.

[Dr. McDonald is having trouble hearing the conversation.]

MR. BLAIR: Margaret.

Agenda Item: Review of the Detailed Outline for the Report

MS. AMATAYAKUL: So I'm on the Table of Contents, Executive Summary, Introduction. Under Introduction we have purpose, background, and general rationale, definition of terms and phrases, summary of focus areas, scope, and process of studying issues and making recommendations.

And then we have a new major head, Overview of Standards for Patient Medical Record Information. Under that overview of data standards issues, and within that, interoperability, comparability, measures and issues associated with data quality and other issues. And then current status of data standards, and within that, message format standards, medical terminology, data quality, accountability and integrity.

Then as another major head we have Issues, Observations, Assumptions, and Recommendations by Focus Area: message format standards, medical terminologies, data quality, accountability, and integrity, diverse state laws and regulations, business case for payment standards, relationship to NHII, privacy, confidentiality, and security, and then conclusions.

MR. BLAIR: Clem, just in case you are struggling to hear Margaret, she just went through the Table of Contents.

DR. MC DONALD: I can't hear anything Margaret is saying.

MR. BLAIR: Okay, she just went through the Table of Contents. I think you already indicated you had no problem with that, correct?

MS. AMATAYAKUL: There are five appendices: the CPR workgroup work plan; questionnaires used to gather testimony; copies of testimony; glossary of terms; and guiding principles for promoting PMRI standards.

Then we have an executive summary that will be written later. Then we have Introduction. I'll read paragraph by paragraph, and look to see if there are any comments?

MR. BLAIR: Yes.

Agenda Item: Review of the Introduction Including Purpose, Background and General Rationale, Definitions, Scope, Process

MS. AMATAYAKUL: "Purpose. This report has been prepared for the secretary of Health and Human Services in accordance with Section 263 of the Administrative Simplification Provisions of the Health Insurance Portability and Accountability Act of 1996, HIPAA.

These provisions state the National Committee on Vital and Health Statistics shall: (a) study the issues related to the adoption of uniform data standards for patient medical record information; (b) the electronic exchange of such information; and (c) shall report to the secretary not later than four years after the date of enactment of the Health Insurance Portability and Accountability Act of 1996, recommendations and legislative proposals for such standards in electronic exchange."

Then we have background.

MR. BLAIR: Before you go to that, let's see if anybody has any question on the purpose. Clem, Margaret just finished reading to us the purpose. Do you have any concerns or questions on that?

DR. MC DONALD: No. Is she on the phone too? Is she another dial in person?

MR. BLAIR: There is no one else on the phone that I know of.

DR. MC DONALD: I can't hear anything from her.

DR. COHN: Clem, were you able to get on the Internet for the transmission?

DR. MC DONALD: No, but we are working on it. I'm on the Internet and I see the screen. It seems like your link is not working. My machine may not be set up right, but they tried it on another machine, and nothing has come across. We're still working on it.

MR. BLAIR: I think we'll just work with you as well as we can, and hopefully you'll be able to do something that will improve it.

Is there anyone else on the committee that has any comments or questions about the purpose?

DR. ZUBELDIA: Yes, I have a question. It mentions the Health Insurance Portability and Accountability Act of 1996. Should it also mention Public Law -- whatever the public law number is?

MR. BLAIR: That's fine. We can do that. Margaret?

MS. AMATAYAKUL: I've got it. I'll yell if I don't get it, or ask you to slow down if I don't get.

MR. BLAIR: Any other comments or questions with respect to the purpose of the report? Okay, do you want to head on to the next?

MS. AMATAYAKUL: Under Background and General Rationale we have two paragraphs that are indented, and they are meant to be kind of scenarios to set the stage for the report. The first one reads:

"In the 1960s local grocery stores struggled with small profit margins in large part caused by constant shortages of some items, and overstock of other items. The only way they could address this problem was to assign store clerks to the task of counting every item on every shelf every day.

In the 1970s stores began to install bar code readers at the checkout stands that not only improved the efficiency of the checkout process, but also gave them continuous real time update the inventory of every single product in the store. They improved their customer service and lowered their cost at the same time."

[Bob Mayes joins the proceedings via teleconference.]

MR. BLAIR: Let me just take one second here to let Bob Mayes introduce himself to the Internet. Bob, could you introduce yourself?

MR. MAYES: This is Bob Mayes, Health Care Financing Administration, staff to the committee.

MR. BLAIR: Okay, Bob, if you have a copy of the document with you, we have gone through the Table of Contents. We didn't have any questions or concerns on that. We have stepped through the purpose within the introduction, and Margaret is now beginning to lead us through the first paragraph underneath the Background and General Rationale section.

Let us know, Bob, if you have difficult hearing Margaret as she goes through.

MR. MAYES: Okay.

MS. AMATAYAKUL: I will continue reading this paragraph.

MR. MAYES: It sounds like you're inside a box.

DR. ZUBELDIA: Bob, if you have access to the Internet, if you could listen to us on the Internet. We can hear you fine, but that will probably be the best way for you to hear us.

MR. MAYES: Okay, I'll try to do that.

MS. AMATAYAKUL: Continuing on. "Why did this not occur sooner? The major delay was not the availability of technology. It was the years that it took for all the different suppliers to agree to a single standard for the bar codes, and how they would put them on their packaging."

MR. BLAIR: Did you say it took a year? It actually took -- some people say it took as long as ten years. I don't want to say ten years. I think we want to say it took many years or several years.

MS. AMATAYAKUL: It was the years that it took.

MR. BLAIR: It is plural, okay.

DR. COHN: Can I make a comment on this first paragraph? First of all, I want to compliment both of you on coming up with some examples. I would just make the editorial comment that it really isn't the major delay, but really the major impediment was not the availability of technology, which I think is probably a better word for there.

I guess we need to think about -- I guess in my own view I would like to see the example probably made even a little more real if there were some figures that we could throw out in relationship to savings or costs or whatever, just to make the example more vivid. I think that would be useful. I obviously don't know this example well enough to come up with figures, but something to actually talk about dollars or dollar savings or whatever I think would make the thing much more vivid for somebody looking at this.

DR. MC DONALD: Is this page 3?

DR. COHN: This is page 2, Background and General Rationale -- at least my page 2.

DR. MC DONALD: Okay. Actually, there are some vivid examples.

MR. BLAIR: Maybe Clem is referring to just before the summary. Margaret included a number of examples with cost savings at that point within health care. But I think that Simon's point is that right at the beginning in this first paragraph, he was looking for cost savings for this example, is that correct?

DR. COHN: Yes, what I was actually thinking of was this is another industry that has gone through what we are expecting health care to go through. I think it would be very powerful if we could talk about significant savings, increased value in more than a general way for this other industry, since we are I think postulating that this is what health care is going to go through because of this increased diffusion of standards.

MS. AMATAYAKUL: I think we can see if we can find some data. We actually went through a whole variety of scenarios, some of which we had kind of been asked not to go into like the Mars issue and so forth. So we wanted it to be outside of health care, but a clear example; something that everybody could relate to. So we'll see if we can't come up with some.

MR. BLAIR: One thing that I guess I would like to hear from the committee, because Margaret and I really struggled on this, there were some examples within health care that were very compelling, but we were advised by some folks that it would be a good idea to have an example that was outside of health care. And then when we got outside of health care, we went through about four or five before we settled on this one.

Is this sufficient and adequate? Is this a good analogy to start with?

DR. ZUBELDIA: I think the example is great. The problem I had when I read it the first time is that it talks more about administrative simplification rather than CPRI. And because HIPAA has the administrative simplification part, it can be a little confusing. But I think it's a great example. I would maybe talk about some of the IOM report examples, or maybe the prescription case in Texas recently; things like that.

MR. BLAIR: We thought about the prescription piece, and we felt like that was within health care. And we had been advised by some folks to have this first example to be outside of health care.

DR. ZUBELDIA: It's an excellent example. I think it's great.

MS. AMATAYAKUL: The next paragraph is, "The health care delivery system is faced with problems of similar nature. For example, information on an allergy to an anesthetic is not in the hospital's standard format, and is missed when preparing a patient for surgery. A brand new home care information system does not use the same standards as the hospital information system, that prevents the communication of the sudden change in a patient's status. A nurse administers an incorrect dosage, because the standard tablet size described in the formulary in the nursing unit is different than that used by the pharmacy."

"The state of health care information standards today impacts the cost of our information systems and the ability to use these systems to improve the quality and efficiency of health care."

MR. BLAIR: Comments.

DR. FITZMAURICE: I would suggest the sentence that reads, "A brand new home health system does not use the same standards as the hospital information system that prevents the communication," maybe emphasizing it, and this prevents the communication of a sudden change in patient status, to make it more dramatic. That the problem that they don't use the standards, this prevents the communication of a sudden change in the patient's status.

MR. BLAIR: Prevents the communication of a sudden change?

DR. FITZMAURICE: Yes.

DR. COHN: Say and this prevents?

DR. FITZMAURICE: After the hospital information system, and this prevents the communication.

MR. BLAIR: Any other observations or comments or suggestions?

DR. COHN: I just had a little clarification. I have the advantage of having an actual printed copy of this, which I'm seeing multiple different shades of change. That has no significance?

MS. AMATAYAKUL: No, I don't know why my changes came out to be Christmas tree colors, red and green. I'm sorry. They are all the same.

DR. ZUBELDIA: Margaret, would you track changes today?

MS. AMATAYAKUL: I'm not going to track -- do you want me to track changes today?

DR. ZUBELDIA: It may be easier if we make some changes today, to know where they are. Or maybe accept all the previous changes, and track changes today.

MS. AMATAYAKUL: That is going to take me a little bit more time then, so bear with me.

MR. BLAIR: Let me ask about that. That is that what we do today is going to be the foundation for what gets presented for review by the full committee later this month. It's not this month, it is February 23-24. As such, we probably don't want to have change markings on that document. Were you thinking, Kepa, that you wanted it because you were hoping we would have another review before February 23?

DR. ZUBELDIA: No, I'm thinking for us to see on the screen, to see what she is changing on the screen right now during this session. Then at the end of the session, just accept all changes, and with fell swoop just get rid of all the marks.

MR. BLAIR: Simon, do you have a comment?

DR. COHN: I don't have a strong feeling one way or the other. I'm just thinking operationally what's easiest?

MR. BLAIR: Margaret, is this something you can accommodate?

MS. AMATAYAKUL: I've been having a little trouble with the tracking changes on this document. I don't know why. Let me try it from here on forward, and we'll see what we can do. I can't guarantee that I can just accept all the changes here, because I have had some previous problems. But I can at least track going forward.

MR. BLAIR: Margaret, if you can't do it, nobody can.

MS. AMATAYAKUL: Oh, no, that's not true.

MR. BLAIR: All right, are we ready to go on to our next section and heading?

MS. AMATAYAKUL: "What are the issues in health care that are relevant to this report? The health care delivery system in the United States is considered to be the best in the world in many ways. The U.S. has outstanding medical schools, prestigious medical research institutions, numerous local health care facilities, state-of-the-art technologies, and more well trained health care professionals than are found in most other countries."

"During the last few decades, the U.S. health care system has achieved significant improvements in the health status of our population, including greater longevity and broad improvements in many key measures of health care and wellness."

DR. COHN: Can I make an editorial comment here, since we're going paragraph by paragraph? The first sentence needs to be somehow modified, strengthened. There is something about the way it is described right now. Maybe we want to say the health care delivery system in the United States is considered to be the best in the world period. I'm not sure the "in many ways," adds a lot.

MR. BLAIR: What about this, Simon? If we kind of took that idea -- I think some folks wind up getting picky about. Is that satisfactory with everybody?

DR. FITZMAURICE: How about many people consider?

MR. BLAIR: Why don't we start out with that part that is at the dangly end? Just start off with many people consider. Does that accomplish the purpose? Or start off with in many ways the health care delivery system is considered the best in the world? Does that do it?

DR. COHN: You're right, I guess this is our opportunity to wordsmith, isn't it? I guess I look to the other subcommittee members to see. I find the "in many ways" to be somewhat offensive, and I'm not sure that qualifying "most people consider" does it any better. I'm trying to think of what point we are trying to make here with the qualifiers.

MR. BLAIR: Just to try to project us from those folks who wind up coming up with examples where we are not the best in the world either in terms of longevity or infant mortality or whatever. Maybe if we said in general.

DR. FITZMAURICE: I think the point we are making is that the structure that we have in place is considered by many to be the best in the world.

DR. COHN: What I see here is a first paragraph that I think should be an unabashed statement of the goodness of the health care system. The next paragraph begins to get in "despite all the accomplishments and advantages, there are some problems." I don't know that we are doing anything particularly by putting such qualifications on the lead sentence. If you all have other thoughts.

DR. ZUBELDIA: Even if you are the best in the world, that doesn't mean you are perfect.

MS. AMATAYAKUL: We also are saying considered to be. We're not saying is.

DR. ZUBELDIA: Yes, so I agree, just remove that "in many ways." It makes it cleaner.

DR. COHN: Dr. McDonald, do you have any comments?

MR. BLAIR: Clem? Let's assume that silence is consent.

Margaret.

MS. AMATAYAKUL: "Despite all the accomplishments and advantages of the U.S. health care delivery system, there remain some complex and serious problems to be addressed. These problems include the difficulty of controlling rising health care costs and limited capabilities to measure and therefore accelerate the improvement in the quality of care. As we examine the root causes and the solutions to these problems, we discover that cost control and quality improvement in health care are often interdependent."

MR. BLAIR: Comments?

DR. FITZMAURICE: I guess I would add in that paragraph just the mention of errors in medicine. I know that we talk about the IOM report about three paragraphs below that. But despite all of our accomplishments and advantages, we do face an errors in medicine problem that is nation in scope. Perhaps it is as important as rising health care costs.

MR. BLAIR: The only thing is do we break the train of thought that we are taking the reader through if we introduce that at this point, since we do mention it just a paragraph or two later?

DR. FITZMAURICE: Well, since we talk about complex and serious problems, we mention some of them. I guess I would consider the errors in medicine to be as important as rising health care costs.

MR. BLAIR: Is that the general feeling of the committee, to add that concept at this point?

DR. FITZMAURICE: Even if it means just putting a comma, errors in medicine.

MR. BLAIR: Including errors in medicine. Is that okay with everybody?

MS. AMATAYAKUL: Mike?

DR. COHN: I guess I would speak against it being the first issue. Maybe it's the second one.

MS. AMATAYAKUL: So it would read, "These problems include the difficulty of controlling rising health care costs, errors in medicine, and limited capabilities to measure, and therefore accelerate the improvement in the quality of care?"

MR. BLAIR: I would put it third in my mind.

DR. COHN: Yes, maybe it's even --

MR. BLAIR: The main points we want to get -- we have sort of thread that we are taking the reader through here. We are trying to keep them on track.

DR. COHN: Once again, wordsmithing here, it feels funny in this paragraph. I'm trying to think of whether --

DR. FITZMAURICE: Well, it's hard to think of another serious and complex problem that we would put in there. And I would put it before accelerating improvements in the quality of care, because that's really not so much a problem, as a way of addressing a problem.

MR. BLAIR: Kepa, Clem, Bob, anyone else have feelings about this sentence? The idea of adding errors in medicine into the sentence, and if so, where it would be?

DR. FITZMAURICE: To keep us moving, we can just keep it as a marker, and it's something to come back to later on.

DR. COHN: Bob or Clem, are you on the phone?

MR. BLAIR: Clem or Bob, can you hear us?

MS. AMATAYAKUL: Maybe what we can do is I'll add an asterisk in where we are not certain we want to make the change, but it's sort of like a note, as opposed to a comment that you can't see unless I highlight it. I'll just put an asterisk and we can go back to them.

MR. BLAIR: The only thought that I would give, as we go through this review process is please to try to look at these next several pages as an introduction to a lay person where a lot of these ideas may be new to them, and we're trying to kind of build a thread here which draws them to a conclusion. So even though there are many other examples and other thoughts that are relevant and true, we don't want to distract them too much from that thread that integrates this whole section.

MS. AMATAYAKUL: I think if you are going to use errors in medicine, there should be some further, a little bit longer phrase that says what that means.

DR. ZUBELDIA: Along those lines, can I make a suggestion here? These problems include the difficulty of controlling the price of health care costs, reducing errors in medicine, and limited capability to measure, and therefore accelerate.

MR. BLAIR: I think I am hearing that people feel comfortable with Kepa's suggestion. Is that correct? Since I didn't hear differently from Margaret, I'm assuming she has captured it. All right, are you ready to move us forward?

MS. AMATAYAKUL: The next paragraph is, "The interdependence between cost and quality becomes even more important as health care enters the information age. This is because the health care model developed during the industrial age treated the provisions of services as a scarce commodity subject to supply and demand. In this model, more health care services and better quality typically generated higher costs."

"In the information age computers and networks make it possible to distribute many types of health care information and knowledge at little or no additional cost. This can significantly change the health care environment that has been constrained by the physical availability of knowledgeable health care professionals to provide services. The information age facilitates a paradigm shift where health care can offer more services, with better quality at the same or lower cost."

MR. BLAIR: Comments or observations on this paragraph?

DR. FITZMAURICE: This paragraph is kind of a little puzzling to me, because we talk about distributing many types of health care information and knowledge at little or no additional cost. Yet the cost of changing our infrastructure to admit computerized patient records, common medical terminology would have a significant cost. So I'm not sure what small addition we could make to bring that information -- make it available.

A second point I have with the paragraph is that we say that this can significantly change the health care environment that has been constrained by the physical availability of knowledgeable health care professionals. Again, in the previous paragraph we talked about having more well trained health care professionals than are found in most other countries.

I think they are so close together that the inconsistency might stand out. And the availability of knowledgeable health care professionals to provide services, gee I don't know, maybe to obtain information. It affects their ability to obtain information maybe more than provide services.

MR. BLAIR: Simon?

DR. COHN: I had a question mark around some of this also. I found myself a little confused between whether services included delivering information. Only because of my clinical practice, we tend to think of services as more of an active role. It does really include the delivery of information, but just to somehow clarify that in the paragraph.

DR. FITZMAURICE: But I think the question is are they constrained in delivering services, or are they constrained in obtaining information so they can deliver services? Are we talking about educating the patient, or are we talking about obtaining medical knowledge for the provider to deliver services?

MR. BLAIR: Let me jump in at this point and clarify, because when we were writing this the imagine in my mind was telehealth providing services to underserved populations, which means both the availability of a clinician to be either able to gather information from a remote site, as well as provide knowledge professional expert guidance to a clinician that might be at a remote site or the patient at a remote site.

I didn't want to go into the details of describing telehealth and go into an example at this point. I just wanted to get the concept of a paradigm shift in place, because later on in the document we build on this with the other examples. But from what you are saying, there is not enough there, and we need to add something to this to be able to fill in the fact that it is both providing information -- it's two way communication. The information and the services could be provided a la telehealth remotely.

DR. COHN: First of all, I think this fundamentally needs to be there. I like the concept of paradigm shift, and I think it begins to talk about some of the value that we believe is going to be being created by the work that is being done.

You are right, I think it need to somehow be insinuating the service and the information sharing. And really part of the service is information. Now as I read this, I didn't see telehealth as the example. I saw more Web-based availability of information for consumers, which I see as something different than telehealth.

MR. BLAIR: Which means that the paragraph was not strong enough to give a broader idea.

DR. FITZMAURICE: I think Simon is right that the paradigm shift is really the way in which people obtain information. And this may affect the services they demand, and the way physicians delivery services to them. That it's the change in the outside infrastructure, this information technology, that is going to lead to changes in the practice of medicine.

DR. ZUBELDIA: The paradigm shift that I saw when I read this is the creation of expert systems that will use the knowledge base to deliver more services, delivered by the expert system itself, without the health care professionals. That's what I saw here. I don't think that is the intent. I think that's disturbing. It's very disturbing, and that's what I read in here.

MS. AMATAYAKUL: Maybe what we should do is just mark the paragraph, and kind of try to rework it and come back to you, since it will be difficult, I think, to get all those concepts in a group. Is that a good suggestion?

DR. COHN: Yes.

MR. BLAIR: Yes, I think everybody agrees.

DR. FITZMAURICE: That sounds good. Let's just move on.

MS. AMATAYAKUL: "The expenditures for health care in the U.S. are now approximately $1.1 trillion per year. This has risen from $5.1 percent of the GDP in 1960 to 13.5 percent of the GDP in 1997. This massive increase in spending has put tremendous financial pressure on federal and state budgets, and the ability of employers to maintain comprehensive employee benefit plans, and on the ability of individuals to afford health care insurance. This increase in spending for health care has undermined the nation's attempt to reduce the number of citizens who are not covered by some form of health care insurance. The latest estimate of U.S. citizens that do not have access to health care insurance has grown to over 44 million persons."

MR. BLAIR: Comments, questions?

DR. FITZMAURICE: The phrase, "The increase in spending for health care has undermined the nation's attempt to reduce the number of citizens." I'm not sure that's the increase in spending that has undermined it. It's made it more difficult to reduce the number of citizens, because if spending goes in one area, then it can't go in another area. I think it's that trade off.

MR. BLAIR: So if we change those words to made it more difficult to reduce the uninsured?

DR. FITZMAURICE: And there we are kind of talking about cost, as opposed to spending. But the notion of spending with absolute constraints. That we can only spend money for this or for that, we can't spend it for both leads me to say it could be okay. But I'm still thinking it's the cost of getting health care to these people, not the total amount of spending that has already taken place that constrains us.

MR. BLAIR: Other comments or observations?

DR. ZUBELDIA: Yes, on the sentence above that --

MS. AMATAYAKUL: Kepa, could I just ask Mike one question on this one before you go on? So you want to leave this as cost time?

DR. FITZMAURICE: No, I would say this increase in spending for health care has made it much more difficult to reduce the number of citizens who are not covered by some form of health care insurance. And within that in my mind I have the fact that we're spending so much already for let's say public programs, it makes it difficult to spend even so much more to cover or to assist the coverage of 44 million people.

That whole thought isn't in there, but it's more easily embedded if we say make it much more difficult than undermine the nation's attempt.

MR. BLAIR: Mike, could I just add one thing on this? I don't feel strongly whether we have cost or spending on this particular paragraph. But as you could see, the thread that we build on as we go through the rest of these few pages is the need to be able to improve the quality of health care, and at the same time control or reduce health care costs.

So at some point we try to get back on the thread of quality and cost. But my only thought is for us to be careful to not replace spending all the way through. Does that make sense? Do you agree?

DR. FITZMAURICE: I can go along with it. I see a second paragraph just to address that one sentence, because we are changing from look at all the spending that is going on and then increase in spending, to what would it cost to cover a large portion of the population that doesn't have health insurance. What would it cost to give them the kind of health, for which we are not currently spending?

MR. BLAIR: I think that there are going to be many people who are going to review this and approve it who are in the federal government. I think that just like you, many of them will tend to look at it in terms of spending. So I think that it is an important change. I somehow don't want to go so far that it makes it difficult for us to make a transition back to cost.

DR. FITZMAURICE: All right, I'm happy to leave it as has made it much more difficult, so that it doesn't destroy the paragraph. I don't know how to make the transition back to cost in the space of a sentence.

MR. BLAIR: Whichever way we want make the spending, that's fine.

DR. ZUBELDIA: Before we go on, Jeff, would you like to introduce Dr. Ferrans, who just joined us?

MR. BLAIR: Dr. Ferrans, would you like to introduce yourself to the Internet, and to everyone here?

DR. FERRANS: I'm Richard Ferrans. I'm staff to the workgroup, consultant to the VA, and I'm with LSU Health Sciences Center.

MR. BLAIR: It's hard for some folks who are on the Internet, and for Clem McDonald and Bob Mayes that are on the phone, so make sure you get real close to microphone, or it's hard to hear you.

DR. ZUBELDIA: My comment is on the sentence right above the one that Dr. Fitzmaurice was talking about. Where it says, "This massive increase in spending has put financial pressure . . . on the ability of employers to maintain comprehensive employee benefit plans, and on the ability of individuals to afford health care insurance." I would scratch out the word "insurance." On the ability of individuals to afford health care. Because then you are talking about insurance in the rest of the sentence as something that the employers do in general.

MR. BLAIR: Comments or thoughts on Kepa's suggestion?

DR. FITZMAURICE: I think it makes it more general, and it also ties in with the next sentence. It's a good suggestion. I would raise a question to the committee about should we leave massive in there or not? Should we be detrimental about it? It is a large increase in the proportion of GDP; $1.1 trillion is a large amount. So it may be massive. I just want us to make a conscious decision to call it massive, as not to.

MR. BLAIR: Thoughts on retaining or not retaining the word "massive" increase?

DR. FITZMAURICE: It connotes that it may be unwarranted, unwise, and yet if it's what consumers want, if that's where they want their resources to go, then there is nothing wrong with an increased percentage of GDP going to health care. If you don't think massive is prejudicial, then let's move on. I just want to raise it as a discussion point, not because I think that I'm firmly convinced that it should not be there.

DR. ZUBELDIA: It is pretty massive.

MR. BLAIR: I think one of the things we want to do with the reader if we can at this point, which I think why the word was chosen was there is a little bit of an emotional context to that word, which I think is what you are picking up on. And that is because there are consequences to that increase. The rest of the paragraph deals with the fact that that very large increase has had consequences, and so anyway.

DR. FITZMAURICE: Okay, then let's leave it.

MR. BLAIR: Is there anybody else that feels uncomfortable with massive before we leave it? Okay, Margaret.

MS. AMATAYAKUL: "When we try to measure the quality of health care in the U.S." --

DR. FITZMAURICE: Before we move on to the next paragraph, on the last sentence I would just change the order. I would have it read, the latest estimate is that 44 million persons in the United States do not have access to health care insurance.

MR. BLAIR: What was the --

DR. FITZMAURICE: As opposed to, "Latest estimates of U.S. citizens that do not have access to health care insurance has grown to over 44 million people."

MS. AMATAYAKUL: Mike.

DR. FITZMAURICE: That's fine.

DR. COHN: Actually, is it that they don't have access? Is access the wrong term here?

DR. FITZMAURICE: They are uninsured. That's a good point, Simon.

DR. FERRANS: They do have access to insurance, they just can't afford it.

DR. FITZMAURICE: Many of them are working and choose not to buy it. You're right.

DR. FERRANS: That's correct.

MR. BLAIR: The word in public policy that has been offered many times is the three key issues are quality, cost, and access. And the access is a word that I think many people will link into in terms of this area of major health care problems.

DR. FERRANS: That's access to care though. Are you talking about access to care?

MR. BLAIR: But the piece on this was that it typically seems to be linked with the coverage. In other words to expand a little bit on it is that Medicaid will cover people who are unemployed. And the elderly is covered by Medicare. And then if you work for a company that provides health care insurance, then you are covered that way. Or if you could afford to buy it yourself, you are covered that way.

But the area where the 44 million people seem to fall for the most part tends to be either small employers, or proprietorships that can't afford health care. They tend to be referred to often as the working poor.

DR. COHN: Jeff, should we change then to have access to affordable health care insurance?

MR. BLAIR: That would do.

DR. FERRANS: I think that what you are saying is that a lack of insurance leads to lack of access to care. That's implied.

MR. BLAIR: Thank you, Simon.

DR. ZUBELDIA: Not to get into that argument whether it's affordable.

MR. BLAIR: Well, actually, I kind of like Simon's suggestion, because I think that the word "affordable" helps you see the discriminator.

MS. AMATAYAKUL: Onwards. "When we try to measure the quality of health care in the U.S., there are several health status indicators that cause us to question whether the effectiveness and quality of care is as good as it should be. For example, the U.S. spends more than any other country on health care as a percentage of its GDP, but many other industrialized nations have lower infant mortality rates and greater longevity. Another indicator of quality that causes concern is the recent report from the Institute of Medicine which showed that medical adverse events have caused more deaths in the U.S. than highway accidents, breast cancer, or AIDS."

MR. BLAIR: Actually, it's combined, all three.

DR. FERRANS: Then we should add that.

DR. FITZMAURICE: And one would say annually.

DR. FERRANS: Causes more annual deaths.

DR. FITZMAURICE: Causes more deaths annually. That's a good paragraph.

MR. BLAIR: Any other comments? I think it was just that sentence, and then I think we can go on. Although I heard several people say it's a good paragraph, so maybe the paragraph is satisfactory and we can continue?

DR. FITZMAURICE: Yes.

MS. AMATAYAKUL: "What has already been done to control rising health care costs and improve quality? Many approaches and methods have been instituted in an attempt to control rising health care costs and improve quality. The organizational approaches that have been employed include: the expansion of managed care organizations, HMOs, PPOs, PHOs, et cetera, with an emphasis on wellness; establishment of integrated delivery networks with an emphasis on continuity of care; the emergency of pharmacy benefit management organizations with an emphasis on prescription compliance; and the growth of group purchasing alliances with an emphasis on reduction of cost. Administrative and clinical programs to address these issues include: risk management, utilization management, case management, capitation plans, physician profiling, care plans, performance measurement, and accreditation programs, wellness programs, and a variety of other techniques."

MR. BLAIR: And Stan Griffith suggested we add disease management to that sentence.

DR. FERRANS: I was about to say --

MR. BLAIR: And I hear from Dr. Ferrans that it's not the same?

DR. FERRANS: No, I said I was about to say that.

MR. BLAIR: Do people feel comfortable adding disease management to our list there?

DR. COHN: I'm actually just sort of wondering why that second sentence would include capitation plans? I'm trying to think of an example of capitation plans that are really not somehow covered in the organizational approaches in the first sentence. It's a question more than a comment. I tend to think of that as being part and parcel of some of the PPO, PHO, HMO, group purchasing alliance type of issues.

MR. BLAIR: Does everybody feel comfortable if we strike the reference to capitation plans?

DR. FITZMAURICE: Yes, I think Simon's right. I think it doesn't fit in with the list.

MS. AMATAYAKUL: I'm sorry, what line are you looking at?

DR. COHN: I'm looking at where it says "capitation plans." I think that we should include case management, but we should strike the capitation plans from that sentence.

MS. AMATAYAKUL: Sorry.

MR. BLAIR: Richard, you had a question?

DR. FERRANS: Yes, on the expansion of managed care organizations with an emphasis on wellness, I would say that there is also an emphasis on cost containment, and that should be recognized. I mean I think that's where a lot of the -- a large measure of at least trying to control short-term costs are being taken, whereas the long-term, yes I would agree on the emphasis on wellness. But clearly, there is a large emphasis on controlling costs.

MR. BLAIR: Simon?

DR. COHN: I think that maybe it's -- I feel uncomfortable as having that listed as one of the two characteristics of managed care organizations. I would say probably the wellness and disease prevention might be -- I would be more inclined to use those as the adjectives. Certainly I think there are HMOs that are primarily focused, as you describe, but I don't think I would characterize that in this document.

MR. BLAIR: Could I add my thought supporting Simon's revision? It's partially because none of these examples is exclusive to what we say emphasize. We're just trying to in a sentence indicate there have been many initiatives. They have added different contributions. I think that your suggestion really is very appropriate.

DR. FERRANS: I will say I think prevention is closer than wellness, or should be added at least. I just don't -- it makes everyone look like -- this would lead the reader to believe that the sort of game plan for HMOs is wellness.

MR. BLAIR: So you would change it to eliminate wellness, and change it to disease prevention? Is that what you are saying?

DR. FERRANS: Or add it.

MR. BLAIR: We're adding it.

DR. COHN: I think we're fine there.

MR. BLAIR: Any other comments on this paragraph? Margaret, next.

MS. AMATAYAKUL: "All of these initiatives have helped to address the cost and quality issues, but they have yet to achieve broad based cost containment, the level of productivity gained, and quality improvements enjoyed by other sectors of the nation's economy."

DR. FITZMAURICE: I would add to that that use information technology.

MR. BLAIR: Actually, we make that point right after that. If I add it to that sentence, it gets unwieldy. We're leading right into it.

DR. COHN: I agree.

MR. BLAIR: So you're right with us, Michael. We're getting there.

MS. AMATAYAKUL: "Why has the health care industry not been able to share the dramatic cost/quality advances experienced by other industries? Some of the reasons are: the additional cost of new procedures and technologies; the rising costs of drugs and other supplies; increasing insurance and litigation expenses; and the rising expectations for health care services.

DR. FERRANS: Should there be any mention at this point about the inability to measure outcomes, or the lack of -- is it too preliminary in the report to mention that?

MR. BLAIR: We do get to that point. But hold onto it, because maybe when we get to it, if you feel like it still needs to be put at this stage, that is one of the pieces in the thread as we go on.

Margaret.

MS. AMATAYAKUL: "These are challenging issues, but they are not that different from the challenges that other industries have been addressing. What may be of greater significance to health care is the fact that the industry faces a task of controlling costs and improving quality with a major disadvantage compared to other sectors of our economy. Other industries, including financial services, telecommunications, transportation, manufacturing, retailing, and other sectors have achieved dramatic improvements in cost containments and productive and quality because they have established information infrastructures that have brought them into the information age."

"For example, the financial industry has developed an information infrastructure that facilitates online banking, automated teller machines, electronic deposits, et cetera. The telecommunications industry has developed an information infrastructure that facilitates touch tone dialing, portable phones, cellular phones, voice mail, Internet access, et cetera. The transportation industry has developed an information infrastructure that facilitates online reservations, services, program equipment maintenance, advanced scheduling and traffic flow management, et cetera. The manufacturing industry has developed an information infrastructure that facilitates mass customization, just in time inventories, condensed time to market for new products, et cetera. The retailing industry has developed an information infrastructure that facilitates customer relationship management, online sales of products and services, automated inventory management, et cetera."

"These information infrastructures have lowered the cost of sharing information, improved the accuracy of data, facilitated improved measurements for performance and quality, enabled continuous quality improvements, and spawned the availability of new knowledge-based capabilities such as decision support and new information services that improve efficiency and effectiveness."

MR. BLAIR: Comments on this paragraph?

DR. COHN: A couple of wordsmithing. Other industries including financial services, telecommunications, transportation, manufacturing, retailing, and other sectors. There are a few too many and others. I would get rid of "and other sectors," since other industries including. One "other" in that sentence is probably enough.

Now the other question is as you read this, there is sort of this general comment that there seemed to be a lot of et ceteras in this. I think overall it's actually a well written paragraph. I'm just wondering, do we want to have sentence after sentence with et cetera as the last word?

MR. BLAIR: I don't have a strong feeling about it. We stuck the et ceteras in there just because we didn't want to imply that there weren't other things that we couldn't think of.

DR. COHN: I'm not sure I have a strong stylistic view on this one.

DR. FITZMAURICE: I tend to agree with Simon. I think having an awful lot of et ceteras is weak. I tend to prefer including at the beginning of the phrase. That way it's open-ended, because you are not saying this covers everything, but it includes these things.

MR. BLAIR: And I think we also start with such as, as well. So we having including and such as. So maybe we don't need the et ceteras.

Other comments? I think we rapidly accepted that. Are there any other comments or suggestions?

DR. ZUBELDIA: Yes, I have a couple of comments. On the banking section where it talks about online banking, automatic teller machines, I would say electronic transfers instead of electronic deposits.

MR. BLAIR: Now would a lay person resonant to electronic transfers? I think that the word "deposits" is something that they would recognize, but I'm not sure electronic transfers would be as understandable to a lay person.

DR. COHN: I think it means the same thing, but I think deposits sounds --

DR. FITZMAURICE: Electronic bill payments would even be stronger.

DR. ZUBELDIA: Then on the manufacturing side a little further down, "has developed an information infrastructure that facilitates mass customization." I know what you are trying to say, but I would just say customization rather than mass customization.

MR. BLAIR: This may be a problem, because within the manufacturing industry they generally refer to it as mass customization. That's the concept, that information systems facilitate that. On the other hand, is the lay person going to understand that? Is that well enough known?

DR. ZUBELDIA: Since I'm not in manufacturing, it's kind of a contradictory term.

MR. BLAIR: Well, that was the whole point. Is that in the industrial age you could have mass production. The information age allows you to not only have mass production, but customize it. You used to have to pick one or the other. Now you can have both at the same time.

DR. FITZMAURICE: You might say widespread individual customization.

DR. COHN: Actually, I come out on Jeff's side of this one. I think there is actually a fair body of literature that actually references mass customization. As a doctor I have actually even read books that refer to mass customization. So I don't think trying to describe what is a main concept using other terms that are unknown to people just causes confusion.

DR. ZUBELDIA: I was not familiar with the concept. I'm familiar with one-on-one marketing.

MR. BLAIR: Other comments or questions?

MS. AMATAYAKUL: So do you want to leave it as mass or take mass out?

MR. BLAIR: Mass customization as is.

DR. COHN: And I think we actually also decided to leave it as electronic deposit. I think it's the same thing. It just a question of how we --

DR. FERRANS: I was going to add, and I don't know whether you all can review this afterwards, Simon and Jeff. In today's Wall Street Journal there were some quotes from Alan Greenspan saying that he expects productivity to increase as a result of information technology in a lot of these different sectors. Tying specifically back he says we have this supply chain management and all these other things that are now allowing people to be productive, and that this is going to drive the engine of the economy. In a report like this, a quote like that is really very solid. So you might want to see whether it is appropriate.

MR. BLAIR: Okay, thank you.

DR. FITZMAURICE: Jeff, I have a suggestion with this paragraph too. It bothered me that we were talking about sectors that have achieved dramatic improvements in cost containment, productivity, and quality. When I look at the telecommunications industry, I don't know that that they have done that with their products, but they have enabled other people to do it. So to leave it in there, I would suggest dramatic improvements in cost containment, productivity, new services, and quality.

MR. BLAIR: Does everybody feel comfortable with that? Margaret, were you able to get that?

MS. AMATAYAKUL: Yes.

Stan Griffith had a comment here. At the end of the second sentence, what may be of greater significance --

MR. BLAIR: Hold on a second, Margaret. Clem, did we lose you for a while?

DR. MC DONALD: For a long, long while.

DR. ZUBELDIA: We thought your silence meant you agreed.

MR. BLAIR: Is Bob on the line as well?

MR. MAYES: Yes.

MR. BLAIR: Okay. Margaret, do you want to point out exactly where we are, and maybe we could ask if they had any other comments up to where we are now.

MS. AMATAYAKUL: We are on page 4, the paragraph that begins with line 16, "These are challenging issues."

DR. YASNOFF: Jeff, this is Bill Yasnoff. I just got in.

MR. BLAIR: Welcome to the group.

DR. YASNOFF: Congratulations for getting to D.C.

MR. BLAIR: Well, thank you.

DR. YASNOFF: I've just got some comments prior to page 4. Is this the appropriate time to go --

MR. KENTSMITH: I'd just say too, Jeff, this is David Kentsmith in Omaha, Nebraska. I congratulate you people for getting in too. I, like some other people, had problems.

MR. BLAIR: Margaret and I flew in Saturday. We have to confess, we cheated to make sure that we got here. Not everyone is able to do that.

DR. COHN: Maybe we should let Margaret go through and ask them if they have additional comments.

MR. BLAIR: Bill, why don't you go first, since you indicated you had some comments to add?

DR. COHN: Why don't we have Margaret quickly go through the changes that we have already made sort of paragraph by paragraph, and then ask if there are additional comments?

DR. YASNOFF: That would be great.

DR. COHN: Is that okay? Because they may have the same comments.

MS. AMATAYAKUL: The first change that we made was on page 2 in line 29. So it now reads, "The major impediment was not the availability of technology."

DR. FITZMAURICE: Margaret, it may be that your line number is different, because you have added some words and pushed some things down to different lines.

MS. AMATAYAKUL: Oh, sorry. Well, on page 2 in the first paragraph under Background and General Rationale. The sentence that reads, "Why did this not occur sooner?" The major delay -- we changed delay to impediment.

DR. YASNOFF: Yes, your lines are moved. Okay, my comment there was right in that sentence actually. The major delay or impediment, I was going to suggest adding the word primarily the availability of technology.

MR. BLAIR: Is that okay with everyone else on the group, adding the word "primarily?" It sounds like everyone else accepts that.

By the way, we now have at least three, if not four folks on the phone, so as each of you speak, would you please identify who you are, so that we know who you are.

DR. ZUBELDIA: We already say the major impediment, so I think saying primarily is redundant with that.

MR. BLAIR: If you couldn't hear that, Kepa is pointing out that we start out the sentence by saying, "The major impediments." So he and Simon both feel that it is redundant to put the word "primarily" in.

DR. YASNOFF: I'm not sure I agree that technology has not been a major impediment. I think that it depends on the time period you look at, and rather than -- this isn't a major comment, but I think it's a little bit too strong a statement. But I will withdraw it if there are objections.

MR. BLAIR: I kind of would weigh in, to be honest with you, with both Kepa and Simon on this. The other piece is that in the Institute of Medicine study back in 1991, when they were doing the computer-based patient and essential technology for change, they began to pretty much come to the conclusion that the major impediments were really not technology.

DR. YASNOFF: The example here has nothing to do with that. The example here relates to grocery stores. There is no way that grocery stores could have put in bar code technology in the sixties. It was incredibly expensive and difficult to use technology.

MR. BLAIR: Actually, I'm familiar with that one also, because when I was with IBM, and I was doing the assurance reviews as we were winding up implementing the point of sale devices in the retail stores. Actually, I diluted this sentence a little bit, because many people were indicating it was up to ten years to get all the suppliers to agree on the bar codes. The technology was there many years before, and could have been implemented before, but the delay was getting consensus on the standards for the bar codes so that that could be put on the supplier packages.

DR. YASNOFF: I'm not disagreeing with that. My point is that if everyone had agreed to the bar code technology in two minutes, there still would have been a technology delay because of the cost of the technology. That's my quibble here. The major point is clear. I just want to make sure that we are completely accurate. But the major impediment satisfied me, so I'll withdraw the comment.

MR. BLAIR: Bill, do you have any other comments or questions as we go through these next four pages?

DR. YASNOFF: Yes, I have several others. The next paragraph, what was originally line 34 in my document before you made any changes, the sentence that says, "A brand new home care information system does not use the same standards as the hospital information. That prevents the communication." This is an editorial change. I think if you substitute preventing for that prevents it's easier to read.

MS. AMATAYAKUL: We actually changed it to be, "The hospital information systems and this prevents."

DR. YASNOFF: Okay, much better.

MR. BLAIR: Do you think it's more efficient for him to just go through this changes?

DR. COHN: Well, I think we should be asking other people on the phone.

MR. BLAIR: I was just going to take him through his.

DR. YASNOFF: Maybe it would be better for everyone to chime in with changes as we go through again. And I apologize for pushing everybody back.

MS. AMATAYAKUL: I think it would be easier if we got everybody's changes paragraph by paragraph, than one person going through and then going back.

DR. YASNOFF: Right.

MR. BLAIR: Clem and Bob, do you have any other changes so far?

DR. YASNOFF: Clem, are you here? He was on the line. He stepped out for a minute. Bob, are you here? Bob Mayes?

MR. MAYES: Yes, I'm here.

DR. YASNOFF: Do you have any changes in this paragraph, Bob?

MR. MAYES: No, I don't.

MR. BLAIR: Maybe Clem has his phone on mute. Clem, can you unmute your phone maybe, so we could hear whether you have concerns?

DR. YASNOFF: Clem said he was stepping out. So should we go ahead?

MR. BLAIR: Yes, continue on, Bill.

DR. YASNOFF: The last paragraph on that page, the last sentence, "During the last few decades, the U.S. health care system has achieved significant improvements," blah, blah, blah. That's not really accurate. It's not the health care system that has achieved those improvements in longevity, et cetera. It's really the public health system that has done that.

So my suggestion to avoid -- again, this isn't a major point. Clearly, longevity has improved. Why don't we just not attribute it. So we can say during the last few decades there have been significant improvements in the health status of the population. Because we don't really care how it happened.

MR. BLAIR: The reason why I think it is important to attribute it, I think the public health system is part of our overall health care system. And the following four pages begin to wind up how do I want to say -- building on these thoughts. So we are sort of setting down steps as we go along, and they build through these four pages, to help a lay person be able to lock into the reasons why PMRI standards are needed.

So could you allow us a little bit of latitude? I do accept that you are correct that the Public Health Service deserves most of the credit for this. But if we could still leave it in the general catch all, and maybe you want to change the phrase to the general catch all of our overall health care delivery system. Maybe you want to modify that?

DR. YASNOFF: I would be happy if you would just say including public health, or something saying public health, because otherwise it's just not accurate.

MR. BLAIR: Okay, why don't we say and public health?

DR. YASNOFF: The health care and public health system.

MR. BLAIR: Maybe say including public health.

DR. YASNOFF: Or including public health. That would be great.

MR. BLAIR: Okay.

DR. FITZMAURICE: It's much less divisive.

DR. YASNOFF: Because the health care system does contribute to this, but it's not the primary contributor, although people perceive that.

MR. BLAIR: Does everybody else feel comfortable with adding and public health?

DR. MC DONALD: This Clem. I can hear you pretty well.

DR. YASNOFF: We are reviewing page 2. Do you have any comments on page 2?

DR. MC DONALD: Well, some of this stuff could use still some further editing, but I don't have content comments.

DR. YASNOFF: We are trying to go through this again, and make sure we pick up comments from folks who were late, like me.

MR. BLAIR: I think Simon was suggesting we go paragraph by paragraph and solicit all of your comments at that point.

DR. MC DONALD: Well, I guess the question is if we don't make comments, do we forever hold our peace? What's the process that would follow this? Because some of this stuff is not a substantive thing. It's just that there are still some things that get missed. It more verbiage.

DR. COHN: Clem, this is our opportunity to wordsmith, so if you don't get to wordsmith now, the next step after this is it goes to the NCVHS in February. And it's not for a final vote, but the closer we have it right.

DR. MC DONALD: Well, is it real efficient to wordsmith on the phone, rather than send you suggestions, that's the question.

DR. COHN: We have been wordsmithing so far.

MR. BLAIR: Yes, that's what we are doing.

DR. COHN: But I think what we need is the actual wordsmith, as opposed to just thinking about something. So any suggestions as we are going paragraph by paragraph. We have already done a fair amount of work.

MR. BLAIR: One last thing is that it's not going to be delivered to the secretary after our February meeting. It is due to the secretary by August. But we wanted to get it as good as we could have it by February 23-24.

DR. MC DONALD: I'm on the ward, so I won't be there. That's the whole committee?

DR. COHN: That's the whole committee.

MR. BLAIR: That's the full committee. They are going to critique it, and I'm sure that we will have changes, and we will have four months to work on it again. We also have a workgroup meeting in March where we could go over additional changes. So it's not your final opportunity, but we do want to wordsmith it to make it as good as -- if you have any ideas on things you really feel uncomfortable with, this is your opportunity.

DR. MC DONALD: Okay.

DR. COHN: Actually, I wanted to get back to Rob.

DR. KOLODNER: We jumped down in the second paragraph in the background were we talked about a new home health care information system. We used the verb does not use. Since I'm not sure what we're referring to, it would be would not -- might not use, or something like that. The way we are referring to it here is as if there is one that doesn't use it, as opposed to one that could use it. And there is no reason that the convergence might not occur. So the danger is here if one doesn't use it, then we've got a real problem.

DR. FITZMAURICE: But I think that's consistent through all the examples. That we're assuming that there is a problem. Again, it's an assumption. It's not a statement of fact.

DR. KOLODNER: But it's an assumption from one that doesn't exist yet.

DR. COHN: Well, I think we give an example of an allergy to an anesthetic and not in the hospital standard format. You can make the same case for the sentence above. I don't know how to handle that. I think we're postulating possible discontinuities.

DR. KOLODNER: I guess the key is in terms of the tone that unless something happens we could have a situation as opposed to discussing it as if it already has happened. And that warning is such that we still have an opportunity to in fact through this process, bring about the convergence that we are saying needs to occur. But the tone of it, for somebody who doesn't know the state-of-the-art might think, oh well, it's already too late. It's already created. We're describing home information systems that already exist, that aren't compatible.

MS. AMATAYAKUL: These three example are real examples of a particular instance. Would it help to say, for example in one hospital information? In a brand new home care information site, or something like that?

DR. KOLODNER: Yes, that would be helpful. Those are existing ones, and it isn't that those are necessarily these standards, but they are already starting to develop. That would be very helpful.

DR. FERRANS: On the second one you could say in an integrated delivery network.

DR. YASNOFF: I'm sorry, I'm having trouble hearing, and therefore having trouble figuring out exactly where you are. Could you help me?

MR. BLAIR: We will try to speak into the microphones as much as possible.

DR. MC DONALD: But maybe keep referencing where.

DR. YASNOFF: Where are you?

DR. KOLODNER: This was the second paragraph under Background and General Rationale on page 2.

MS. AMATAYAKUL: How about if I read this paragraph, because I made some changes.

DR. YASNOFF: Great.

MS. AMATAYAKUL: "The health care delivery system is faced with problems of similar nature. For example, in one hospital, information on an allergy to an anesthetic is not in the hospital's standard format, and is missed when preparing a patient for surgery. In an integrated delivery network, a brand new home care information system does not use the same standards as the hospital information system, and this prevents the communication of a sudden change in a patient's status. At another hospital a nurse administers an incorrect dosage because the standard tablet size described in the formulary at the nursing unit is different than that used by the pharmacy."

DR. COHN: Can I just ask a question, Margaret? Is that example that you give, was it actually missed?

DR. YASNOFF: Are there some examples of problems with standards causing errors in the recent IOM report that we could reference?

MR. BLAIR: We do reference that down in the document further. As a matter of fact, have you had a chance to look through this entire four pages or the entire document, Bill?

DR. YASNOFF: Yes.

MR. BLAIR: Okay, you wind up seeing that we start to reference those further on.

DR. YASNOFF: But I'm wondering if we shouldn't reference them here? If there are a lot of them there, we could say many more examples of this can be found in this IOM report so and so, so that we make it clear that it's a big problem, and that other people have seen it also.

DR. MC DONALD: There are two other little complications. We're saying problems with the standards, but the problem is that there aren't standards more often than the problems with standards. Later on in the document you talk about all the standards that exist. There may be some problems in not understanding that that is what you are saying here.

The second thing is some of these things are sort of non sequiturs. You say they have this thing, but nothing about whether anything happened because of it. So they administer an incorrect dosage, because the standard size was different. Well, so what if it's 300 versus 375? Most of these things you don't go on and say what happened because of that.

DR. KOLODNER: But, Clem, under the patient safety approach, if that's a near miss --

DR. MC DONALD: I was assuming that these things did have something happen. This is not going to hit someone over the head. Like you hear about an airplane crash. You wake up and you read about it. You hear about the 37,000 near misses, and you ho hum.

DR. FERRANS: Well, taking that point, Clem, at the end of that sentence when we talk about the state of standards impacting the cost of systems and the ability to use them, if one felt stronger about it, they could add language that is saying that this also impacts --

DR. MC DONALD: Well, I kind of don't know that people will get the point. Did these events really cause problems are not? That's the first thing I'd like to know.

DR. YASNOFF: I tend to agree with Clem. I don't think it's scary enough.

MS. AMATAYAKUL: How about, "For example, in one hospital information to an allergy to an anesthetic is not in the hospital standard format, and is missed when preparing a patient for surgery, resulting in patient death."

DR. MC DONALD: Yes, I like that.

DR. YASNOFF: In fact, I would start out saying, in one hospital a patient died because of X. In another hospital a patient was a vegetable because of Y. I think you need to be pretty dramatic. These reports tend to be pretty dull. And I think the IOM did a great job with the errors report in that regard. I don't think we are overdramatizing this. This is a serious problem.

MR. BLAIR: Bill and Clem, I think you've got a lot of agreement here on the committee to strengthen this paragraph.

DR. MC DONALD: Just to make the point you're trying to make. I think there is an awful lot of ellipses in there, and you are assuming the reader is going to make a judgment that they may not without drawing the conclusion for them. Now if those are true -- we don't want to just make them up -- I'm assuming these things had some real effect, or you wouldn't have brought them up.

MS. AMATAYAKUL: Why don't we follow like we did before, once we get the essence of the change that is desirable, mark it and go on?

MR. BLAIR: Yes. Okay, Clem, Bill, and Bob, do you have changes on the next paragraph?

DR. YASNOFF: Are we on page 3 now?

MS. AMATAYAKUL: We're on the paragraph that says, "What are the issues in health care that are relevant to this report?"

DR. YASNOFF: I already commented on that.

DR. COHN: And actually, I want to actually pull that one back in, Bill. I'm trying to figure out why -- other than the fact that I know what your interest is, I'm trying to figure out why we need to add including public health to the particular sentence?

DR. MC DONALD: Which sentence again?

DR. COHN: Margaret, maybe you should just read what we have here.

DR. MC DONALD: Never mind. I could help if you told me what row and column we're on.

DR. COHN: We're in the next paragraph.

MS. AMATAYAKUL: "During the last few decades, the U.S. health care system, including public health, has achieved significant improvements in the health status of our population."

DR. MC DONALD: I think including public health sounds weird.

DR. YASNOFF: My point on that Clem was -- I'm not insisting that we say public health, but I just want to make sure that we're not making a statement that is inaccurate.

DR. MC DONALD: I think what I would suggest is make a sentence that says what you wanted to say, that says it like a real sentence. Because just sticking it in there doesn't do it.

MR. BLAIR: The intent of health care -- does it say health care delivery system, or just health care system?

DR. MC DONALD: I think the point is we're trying to say we're doing a good job, but not perfect.

MR. BLAIR: The intent was for that to be broad. And maybe if we said the health care delivery system, or if we wound up having a phrase in there which is a global reference to our health care, which was what I thought it was trying to do.

DR. YASNOFF: Jeff, can I suggest an easy way out of this? I didn't have any problem with the first sentence, the health care delivery system, because it seemed very generic. And that kind of refers to the overall system. And you say in the second sentence, "During the last few decades significant improvements in the health status of our population have been achieved including" so on. I think that that would satisfy my concern, and still it all generically refers to that kind of the health care delivery system.

What really raised a red flag for me, when you said the U.S. health care system has achieved significant improvements, then that raises a red flag for me.

MR. BLAIR: Kepa has a comment about your comment.

DR. MC DONALD: Well, does that include -- the whole system is even bigger than the delivery system.

DR. ZUBELDIA: I would not make attribution to anybody and say during the last few decades the U.S. population has achieved significant improvements in the health status, including greater longevity.

MR. BLAIR: Bill Yasnoff is suggesting that we simply remove "health care system" from the sentence, because he feels as if we have set the stage by having "health care delivery" in the preceding sentence.

DR. YASNOFF: A lot of the improvements in longevity and so on come from things like seat belt use, helmet use; things that have nothing to do with the health care system really, except in a very generic fashion.

MR. BLAIR: Let me just see if everybody accepts that. Does everybody feel comfortable eliminating "health care system" from the sentence?

DR. MC DONALD: That sentence I think reads as -- it's one of the good sentences in here in terms of rhetoric. A system is everything. And I think a whole lot of improvement in cardiac death rate more recently. The helmet laws have gone backwards. I'm not trying to diminish public health or the fact that we really want to keep people from getting sick, but I don't know if this is the place to fight that fight.

What we're really trying to do is to give a little bit of bow to the health care folks who don't get all mad when we say it's just all crummy, as the first sentence, because the next paragraph goes on to say what all the problems are.

DR. YASNOFF: Well, when you refer to the health care delivery system in the United States at the beginning of the paragraph.

DR. MC DONALD: But delivery is narrower than the health care system. It is not the delivery the medical care that we are talking about. It's the whole system. So maybe we have said -- what would be more generic that would include public health?

DR. FERRANS: I think this is a report to the secretary, and she is able to see all these nuances very well.

MR. BLAIR: I think I'm hearing here both from Clem and from other folks that they seem to be inclined to leave it the way it is, is that correct?

DR. MC DONALD: Make sure we distinguish those factors that are important. I don't want to take anything away from public health, because I agree with him. Most of the longevity in this country has come from keeping babies alive.

DR. YASNOFF: The fact is that 25 of the 30 years of increased life expectancy in the last century was due to public health. That's a fact. Now we can ignore it --

DR. MC DONALD: But I would take the U.S. health care system to include physicians offices, public health, advertisements on TV about -- the system is a very large creature. The delivery system is narrower.

DR. YASNOFF: I agree with you. I think we need to make it a general -- all I ask is that we make it as general as possible so you are not implying incorrectly that it's medical care that is doing all these things.

DR. MC DONALD: I'm not trying to do that.

MR. BLAIR: I'm hearing from the folks here that we should leave it the way it is and move on. But Bill, we want the rest of your suggestions. Let's go on to the next paragraph.

MS. AMATAYAKUL: We made a change here. This paragraph is, "Despite all the accomplishments and advantages of the U.S. health care delivery system, there remain some complex and serious problems to be addressed. These problems include the difficulty of controlling rising health care costs, reducing errors in medicine, and limited capabilities to measure, and therefore accelerate the improvement in quality of care."

DR. MC DONALD: This is one that needs just a couple of little fixes. It's just rhetorical. You don't have to say, "there remain some complex problems to be addressed." You just say complex and serious problems remain.

MR. BLAIR: Complex and serious problems remain. Does everybody feel comfortable with that? We're hearing a yes on that.

DR. MC DONALD: Then you break parallelism. "The problems include the difficulties in rising costs." That's okay.

MR. BLAIR: I think Simon has a reaction.

DR. COHN: Actually, Clem, what you meant was leaving the first part of the sentence, and just getting rid of -- if you want to say despite all the accomplishments and the advantages of the U.S. health system, complex and serious problems remain. Is that correct?

DR. MC DONALD: Yes.

MR. BLAIR: Hold on a second, Clem. We want to make sure we capture that correctly, and Simon kind of has kept us honest on this.

DR. MC DONALD: Thank you, Simon.

DR. COHN: Clem, thank you.

Next?

DR. MC DONALD: This is complicated. The first part of these problems is very direct. These problems include you've got a difficulty. The second problem is limited capabilities. I can't work that over the phone. It just isn't clean as rhetoric, not as ideas. I can put my editor's hat on.

DR. COHN: It's actually even worse as we look at it, because we're describing it as a problem of reducing errors in medicine, which is sort of a double negative I think here.

DR. MC DONALD: Yes.

MR. BLAIR: Could I suggest this? Clem, if you have a bolt of insight, and you feel like you could rip off a sentence or two to Margaret on that after the meeting or something like that --

DR. MC DONALD: Well, one of the problems, I think my version is not identical to what she read. I don't have that reducing word in this version.

MS. AMATAYAKUL: We just added that today, Clem.

MR. BLAIR: That was why she was reading it to you, is because Michael had suggested that one, and we had added that.

DR. MC DONALD: The problem isn't reducing.

DR. FITZMAURICE: It's persistent errors in medicine.

DR. MC DONALD: Yes. That's the problem with doing this sort of as a committee. That's why a camel is a horse made by a committee.

MR. BLAIR: As long as we don't have something where we really feel uncomfortable that it is accurate or untrue. I think there is sort of a degree of how finely --

DR. MC DONALD: But you can be embarrassed by cobbled together writing.

DR. KOLODNER: From a grammatical point of view, it's the difficulty of controlling rising costs, and of reducing errors in medicine. Those both are difficulties.

DR. FITZMAURICE: Unless we are talking about what the problems are.

DR. KOLODNER: Is the problem the difficulty of controlling or the difficulty of reducing errors?

DR. MC DONALD: I think that's right. You want parallelism. You can't have a gerund on one end, and have some other kind of creature on the other end.

DR. KOLODNER: You could just say difficulty of controlling rising health care costs, and of reducing.

DR. FERRANS: Is there any place in this sentence for talking about getting people to adhere to best practices, or communicating to patients in an effective manner?

DR. MC DONALD: Those are means to the bigger ends. They are not purposes in and of themselves to reduce errors, to control costs, to make the care better.

DR. COHN: I think we are find.

MR. BLAIR: Clem, unless you feel very strongly, or have a specific suggestion, maybe we could roll on. Is that okay, Clem?

DR. MC DONALD: A whole lot of these paragraphs were if you just want a good editor --

MR. BLAIR: And after February, I suspect we'll go through probably at least one, if not two more cuts at editing.

DR. MC DONALD: Okay.

MR. BLAIR: Margaret was going to take you through the next paragraph.

MS. AMATAYAKUL: The next paragraph begins with, "The interdependence between cost and quality." And the suggestion was to strengthen this. We captured some thoughts about the paradigm shift, including the current Web enablement, expert systems, the way people get information, et cetera. We didn't wordsmith, but we've got ideas to strengthen the paragraph.

DR. YASNOFF: Jeff, I had a question about this. The last sentence, "The paradigm shift where health care can offer more services with better quality at the same or lower cost." Is that proven, or should we say can potentially offer more services? I'm not comfortable being so clear about that.

DR. MC DONALD: The whole paragraph has some interesting ideas and thoughts, but it's all jumbled. It's got that same kind of problem. It just needs to be much tighter to be a good paragraph.

DR. FITZMAURICE: Suppose we let Margaret work on that given our discussion. And we'll come back with another paragraph.

DR. MC DONALD: There are good ideas in here. What you are really trying to say is we maybe can escape from certain things that were true in the past. Now there are some very large things that you asserted that you will escape from supply and demand, which some economists think that's like life and breath.

DR. FITZMAURICE: Me too.

DR. MC DONALD: Why you'll never escape from supple and demand. But the idea is that we may have different venues, different ways. I think the idea is a good one. It's hard to say. I don't think it's said well enough.

DR. YASNOFF: Clem, do you feel that that last sentence is proven?

DR. MC DONALD: No. There are too many platitudes and/or assumptions made.

DR. YASNOFF: I would agree that there is a potential for that, but I don't think it's proven. So my concern there, and I agree with Clem's concerns, but my concern is that that last sentence as stated is probably not supportable.

DR. COHN: Bill, we're fine with that.

DR. FERRANS: The sentence about little or no additional cost for distributing that information. When you look at the total cost of ownership, I would at least strike the word "no." You can't really distribute that information at no additional cost. I think that's stretching it.

DR. YASNOFF: Minimal.

MR. BLAIR: The thought here, just so we are in sync, and maybe we'll still do that is the idea the was that over the Internet it's as inexpensive to distribute something to 1,000 people as it is to 100. There is no additional cost in sending it electronically in terms of information. So it was trying to capture that idea.

DR. FITZMAURICE: Yes, but I think with some places that don't have the systems that can receive that and interpret that well, that there is a cost.

DR. YASNOFF: Yes, there is always some cost. It may be hidden, and the marginal costs may be very low, but I think you get the same point across with minimal.

MR. BLAIR: Okay.

MS. AMATAYAKUL: The next paragraph is, "The expenditures for health care in the U.S." The changes that we made here are in the last two sentences. "This increase in spending for health care has made it more difficult to reduce the number of citizens who are not covered by some form of health care insurance. The latest estimate is that 44 million persons in the U.S. do not have access to affordable health care insurance."

DR. MC DONALD: See I think that's a non sequitur. It may be true, but it isn't the point you're trying to make there. You're saying it's real expensive, and we need to do something about that expense.

DR. FITZMAURICE: But it's hard for us to go from spending to cost.

DR. MC DONALD: The problem is you have gone from high cost to complete universal coverage in three sentences.

MR. BLAIR: Clem, the reason that this was in here, again, it's being addressed in large part to the secretary of the Department of Health and Human Services. And in some ways there is a political element.

DR. MC DONALD: Well, then start with it. If your argument is about the non-coverage, lead with that.

MR. BLAIR: Clem, let me finish a little bit. The idea here was to indicate that if we cannot control the costs of health care, it impacts things that have serious widespread public concern such as the number of people that are not covered by health care. So it ties to something that people resonant to, like this is really serious. We're really paying a price on this. We could feel it. We could see it. There are numbers.

DR. MC DONALD: I think you wanted to say that, but I don't think it says it. I think what you say is here is Point A, and here is Point B, and besides, it's all due to Point C. And I don't think they connect the way that you are saying it.

DR. YASNOFF: This relates to comment that I had. I think there is an important point missing here that could go right after the first sentence. That is of this huge $1.1 trillion, the government pays a huge percentage of it. We miss that point. Therefore, both the government and the taxpayers have a strong interest in dealing with that cost, not just for their own coverage, which may not relate to the government, but because the government is paying a big part of this. That tends to emphasize the buy in by people who are affected by it.

MR. BLAIR: I think we could add that sentence. I don't have any problem with adding the government sentence, but a lot of the folks that don't have access to health care insurance, the 44 million people, it's because they are trying to get covered by their employers.

DR. MC DONALD: Could I make some suggestions? I think you are just trying to pack in too many linkages into one paragraph. The point that the costs are going up is very important. I think you could flow that into what Bill was saying, and saying half of this is federal government spending, which of high interest to the government. You haven't gotten to the logic yet that you are going to save money with the computer. That's the part that really is the closing argument on this.

The second theme is that more people are uninsured now. I think that's true, because of this cost. Still the closing argument is that somehow the computer is going to save us money and solve everything. You're not saying that explicitly, and of course maybe you can't say it explicitly.

MR. BLAIR: Yes, we can't say it explicitly.

DR. MC DONALD: I think the march of the ideas is not optimal. The big cost would go immediately to the federal government. The federal government needs to be interested in this, because that's who you are addressing.

The second is I think we have had an increase that it uncovered because of this cost increase. Those stand on their own. Then you go on to somehow make the linkage back to why this has to do with the standards for computers.

MR. BLAIR: Margaret, are you able to make a note to capture those? Does everybody else agree with adding those items?

DR. MC DONALD: I may be overly editing it, but you've got some good sentences, but when you stack them up against each other, they don't necessarily make the point you are trying to make, and I think you could.

MS. AMATAYAKUL: I think we've got the essence and we'll work on the paragraph.

DR. COHN: Clem, this is Simon. I do think you have to admit though that this is a much better effort than we have seen previously.

DR. MC DONALD: Yes, yes.

DR. KOLODNER: Also, I think that that phrase, "large percentage," we can put in an accepted percentage.

DR. YASNOFF: That essentially what I wrote was, the government pays X percent, and thus has a strong interest as a payer, as well as in the health of the nation.

DR. MC DONALD: In trying to reduce these costs, or reduce their growth.

DR. FITZMAURICE: Margaret, the answer for the question would be found in the same references as for the 13.5 percent of GDP, Katie Lipid's(?) article. I think it's about 40 percent.

DR. YASNOFF: A lot of our recommendations relate to that later. And I think we say it later, but I think it would make this a lot stronger. And I also agree with Clem's point that the points are all here, but it needs to be clearer.

DR. FITZMAURICE: But the one point that is missing is anything dealing with costs. Because the spending could be going up just because people want to have more health care. We're having increases in quantity. And so if we're going to say that it's the cost of this health care that keeps us from giving it to everybody, then we have to make the link between these numbers and cost of health care.

DR. MC DONALD: Yes.

DR. FITZMAURICE: And another number that relates to cost of health care.

MR. BLAIR: How do we do that?

DR. FITZMAURICE: One way is to look at the cost of premiums that people pay. There are several surveys on premium costs, and that would relate to the cost of providing care.

MR. BLAIR: Are you able to get some information and reference this to Margaret on that?

DR. FITZMAURICE: Let me look. I think Faulkner(?) and Gray does a survey. I will look for that and get it to Margaret.

MR. BLAIR: That could help bridge that concept of spending and cost.

Margaret, should you read the next paragraph?

MS. AMATAYAKUL: Okay, the next paragraph is --

DR. MC DONALD: Are these paragraphs different than what we have in front of us?

MR. BLAIR: Sometimes when she reads it she is including the editing that we have already done earlier this morning.

MS. AMATAYAKUL: The next paragraph has no changes in it.

DR. MC DONALD: Can I make a simple suggestion? If you just said there are several health status indicators that suggest there is room for improvement, that would be less convoluted, and says the same thing I think, and it may not be as accusatory.

MS. AMATAYAKUL: "When we try to measure the quality of health care in the U.S., our several health status indicators that suggest there is room for improvement."

DR. MC DONALD: Because then as you go on it becomes apparent what the improvement is.

DR. COHN: Good. And actually, there is a change to the last sentence also, isn't there?

MS. AMATAYAKUL: The last sentence in that same paragraph we have changed to, "Another indicator of quality that causes concern is the recent report from the Institute of Medicine which showed that medical adverse events have causes."

DR. YASNOFF: Yes, that was my comment, "have causes" is not right.

MS. AMATAYAKUL: "Causes more deaths annually in the U.S. than highway accidents, breast cancer, and AIDS combined."

DR. MC DONALD: I thought they said it was 50,000-80,000 a year, or 50,000-100,000 a year?

DR. FITZMAURICE: It's only 44,000-90,000.

DR. MC DONALD: When I add up the numbers, highway accidents is 37,000. I don't know if that is true.

MR. BLAIR: Clem, we did get this right out of the report, those three combined. And the numbers were also taken out of the report -- the IOM report on errors in medicine.

DR. MC DONALD: Okay, but from what I understand is the lower number is the one that's more accepted as being accurate.

MR. BLAIR: Do you want to put the lower one in?

DR. MC DONALD: The range. They said something to something.

DR. FITZMAURICE: Forty-four to 98 was the range.

DR. KOLODNER: I think we just quote the report.

DR. MC DONALD: Okay, I'll drop my concerns.

MS. AMATAYAKUL: The next paragraph, "What has already been done to control rising health care costs and improve quality?" We have added disease prevention. So it reads, "with an emphasis on wellness and disease prevention."

We have struck capitation plans at the end of the paragraph, and we have added wellness and disease management programs at the end.

DR. MC DONALD: I can't read a paragraph that way, and I don't think it matters terribly. I can't project those words onto the hard copy I'm looking at. I don't think it's worth the struggle here to do it that way.

MR. BLAIR: Shall we go on to the next paragraph?

DR. YASNOFF: My only comment here was there is a phrase here, "pharmacy benefit management organizations with an emphasis on prescription compliance." That doesn't strike me as being right. That's the emphasis of the PBMs.

DR. MC DONALD: Yes, that's right.

DR. YASNOFF: So there may be two different thoughts there, but the implication that PBMs are primarily focused on prescription compliance just doesn't strike me as being correct.

MR. BLAIR: What do you suggest that we do? We have several options. We could either completely eliminate the reference to pharmacy benefit managers. Or we could put in a phrase that reflects their emphasis as a contrast to the emphasis of the others. What do you suggest we do?

DR. YASNOFF: How about pharmacy benefit management organizations that emphasis improved medical management, or something more generic.

MR. BLAIR: Improved medication management.

DR. YASNOFF: Kepa could probably give you a good phrase.

MR. BLAIR: Margaret, do you have that?

MS. AMATAYAKUL: Yes. The next paragraph, "All of these initiatives have helped," there were no changes.

MR. BLAIR: Clem, there were no changes to this paragraph.

DR. MC DONALD: Which one are we on now?

MS. AMATAYAKUL: "All of these initiatives have helped to address. . . "

DR. MC DONALD: Yes, that's fine -- well, again this is small. What does broad-based cost containment mean? What is a broad-based adjective? Do you mean have not achieved a large amount, or significant, or have not --

MR. BLAIR: I think the implication there was you could have cost containment that is contributed to in part by many different sources.

DR. MC DONALD: I don't know if you need the "broad-based." What you are really doing is contrasting it with other sectors of the economy. I think that would be easy to say. They haven't achieved the cost containment, level of productivity, and quality improvements enjoyed by the other sectors. Does the broad-based add anything here?

MR. BLAIR: I'm not in love with the phrase "broad-based," but I was just fearful if we just simply said cost, then people would look at it as specific example, and wind up --

DR. MC DONALD: Well, how about the amount of cost containment, the level of productivity gains, and the quality improvements. That's not a big deal. I don't care about that. Go on to the next paragraph.

MS. AMATAYAKUL: Leave it as it was?

DR. MC DONALD: It's okay.

MR. BLAIR: Next paragraph.

MS. AMATAYAKUL: The next paragraph is, "Why has the health care industry not been able to share the dramatic cost/quality advances experienced by other industries? Some of the reason are . . ." That paragraph has not changed, that first little paragraph.

MR. BLAIR: Clem and Bill?

DR. MC DONALD: It's a hard question to answer. I think certainly the general thing in the first categories, it's the expansion of technology and the increasing costs of that technology. But it's not bad.

DR. YASNOFF: I don't have any comments on that.

MR. BLAIR: Next paragraph.

MS. AMATAYAKUL: Next paragraph, "These are challenging issues, but they are not that different from the challenges that other industries have been addressing. What may be of greater significance to health care is the fact that the industry faces a task of controlling costs and improving quality with a major disadvantage compared to other sectors of our economy. Other industries, including financial services, telecommunications, transportation, manufacturing, and retailing have achieved dramatic improvements."

We took out "and other sectors."

MR. BLAIR: Is that the end of the paragraph?

MS. AMATAYAKUL: No. ". . .improvements in cost containment, productivity, new services, and quality, because they have established information infrastructures that have brought them into the information age."

DR. MC DONALD: Well, you're making a very strong position here. Firstly, the issues in health care I think are drastically different from the other industries, or at least one could argue that. You're not dealing with widgets, and I think you could find the legal industry hasn't gotten a lot cheaper. I think there are other service industries that haven't gotten a lot cheaper.

But what you are really trying to say is that there are opportunities -- these other ones have gotten huge opportunities from information structures, and health care could too, rather than say health care is just the same and they are screwing up because they haven't done it.

My response is tangled, and it's not easy to change it here.

DR. COHN: Clem, is this something where the next couple of paragraphs allow us to begin to surface the issues? I think what you are saying is health care is different, but there are also opportunities.

DR. MC DONALD: What you are trying to do is make a set up argument for the reason why you should do standards. I don't think it's that simple. I agree that we should do all of this. I agree that we should do this information infrastructure, but I don't believe that it will have a radical effect on all the costs in health care, because they come from other forces.

I don't think we have to say that here, but I think you are making a very strong statement when you are saying that the challenging issues are no different from the other industries like telecommunication, which altogether is bits and wires. They don't even have employees anymore.

MR. BLAIR: We do have a sentence in there which kind of preceded this, which I thought wound up saying that there are many things that contribute to cost and quality, but we're starting to drill down. The attempt here was to drill down to wind up saying well, what role can information systems --

DR. MC DONALD: I buy where you are trying to go. I think the first sentence almost doesn't make sense to me. What may be of greater significance to health care is the fact that the industry faces a task of controlling costs and improving health quality with a major disadvantage compared to other sectors of the economy.

First, there are a lot of reference problems. Secondly, what are these disadvantages? You haven't mentioned them. They just said they are no different in the sentence before.

MR. BLAIR: The rest of the paragraph and the next paragraph go into describing how health care is disadvantaged. So it is a set up sentence. The answer is not in that sentence. It's in what follows.

DR. MC DONALD: Well, I think there is an ordering problem. You might just want -- this is something you can't do over the phone and just as a committee. Does anyone else have trouble with the flow?

DR. YASNOFF: I do. I think it's a very complex problem, and I think if you back off as Clem is suggesting, and instead of saying essentially that health care has screwed up, you can say that obviously all these other industries have gotten a great deal of benefit from this, and health care can too.

DR. MC DONALD: That's right.

DR. YASNOFF: You don't have to say health care is screwed up. You can say it in a positive way. Then the question is, well, how come health care hasn't taken advantage of these potentials to do better? And that leads you where you want to go without having to say so many negative things.

DR. FERRANS: I think the point is that perhaps it's the first two sentences that need to be adjusted. I think the point has always been made that health care lags chronologically behind the other industries. That's not to say we have screwed up, and we could explain why we are lagging behind, and people quote that we are five years behind, or X number of years behind. That's one potential way to approach it. And then to explain why it has been difficult.

I guess we put there not that different from the challenges? Did we change that?

DR. KOLODNER: I'm not sure that I would put the years behind kind of thing, because again if what we are trying to do is to say others have gained from it, health care can too, we can either try and blame, or we can just leave it as positive and go forward.

One of the things that I think we are wrestling with is, and it gets to the heart of what our work in this committee is at, is if you look at all those other industries, some people point out that all the other industries that have made gains, automate their core processes. Up until now, health care hasn't automated its core processes. It's been automating all of the administrative stuff around it.

And the computer-based patient record, which is very difficult, very complex, and the thing that we are beginning to move into is that a core process where there are positive outcomes.

MR. BLAIR: That is, I think, a very important point. You'll notice that if you go down a little bit further, we wind up indicating the things health care has been able to achieve in information systems with laboratory departmental systems and admission/discharge transfer systems, but we wound up building the thread towards the fact that although they have made a lot of progress with information systems, they haven't been able to make as much progress with clinical information systems. And the reason then drives down to the need for the standards.

DR. MC DONALD: I think what you really want to do is to either make two pages of good base for the more complex argument you started to make, or drop it and jump right in. I don't know if you can answer this question you set out to raise, or whether you have to.

But you could say the answer is more complicated. It's more fragmented. It's da da da. But I don't know if that really matters to where you are trying to go. You want to say that other industries have done this, and health care can too. I think you can keep on moving with your logic then.

DR. COHN: I'm actually wondering as I look at this whether or not we ought to just get rid of the second sentence, or at least consider that. And if we leave the first sentence, and then talk about other industries, that may be what we need to do here, with the idea that within the next paragraph we loop back to more about health care.

The second sentence is, "What may be of great significance to health care is the fact that industry faces the task of controlling costs and improving quality with a major disadvantage compared to other sectors of our economy." Really go these are challenging issues, but they are not that different from the challenges that other industries have been facing.

Then say other industries, including financial services, telecommunications, et cetera, have achieved dramatic improvements in cost containment, productivity, and quality because they have established information infrastructures that have brought them into the information age.

I'm just wondering, because I think we are having some problem with that transition, or the immediate application to health care, where we haven't made the case yet.

DR. FITZMAURICE: I think Simon has got his thumb right on it. If we delete that second sentence, and then put in there after showing what the other industries have achieved, saying health care can do this too. We don't have to get into a justification in this in explaining why health care hasn't done it.

MR. BLAIR: Could I ask you do this, because I would love that to be the fix. My concern is that that was a link, a transition. Is it possible, Margaret, for you to read that paragraph without that sentence in it, the way Simon has suggested, and see if without that sentence in there, that that fixes it and still provides the linkages? If it does, that's great.

DR. YASNOFF: Why don't you start the paragraph with the sentence that says other industries, and actually drop the first two sentences?

DR. MC DONALD: Yes.

DR. YASNOFF: Because if you start it that way, it is very clean, and it gets rid of all these problems I think.

MR. BLAIR: That probably would help a lot, because if I recall, the first two sentences wind up trying to cover ourselves by saying there might be other issues, but we're not going to get to those. So why don't you try that, Margaret?

DR. YASNOFF: Well, we do get to them later. When we ask ourselves the question why hasn't health care done this, that's where we talk about the differences and the challenges, and the fact that if you go to McDonald's and ask for a hamburger and you don't have money, there is no law that says they have to give you a hamburger.

MR. BLAIR: Margaret, why don't you read it without those first three sentences. Is that right?

MS. AMATAYAKUL: This little section starts out, "Why has the health care industry not been able to share the dramatic cost/quality advances experienced by other industries? Some of the reasons are the additional costs of new procedures and technologies, the rising cost of drugs and other supplies, increasing insurance and litigation expenses, and the rising expectations for health care services."

New paragraph, "Other industries, including financial services, telecommunications, transportation, manufacturing, and retailing have achieved dramatic improvements in cost containment, productivity, new services, and quality because they have established information infrastructures that have brought them in to the information age. For example, the financial industry has developed an information infrastructure that includes online banking, automated teller machines, and electronic deposits."

MR. BLAIR: Does everybody feel satisfied then with our striking those sentences? I don't hear any complaints or nos. Okay, let's take that and roll on.

MS. AMATAYAKUL: This is where we ended when all the folks came on.

MR. BLAIR: Let me just in fairness to everybody that might have biological needs, Simon just pointed out to me, and I knew that it seems like we're on a roll. We're really moving here. Is it okay if we go to like 12:30 p.m. before we break for lunch, or does somebody need to have an earlier break?

DR. MC DONALD: Could I point out that we've gotten to page 3 out of 35.

MR. BLAIR: Yes?

DR. MC DONALD: It doesn't sound like a very successful roll, but of course we were down for a while.

MR. BLAIR: Maybe we'll be able to pick up the speed. Is that okay? Simon is also suggesting a logical break at which section?

DR. COHN: Next paragraph.

MR. BLAIR: At the end of the next paragraph.

DR. COHN: Why don't we make it through the end of this section.

MR. BLAIR: Tell them what section it is that you are talking about.

DR. COHN: We're talking about the next two paragraphs.

MR. BLAIR: Just the next two paragraphs?

DR. COHN: That's right.

MR. BLAIR: Okay. Margaret, forward.

MS. AMATAYAKUL: The next paragraph is, "These other industries have typically viewed the establishment of an information infrastructure as a strategic investment and a competitive advantage. In contrast, the health care industry has tended to regard information systems as a cost that should be minimized. As a result, financial services, manufacturing, and transportation industries typically spend 8-10 percent of their operating expenditures on information systems. Despite the fact that health care is information intensive, the expenditure investment for information systems averages 2-3 percent of operating expenditures for acute care institutions, and is often less in ambulatory settings."

MR. BLAIR: Comments, suggestions?

DR. FERRANS: That's correct.

MR. BLAIR: Next paragraph.

MS. AMATAYAKUL: "In most acute care institutions this level of investment has been sufficient to establish information systems that support financial and administrative processes, automate departmental systems such as laboratory and radiology, and computerize some clinical processes such as order communications and results reporting. However, it has generally not been sufficient to support the basic functions of clinical care, including the capture and process, review and analysis of clinically specific information as a normal part of the patient care process.

The capture of patient history and progress notes continues to be performed manually and stored on paper in most health care settings. Physicians continue to write orders that are transcribed into order communication systems by cleric staff. The medical records folder in intensive care units may have over 100 pages of paper, which contains information that is often difficult to find, sometimes illegible, sometimes incomplete, and not always timely. Moreover, the file itself may not always be accessible to the appropriate caregiver at the appropriate time.

This lack of timely, comprehensive, comparable, and relevant health care data severely impairs the ability to identify those clinical processes that need improvement, which is essential to advance the performance of health care delivery in the U.S."

MR. BLAIR: Comments?

DR. COHN: Maybe I'll start here. First of all, I'm trying to figure out, I guess by acute care institutions we mean hospitals, right? We mean acute care hospitals.

MR. BLAIR: Correct.

DR. COHN: I find myself going, gee is that really the state? And if we are saying that really is the state, I would love some data to back that up. The question is how many hospitals really have order entry systems? How many hospitals have X, Y, and Z? I would love to see the data on that.

MR. BLAIR: I just happen to have completed a survey.

DR. COHN: I also know that for example physician histories and physical for hospitals are typically dictated. So I'm not sure that the example you have is right now. As I say all of this, I'm trying to figure out if we actually even need the paragraph at all. I guess that would be the question I would ask here is what this particular paragraph does in the overall scheme of things? Maybe you guys can help me with that.

MR. BLAIR: The intent of this paragraph was to -- in a sense it's a defensive paragraph. That people would wind up taking the rest of the thread as we drive forward, and wind up pointing out that there are limited standards to help us with patient medical record information. People would wind up saying, yes, but you didn't recognize the areas where health care has made progress. So this tends to wind up saying here is where they made progress, and here are where the limits are. Maybe that's not needed, and if you don't feel it's needed, I don't mind.

DR. FERRANS: Here's what I suggest. I agree with Simon. This is really the snapshot. I think some of it is overly optimistic in terms of snapshot. If I had my way with the paragraph, I would sort of take it up to a higher level, and it would say here are things it's doing, and here are the things it's not doing.

What I don't like about it is that it focuses on the acute care setting. And it doesn't take into account the shortcomings of yes, there's an order entry system, but the clerks are doing it, so there's no time for the decision support of the old entry systems. Or more importantly, the acute care information is not available in the clinic, and vice versa.

There is a problem with information distribution to the point of care, no matter where it is. So I would try and go for, if I could, a balanced view. I agree with some of the parts of the first sentence. But in general it's not sufficient to support the basic functions. Then I would add, furthermore, it does not support information distribution to the point of care between the acute and the outpatient setting.

DR. MC DONALD: Could I make a different spin on that?

MR. BLAIR: Go ahead, Clem.

DR. MC DONALD: First of all, I think editorially this thing reads pretty well until the last sentence, and I think it flows pretty well. I think the issue about narrowing it too much, if you just take away acute care institutions, you might say in many care institutions, don't specify it. Then we don't have it so narrow.

Then when you say it's not sufficient, you can add one more parallel thing saying capture, process, review, transmit. We could capture all the efficiencies. Then you give some examples of the problems. I think they are fine.

The very final sentence I don't think is necessary or supported by the arguments.

MR. BLAIR: Could you read the final sentence?

DR. MC DONALD: "The lack of timely, comprehensive, comparable, and relevant health care data severely impairs the ability to identify those clinical procedures that need improvement."

Now this is a whole other theme, that if we don't have statistical data. What you are talking about is we can't even run the process well. So if you don't have enough back up for that. It's a different thought. And I think all you want to do is to close the paragraph saying that there is not automation on this or the production process of the health care system.

MR. BLAIR: I think we have like three different proposals here.

DR. MC DONALD: I'm kind of agreeing with one of them. I think you just don't have to change as much to get the acute care.

MR. BLAIR: Let me articulate them, and you tell me if I'm right. Simon is suggesting that maybe we delete the paragraph overall, in toto. And Richard is suggesting that we delete the areas that get more specific. And Clem is suggesting that we do just a little bit of wordsmithing on the end.

DR. MC DONALD: I suggesting that we change the middle to make it fit Richard's issues. I think the paragraph is a stand alone paragraph. It's a good paragraph. That's an editorial view, not a content view. Now the business where we focus right down to acute care institutions, I don't think you have to. You can just say in many care institutions, the level has been sufficient, but it's not sufficient to support the basic functions. And then you add some more functions in there, including the transmission or the distribution.

DR. FERRANS: If I can just add to what Clem said, I think when he talked about striking the last sentence, he was saying here we are talking about outcomes. The previous sentences referred to the improvements in productivity in the other industries. Here we are saying this lack of this affects the ability to essentially produce care or provide services. I think if we are going to end on a sentence, it should be something about how it affects point of care.

DR. MC DONALD: Yes, you have launched over to about how we are going to collect data about quality and manage it improve the processes, when you're not going there with this paragraph. You just all of the sudden did a right turn. What this paragraph says is we are not doing things to do the processes. You're saying it's hard to find the data.

MR. KENTSMITH: This is Dave Kentsmith. What strikes me from what Richard just said had to do with continuity of care. That is, what the paragraph seems to be talking about is bringing together all the fragments of the patient's record into something that is continuous, so that you really are providing a process that allows for continuous care or unfragmented care.

MR. BLAIR: What I'm seeming to hear, Simon just indicated that he feels comfortable with the direction that both Richard and Clem are taking us. It seems as if Clem has refined Richard's thoughts. Are Clem's comments a point of convergence that everybody else can gravitate towards? I'm hearing yeses.

Clem, could you just repeat some of your comments?

DR. MC DONALD: Richard is arguing that we're talking about a very narrow sector. The whole thing is on health care, and now we jump right immediately into acute care, and that's too narrow. So take away this acute care. Just say in most care institutions --

MR. BLAIR: Wait a second, so that Margaret can --

DR. MC DONALD: Line 1 on page 5, get rid of the word "acute." Then what you have to add in when you say what it's not sufficient to do, you need to add in some more phrases including transmission, distribution. You might want to have another sentence in there, for example, we can't get the results to the physician's office.

MR. BLAIR: We can't get clinical results from the physician's?

DR. MC DONALD: Any one example, from the nursing home to the office, or the office to the hospital.

MR. BLAIR: Okay.

DR. MC DONALD: To the lab to the office. Then the last paragraph it just sort of jumps into hyperspace. It's talking about something that is kind of related, but it doesn't set up at all for it, namely, that if we did collect all this information, we could understand the process better. If we understood the process better, we could improve it.

So you either need a whole lot more, a whole other couple of paragraphs, or you should drop this sentence and say something summarizing like -- I forgot what I said. But we need electronic capture of this information, or electronic processing could greatly solve the above problems and make the actual process of care more efficient.

DR. FERRANS: Provide for continuity of care.

DR. MC DONALD: Yes, continuity, you could throw that in there too.

DR. KOLODNER: There is a change that Margaret has up there that I don't think we want to capture, which is about the capture of patient history and progress notes continues to be performed from dictation and stored on paper. I think, yes, there are places that do dictation, but there is a lot of illegible handwriting.

DR. COHN: I don't think progress notes are typically typed in, but usually -- these places where I have been, initial physical, now of course we're moving now from acute health care institutions to many health care institutions. So probably now we are back in a place where it's no longer dictation. When we were taking about hospitals, most admission physical are dictated.

DR. FERRANS: It just gets into the information fragmentation issue too, because that information may not be available for 24 hours or longer, and reside somewhere separately.

MR. BLAIR: Does this finish the two paragraphs where we want to break?

DR. COHN: Yes, I think this actually looks a lot better. I actually want to thank Dr. Ferrans and Dr. McDonald for help on this one, because I was ready to throw it out. I think it's actually gotten a lot better.

I guess we should talk about how long we want to break for. Believe it or not, it's 12:20 p.m.

MR. BLAIR: It's 12:20 p.m., and I was mentioning that I've been admonished a little bit for either not having the breaks long enough, or not keeping things on time. So let me ask everybody before we take our break, if we were to reconvene at 1:30 p.m., does that give people enough time? Too long? What time should we reconvene?

DR. FITZMAURICE: How about one o'clock?

MR. BLAIR: One o'clock? That's about 35 minutes for lunch. Is that okay with everybody? Can you get back here? Because I have been asked to start on time, whenever we say it's on time.

DR. FITZMAURICE: There probably aren't that many people up in the cafeteria today.

DR. COHN: Actually, why don't we make it 1:05 p.m. That will give us 45 minutes to make it through lunch. I think that would work for people.

MR. BLAIR: We're reconvening on time at 1:05 p.m.

[Whereupon, the meeting was recessed for lunch at 12:25 p.m., to reconvene at 1:05 p.m.]

A F T E R N O O N S E S S I O N (1:05 p.m.)

MR. BLAIR: Margaret, on to the next paragraph and we'll burn forward.

MS. AMATAYAKUL: The next paragraph is, "Why has the health care industry been slower than other industries to establish an information infrastructure? A health care information infrastructure includes standards, laws, regulations, business practices, and technologies. For example, information systems standards are needed to facilitate the sharing of comparable data. State and federal laws are needed to protect the privacy of health care information and remove barriers to sharing data between states. Federal regulations are needed that define consistent policies and practices to protect the integrity of, and provide security for health care information. Cost effective systems and technologies need to be developed that utilize the infrastructure and translate its efficiency and effectiveness into a value for the user. While progress needs to be made in all of these areas, the focus of this report is limited to those standards that facilitate the sharing of comparable data."

MR. BLAIR: Any comments or concerns or questions about this paragraph?

DR. YASNOFF: It doesn't answer the question.

MR. BLAIR: It does answer what question?

DR. YASNOFF: The question that was stated, why has the health care industry been slower?

MR. BLAIR: I think if you go to the next paragraph --

DR. YASNOFF: I know the next paragraphs answer it, but --

MR. BLAIR: The reason that this paragraph was put in was because the last time we went through this review, Clem challenged us and indicated that it doesn't make it clear, the difference between an information infrastructure and standards for PMRI. He thought they were one in the same, so this paragraph was added to clarify what an information infrastructure is, and then brings us down to PMRI as a set up for the next paragraph.

DR. YASNOFF: Well, can we say in order to answer that question we need to define some terms, just so that people understand why they are not getting the answer to the question?

DR. FERRANS: Absolutely. I agree with that.

DR. COHN: I guess I'm wondering myself whether or not this paragraph needs to be somewhere maybe a little bit earlier. I'm just mulling about that, because I looked at this, and I had some of the same questions that you did, Bill.

DR. FERRANS: Shouldn't it be a different question? Should be a question, what is a health information infrastructure?

DR. COHN: We actually first on the piece before start talking about information infrastructure as a strategic investment and a competitive advantage. I thought it was awkward that we went through a couple of paragraphs before we actually started saying what it was.

DR. YASNOFF: Why can't we move the question to just after this paragraph?

DR. COHN: So basically that's the first question, and the next question is why has the insurance industry been slower to establish an information infrastructure?

DR. ZUBELDIA: This paragraph becomes the last one of the previous question.

MR. BLAIR: Margaret, can you follow that?

MS. AMATAYAKUL: Yes.

DR. COHN: So the suggestion is just to put this in the end of the last section?

MR. BLAIR: But what into the end of the last section? What Margaret read? In other words move it to the end of the previous section. Is that what you are saying?

DR. COHN: I guess that's what somebody had suggested.

DR. FITZMAURICE: We have a section near the end of the report on definitions. It might also go there as well too.

MR. BLAIR: Well, is Clem on board here? This paragraph really was written to address his concern. If he's not, what if we go forward, and when Clem joins us we come back to this topic and see if he feels comfortable with the way we have handled it? Is that okay?

MS. AMATAYAKUL: So I have made the change to leave that paragraph as the last paragraph in the previous section, and moved the question, "Why has the health care industry been slower than other industries to establish an information infrastructure?" to head the next section.

Which now reads, "Many of the reasons why health care has had difficulty in establishing an information infrastructure are related to the need for more complete and comprehensive standards for patient medical record information, PMRI. This has resulted in the following conditions: limited interoperability among different health care information systems that increases the cost of sharing and integrating data; limited capabilities to capture clinically specific information, and have it automatically converted into computer-readable codes which retain the accuracy and precision of meaning; impairs the ability to share comparable data; and limited comparability, including precision and accuracy of PMRI, which impairs the ability to measure quality, and therefore the ability to improve clinical processes. These constraints continue to relegate many clinical activities to suboptimal levels of performance and quality."

DR. YASNOFF: Well, I have a problem with this, because it doesn't answer the question. Although it answers the subpart of the question. If the answer to the question was there are 16 reasons why the health industry has been slow, one, and then you go through those reasons. And one of them involves standards, then this text flows from that.

But standards are not the reason why the health care industry has been slower. And we can debate what those reasons are. Among them are the fact that there was no reimbursement for information systems. I think that's probably the biggest reason. And the second reason is the way the health care payment system is structured, there was absolutely no benefit to health care organizations for many years to know what was going on. All they really needed to do was get the bills out.

MR. BLAIR: What you say is correct, and we struggled with that. And we knew that we had to somehow bring the reader down to the need for standards for patient medical record information. And we knew that the impediments to an information infrastructure, one of the key ones was the lack of standards. So we attempted to drive it towards that.

But you're saying that as a reader when you read this, you start thinking of all of the other reasons, and that was why that sentence was there, that last sentence on the paragraph we just moved. That last sentence said, yes, we acknowledge all of these other things, but the focus of this report is on the impediments caused by the lack of standards for patient medical record information.

DR. FITZMAURICE: Jeff, let's pick up on what Bill has said. Since we're not answering the question, let's change the question to read something like, what is the consequence of not having widespread patient medical record information standards?

DR. FERRANS: Shouldn't we answer the question though?

DR. FITZMAURICE: I think that's a whole report in itself.

MR. BLAIR: I think Bill Yasnoff's point is correct in that the answer to that question is that there are many reasons why, and impediments to standards for patient medical records is only one of the reasons. So I would kind of agree with Michael that maybe we ought to change the question so that we don't --

DR. FERRANS: Let me take an opposing view that I think will work to the benefit of this report. I actually had the opportunity to ask this very question, why are health care standards taking so long, I actually asked it in a conference in Seattle a year and a half ago to Bill Gates. His answer was very interesting.

His answer was it's because this industry is so fragmented. You've got the payers, the providers, government, everyone else. He said when we establish EDI transactions for online trading, and the largest investment house bought into it, everyone rolled in behind them. The problem with health care is that there are many, many, many stakeholders.

MR. BLAIR: Do we want to take the reader down that path?

DR. FERRANS: Well, I think one thing it does is it says well, if one of the responsibilities of government is to promote and protect the health care system, then perhaps this is an appropriate thing that we are trying to do. Since there are many stakeholders, since the testifiers have said that progress has been made, but progress has been slow --

DR. COHN: Can I make a comment about that? Because I think this is actually a useful path, and I don't know where it fits in the report. But when we talked about the initial HIPAA standards, part of the rationale for why the government needed to act had to do with the fragmentation of the health care industry. And the fact that even though the health care industry wanted standards, they could not do it alone. That was the initial argument, which you are making now.

DR. FERRANS: And the testimony to this workgroup supports that.

DR. FITZMAURICE: But I don't see the industry going to Congress and saying we want uniform clinical data standards. There is not the same outcry for that from clinicians as there was an outcry from businessmen saying we want to streamline the processes of business.

MR. BLAIR: Well, let me try to pull together, because I think that Simon gave the hook that helps us bring the fragmentation back in where it's relevant, and draws the reader right back to our thread. Margaret, I don't know how you want to capture this but, if I'm paraphrasing your statement, it's to point out that one of the reasons why the health care industry hasn't been able to move towards an information infrastructure is that the fragmentation of the health care industry has made it difficult for it to come to a consensus on the information system standards as quickly as other industries. Is that a good paraphrase?

DR. COHN: Yes, and I think once again that this ties in to the overall rational for why the government had to this.

MR. BLAIR: Did I hear Clem come back on the phone? Clem?

DR. YASNOFF: I don't think Clem is back yet, but Jeff, can I suggest that a slightly different spin on that, that might be helpful. There are many reasons why the health care industry has been slow, and we could give some examples. But now what we have heard in our testimony is that there are tremendous efforts underway to try to move in that direction. And so essentially the incentives are changing, and the industry wants to move in this direction. Now the issue of standards is becoming a severe impediment, now that other impediments seem to be less important.

MR. BLAIR: Margaret, did you capture that, or should Bill --

MS. AMATAYAKUL: Yes, I got it.

DR. YASNOFF: Does that make sense? Because I think we have to answer the question, since the way the argument is flowing in this document, we have to answer this question somehow, because we have set ourselves up to answer it, that the health care industry has been very slow. But I think now people really are trying to move ahead. And what they are finding is that this is now one of the biggest barriers to moving ahead. That helps to emphasize how important it is to get some answers on this issue.

DR. COHN: I don't think Margaret has quite captured that yet. I think what you are saying here, and it sort of reminds me of that initial example that we used, where we were talking about the bar codes. The one thing I sort of liked about that example was that in that case the technology was a barrier, but the technology got to be less of a barrier, and then standards became the main barrier. I think that's the sort of example you are talking about, or the case you are sort of making.

DR. FERRANS: Do we have a consensus here that the technology exists today to do a lot of the things that we want to do?

DR. COHN: Well, not everything, but a lot of the things.

DR. FERRANS: A lot of things. So standards is the barrier.

DR. YASNOFF: The technology exists to do a lot better than what we are doing.

DR. ZUBELDIA: I think technology was in the critical part. Now standards are in the critical part. I think another thing, once the standards are in place, what will become the bottleneck is addressing the issue of what is in it for me, and how much is this going to cost, and what's the return on my investment. That's going to become the critical part pretty soon.

DR. COHN: Can I actually add then -- we're obviously making too many changes here, that it's getting confused. But I actually thought that part of the case for standards had to do with the fact that it made systems cost less. It costs less to develop and implement. Part is the case around standards is that the information systems themselves costs less to develop and implement.

MR. BLAIR: Now I do think that point was in there with respect to the vendors needing standards to be able to provide these services at a reasonable cost. I can't point to the exact bullet point.

DR. COHN: I was actually referencing that I think that we mention as the first bullet, it says, "limited interoperability among different health care information systems that increases the cost of sharing and integrating data." I thought there was as either part of that or as a separate piece, that this limited interoperability also affects the cost of developing and implementing these systems. Because I think that begins to speak to, Kepa, your point that -- it might be redundant.

DR. YASNOFF: I think that point is made sometime later, but it's a very important point.

MR. BLAIR: We could move it.

DR. COHN: Let's see if it's redundant.

MR. BLAIR: It is a very valid and relevant point.

DR. COHN: Let's see. Maybe it is in the next set of bullets.

DR. FERRANS: Getting back to my previous comment, we talked about the fragmentation of the health care delivery system. I think it's not just the fragmentation of the system, but the large number of important stakeholders, which is somewhat different.

MR. BLAIR: In addition.

DR. FERRANS: Yes.

DR. FITZMAURICE: There is also a culture in medicine that a doctor is trained to make the best decision possible with whatever information he or she has. And so a doctor can take pride in doing the best thing possible for the patient with existing information, and the feeling is that that hasn't been so bad. So the return on investment from getting an additional bit of information hasn't been shown in a lot of cases.

So for someone to come out and make a major investment in an information system, whether it's a physician's clinic office or a hospital information system is difficult. So the business people have to decide where to allocate the scarce capital that these organizations have. I don't how to get at that or phrase it, or whether it needs to be said. It's a cultural argument I would guess, that the culture of medicine is that each physician is the world's best expert for the patient in front of him or her.

DR. YASNOFF: Mike, isn't that partially captured in the first full paragraph on the next page, page 6? It starts, "The incentive for providers to invest . . ."

DR. FITZMAURICE: Yes.

DR. YASNOFF: I don't think it captured all that idea, but I think that paragraph captures some of it.

DR. FITZMAURICE: It captures the fragmentation that has spread it so far apart that the cost of getting together to do something outweigh for any one person, the benefit that person receives.

DR. YASNOFF: Yes, I was going to suggest that we move that paragraph up to the point where we are giving the various reasons why the health care industry has been slow before we make the transition to focusing on standards as an obstacle. It seems a little out of place where it is.

DR. ZUBELDIA: Also, along those same lines with Mike, the question of what's in it for me has not been answered. For people to implement this, they need to have a clear answer of what's in it for them. I can see for instance how radiologists and pathologists that always provide medical records for consumption by others have to be extremely interested in exportability of their medical record information. But the pediatrician that scribbles some notes for him is not that interested in a uniform, exportable medical record information set.

MR. BLAIR: Let me get back to one piece here. It is clear that this section does not do a good job of answering the question readily. And apparently you are discovering that some of the answers are further down, and the inclination, Bill, was to move it up. Maybe that's the right thing to do, but here's a concern, and you tell me whether or not this is valid, or we should change it or what.

The section was constructed this way for a couple of reasons. Number one, those bullet points on interoperability and clinical specificity, those pieces, back in December that was indicated to be critical points that we should make sure are highlighted and made very visible, because they felt that they were linchpin ideas.

So the thought here was that there are also foundations for the benefits and the reasons that follow in the subsequent paragraphs. But apparently those ideas came so late in that section that you either got impatient, or you wound up coming to the conclusion that the section didn't answer the question, even though eventually you seem to feel like it does.

DR. FITZMAURICE: It answer a question, Jeff, that I think has not been asked. And we were lacking for answers to the first question that hasn't been answered.

DR. FERRANS: Jeff, I have another question about the first question. That has to do with when we look at why have we been slow in moving towards standards, if we start at the end, and certainly I've seen the draft report, so I know what some of our recommendations are about government "support" for standards efforts, and that sort of thing, some of the concepts we have talked about, about helping to underwrite that.

If we know that, it would be helpful early on to say one of the barriers has been the lack of financial support, which as a consequence people have had to invest significant dollars and especially time efforts in developing, which have led to high licensing fees, which have led to poor market penetration, et cetera, et cetera, et cetera. Isn't that one of the reasons why we have had problems establishing standards?

MR. BLAIR: I don't mind doing that. If we do that though, help me with those bullet points there on interoperability. Maybe they don't belong here, or maybe they belong in a different section, but I had thought that they were prerequisites to making those points, because it explains that.

DR. FITZMAURICE: Jeff, to answer the question what is the result of not having patient information standards.

MR. BLAIR: If we had it under that heading, is that what you are saying?

DR. FITZMAURICE: Yes.

MR. BLAIR: Margaret, did you capture that? Does everybody agree that that's a good solution?

DR. COHN: I sort of missed it.

DR. FERRANS: We separate that out into a different question. What is the result of not having standards? Then we separate this section out from the previous question why has it been slower than others. We put a separate question about that. So now we have two questions. The second one is answered fairly appropriately. We know what the result of not having standards does.

Now the question is, is there more to the first one? Why has the health care industry been slower? And the point I was making, my number two reason why it's been slower is not just the number of stakeholders and the fragmentation, but the cost of standards development that has been borne privately, which has led to licensing fees, low market share.

DR. ZUBELDIA: Should we have a long list instead of just three or four bullets? Just have a long list of all the reasons why.

DR. COHN: I'm just going to comment. I'm looking at the first sentence of what used to be this first paragraph. I think we took the whole paragraph and moved it somewhere else. When in reality everything other than the first sentence of that paragraph relates to these issues I think.

I'm just drawing everybody's attention back to this one where we talked about information system standards are needed. Other than the definitional first sentence, everything else are issues that explain why other we have been slower than other industries to establish an information infrastructure. So we may want to turn that into bullets, and put that back as part of this piece here.

Margaret, do you want to look at that one, or are you so far beyond at this point? I don't want to confuse you too much here.

MS. AMATAYAKUL: So far what I've done is, "This question of why has the health care industry been slower than other industries to establish an information infrastructure." As an opening sentence, "There are many reasons why health care has had difficulty establishing an information infrastructure," and then bullets. "Primary among these is the fragmentation of the health care delivery system, and the large number of important stakeholders."

These are not completely polished sentences or thoughts.

DR. COHN: Look at the paragraph above that. I think other than the first sentence, they are all reasons once again. They are sort of backwards, but isn't that another sort of list of the reasons?

DR. FERRANS: I think actually the heavy regulatory environment of health care is probably a reason.

DR. COHN: I just looked at that, and it looked somewhat redundant to what were trying to do.

DR. YASNOFF: You better state the reasons. I think you need to include that the cost of information infrastructure has not been considered a valid reimbursable cost. So nobody could really charge for it.

DR. FITZMAURICE: But likewise for groceries too.

MR. BLAIR: That's true for other industries also?

DR. YASNOFF: It's not the same for health care.

MR. BLAIR: Well, help us understand the point.

DR. FITZMAURICE: They would build that into --

DR. YASNOFF: The grocery store can set whatever price they want, and they have to compete with other people. So if they invest in information infrastructure, they have to get it from their revenue. In medicine the prices have been heavily regulated and controlled, and the providers are not able to set prices very effectively.

MR. BLAIR: That's an insightful point.

DR. FITZMAURICE: But even where there is competition, and there are bids for managed care contracts, do you think they build in the cost of an information system there?

MR. BLAIR: But I think he's saying that's something that has kind of been overlooked when health care has been reimbursed. There has been not very much recognition to reimbursement health care for the development of an information infrastructure. It's only the specific care of this patient within 15 minutes or whatever.

Is that what you're saying, Bill?

DR. YASNOFF: Yes. And I think the recent developments in terms of DRG payments and managed care capitation rates have actually served to be incentives towards developing information systems.

MR. BLAIR: See, the only thing is, Bill, if we go down that viewpoint, we are starting to look at an information infrastructure as a cost. And the thread that we are going through here is that an information infrastructure, like other industries, will be an investment which will help to contain or reduce costs, as well as improve quality. So are you sure we want to start down this path? Maybe we still do. Maybe it's a matter of phrasing it right.

DR. YASNOFF: I think it's logical to ask this question, why has health care been slow? And I think we want to say there are a number of factors, such as reimbursement, the large number of uncoordinated small stakeholders, the lack of emphasis on quality. There are a number of issues. We just want to state those, one, two, three, four.

And then we can say that more recently the health care system has been evolving to a point where there is more of an incentive for information infrastructure. People are actually trying to build it, and they are finding now that the lack of standards is a big obstacle. So I don't want to get into a long discussion of it, but I think we should just tick off those points and acknowledge them, and then get into standards as quickly as possible.

DR. FERRANS: Perhaps if we could hit the salient five or so bullets points as to why. I actually take a different view, because if you look at fixed reimbursement and you say, well, okay then you need to focus on cost. And if you want to decrease your cost, you're going to try and make your processes more efficient. That's a good reason to invest in information technology.

But I think a different view would be that at least in the past ten years that there has been a scarcity of capital dollars that is sort of required for that investment.

MR. BLAIR: Kepa has a thought?

DR. ZUBELDIA: There is also a fundamental difference between health care and other industries. For instance, the retail industry. It's in general acceptable that when you connect to Amazon.com they tell you that based on your previous purchases from them, you should look at buying these new books.

It's still not acceptable in health care when you connect to a Web page that they tell you, based on your past illnesses and your profile, that you should look at these things. That's a way that I think the retail industry extracts value out of the information infrastructure that we cannot extract value in health care.

DR. FITZMAURICE: So, Kepa, you're saying that patients don't see the value of their physician accessing that information about their past use in order to take better care of them?

DR. ZUBELDIA: The patients may still not perceive that as something that should be used as a marketing tool.

MR. BLAIR: Could I try to bring this back to Bill's suggestions? And I think Richard was echoing them a little bit in that we ought to list maybe four or five reasons to answer the question. The fragmentation a was one piece. Margaret, maybe you could capture these, and Bill could add to whatever I'm not able to articulate.

The second one that Bill referenced is there is a lack of recognition of the need to invest in an information infrastructure when health care is being reimbursed, because it's semi-regulated.

Bill, what are some of the other reasons that we should capture in here?

DR. YASNOFF: I think it's that one that is in that paragraph that is on the next page --

MR. BLAIR: Vendors being more efficient?

DR. YASNOFF: No, the paragraph that starts, "The incentive for providers to invest is further impacted by the fact that many of the benefits that result are enjoyed by other sectors of health care." So there are externalities of benefit, because of the way health care is structured. That's another important one.

DR. FERRANS: Misalignment of incentives.

DR. YASNOFF: Yes. And in the cost area, the way I would say it is that information infrastructure has not been an allowable cost. You can say it however you want.

MR. BLAIR: My phrase was that the information infrastructure was not recognized as an investment within the reimbursement structure. Is that close or not?

DR. FITZMAURICE: What that says to me is that investment in information technology has not shown itself to reduce costs, because then people would do it anyway and pocket the difference.

DR. FERRANS: I'll give an example of that, and then I'll take this view. When HCFA did the Medicare reimbursement for telemedicine, they specifically excluded the ability to reimburse for telecommunication costs and infrastructure. Now whether that's a good policy or a bad policy is sort of out of scope. But that was a regulatory decision saying information technology is not within the scope of reimbursement.

DR. FITZMAURICE: But what that tells me is that either the additional business they attract, or the existing business they are doing would not be done cheaper with telemedicine, otherwise they would do it with telemedicine and pocket the difference.

DR. FERRANS: For those of us who practice telemedicine I think what the signal was, is that they were afraid that if they opened Pandora's box, that it was going to lead to a lot of costs, and they were very concerned in a balanced budget environment about allowing a lot of new reimbursements.

DR. COHN: Let me make a comment. I think we're all getting a little too verbal, a few too many directions here. We actually have to get a report to the NCVHS in February, and I think we need to be careful, uncovering too many rocks and investigating what is under it.

Now I'm a little confused about where we are with this section. Maybe Margaret can help us with this one. I did see a whole bunch of bullets that had nothing to do with what we are going to talk about in the report. And I'm getting concerned that we're sort of missing the key elements here. So can you tell us what is in this section?

MS. AMATAYAKUL: So far I've got, "There are many reasons why health has had difficulty establishing an information infrastructure." Bullet, "Primary among these is the fragmentation of the health care delivery system and a large number of uncoordinated but important stakeholders."

MR. BLAIR: That can't help to develop standards. That was the key.

MS. AMATAYAKUL: That what?

MR. BLAIR: Which makes it difficult for them to develop standards.

DR. ZUBELDIA: And can I make another connection to what we are going to recommend later? In other industries there has been leading catalysts that have led the fragmentation effort, and consolidated the fragmentation. For instance, GM, Ford, Chrysler in the Automotive Network Exchange, have capitalized on that. Wal-Mart has been a catalyst in the retail industry.

In health care we have the biggest players, which is Medicare and Medicaid, that are not acting as a catalyst in this arena.

MR. BLAIR: I think you're right, but I'm not sure I want to add it in the report.

DR. FITZMAURICE: But Medicare and Medicaid don't deliver services. They just pay for them, for the most part.

DR. FERRANS: No, I think the way to positively see the point is that in health care the largest payer and provider of health care is the U.S. federal government.

MR. BLAIR: I thought the largest segment was the employers. I thought about 45 percent is government, and 45 is private employers. Is that not correct statistically?

DR. ZUBELDIA: But it's as a single entity.

MR. BLAIR: That's true.

DR. ZUBELDIA: Maybe we can spin it in a different way and say this largest single entity should serve as a catalyst, and then going to recommendations.

MR. BLAIR: But the thing is that may be true, but again, as Simon was saying, we are trying to take the reader down the thread of understanding why standards for patient medical record information -- well, I guess that does. That supports it.

DR. FITZMAURICE: I would say that's more a recommendation that it is a reason why, but I wouldn't want to lose it.

MR. BLAIR: Margaret, can we get back to your giving us those bullets?

DR. FERRANS: To date there has been no single catalyst for addressing number one, however we say that. Then we walk them down the path.

DR. FITZMAURICE: That's a good suggestion.

MS. AMATAYAKUL: Second bullet, "In health care to date there has been no single catalyst for standards development."

DR. ZUBELDIA: For PMRI deployment.

MS. AMATAYAKUL: Deployment?

Third bullet, "The cost of information infrastructure has not been considered a valid reimbursable cost in a heavily regulated and controlling pricing reimbursement environment."

DR. FERRANS: I thought we dropped controlled. Heavily regulated. And heavily is a little pejorative. Is that what we want to say?

DR. FITZMAURICE: The prospective payment system covers an awful lot of stuff.

DR. YASNOFF: I don't think heavily regulated is overdoing it, but I agree that controlled is a little much.

DR. FERRANS: How about competitive? It's extremely competitive.

DR. COHN: Once again, I'm not even exactly sure where we are with this section. We may decide at the end that we actually did better with the last version.

MR. BLAIR: Okay, what's the next item that you have?

MS. AMATAYAKUL: The next items is "Externalities of Benefit. Many of the benefits that result from an information infrastructure are enjoyed by other sectors of the economy, but the costs have not been borne by those sectors."

MR. BLAIR: Did you want to just import the sentence that you already had in there?

DR. FERRANS: The department of pathology will benefit. That's some of the stuff that Paul Tang was talking about when he talked about alignment of incentives. Who actually pays for the information system versus what part of these big organizations are deriving the benefit.

MS. AMATAYAKUL: But I think Paul's point is not just other stakeholders in health care, but other sectors of the economy like the employers.

DR. YASNOFF: I think that both of those points are valid. That there is an imbalance within the health care system where the people who pay and the people who are asked to do more work because of an information infrastructure are not necessarily the ones who benefit. Then there are also external benefits in terms of improving quality, getting people back to work sooner. If you get somebody back to work sooner --

DR. COHN: Bill, I think the paragraph is already in there.

MR. BLAIR: Simon, I think it's pretty good.

DR. COHN: Yes.

MR. BLAIR: So I think it really does cover fairly well, even with Richard, your points, I think Margaret's paragraph covers it pretty well. It's something you already have in there.

MS. AMATAYAKUL: The next one is misalignment of incentives. That's the same thing.

Then there is a need for more complete and comprehensive standards for -- that I just picked up. We don't need that any more.

Scarcity of capital dollars and value in the use of information, Kepa's point.

DR. COHN: Is there more here, or are we moving onto the transition here?

MR. BLAIR: Could we just do one thing with the scarcity? Kepa, could you tie that to the lack of standards for PMRI, the scarcity of dollars?

DR. FITZMAURICE: You could tie that with the regulation, the heavily regulated.

MR. BLAIR: So scarcity of dollars replies to a lot of things, but how did you tie that to how it's impeding standards?

DR. FERRANS: I tied it to the difficulty of establishing an information infrastructure. Many health care settings were not able to invest in their particular part of the information infrastructure because of the scarcity of capital dollars over the past ten years.

MR. BLAIR: That we do have covered. As you get down in the scope section, we indicate those things that are valid, important things that affect this, but are beyond the scope of what we are focusing on.

DR. FERRANS: That's fine. As long as it is covered.

DR. COHN: Can I make a comment here? Maybe down a little lower I would -- in the current version you talk about this limited interoperability that sort of increases the cost of everything. You talk about the increased cost of sharing and integrating, but it's really having to do with everything. But it also of course limits the benefit, because you can't share or you can't whatever.

So it seems to me that there is a fundamental issue here about -- I get confused about what an infrastructure is. Somebody said infrastructure is really the technology and the networks and all that. The standards are sort of what enable the infrastructure. Without the standards, why would you even invest to begin with? Because you can't drive any of the benefits that you might otherwise.

DR. FERRANS: In fact, the lack of standards has caused people not to invest. Absolutely.

MR. BLAIR: How did we miss making that point? Where are you looking that you're seeing that connect is not made?

DR. COHN: Right now it's under a section, what is the result of not having PMRI standards? It used to be at least tangentially referred to in this particular section. I'm just sort of making the point that I think maybe it's the transition point, really the one that we are talking about, but it's sort of a strong statement that yes, you can talk about fragmentation, and you can talk about capital costs or whatever, but without the standards you can't even make a value equation about why you would even do all of this.

MR. BLAIR: See if we can do this. The last sentence -- we moved the paragraph before this section -- the last sentence essentially I think said that. It wound up saying all of these things are valid things that impede, but the focus of this report is patient medical record. Is that sentence a good one, or does that need to be changed?

DR. COHN: Where is that?

MR. BLAIR: It should be the last sentence of the paragraph that we moved of this section that was talking about information infrastructure. It sort of defined what an information infrastructure is.

DR. ZUBELDIA: I think that could be the last sentence of this list we just made.

MR. BLAIR: Maybe it needs to be restated or something.

DR. ZUBELDIA: Maybe this list that you are referring to, Jeff, is one that should be compared to bullets as Simon was doing.

MS. AMATAYAKUL: You want me to move this sentence?

MR. BLAIR: It's a transition point.

MS. AMATAYAKUL: From progress needs to be made.

MR. BLAIR: Okay, move it down below all the bullets we just created.

DR. YASNOFF: Jeff, I don't think we're sufficiently making the point that now as people are trying harder to build these information infrastructures, the lack of standards is an increasingly important obstacle. I think that sentence you just referred to makes it seem like well, there are all these other major problems, but we're dealing with this teeny, tiny, probably not very important area of standards, because that's what we're supposed to do.

MR. BLAIR: It needs to be stronger?

DR. YASNOFF: Yes, I think it needs to be much stronger. I think we believe and have heard that this is a major obstacle. But my concern is we have listed all these reasons why health care has been slow. And I think we have to say something like --

MR. BLAIR: Let's get it so Margaret can capture this sentence. And this would be after all those bullets on why the information infrastructure has been slow.

MS. AMATAYAKUL: Actually, I had a sentence after those bullets. "There now are tremendous efforts to try to move toward achieving a health information infrastructure, but standards are missing, and are an increasingly important obstacle."

DR. YASNOFF: How about something like a lot of progress has been made in overcoming these aforementioned obstacles, and now as people try to move forward, they are finding that the lack of standards is a major impediment.

DR. MC DONALD: Could we say lack of comprehensive standards, because it's not quite true that there are no standards.

DR. YASNOFF: Yes, there are too many standards, that's the problem.

MR. BLAIR: If you've got that captured, and if Clem is back on the line, we have changed a lot of this stuff.

DR. MC DONALD: Don't go back over it. It's more important to make progress than you go back over it with me.

MR. BLAIR: Okay.

DR. COHN: I'm sure Margaret knows exactly what we are doing at this point, because I would think that she's going to have to merge this in with some of the other changes and significantly reformat this area. I think it's getting better, but I think it's not something we can make an informed decision on today.

MR. BLAIR: Margaret, maybe you could take us to what is next.

MS. AMATAYAKUL: You want to go on? Okay. Well, the next thing is we added a question, "What is the result of not having PMRI standards?" We are making the header for the three bullets on limited interoperability, limited capabilities to capture clinically specific information, and limited comparability of PMRI, which impairs ability to measure quality. So go on from there?

DR. COHN: Now is that from not having PMRI or not having comprehensive PMRI standards? Because if you don't have any standards, it isn't limited interoperability, it's no interoperability, at least as far as I can tell.

MR. BLAIR: Let's get those adjectives in there, comprehensive and complete standards.

MS. AMATAYAKUL: Yes, I've got it.

The next section is, "From a vendor and user perspective, the lack of complete and comprehensive PMRI standards has resulted in the impaired ability of vendors to develop information systems which are more cost effective. The impaired ability of providers to integrate these systems in a timely and low cost manner, and the impaired ability of providers to capture clinically specific information to support evidence-based medicine, clinical decision support, and continuous quality improvement."

DR. COHN: Can I make just an editorial comment that I think if you say the "impaired ability of" three times, maybe it should be before the colon. It sounds a little stronger there.

DR. ZUBELDIA: But I have a question. Why are we separating the vendor and user perspective from the other two bullets?

MR. BLAIR: I guess I can't recall the words closely enough to answer the question. Be specific and read me exactly what you are talking about.

MS. AMATAYAKUL: "Vendors, to develop information systems which are more cost effective; providers, to integrate these systems in a timely and low cost manner; providers, to capture clinically specific information to support evidence-based medicine, clinical decision support, and continuous quality improvement."

MR. BLAIR: I think we separated them out to make sure each point was clear, not muddled. Is that a problem?

DR. FERRANS: I wanted to wordsmith the second bullet about providers. "Providers to integrate these systems in timely and low cost manner." I guess it strikes me as sort of dry. Is there some way that we can say what it impedes is the ability for people to take data from these different systems and present it in a unified way to the clinical at the point of care that is relevant to taking care of the patient? I don't know how to say that.

MR. BLAIR: That is also a point. This one was really trying to get to a different point. And that is that it's expensive for a provider to take one laboratory system and make it work with an ADT system. It is timely and consuming, because the standards aren't there. They have to build an interface engine. That was what this point was trying to get to, which is a different point.

DR. FERRANS: It is a different point, and a valid point.

MR. BLAIR: But apparently when you read it, it wasn't written well enough that it was clear to you. So I think we do need to improve that sentence.

DR. YASNOFF: Jeff, could I suggest that you add something about the inability of providers to integrate these systems without expensive, customized interfaces between them? You might even say to compensate for the lack of standards.

DR. MC DONALD: I've got to disagree with some of that. I mean it's sort of damning by faint praise. And we do a lot of interfacing with a lot of products, and they are getting pretty good. Now whether they charge a lot for them is sort of a marketing issue, rather than the ability to interface. Now practitioners have a tougher time, because they don't have any capability to do anything at all.

We're stating this as though there is some fair amount of stuff going on, and I don't like the idea of it stated that there is nothing there, and everything is always expensive and customized. The truth is some of the vendors will charge you $50,000 to change one field, but they just choose to do that.

DR. YASNOFF: Why don't we leave out expensive and just say customized? I'm trying to motivate the issue of standards.

DR. MC DONALD: That has nothing to do with the standards. It has to do with the codes, depending on what we are talking about.

MR. BLAIR: Again, Clem, I think your words complete and comprehensive standards. That's what we want to drive towards.

DR. MC DONALD: Okay.

MR. BLAIR: So if those words are reiterated here, then could we capture at least a little bit of what Bill Yasnoff is getting in terms of --

DR. MC DONALD: Well, the other piece is it's not widely enough adopted too.

DR. YASNOFF: See, I read these points, and I understand what you are talking about. But they don't explicitly tie back to the issue of standards. And so all I'm asking for a little bit more verbiage.

DR. MC DONALD: I agree with your goals.

DR. YASNOFF: And I have the same problem with the first point, because what you are talking about there, the impaired ability of vendors. It's the inability of vendors to take advantage of economies of scale by building standardized systems. And then it ties back, rather than saying what do you mean by not cost effective. It says, oh, I see, they have to customize a system every time, and that makes it much more expensive, because there are no standards.

MR. BLAIR: Rob, you are next here. I think that Bill is still in the middle of maybe suggesting some words to Margaret.

DR. KOLODNER: Why don't we go ahead and let him finish.

MR. BLAIR: Bill, do you want to give another shot at the wording that you would suggest to Margaret before we go to Rob?

DR. YASNOFF: On which point?

MR. BLAIR: Well, actually you've made it on two points here.

DR. YASNOFF: On the vendors I was suggesting adding some language to the effect that the vendors are unable to build standardized systems and take advantage of economies of scale, because of the lack of standardization. Sometime like that.

DR. MC DONALD: Inadequate standardization.

MR. BLAIR: And then the second?

DR. YASNOFF: The second one, Clem, do you want to take a crack at this, because I think I may have overstated it a little bit.

DR. MC DONALD: Which line is that?

DR. YASNOFF: The ability of providers to integrate. In other words, it's difficult to integrate, but the reason it is difficult to integrate is because you have to think about and implement these interfaces between different codes.

DR. MC DONALD: It's like at three levels. I don't know how to say it easily. You can send all the data across in ways that if it was a record of music, it would be fine, or if it was text, it would be fine. But we want to deal with it at a more granular level. That's the problem.

DR. COHN: Well, Clem, I think you are basically agreeing with this case, which is customized interfaces.

DR. MC DONALD: It actually is not where most of the trouble is. This is a subtle distinction, but when you are saying customized interfaces, you are talking about message standards. Most of the trouble is they can build customization, but your codes aren't the same as their codes for glucose or for chest x-ray, and it doesn't help.

DR. YASNOFF: How about saying with customizable interfaces there has to be case by case harmonization with the standards.

MR. BLAIR: In an effort to move things forward, would it be okay, Clem and Bill, if Margaret and I worked to strengthen the language, but still do so in a manner that the lay person will be able to understand these concepts concisely? Would you allow us to do that?

DR. MC DONALD: The blanket standards, especially when it's led by some other phrasing is misleading. It applies all the stuff we are interested in. But vocabulary is the huge sticking point, number one. Number two is even if I wanted to send it through a nice easy message like mail, I can't because of security issues and certificate issues, because it's public.

MR. BLAIR: Clem, here is my thought. I would make an argument this way with you. That is that at this point the reader is looking at standards kind of generically, just uniform standards for patient medical record information. Later on in the report we begin to refine that into what portion is medical terminologies, and what portion is --

DR. MC DONALD: That's fine, but when you say customized interfaces, I don't think it means dealing with the security across the Web.

DR. COHN: Clem, are you upset with the word "interface?" Do we need to come up with another word than interface?

DR. MC DONALD: Frankly, I don't even know where we are exactly, so it's even worse. What line exactly is this?

DR. YASNOFF: It's page 5, line 50.

MR. BLAIR: This was describing the impacts of not having complete and comprehensive --

DR. MC DONALD: I think the way it's stated, it looks pretty good.

DR. YASNOFF: I guess what I was suggesting, Clem, is that we have to say something to help the reader understand how the lack of standards results in the impaired ability of providers to integrate in a timely and low cost manner.

MR. BLAIR: Bill and Clem, let me do once more, I think I heard both of your viewpoints. And I think we could strengthen this to meet a little bit what you are looking for, Bill, in a manner where Clem is still comfortable that we're accurate.

DR. YASNOFF: I'm happy to leave it to you, Jeff.

DR. MC DONALD: We've got to move on, so I am too.

MR. BLAIR: Rob Kolodner had a comment.

DR. ZUBELDIA: Excuse me, Margaret, can you capture the thought that it's not just the interface, it's the mapability of the standards.

DR. KOLODNER: Two things. One, in the third bullet where we talk about providers to capture, given that we're usually talking about entities rather than individuals. I'm wondering whether we ought to get practitioners to capture something like that? Differentiate down to the individual level.

But more importantly, what strikes me as I look at this is that we have left out something when we talk about what the results of not having comprehensive and complete PMRI standards, and that is from the patient point of view. It's the continuity of care. It's the ability to provide a complete electronic copy of my record to somebody so that they know the allergies I've had, or the adverse reaction 20 years ago, or something like that.

I think while we are listing vendor and provider and practitioner bullets, I strongly recommend we put something in there from the person point of view.

DR. COHN: Patients, not consumers.

DR. FERRANS: What it also boils down to for patients is that medical decision-making is often based upon their recollection of their history, and they are the least qualified people to do this, because of the absence of information at the point of care in a timely manner.

MS. AMATAYAKUL: Rich, could you repeat that?

DR. FERRANS: I probably couldn't. That medical decision-making is often made based on the patient's subjective recollection of their medical history, because of the lack of timely information to the point of care. And that the patients are often the people who are the least qualified to provide that information.

DR. KOLODNER: I don't know that I would use the pejorative least qualified, because any of us as patients also have the same foibles when we walk in.

DR. FERRANS: Compared to a standardized reporter, it's not necessarily objective data. But even for those of us who are physicians trying to recount our own.

MR. BLAIR: You are expanding on Rob's point that standards facilitate interoperability, which helps the patient? I mean not interoperability, continuity of care?

DR. FERRANS: Yes. At different points of care they repeatedly have to pass on information verbally, because information systems do not support continuity of care.

DR. KOLODNER: The way we say it is the impaired ability of patients to receive continuity of care due the ready access due to their records, or something.

DR. FERRANS: Their information does not follow them in a timely manner. The point I had made earlier was from the individual provider's view is that whereas there is this base of information systems in given institutions or care settings, the information cannot be presented together from these different systems in a way that is meaningful, like a chart, where someone can get a very accurate snapshot of that patient's health, and be able to do medical decision-making.

MR. BLAIR: So in other words, we need to add a point in there that stresses the benefits to the providers. Actually, we have another section on benefits to the providers. In this case it's the limited availability of comprehensive and uniform standards prevents the provider from having ready access, complete information. I don't want to get to decision support yet. I think it's premature for the reader I think. Don't you think, on decision support; the words.

Anyway, if you can get that much, we can work on that.

MS. AMATAYAKUL: I've got it.

MR. BLAIR: Next paragraph.

MS. AMATAYAKUL: "The incentive for providers to invest in health are information systems is further impacted by the fact that many of the benefits that result from these systems are enjoyed by other sectors of health care."

DR. YASNOFF: We already covered this point.

MS. AMATAYAKUL: So I should take this out?

MR. BLAIR: That was what we were going to move up into those bullets.

DR. YASNOFF: Yes, it belongs further up with the bullets.

MS. AMATAYAKUL: Next section is, "Why is it taking the health care industry so long to develop and adopt complete and comprehensive standards for PMRI? The terminologies and processes necessary to communication information about the health of the human body are more complex than those in other industries. Standards to exchange data about health care must be extremely comprehensive and flexible. Terminology is also dynamic, and requires precision and flexibility. It is very costly and time consuming to develop these standards and terminologies."

DR. FERRANS: I would say that it's much more complex than those in other industries, when we look especially at the terminology issues. The thing about terminology is this is a good place to say how many new drugs we have every year. And how that somehow needs to be added into whatever code sets or standards or new organisms.

MR. BLAIR: New therapies, new drugs. We just tried to make it simple by saying dynamic. Do you really feel like you want to try to explain it all at this point?

DR. ZUBELDIA: There is a section later on that talks about the J codes.

DR. KOLODNER: I don't know that that distinguishes us from a Wal-Mart that has gobs of new products that come out. I think the complexity of the language and the interrelationship and the different dialects.

DR. FERRANS: It makes it more difficult to construct a model that is useable more than just adding the terms, the overhead of doing that, I suppose.

MR. BLAIR: Well, is it the consensus of the group that we should add more detail to the concept that health care information is dynamic? Should we add that additional detail, or should we leave it at the level where it is?

DR. COHN: I wouldn't mind more detail, but I don't know, those examples might cause people to think that it really doesn't need to be dynamic. What are there, 500 new drugs every year? It may not be compelling.

DR. KOLODNER: One of the things that I think may be more unique, although somebody may contradict me real quickly is the fact that the data we collect now we want to be valuable and understandable 20 years from now.

MR. BLAIR: Again, this is still kind of like a background and general rationale. I would argue that if we have just taken that lay person reader to this point, let's try to help them drive towards the major point we want to make. I'm not saying that those examples are not valid examples, but it takes time for them to read through the detail, if we could just set the point. Is that okay?

DR. ZUBELDIA: On the end it says its very costly and time consuming to develop these standards and terminologies. Do you want to separate them there, standards and terminologies, or just say standards?

MR. BLAIR: That's a good point. What is your take? Should we introduce the reader at this stage to the fact that terminologies are separate from message format standards, or should we just leave the phrase "standards" at this point in this part of the document?

DR. ZUBELDIA: My preference would be to leave standards to include both.

MR. BLAIR: Margaret, let's do that. So just the word "standards" at this point.

Clem, are you with us? We are being consistent with the idea that in this part of the document we are using standards in a broad, general sense that includes identifiers, codes.

DR. MC DONALD: No, that's all okay. It's just when you start talking about interfaces, it does sound more specific.

MR. BLAIR: Right. Okay, next.

DR. COHN: I was just looking at the one sentence here that gets a little awkward, where it says, "Standards are also dynamic and require precision and flexibility." I guess we need --

MR. BLAIR: It's not the standards that are dynamic, it was there are medical diseases, terminologies, and therapies and medications are dynamic. I think that was a typo.

DR. ZUBELDIA: And instead of saying "and the ability," I would say while maintaining the ability to retain.

DR. COHN: Maybe what we can say here is standards for terminology.

MR. BLAIR: You point was a good catch though.

DR. KOLODNER: You might want to read what you have there.

MS. AMATAYAKUL: All right, "The standards and processes necessary to communicate information about the health of the human body are much more complex than those in other industries. Standards to exchange data about health care must be extremely comprehensive and flexible. Health care language is also dynamic and requires precision and flexibility while maintaining the ability to retain meaning for a long period of time. It is very costly and time consuming to develop these standards."

DR. COHN: Let me start, and then, Rob, you can go. I'm just wondering as I look at these two paragraphs, how different are they than the question why has the health care industry been slower than other industries to establish an information infrastructure? I'm having a hard time sort of conceptually separating these things very well. I made notes where I wanted to throw some of the reasons for the infrastructure reasons into this issue. This fragmentation similarly is a major reason. There's lots of competition and fragmentation in the marketplace.

MR. BLAIR: In a sense -- and I'm not sure this is working. I'm just going to give you the rationale. We'll see if it holds together. In a sense what we thought we needed to do was -- because up until maybe the page before we had basically taken the reader through the idea that the information infrastructure is what provides benefits and values.

And then we were drilling down from an information infrastructure to that portion of the infrastructure where the lack of complete and comprehensive standards was an impediment. And then when we got down to that level, we then wind up going to the issue of well, what is delaying the development of complete and comprehensive patient medical record standards.

So we thought we needed to take them through all of those stages, all of those steps for them to follow. But if we don't have to.

MS. AMATAYAKUL: I think the problem is that we had initially -- why has it been slower to establish an information infrastructure, and then we got to standards. But now we have introduced another section, so we have to reconcile that, which we will do.

DR. ZUBELDIA: Probably the two questions could be merged.

MR. BLAIR: Maybe we can.

MS. AMATAYAKUL: "In addition, the capture documentation and coding of data to support the reimbursement process has a higher priority than the investment of time and money to support these same processes to improve the quality of care. This is because government payers, employers, and individuals have employed fewer incentives to hold providers accountable for improving the quality of care, than for improving the reimbursement process. If these customers and users of health care develop better incentives to improve the quality of care, it would accelerate the need for PMRI standards that are more complete and comprehensive."

And Stan Griffith sent me a change that like changes the whole paragraph. Could I read that for you?

"In addition, the capture documentation and coding of data to support the reimbursement process has had a higher priority than the investment of time and money to support these same processes to improve the quality of care. This is because government payers and employers have had fewer incentives to improve quality of care than they have had to improve the reimbursement process. Thus, many care providers have had a difficult time in convincing administrators to devote adequate resources to implementing information system components directed primarily to improving quality of care in contrast to reimbursement. While at the same time, administrators who are prepared to commit those resources do not have the uniform standards they would need to more easily and accurately measure the quality of that care, and hold providers accountable."

DR. FITZMAURICE: Is that true? Is there a group of providers out there who are clamoring for this stuff? Clamoring for decision support systems, clamoring for the standards to give them a computer-based patient record, and their administrators won't give it to them?

DR. YASNOFF: I was fine with the change until that last sentence. I think I agree with Mike, that I don't see that as the problem. But some of the rest of it is good.

DR. MC DONALD: Well, this used to be a very contentious thing, and I think it's very arguable, no matter how you say it. The first sentence is certainly true, but the explanation really begs a lot of questions.

DR. YASNOFF: I don't think we need to say that. Actually, I had a comment based on the original paragraph, to add prior to the last sentence to say, since quality of care improvement is greatly facilitated by information systems, these customers and users of care, better incentives to improve the quality of care would accelerate, et cetera, et cetera.

DR. MC DONALD: See, we're thinking that we want these standards, which is all true. But the standards are a means for all the rest. So if we are saying the end helps us get the means, who cares?

DR. COHN: I wonder if we need this paragraph at all, actually. Certainly, the incentives piece might be a recommendation. I'm just wondering if it should be here, or as we move further into the recommendations, which I think it already is.

DR. YASNOFF: Actually, Simon, I'm not sure I heard you, but I think I agree. I think that this in part goes up above with our other bullets about why things have been so slow. And then in part it relates to a recommendation that there be more focus on quality of care. And it really doesn't relate to the issue of standards. It doesn't flow in this section. I think that's what you were saying.

DR. COHN: Yes, I actually think it's probably more of an argument about the infrastructure almost than it is about why it is taking so long for standards. I guess I get confused when we start talking about these things, because you start pointing fingers in various directions.

DR. YASNOFF: I think in answer to the question on lines 11 and 12, why is it taking so long, I think it would be more helpful at this point to reiterate the issue about the extreme fragmentation and large number of stakeholders in the health care industry, rather than get into this particular area.

DR. FITZMAURICE: Now one thing that argues for this area is that by the time we release the report, the government will have decided how it wants to respond to the "Errors in Medicine" report, and we'll have actions. And if there is a tie in that says, you know if you have better standards, you could have better measures of quality of care, without pointing fingers at people, that would be a nice tie in. We may have to wait for a little bit to see just how to word this so that it works its way in without saying that nobody is interested in quality of care.

DR. YASNOFF: I agree with that very strongly, but I just don't think it belongs at this point in the report.

MR. BLAIR: Now if we remove this paragraph, have we lost the concept that there is lack of incentives for quality?

MS. AMATAYAKUL: I thought we were going to put some of these points in up above, why things have been so slow.

MR. BLAIR: So we're moving it?

MS. AMATAYAKUL: Yes, moving the concept.

MR. BLAIR: All right, any other comments? Should we move on?

MS. AMATAYAKUL: "What other issues need to be considered? Uniform data standards for PMRI are clearly essential to the establishment of a health information infrastructure. The role in the government is to promote and support the development of these standards in the private sector. As these PMRI standards facilitate the development of the health information infrastructure, more and more vendor solutions are likely to be developed to utilize this infrastructure. However, it is the marketplace that will evaluate the extent to which it will invest in these solutions, such as clinical data warehouses and advanced data mining tools, clinical decision support systems, computer-based patient record systems, natural language processors, systems that use ontological principles, et cetera."

DR. FITZMAURICE: Jeff, could I add something to one of those sentences? The second sentence on line 33, page 6, "The role of the government is to promote and support the development of these standards in the private sector." I would change it to saying, the role of the government is to promote and support the development of these standards when incentives for these public goods are lacking in the private sector. If the private sector is doing a good job, most people say don't mess it up.

MR. BLAIR: I don't know if we could go as far as to saying incentives are lacking. Clearly, I think what you are trying to say is that the government is to promote these to enhance and support and complement the efforts in the private sector.

DR. FITZMAURICE: Yes. And to think of it though as a good that has externalities as we have talked about earlier. That is the case for government support, when you have fragmentation, when it affects other people than those who are just working on it, when you can't collect enough benefits to pay for the costs, and yet overall, the benefits are greater than the costs. Then there is a case for government action.

MR. BLAIR: Margaret, do you have these thought, or should Michael or I repeat them?

DR. COHN: I guess the only question I have is that is it important at this stage of the discussion that we include in the private sector there? Because I think the role of government is to promote and support the development of standards.

DR. FITZMAURICE: But not if the private sector is already doing a good job. And some people would say gee, you want the government mucking in everything? The answer is well, there are occasions when you do, and there are occasions when you don't. If there is something lacking in the private sector, we want the government to get involved in this case. It's a public good, and has benefits greater than the costs.

DR. KOLODNER: Well, there is also government beyond HHS. So you've got providers like DoD and VA who need the standards as much.

DR. FITZMAURICE: Yes, even though it's government financed and government run.

DR. ZUBELDIA: But to promote and support the governmental standards doesn't mean that they are going to be monkeying with the standard development methods. It could be by using the standards. So I would scratch it out and just say the standards period, not even saying the private sector.

MR. BLAIR: Well, let me argue it the other way. I'm not saying the other way really. I wanted to be careful with this sentence that some people don't read and interpret that the government is setting or driving standards. We really wanted to say that the government is in support of the private sector in the development of standards. So maybe we need to rewrite the sentence, but if we just eliminate private sector, I'm afraid some people will misread that.

DR. KOLODNER: Government setting the standards and forcing it onto others?

MR. BLAIR: Yes. You and I, since we know the industry so well, we may not need the word. But I'm afraid that the lay person or a journalist --

DR. COHN: I guess what you're saying makes sense though. Does this mean that NCVHS can't deal with ICD, if ICD were one of the clinical standards that we're referencing?

DR. FITZMAURICE: I was thinking of the same thing. There is a whole continuum here. Like Simon, I wouldn't want to cut out parts of the continuum that seem to be working, even if they are developed by the government or updated by the government.

MR. BLAIR: Maybe public and private.

DR. FITZMAURICE: You did it, Jeff.

DR. COHN: Thank you, Jeff.

MR. BLAIR: Thank you.

MS. AMATAYAKUL: Wait a minute. I have the role of the government is to promote and support the development and use of these standards in the public and private sector.

MR. BLAIR: Is to support public and private development and use of these standards.

Next?

MS. AMATAYAKUL: "It is also important that the PMRI standards support a health care information infrastructure that addresses needs of all PMRI users including: providers, payers, public health officials, researchers, and the individual health care consumer."

DR. KOLODNER: Do we want to put health care consumer last?

DR. COHN: I was just wondering how you came up with these particular examples.

MS. AMATAYAKUL: Rob, I'm sorry, did you want me to move something?

DR. KOLODNER: I think that as we do this, we need to actually have the focus on the individual be number one wherever it can be. And that the health care community is there to support the individual. So the question is whether the emphasis on the consumer is best if they are last on the list or first on the list.

MR. BLAIR: Should we make it as a separate point where we could focus specifically on the consumer?

DR. KOLODNER: I think the more the better, because I think ultimately that's what we are all about.

MR. BLAIR: I'm assuming you've captured that somehow. And, Simon, you felt uncomfortable with something here.

DR. COHN: It's fine. I was just looking at the listing of all users, and thought it was sort of an odd list, but I think with the changes we're making it should be fine.

MR. BLAIR: Any other comments? Clem and Bill, are you with us?

DR. ZUBELDIA: I would like to add to this list of other issues that need to be considered, privacy. Because we need to tie into later discussing privacy, and so far we haven't talked about it yet. So now that you are talking about the individual health care consumer, that may be a good place to plug in the privacy need.

DR. FITZMAURICE: Protect the confidentiality of consumers' information?

MR. BLAIR: Standards would help to protect the privacy. Is that what you are saying?

DR. ZUBELDIA: Both that the standards would help protect the privacy, and that the use of the standards would be done respecting the privacy, and with the appropriate security measures to protect the privacy.

MR. BLAIR: Next?

MS. AMATAYAKUL: "What benefits can we expect when data standards for PMRI facilitate a health care information infrastructure? When complete and comprehensive standards for PMRI are available, vendors and users will be able to develop information systems that will:

capture clinically specific information more accurate, more quickly, and less expensively;
enable authorized caregivers to access this information from many different locations in a manner that can improve continuity of care;
provide clinical guidelines and protocols to clinicians concurrent with the patient care process;
provide information on drug-to-drug interactions, and warnings of other adverse events to the clinicians concurrent with the process of patient care;
provide more complete and comprehensive clinical data for outcomes analysis which can facilitate continuous quality improvement of clinical processes;
monitor the health status of elderly and homebound patients by a real time telecommunications to caregivers;
extend the knowledge and expertise of health care professionals at leading edge medical facilities to underserved populations via telehealth;
facilitate low cost information exchange between patients and providers via the Internet;
improve the ability of public health services to react quickly to national health emergencies, because more accurate, complete, and timely information is available;
increase the efficiency and effectiveness of clinical research; and
improve the ability to protect the confidentiality of health care information."

MR. BLAIR: Now are there comments or thoughts about this list of benefits? By the way, we are leading right up with these benefits. Now we're at the stage where we feel like the reader has an understanding for information infrastructures, health care information infrastructures, and the problems of the lack of standards. So now we are hitting the benefits just before we drive to a few examples that some of these benefits are real, and then the summary.

DR. FERRANS: Jeff, we haven't talked about a comprehensive, lifelong medical record. We have tried to say this is not the CPR or the PMRI workgroup, but really what standards in having all this comparable data enables us to do is to construct a comprehensive, lifelong medical record. I know we talked something about the continuity of care, and that sort of implies in different locations, but I'm talking over time.

DR. COHN: Are you saying enabling the capability to do that?

DR. FERRANS: Enabling the capability to do that. I don't want to say well, bingo, we have a computerized patient record.

MR. BLAIR: Facilitate the development of longitudinal --

DR. FERRANS: Lifelong, however we want to say it.

DR. ZUBELDIA: I tried to read this list trying to put myself in the shoes of a rural provider in Utah, in the middle of the desert, and say, what's in this for me? How do I benefit from PMRI? And I'm not sure the question is answered. I can see how other people benefit from PMRI.

Let me tell you where we tried to address that, and apparently we must have failed. We tried to address it with that point about providing access to experts to underserved populations via telehealth. The one I think is above it also is trying to provide information to remote locations. But those don't address it?

DR. ZUBELDIA: The use of telemedicine that is being used in Utah, where there is a telehealth project, it's just video conferencing, and the PMRI does nothing for it.

MR. BLAIR: I don't think we're saying teleconferencing. We're saying that if the standards are in place, you can exchange a radiology report, you can exchange progress notes and lab reports inexpensively. So it's much richer than what exists today. Today we don't have the standards to do much more than just a teleconference. But apparently nevertheless, if when you read that, it didn't communicate that. Maybe we have to enrich those sentences.

DR. ZUBELDIA: I can clearly see how other people benefit from my keeping the records with PMRI. I'm not sure I can as clearly see how I benefit from doing it.

MS. AMATAYAKUL: How would you benefit from standards for PMRI?

DR. ZUBELDIA: Well, if we can't answer that question --

DR. FITZMAURICE: Are you speaking as a consumer, or as a physician?

MS. AMATAYAKUL: As a physician.

DR. ZUBELDIA: As a physician, because I'm the one that is going to have to spend X amount of time and money in converting to PMRI, and in entering all that data into PMRI.

DR. FITZMAURICE: You might save time with a new patient. A patient comes in from a managed care company, and here is my data, plug it into your system.

DR. FERRANS: How about eliminating physician isolation or whatever of rural physicians by sort of plugging them into this larger knowledge base, and real time communications? Something along those lines is, I think, what you are looking for, right?

DR. ZUBELDIA: Yes, I think that's one of the points that Mike was saying. It's another very good point that needs to be expressed in this.

DR. FITZMAURICE: With turnover of staff, you will know that your records are still in the same format, no matter who your nurse is, who your clerk is.

DR. KOLODNER: The other thing is that we have this incredible process of retaking data that static for an individual -- the past medical history, their social history, and other things that we redo again and again for new patients, instead of being able to build on a reliable history that moves forward with the person.

DR. ZUBELDIA: That needs to be expressed in this list.

MR. BLAIR: Is Margaret able to catch these?

DR. FITZMAURICE: There may be value in history in physical from being able to say, oh, I see you have this and this. Is that true? Is there anything else you want to tell me? That may be faster than saying, all right, let's start from scratch. Tell me about your childhood illness. Tell me about any illnesses you have had in the past ten years. Oh, I forget, doctor. Let's move on. It doesn't promote continuity of care.

DR. KOLODNER: The other thing again is when we ask the question what benefits can we expect from data standards facilitate this health care information infrastructure, I would start with the patient. That's again what it's all about. If we can't start there.

MR. BLAIR: Margaret, did you get that idea?

MS. AMATAYAKUL: No, I did not get that.

DR. KOLODNER: That we should start with the patient, with the person again, when we go to answer what's the benefits of PMRI standards.

DR. MC DONALD: I'm having trouble hearing the last speaker. I can't recognize the voice.

DR. KOLODNER: It's Rob Kolodner.

MR. BLAIR: The essence of what Rob was saying, Clem, was that on this list of benefits, that we try to prioritize this so that we start to point out the benefits to the patient probably first.

DR. FERRANS: Why don't we break it out, since what benefits can we expect, since we said vendors and users, what do we say patients will expect?

MR. BLAIR: The reason we didn't break it out was that many of these benefits accrued to both patients and the payers. It's redundant and overlapping.

DR. MC DONALD: I would like to support this as it is. I couldn't hear the criticism because the thing got muffled. But this is clear, crisp, it reads well. I don't find anything that needs to be edited in here. It just comes across. It's clear. You've got a whole litany that impresses you.

DR. KOLODNER: My point is that it does if you are a vendor or a provider. But the consumers should see that benefit as well, and that when --

DR. MC DONALD: You mean rephrase a couple of them to get it more --

MR. BLAIR: Either that or add some additional bullets or prioritize them to put a little bit more emphasis on the value to the patient.

DR. MC DONALD: Okay.

DR. YASNOFF: Jeff, I had one editorial suggestion. On the third bullet on page 7, can I do that now?

MR. BLAIR: Yes, how does that bullet read now?

DR. YASNOFF: It's provide information on drug-to-drug interaction. What I wanted to suggest is we start at the beginning by saying prevent adverse events by providing information on drug-to-drug interaction, and warnings of other -- instead of other adverse events -- warnings of other potential problems to the clinician. Warnings of adverse events doesn't make sense.

MR. BLAIR: Does everybody feel comfortable with that rephrasing?

DR. YASNOFF: Let me read that again. It would say prevent adverse events by providing information on drug-to-drug interactions, and warnings of other potential problems to the clinician concurrent with the process of patient care.

MR. BLAIR: Good.

DR. COHN: Just a quick wordsmith. I saw this public health services. Is it public health services or is it public health?

MS. AMATAYAKUL: Simon, where are you?

DR. YASNOFF: Yes, you can delete "services."

DR. COHN: Good, thank you.

MR. BLAIR: Any other suggestions, observations? Then, Margaret, maybe you could go into the examples.

MS. AMATAYAKUL: "It is not possible to measure the full benefit of the above functions and capabilities until a threshold level of activity within the health care information infrastructure is reached. However, there are many examples of pioneering efforts that have produced impressive results. Brigham and Women's Hospital in Boston found that a system displaying charges for lab tests being order prompted physicians to choose less expensive tests. In one year, a 5 percent reduction in ordering saved the hospital approximately $1 million."

"LDS Hospital in Salt Lake City employs computerized adverse drug event monitoring. In 1992, there were 569 adverse drug events prevented, which would have added an average of 1,104 extra inpatient days at a cost of $1,103,291."

"At Kaiser Permanente of Ohio smoking cessation reminders automatically provided to the caregivers at the time of visit reduced smoking prevalence in the region by 12 percent."

"In a final example, at Queens Medical Center, Hawaii, automating the guideline for ordering restraints improved compliance with the guideline from 9 percent to 98 percent within weeks."

MR. BLAIR: Comments and critiques? Simon says great.

DR. MC DONALD: Just a sentence. The first sentence takes away a bit. I don't know why you need to announce it that strong, and it isn't that clear what you mean by that infrastructure threshold. I know what you mean, but it isn't easily grasped. Couldn't you say that a little more positively, and say already measures on a small basis, even before we have much -- sort of turn it around a little bit.

Say even before we have a large system in which we can actually measure these benefits, we can find it in smaller scales.

MR. BLAIR: You mean have a health care infrastructure place?

DR. MC DONALD: It sort of takes away a lot of the thunder in that first sentence.

MR. BLAIR: Do other folks agree with recharacterizing that first sentence?

DR. FITZMAURICE: Yes.

DR. MC DONALD: And you could probably put another four or five lists on there. In Hawaii they did the study of sending the results electronically. I think they got five times as many results, and got them there ten times faster, or something like that.

DR. YASNOFF: Yes, they got a lot more reports when they are doing electronic lab reporting. That seems like it's a benefit, but I don't think it's as clear cut as these other ones.

DR. MC DONALD: Well, it gets public health. It's not just dollars.

DR. YASNOFF: But what I'm saying is that having more things reported is probably good, but you can't yet link it to a real public health benefit.

DR. MC DONALD: Well, faster. I think it was like a month faster.

DR. YASNOFF: Faster is good.

DR. MC DONALD: I don't know if it's come out yet.

DR. YASNOFF: I know about. I'm very familiar with it. That's one of the reasons I'm reluctant to cite it.

DR. MC DONALD: We had a 13 percent reduction in costs as Worcester(?) here with the computer system. There are others. There's at least a handful of them.

MS. AMATAYAKUL: Send them along to me, and I'll get them in.

MR. BLAIR: The only thing that I would ask, Clem, is that we could continue to add to this list. However, in this part of the report I think all we want to do is get the reader to be able to understand where we are going from here, and get them to accept the ideas and concepts. And we don't want to make this section any longer than it has to be.

What about if we were to add -- maybe we could have an appendix with additional examples, or am I blocking you out, Clem? You tell me.

DR. MC DONALD: Most of this document is just sort of speculation. Then this last page starts to pound away. I'm not trying to take a position on this at all, but it's just that when you start to get some teeth to it, I would hate to have you pull your punches.

DR. FERRANS: How about -- and, Clem, you might be a good person to wordsmith this -- but if some way we were able to say as the final sentence of this paragraph is that these and many other examples in peer reviewed medical literature --

DR. MC DONALD: Yes, just cite them.

DR. FERRANS: No, just say led to the conclusion that information systems can both lower the cost and improve the quality of care. Just hit them with it. Here are a few specific examples, and here is the conclusion. That leads nicely into the summary.

MR. BLAIR: Is that okay, Clem?

DR. MC DONALD: Well, it's really inexpensive to put citations in, and I think you've got so little.

MR. BLAIR: Send them along. We'll get more citations in.

DR. MC DONALD: You don't have to talk about them.

DR. FERRANS: But do you think we should have a summary statement like that?

DR. MC DONALD: Yes, I do.

MR. BLAIR: This leads right up to the section that is the summary. And I think what you just articulated is in that next paragraph there.

DR. FITZMAURICE: Jeff, can I make a suggestion? As I read through this list of great results, they tend to get lost, merged in with one another. If there is any place that I would put bullets, it would be on these benefits. Separate them out.

MR. BLAIR: Fine. We have a lot of sections with bullets here.

DR. FITZMAURICE: I'm not encouraging an awful lot of bullets, but in this case each one needs to be punched.

MR. BLAIR: To stand out a little more. Okay. Richard, when Margaret goes through this next paragraph, see if that captures the summary. If not, then we go back and add a summary to the paragraph we just read. Is that all right?

DR. FERRANS: Sure.

MS. AMATAYAKUL: Summary, "The ability of our health care delivery system to manage costs, improve productivity, and enhance quality of care is severely constrained by the lack of complete and comprehensive PMRI standards. This report discusses the issues related to the development of these standards, and offers the appropriate recommendations to address these issues."

MR. BLAIR: Richard, do we need to still go back and add a summary?

DR. FERRANS: She actually added one for that previous sentence, and she put, "These and many other examples in peer reviewed medical literature leads to the conclusion that information systems can both lower the cost and improve the quality of care." Then we go back to the PMRI standards in the summary, which is the broader. It makes sense.

DR. COHN: On the summary, maybe we can get rid of the word the "appropriate" recommendations. I think it offers recommendations. I never think that we would spend this much time doing inappropriate recommendations.

DR. ZUBELDIA: Also, I would capture this part for the executive summary at the very beginning, because it's a good introduction for the executive summary.

MR. BLAIR: Well, it sounds like we have gotten through this background rationale section. And if we have, is this a good time for break for folks? How much time should we have? Is this a 10 minute, 15 minute, or 20 minute break? Ten minute break. Clem, Bill, 10 minute break.

[Brief recess.]

MS. AMATAYAKUL: Definitions of terms and phrases. The first term is patient medical record information may be defined as "Information about a single patient. This information is generated by health care professionals as a direct result of interaction with the patient, or with individuals who have personal knowledge of the patient, or with both." PMRI includes: patient demographics data; health history; details of present illness or injury; orders for care and treatment; observations; records of medication administration; care plans; and other information.

PMRI documents the course of a patient's illness and treatment, communicates between care providers, evaluates the adequacy and appropriateness of care, substantiates claims for payments, protects the legal interests of all concerned parties to the information, and provides case studies for education and data to expand the body of medical knowledge.

DR. COHN: Margaret, can I make just a comment, and this is probably more of almost formatting than anything. I'm actually wondering if I'm a reader of this, why I would want to wait until the end of the first section to understand what PMRI or any of these terms really is. I'm thinking that they may be better as footnotes on the first occasion the term is used. I bring that to committee for question.

Similarly, I think we have earlier a definition of information infrastructure which we might want to similarly use a footnote to define that, and that might be a better way to handle it, rather than trying to define things at the end of the first section.

DR. FITZMAURICE: Simon, do you think there ought to be a place where we collect all of the definitions that we sprinkle throughout here and have a definition page, or a definition section?

MR. BLAIR: We do, but I think that Simon is saying that in addition to the definition page, since people don't get to that until after they have read through this general rationale and background, that he is saying also add a footnote, so that as people are reading through --

DR. COHN: No, actually, I'm saying instead of the definition page. Because at least in the things that I have read, it's typically traditional that the first time you mention a term, you typically offer to define it.

MS. AMATAYAKUL: Oh, so what you are saying is take these and put them in footnotes.

DR. KOLODNER: But I think that there is value in bringing together someplace, even if it's in an appendix, we've got to bring them together.

The other thing is we have the PMRI that we've been talking about. But certainly over the course of the last year or two we talk about three different types of records, the personal health record and the community health record. It might be useful in defining PMRI to contrast it a little bit with those others, just to show that there are other things, and that there is a relationship. That may go in the appendix, rather than up front.

DR. COHN: Could I echo what Rob indicated? I also think that the idea of footnotes is good, but I do think we should also have a definition section, because different people go through documents in different ways. Some people like to have all the definitions referenced in a place they know they can keep going to that section.

DR. COHN: Sure, as long as it's an appendix.

MR. BLAIR: Is that okay? An appendix is all right?

DR. COHN: Yes.

DR. ZUBELDIA: I think that might be a little confusing to have the definition in the footnote and in the appendix. I think the footnote is very valuable, and maybe a footnote that says see the definition of blah, blah. That tells you that there is a defined term, that there is a definition, and that you can turn to the appendix and look at it. So you know what terms are defined.

MR. BLAIR: I don't have a strong feeling about that. What were you about to say? Margaret, you had a thought on that?

MS. AMATAYAKUL: Rich.

DR. FERRANS: I was going to say the other records that Rob was referencing, probably a good reference is the National Health Information Infrastructure paper.

MS. AMATAYAKUL: Right.

DR. FERRANS: That has all the definitions right there that we have used for those, the ones that Rob was referencing.

MS. AMATAYAKUL: But we actually have them later on in the report as well.

Getting back to the issue of footnotes and glossary. I think it's helpful to have a glossary, just because you could get through and then decide you still would like to go back and see what that definition is again, and you can't remember what page the first appearance was on. But do you want to just reference to see the glossary, or do you want to have the whole thing repeated?

MR. BLAIR: Simon, what is your thought?

DR. COHN: Well, I think that these definitions are awkward enough -- once again, I include information infrastructure as part of the definitional piece, because these terms don't exactly sing to you. Patient medical record information, for us to get a concise definition is four sentences. So I think that since that these things are not immediately understandable in the way we intend them, if we only have a glossary at the end, we are likely to have people misunderstanding what it is we are talking about.

As I say, there must be some standard for how this is handled in government documents. I doubt at the end of the first section is where they are stuck usually. So I guess I would defer to --

DR. FITZMAURICE: We can pick and choose. For example, I agree that patient medical record information ought to be defined the first time we start talking about it. What is it that is the subject of this report? But it could also be duplicated in the back in the glossary.

Now, does it make sense to put everything in a footnote, in different footnotes, and then also have it in the glossary? That may be cumbersome. But if we pick and choose what we define, we're all right. Or if we include them in both, at least there is a place where people can go to get it. Whatever the will of the group is. But I do feel strongly about the patient medical record information, we should define that up front.

DR. FERRANS: That's the only one that really needs to be up front.

DR. COHN: I've said what I think needs to be done.

MS. AMATAYAKUL: Why don't we see how it looks, and you can chew it up next time?

MR. BLAIR: My vote is that we have the footnotes, because I do think that is important with those definitions. For those folks that don't read things from cover to cover, they may get into something, and they also need some type of a definition section or glossary or both in addition to the footnotes.

MS. AMATAYAKUL: Yes, sir?

DR. ZUBELDIA: Margaret, can you bring the definition of health care information infrastructure into this? It's on page 5, lines 20 and 21.

DR. FITZMAURICE: I would also add acronyms to the glossary, NLM, NCVHS, AHRQ, HCFA.

MS. AMATAYAKUL: Shall we go on with the other terms?

DR. COHN: Please.

MS. AMATAYAKUL: "Electronic exchange of PMRI is a communication of data, audio and/or images in electronic format between health care information systems in a format that complies with uniform data standards for PMRI."

DR. FERRANS: How about electronically rather than electronic format? You have format twice.

DR. ZUBELDIA: How about it's the electronic communication of data, audio or images between health care information systems?

MR. BLAIR: Bill and Clem, are you with us on these changes?

DR. YASNOFF: This is Bill. I'm here.

MR. BLAIR: Okay.

DR. YASNOFF: You know I won't hesitate to speak up.

MR. KENTSMITH: I'm still here too.

DR. FITZMAURICE: Now you know you can have the electronic exchange without it being in a format that complies with uniform data standards? You may not be able to make much sense of it, but is that an extra condition we are burdening this definition with? No thoughts? Leave it.

MR. BLAIR: Onward.

MS. AMATAYAKUL: "Health care information systems are computer systems that capture, process, store, communicate and/or present health care information."

DR. YASNOFF: That's kind of a circular definition. Don't you mean at the end to say PMRI instead of health care information at the end?

DR. FERRANS: I guess the only reason I wouldn't say that is that a lot of financial systems in health care are considered to be HIS systems. They don't necessarily have to do with PMRI.

MS. AMATAYAKUL: Should we say any health care information?

DR. YASNOFF: Including PMRI.

DR. FERRANS: Including PMRI, yes.

MS. AMATAYAKUL: "Uniform data standards are methods, protocols, or terminology agreed on by an industry to allow proprietary information systems to operate successfully with one another. Uniform data standards for PMRI include message format protocols, medical terminology, and data quality methods that are adopted across the health care delivery system."

DR. FERRANS: How about in the first part it's protocols or terminologies, not singular. And we didn't mention anything -- should there be any mention of any other standards like communication standards? No?

MS. AMATAYAKUL: Communication protocols?

DR. FERRANS: I don't know.

DR. FITZMAURICE: I would add to it uniform data standards are data definitions, methods, protocols, and so forth. Initially, what they are is I've got this bit of data. What does it mean? How do you define it? What is the definition of the field?

DR. ZUBELDIA: How about data models also?

MR. BLAIR: Models are usually vehicles to facilitate or enable.

DR. FERRANS: The RIM would be a reference.

DR. FITZMAURICE: A model could be a standard.

DR. FERRANS: Or you could say a reference model.

DR. COHN: Let's stay away from models in this discussion. I don't think that that provides particularly great light.

I think Mike made a comment about electronic exchange of PMRI, and actually I agree with him. We should look at it. I think you need to go back up there and get rid of the last part of that sentence; just basically after health care information systems period.

DR. FITZMAURICE: I'm bothered a little bit by the proprietary information systems. Can't non-proprietary information systems also operate successfully, and don't they have anything to communicate with proprietary information systems and each other?

DR. COHN: That's in uniform data standards?

MR. BLAIR: Do we have the word 'proprietary' in there already?

DR. FITZMAURICE: Yes, it is in there. I'm wondering -- I wouldn't want to restrict it just to proprietary information system. I would delete proprietary.

MR. BLAIR: Yes, I'd rather not even get into that issue in terms of this definition.

DR. COHN: Do we mean disparate?

MR. BLAIR: I think that's a better word, different or disparate.

MS. AMATAYAKUL: Summary of focus areas.

MR. BLAIR: You said start off with data definitions. I would think including data definitions, not to start off with saying standards are data definitions. Would you?

MS. AMATAYAKUL: "Uniform data standards are definitions, methods, protocols, or terminologies."

MR. BLAIR: That's fine.

DR. COHN: Do you want to say include rather than are?

MR. BLAIR: Yes, include instead of are. Michael, is that all right?

DR. FERRANS: Actually, doesn't he want it in the second sentence where it is, "include message format protocols, data definitions, medical terminologies, data formats." That's probably the better place to put it.

MS. AMATAYAKUL: I've got includes.

DR. FERRANS: No, put it on that one. Put data definitions in that one, not in the first sentence.

MS. AMATAYAKUL: Oh, don't put it here?

DR. FERRANS: Right.

DR. FITZMAURICE: I see what you are saying. The first sentence there is a higher level, and the second sentence is more specific. So definitions would be more specific. That fits the parallel structure.

MS. AMATAYAKUL: "Summary of focus areas. In order to study the adoption of uniform data standards for PMRI and the electronic exchange of this information, the NCVHS divided this subject area into the following focus areas: message format standards; medical terminologies; data quality, accountability, and integrity; diverse state laws and regulations; business case for PMRI standards; and relationships to NHII; privacy, confidentiality, and security. The body of this report will identify the issues and recommendations developed for each of these focus areas."

DR. COHN: It probably isn't "diverse state laws and regulations," just state laws and regulations.

MR. BLAIR: What would it be instead of diverse?

DR. COHN: Just state laws and regulations.

DR. ZUBELDIA: They are diverse by nature.

MS. AMATAYAKUL: What?

DR. COHN: Get rid of the word "diverse."

MS. AMATAYAKUL: Because that's what you had in your list to the secretary.

DR. COHN: Okay, fine.

MS. AMATAYAKUL: "Scope. The scope of this report is to study the adoption of uniform data standards for PMRI and electronic exchange of this information. There are other issues that affect the development and acceptance of health care information systems that were mentioned in the hearings for this workgroup, but they remain beyond the scope of this report as defined by HIPAA. For example, despite the fact that health care is information intensive, many providers have had difficulty developing a compelling business case for investing in more advanced health care information systems at this time. Second, the HHS has explored the issue of how to create a standardized patient identifier as required by HIPAA, but public concern about confidentiality of health records has caused further consideration of this issue to be deferred until after Congress passes health care privacy legislation. Many clinicians have been reluctant to accept information system solutions due to lack of trust in data collected from sources other than themselves. They perceive clinical protocols and guidelines as restricting professional freedom, and are resistant to change. These are business case, political, and cultural issues that require solutions that are beyond the scope of PMRI standards to address."

DR. YASNOFF: Can be -- in line 26, "they perceive," -- can we be a little less dogmatic and say they also can perceive or may perceive.

DR. MC DONALD: I go higher in the logic on this and wonder why we are putting all this in.

MR. BLAIR: I think we are putting it in, because there were individuals on the committee back in December and earlier that felt that these were important issues. When we didn't recognize, there would just be other discussions. So this was again, another defensive set.

DR. MC DONALD: First, some of these things, you haven't explained why they might even be in scope. And some of them you haven't explained what you want to do -- it just seems like you haven't said enough, or you have said too much.

MR. BLAIR: Let me ask you this, because I'll tell you, if the group wants to eliminate all these references to the things that are out of scope, I would be delighted. I just don't want to violate points that were made by committee members earlier.

DR. MC DONALD: Well, the thing you might say -- you might just simply say we are not going to discuss the issue about patient records -- the patient identifier. You need it, but I don't know whether you want to say that and/or -- some way generically describe these issues that are you saying are outside of our scope. It just seems like you are saying some facts. You have talked all over about physicians not using it as much earlier. It's not incented by cost, by this and that. So this seems just like those things.

DR. FERRANS: I would agree with Clem. If anything, if we put some of this -- there are other issues that affect this that were mentioned in the hearings, such as universal patient identifiers, privacy regulations.

DR. MC DONALD: And some distaste by some practitioners of excessively technical solutions to health care, or something just very generic and say we're not going to cover these.

DR. FERRANS: Drop it right there.

MR. BLAIR: So you're saying collapse this down into a sentence that just alludes to the cultural, political, and other issues?

DR. MC DONALD: Well, the problem with the cultural is you open up as many questions as you close. You're talking all around it for the rest of the paper.

DR. FERRANS: I would really focus more on the political, rather than the cultural. This thing about "many clinicians," I would say some clinicians. I disagree with the "many clinicians" statement to begin with. I don't think, at least from the testimony I heard, that that was a huge point that I heard.

DR. MC DONALD: Actually, I think it's wrong, because everybody trusts labs, and the labs come from sources other than themselves.

MR. BLAIR: Let me see if we have agreement here. Does everybody agree to either collapse these?

DR. MC DONALD: Collapse the heck out of them. The only one that really sticks out is the patient identifier. That's something that we can't deal with until it's --

DR. COHN: Isn't the patient identifier somewhere else? Don't we make a brief reference to it someplace else?

DR. MC DONALD: Yes.

DR. COHN: I guess, Clem, I agree with you. I actually can't see a point for this entire section. I'm concerned that we have already talked about the focus areas. I'm actually wondering --

DR. FERRANS: And we made recommendations about business case, so it's in there.

DR. MC DONALD: Sure we did.

MR. BLAIR: When I looked at other reports that were generated within the Department of Health and Human Services, there appeared to be a standard that there was a scope section. However, if we just simply said what our scope is, and we didn't include the things that are out of the scope.

DR. MC DONALD: If you have some real clear border areas, boundaries you can simply about why you are including it or not. I don't think these bullets help here.

DR. FERRANS: We mention at page 32, there is a section on privacy, confidentiality, and security. It doesn't mention universal patient identifier there, but that would be an appropriate place to put that. So now I'm thinking we could even just choose to mention that in terms of the recommendations or collapse it, either way.

MR. BLAIR: What I'm hearing is that it would be even more than collapsing that paragraph, the only thing that we would have in this section then would be the statement of what our scope is, and no reference to the things that are out of scope? Is that what everybody would agree to?

DR. COHN: I just think that the scope is basically redundant with what we say about 10,000 times in our first eight pages. I think that my view is that this report is not going to be overly short, and we don't need to pad. I guess I would defer to view on how it turns out, but I'm not see a strong reason to put a scope sentence there.

MR. BLAIR: Let me ask Michael on this, because he's seen a lot of these reports. The ones that I reviewed, every one of them had a scope section in them. Is it pretty standard to do that, or what?

DR. MC DONALD: You can have scope, but leave those bullets out.

MR. BLAIR: I think I was asking Michael, because he is familiar with the government reports.

DR. FITZMAURICE: I think Clem's right. When you talk about the scope, you say here is what we are going to do, so that the reader doesn't expect you are going to do more than what you say you are going to do. On something like the patient identifier, I would mention it as an important standard, but it is being addressed elsewhere, and will not be the focus of these standards.

DR. FERRANS: And privacy, since that seems to be on the public's mind.

MS. AMATAYAKUL: So the scope section will have, "The scope of this report is to study the adoption of uniform data standards for PMRI and the electronic exchange of this information. There are other issues that affect the development and acceptance of health care information systems that were mentioned in hearings for this workgroup such as standardized patient identifier and privacy, but they remain beyond the scope of this report as defined by HIPAA."

MR. BLAIR: Well, the actual definition in the law was exactly that first piece, uniform data standards for PMRI and the electronic exchange.

DR. COHN: Focus areas is privacy, confidentiality, and security. So it becomes a little awkward in the next sentence.

MR. BLAIR: Why don't just leave that out?

DR. ZUBELDIA: Just remove privacy.

MR. BLAIR: Yes, just the privacy piece; remove that.

DR. ZUBELDIA: In fact, I would generalize it and say such as standardized identifiers. Not just patient identifier, but other identifiers are outside of our scope.

MR. BLAIR: Just delete that phrase.

DR. FERRANS: Is it useful to say that there are some things that we cover that are really the purview of other subcommittees or anything like that?

MR. BLAIR: We do actually when we get into the recommendations pieces, and we start to cover privacy and stuff, we defer to the other committees.

MS. AMATAYAKUL: So this last sentence reads, "There are other issues that affect the development and acceptance of health care information systems that were mentioned in the hearings for this workgroup such as standardized identifiers."

MR. BLAIR: I thought we were deleting the "such as standardized identifiers."

MS. AMATAYAKUL: Oh, delete that also?

MR. BLAIR: Yes, and just simply say they were beyond the scope of this report. Is that right?

DR. COHN: I guess it sort of leaves you hanging.

MR. BLAIR: Or maybe delete the sentence altogether. Do you want to do that?

DR. COHN: The question is though it's a single sentence that says the scope of this report is to study the adoption of uniform data standards for PMRI and the electronic exchange of this information. Whether that is worthy of a whole section.

MR. BLAIR: How about this -- maybe this would work. In our purpose section what if we defined that title as purpose and scope, and then we delete this section?

DR. FITZMAURICE: Perfect. In fact, if you have a purpose section, often that is the scope. You don't need to have two separate sections in the report.

MS. AMATAYAKUL: So the next section is, "Process of Study Issues and Making Recommendations. In order to study the issues and make recommendations associated with uniform data standards for the electronic exchange of PMRI, the NCVHS -- 92 testifiers over 11 days of testimony. An appendix provides transcripts of all testimony. Testifiers were asked to: comment on their definition of PMRI; discuss the need for comparability of PMRI; address specific issues relative to the focus area being considered; identify problems within these focus areas, and recommend what the role of the government should be in addressing these problems."

MR. BLAIR: I don't hear any comments. The only thought that I would have is where it says 11 days of testimony, I would think it would be more meaningful to somebody who is reading this that the 92 testifiers -- testimony from all those folks was done over a period of 12 months or something like that. If we wind up saying the days, I think people wind up saying, gee, 11 days all in a row or something.

I don't think the days are as relevant as the fact that it was over an extended period of time, like what was it 12 years, 12 months, something like that. I don't know how other folks feel, and I don't have a strong feeling on it.

DR. FERRANS: That's a good idea.

I noticed in that next paragraph that was struck about what many testifiers identified, the frame of reference to electronic PMRI. Are we ever going to state in here something about there was a majority of testifiers, or a lot of the testifiers agreed that standards needed to be -- is it appropriate in the report to say our recommendations support the view of the -- it would just be helpful. I know we took this from an informational setting, but to turn around and say, there was broad consensus that the government should do more to promote standards.

It helps the case. Now we are going to turn around and make all these recommendations. And I did get that sense with a couple of notable exceptions. But by and large there were some generalizations that we can make that certainly support the recommendations of the panel.

MR. BLAIR: There certainly was a consensus among those that testified.

DR. FERRANS: Experts in the field, from diverse stakeholders.

MR. BLAIR: The government should promote and develop and standards.

MS. AMATAYAKUL: If we go on in this section, the last paragraph in this section has, "Based on the testimony, the NCVHS identified key issues, observations, and assumptions." Maybe that would be a good place to put based on the testimony, consensus was.

DR. FERRANS: Did we put some language already in the letter to the secretary to that effect? I don't remember it made it into the final version or not.

MR. BLAIR: I think we were careful to avoid any allusions to recommendations. There was one thing.

DR. FERRANS: What the testifiers said.

MR. BLAIR: In terms of -- I don't think so.

DR. FERRANS: Okay.

DR. FITZMAURICE: Could I offer a suggestion on the first sentence? It reads, "The NCVHS developed a CPR workgroup and work plan to solicit information," et cetera. I would change it to the NCVHS created a CPR workgroup, and a work plan charged it to then solicit information, guidance, and recommendations from experts in the field.

DR. COHN: Yes, I was actually also going to comment that there needs actually to be a reference to the CPR workgroup as part of the Subcommittee on Standards and Security, primarily because if this workgroup is folded back in, we don't to have this product appear to be orphaned.

DR. FITZMAURICE: That's right.

MS. AMATAYAKUL: Under the subcommittee what, Simon?

DR. COHN: On standards and security.

DR. FITZMAURICE: Put that right after CPR workgroup, under the Subcommittee on Standards and Security.

MS. AMATAYAKUL: Mike, what did you say about this charge?

DR. FITZMAURICE: The NCVHS created a CPR workgroup under the --

MS. AMATAYAKUL: Subcommittee on Standards and Security.

DR. FITZMAURICE: And a work plan charged it to solicit information.

DR. COHN: You can actually get rid of the work plan part I would imagine. And charged it to solicit information, guidance, and recommendations.

DR. FITZMAURICE: That could reduce the number of appendices.

DR. COHN: Why, do we need to reduce the number of appendices?

DR. FITZMAURICE: It's supposed to in a work plan in an appendix somewhere.

DR. ZUBELDIA: But you can say charged it, and then see appendix to solicit information. The appendix contains the charge.

MS. AMATAYAKUL: Onwards?

DR. COHN: Onwards.

MS. AMATAYAKUL: "PMRI supports an essential chronicle of an individual's health status and interventions. PMRI includes patient demographics, orders, schedules, clinical pathways," --

MR. BLAIR: Let me go back on one thing, okay? My first reaction was I don't really care about the work plan being in there. The one thought, the second thought I had was as people read this, that's the only place that I know of where we reference the schedules and topics and the people we solicited, and how we solicited them. So rather than create something new to do that, maybe we should have that in there.

MS. AMATAYAKUL: Jeff, I'm sorry, I didn't read this to you. We changed it so it reads, "The NCVHS created a CPR workgroup under the Subcommittee on Standards and Security, and charged it (see appendix for work plan) to solicit information and guidance."

DR. FITZMAURICE: I think that's got to be right what you want, Jeff.

DR. COHN: And actually we probably should put there and see appendix for charge and work plan. We'll include the charge in there. The point I was making is that within the appendix ought to be the charge as well.

MS. AMATAYAKUL: "PMRI supports an essential chronicle of an individual's health status and interventions. PMRI includes: patient demographics; orders; schedules; clinical pathways, for example, care plans and protocols; observations; diagnoses; problems; allergies to medications; and other information. For clinical service events, PMRI describes the clinical and operational context, and ascribes accountability, who, what, when, where, and if applicable, why, how, and under what conditions. PMRI is also a foundation for the operation's business record for health care providers, and to the service record for individual health care professionals."

DR. FERRANS: It should also be the foundation for the longitudinal health record, or for a computerized patient record before it is the foundation for those other two things. That would be my only addition.

MR. BLAIR: Instead of foundation we can say facilitate, because we were trying to be very careful. There were some people who were very sensitive that this document was going to mandate or strongly push computer-based patient records. We really wanted to step away from that. But if we said facilitate lifetime health records or something like that.

DR. FERRANS: Facilitates lifetime longitudinal health records for individuals, operational business records for health care providers, and service records for individual health care professionals. Does that seem to flow?

MR. BLAIR: I was staying away from longitudinal, because I thought a lay person might not connect with longitudinal, but they could with lifetime.

DR. FERRANS: The other thing is rather than operational business records for health care providers, we want to say -- sometimes you think of providers as being professionals. I know we have professionals below it. Providers and systems, or health care delivery systems. Because I get confused. When I say for health care providers, I think of individual providers.

DR. FITZMAURICE: You mean on line 10, instead of providers put systems?

DR. FERRANS: Yes.

DR. FITZMAURICE: That's good.

DR. FERRANS: Or organizations. Health care delivery organizations.

DR. COHN: Is there where we should insinuate the personal provider -- the various views from the NHII work? Would this be the place to do that?

MR. BLAIR: We have that language included when we get to the discussion of the NHII. We wind up having a fairly extensive discussion on that. My inclination is to leave it there.

DR. COHN: Okay, not put it here instead. Okay.

DR. FITZMAURICE: I would suggest that "and to the service" be replaced with and for the service record for individual health care providers.

DR. FERRANS: Service records?

DR. FITZMAURICE: Whatever that means.

DR. FERRANS: I don't understand what service record means, I guess is what I'm trying to say. I'm confused.

DR. FITZMAURICE: Is that the medical record held by the provider?

MR. BLAIR: Margaret, could you help us with that phrasing?

MS. AMATAYAKUL: I think that was yours, Jeff. "PMRI also facilitates longitudinal health records for individuals, operations business records for health care delivery organizations, and for service records for individual health care professionals." Did you mean like records that I did this many procedures for residents or something like that?

DR. FITZMAURICE: Or did you mean the medical record maintained by the professional?

MS. AMATAYAKUL: But that's a business record.

MR. BLAIR: What should it be?

MS. AMATAYAKUL: Let's take it out.

DR. FERRANS: I like the idea of multiple types of records, but I'm having trouble defining them.

DR. COHN: As I look at this last sentence, it's sort of non-value added, as best I can tell. When it says, "PMRI also facilitates a longitudinal health record for individuals, operations, business records for health care delivery organizations, and service records for individual health care professionals."

MS. AMATAYAKUL: You know where this came from? This is Joint Commission. We added this. That's why I didn't recognize it. This was from Al Buck.

DR. COHN: Why don't we go back then to the whatever it is that he said, so that we can -- if we are going to footnote him, we probably ought not to change it too much.

MS. AMATAYAKUL: The original is probably what he said.

DR. FERRANS: I think more important -- to be honest with you, more important than this, and where our focus has been, and it's just my opinion. When you look at all those things, and you say here is what it does for each individual patient. I would think the logical thing after this is health care delivery organizations can roll up this data to look at their populations, and however we want to state that.

But here we are focusing on what PMRI is to the individual. Because that facilitates the duality of we're trying to improve this to do this to improve patient care, and the whole outcomes piece. Does that make sense? I'll say when PMRI data of many patients is aggregated, it provides the basis for quality analysis, outcomes measurement, continuous quality improvement.

MR. BLAIR: Does everybody feel okay with that?

DR. FERRANS: That was we don't have to deal with service records and what not. Continuous quality improvement.

DR. COHN: There is stuff in the NHII section that -- I don't think you need to wordsmith this piece.

DR. FERRANS: We could actually mention the JCAHO thing now, like accreditation compliance.

DR. FITZMAURICE: Supports comparable quality measures.

MS. AMATAYAKUL: Instead of continuous quality improvement? It provides a basis for.

DR. FITZMAURICE: Continuous quality improvement is within an organization are we getting better. I was thinking in terms of quality measurement across different institutions, across organizations.

MR. BLAIR: So you're saying in addition to continuous --

DR. FITZMAURICE: Like HEDIS.

DR. FERRANS: Population-based care management.

MS. AMATAYAKUL: Oversight? No. That's it. Good? It now reads, "PMRI facilitates longitudinal health records for individuals."

MR. BLAIR: Can we make that lifetime instead of longitudinal for the lay reader.

MS. AMATAYAKUL: "PMRI also facilitates lifetime health records for individuals. Health care delivery organizations can aggregate PMRI of many individuals providing the basis for continuous quality improvement, outcomes analysis, and population-based care management."

MR. BLAIR: It seems like everybody is accepting it.

MS. AMATAYAKUL: The next paragraph, "Based on the testimony, the NCVHS identified key issues, observations, and assumptions relative to the standardization and electronic exchange of PMRI. The NCVHS also reviewed and enhanced the guiding principles for selecting standards that were published in each notice of proposed rulemaking for HIPAA administrative simplification of standards. These principles then became the guiding principles of the development of recommendations for adopting funding or otherwise supporting the development and adoption of uniform data standards for PMRI (see appendix). Finally, the NCVHS considered that support for adoption of standards could be accomplished through the following four levels:

use within agencies for government business;
use within agencies and in all health plans that covered government employees;
above uses and in health plans that are paid for by the government, that is, Medicare;
for use by everyone in the entire country.

At issue is a need to exchange PMRI across disparate systems as seamlessly as possible, permit the information to be understood at each point in the exchange, and insure the quality of data."

Then we were going to add something here about consensus; reflecting the consensus.

DR. YASNOFF: Jeff, I have an editorial suggestion. On the sentence that says, "Finally, the NCVHS considered . . ." That's line 18. "Finally, the NCVHS considered that," insert the word 'government' support for adoption of standards could be accomplished through the following four, insert the word 'incremental level.'

MR. BLAIR: I like that. How does everyone else feel? Is everyone else satisfied with that? Good.

MS. AMATAYAKUL: So this now reads -- I made two changes. In the first sentence, "Reflecting the consensus of testimony, the NCVHS identified key issues . . ." Then the last sentence, "Finally, the NCVHS considered that government support for adoption of standards could be accomplished in the following four incremental levels."

DR. FERRANS: The last one, "For use by everyone in the entire country." There has got to be a better way to state that. We've got everyone in the entire country. All health care users or systems.

DR. ZUBELDIA: By the entire health care system.

DR. YASNOFF: What you really mean is mandatory required adoption by all health care users. But I don't know if you want to say it in that way.

MR. BLAIR: Bill, it appeared to me as if the HIPAA legislation, the administrative simplification provisions was very careful to avoid the use of the word 'mandatory.'

DR. YASNOFF: I'm not suggesting that we use it. I'm just saying that that's what I think we mean.

MR. BLAIR: Could you repeat it again without the word 'mandatory?'

DR. YASNOFF: I don't think so. How about universal use throughout health care?

MR. BLAIR: That's good.

DR. YASNOFF: That sounds very benign.

MR. BLAIR: Well, we are benign.

MS. AMATAYAKUL: For universal use in all of health care?

DR. FERRANS: Yes.

DR. YASNOFF: Yes, that's it.

DR. FERRANS: Or universal use in health care. I don't know if 'all of health care' is redundant.

DR. YASNOFF: Yes, it's redundant. And for all practical purposes, if you get to level three, that accomplishes the purpose.

DR. FERRANS: That would be correct.

MS. AMATAYAKUL: We have i.e., Medicare. Should it be e.g.?

DR. FERRANS: Yes.

DR. FITZMAURICE: Could we consider what we are saying here? It's, "Finally, the NCVHS considered that government support for adoptions of standards could be accomplished through the following levels: through use within agencies." Now how does that tie in with government support? That would be government mandating itself.

DR. MC DONALD: Encourage -- isn't that the word you want?

DR. FITZMAURICE: Yes, I think you're right. Government adoption could be encouraged through.

DR. FERRANS: My only issue with this is that what we're talking about doing incorrectly leads the reader to the conclusion in this preliminary section, before they read the report, that all we're going to do is say the government is going to have to use it, or everyone is going to have to use it, or somewhere in between. There is no mention here about support through underwriting standards development, coordination of standards groups. If we can weave that in after this, say in addition other recommendations were made based on --

MR. BLAIR: Richard, my reading on it was that this section was focused on defining the word 'adopt' in the four levels of adoption. Maybe that's not --

DR. FERRANS: Isn't there financial support too? Because financial support, if the government theoretically were to help defray the cost of implementing standards, that would certainly support the adoption of standards.

DR. FITZMAURICE: Why do we need to address adoption?

MR. BLAIR: I think it was because there was confusion and ambiguity as to what was meant by adoption.

DR. FITZMAURICE: But it's not in our charge. We're creating a straw term here, and then defining it. I don't see the benefit of talking about those levels.

MR. BLAIR: The thought was that as we go on in the recommendation sections, and as this document matures, and our recommendations mature, that we have this as a reference point to point back to at to which level of adoption we are relating to, for which particular standard recommendation.

DR. FITZMAURICE: Well, if the government is doing the adoption, and the government is telling one of these entities use it or else.

DR. FERRANS: My point is before we get to the recommendations we are saying -- this incorrectly leads the reader to the conclusion that there are only four possible recommendations that we're making. That was my take on reading it. If we are going to put something like this in here saying these are not the only types of recommendations we are making. Other types of recommendations include government financial support were also included after careful reflection of the testimony.

MR. BLAIR: I see. Does everybody else feel like that's needed?

DR. COHN: Well, I guess I would speak for Mike. This is useful for us to talk to the NCVHS about in February when we go there, and say, we thought about these four levels that were applicable. We describe them, but there is very little in our report that actually relates to any of this. So I can't see what the point is of laying these out if later on we're not vigorously using them.

Now if it's such a point suddenly every recommendation becomes one of these four categories, then we may want to put it back. But for the moment, I don't think that it's a value-added. And as I think Richard was commenting, it just is confusing.

DR. FERRANS: Could we revisit this section after we have gone through all the recommendations, to see what kind of foreshadowing of the recommendations we do in this section. This is sort of like the executive summary piece.

DR. FITZMAURICE: That would be fine. If we don't ever look at it again, we ought to drop it out.

DR. FERRANS: Exactly.

DR. YASNOFF: I agree with that, but I think we ought to add something relative to Richard's comment. Something to the effect that we considered a wide range of options for encouraging the additional adoption of standards, or some language to that effect, saying we were very open-minded in essence, because I think we were.

MR. BLAIR: Both benign and open-minded.

DR. YASNOFF: It's kind of self-serving, but on the other hand you don't want to -- if you don't say it.

MR. BLAIR: I didn't hear anybody object to adding the additional phraseology.

MS. AMATAYAKUL: How about, if we keep this in, "Finally, the NCVHS considered that government support for adoption of standards could be accomplished through a wide range of options including financial support for standards development, as well as government adoption of standards in one of the following four incremental levels."

DR. FITZMAURICE: That still sounds a little heavy-handed.

DR. YASNOFF: Yes. Let's come back to it.

DR. FERRANS: Once we see the big picture, we can probably shorten this significantly, and make it more benign and open-minded.

DR. FITZMAURICE: Jeff, can I offer a suggestion. Maybe it's not a very good suggestion, but I want to put it out. Given the time, does it make any sense to jump right to the recommendations so that we get a good consensus of people looking over the recommendations?

MR. BLAIR: Does the rest of the committee feel comfortable with that, if we jump to the recommendations at this point, because we have a limited amount of time? Does everybody accept that? Margaret?

Clem and Bill and Ken, we are jumping to the recommendation section. Are you with us?

DR. YASNOFF: I have it on page 21. Is that right?

MR. BLAIR: It starts with doubling the salary of Bill Yasnoff as the first recommendation.

DR. YASNOFF: Yes, great, thanks a lot.

Agenda Item: Message Format Standards: Issues and Recommendations

MS. AMATAYAKUL: "Issues, Observations, Assumptions, and Recommendations by Focus Area. Message format standards. Considerable progress has been made to achieve interoperability in PMRI standards through message format standards, several of which enjoy wide market acceptance in their respective fields such as HL7, DICOM, and NCPDP. However, users are still compensating for the lack of fully seamless, unsupervised data exchange by employing bilateral agreements to make the message format standards work."

MR. BLAIR: Is Clem there?

DR. MC DONALD: Yes.

MR. BLAIR: Is that all right.

DR. MC DONALD: How did you know I have a comment?

DR. YASNOFF: I have a comment. We all understand the problem with bilateral agreements, but I don't think necessarily anybody else does. The problem with bilateral agreements is then you have to have -- correct me if I'm wrong, Clem -- special implementation software to implement the agreement, right?

DR. MC DONALD: Not always. It's just how you are going to use stuff.

DR. YASNOFF: What I'm missing here is I would like to see -- so you have to have agreements? People have agreements all the time. Why is that a bad thing? Tell me why it's bad.

MR. BLAIR: Oh, okay. Hopefully, we would have alluded to this before, but that it's an additional cost, because you can't automatically do plug-and-play between one system and another. You have to invest in either customizing it or modifying it to each system that you connect to. So apparently we didn't communicate that here, but do we need to communicate it here?

DR. YASNOFF: I think you do, because a lot of people will go right to this page and just read the recommendations.

DR. MC DONALD: Well, actually some of that may not be all bad. I almost worry that we've got too much front text on some of this, but that's another story.

What line are you talking about now?

DR. YASNOFF: I'm talking about line 9. It's the sentence that starts on line 8, "However, users are still compensating et cetera, by employing bilateral agreements to make the message format standards work." Bilateral agreements which are costly to implement. Bilateral agreements which are difficult to administer and make systems hard to build, something.

DR. MC DONALD: I've lost it. I'm not finding the right page.

DR. YASNOFF: Page 21.

MR. BLAIR: So we jumped to the recommendations. So we moved to under the message format standards we started with the first piece. I knew that this was something you had previously been focused on.

DR. MC DONALD: It might be better just to say by doing additional work and negotiating to make them all -- I think you're right. I don't think we need to get into the technical nature of this. I think you just have to say they've got to do additional work to negotiate and perhaps sometimes reprogram to make the message standards format work.

DR. ZUBELDIA: I think the word 'bilateral agreements' to a naive reader would read more like a contract. And I think that's not the message we are conveying. We need to say something like specific implementation agreements or technical implementation agreements.

DR. MC DONALD: But that's not what makes them bad. What makes them bad is the extra work they have to do.

DR. YASNOFF: If you are going to exchange data, even if there was a seamless standard, if you are going to exchange data, probably you are going to have to negotiate an agreement. So I read this, and I say, oh, so we have to negotiate an agreement? So what?

MR. BLAIR: Clem, I want to pick your words, if I can.

DR. MC DONALD: The concept by performing additional negotiations and work on software or coding to make the message communication work, or to interpret the messages correctly. Interpret the content correctly.

DR. ZUBELDIA: Something like implementation adjustments instead of agreements.

DR. FITZMAURICE: Or how about by employing bilateral agreements with each other user with whom they want to exchange data.

MR. BLAIR: I think Clem is picking words now.

DR. MC DONALD: The point I'm trying to get through is they have to understand what is the downside. The fact that they do the agreements isn't a downside. It's the work involved with the involvement.

DR. FERRANS: That leads to increased cost of implementation.

DR. MC DONALD: And even if they don't have an agreement, they have that amount of work. We do stuff without formal agreements, but we have to rework it to make it understandable ourself.

MR. BLAIR: Clem, could we wind up indicating that that additional work involves time and resources.

DR. MC DONALD: For additional work you could say to negotiate understandings -- well, to discover the understandings, to revise the message, to map code.

MR. BLAIR: Can we add costs to this?

DR. MC DONALD: All those cost.

MS. AMATAYAKUL: How about if we say, "However, users are still compensating for the lack of fully seamless, unsupervised data exchange by requiring costly additional work to negotiate and reprogram software to interpret content correctly."

DR. MC DONALD: Make sure about that coding and mapping, because that's actually most of the work nowadays. It's relatively little with what you just described, but there is tremendous amount of mapping codes.

MR. BLAIR: Translating and mapping?

DR. MC DONALD: Yes, that's why the words about interface are not cuing properly.

MS. AMATAYAKUL: Translating and mapping what?

DR. MC DONALD: It's the codes that people are using. It's the vocabulary issue.

DR. YASNOFF: I like that a lot better.

MR. BLAIR: Well, this was an important point for us to make sure we all agreed on.

DR. FITZMAURICE: Can I give you another suggestion, Margaret? And that is to move the "such as HL7, DICOM, and NCPDP" right up to after which -- several of which, such as HL7, DICOM, and NCPDP enjoy wide market acceptance.

MS. AMATAYAKUL: I'm sorry, Mike, what did you say?

DR. FITZMAURICE: I would move what you have in parenthesis up to right after which, such as HL7 and so forth comes right after which, rather coming right after their respective fields.

DR. ZUBELDIA: I would add X12 to that, please.

MR. BLAIR: I guess this is where we were mentioning for the first time, specific standards. Actually, before this we did, when we did the overview.

Kepa, if you feel we should have X12 in here, I would accept that. My general thinking is I tend to think of X12 in terms of financial and administrative message formats as opposed to patient medical record information. I know that it could have an envelope, which would have some patient medical record information in it. But I didn't think that that was its focus.

DR. ZUBELDIA: The reason why I said X12 is because you have NCPDP. They are both in the same area.

MR. BLAIR: Margaret?

MS. AMATAYAKUL: I lost my cursor.

[Instructions are given by Dr. Zubeldia to correct this problem.]

So do you want me to leave it out?

DR. ZUBELDIA: It doesn't matter.

MR. BLAIR: It doesn't matter to me either. I guess the question is does NCPDP have patient medical record information in it? It has prescriptions. Let's leave it in for now and go forward. If somebody picks on it, we'll react.

MS. AMATAYAKUL: Next paragraph, "Detailed implementation guides for the message format standards do not typically exist in a comprehensive and consistent format, resulting in users having to create their own non-standard guides. A single implementation guide for each standard lowers cost, eliminates the need for trading partner agreements, and improves interoperability and data integrity. A standard is more time consuming and expensive to implement without the specificity of an implementation guide."

MR. BLAIR: Clem, were you hearing this?

DR. MC DONALD: Yes. The problem with it is that most of the standards have implementation guides. So I'm not sure what we are really speaking of.

MR. BLAIR: Right after she said implementation guides, I think she said comprehensive and complete or something. So it wasn't that they didn't have guides. The problem was that they -- and Margaret, maybe you could read that or maybe put those words in front of the word 'implementation guides.'

MS. AMATAYAKUL: "Detailed implementation guides to the message format standards do not typically exist in a comprehensive and consistent format."

MR. BLAIR: In a comprehensive and consistent format.

DR. MC DONALD: Well, I don't know how to explain it or express it. I think that there is nothing terribly wrong with saying you want implementation guide. I think you want to. It's just that I think that doesn't solve it. That's not where most of the work it.

MR. BLAIR: While you're thinking about it, Kepa had a comment?

DR. ZUBELDIA: Should we put at the beginning of the sentence something like until HIPAA administrative simplification formats, detailed implementation or administrative simplification standards, whatever, detailed implementation guides for PMRI do not --

DR. FERRANS: Well, but the section strictly deals with message format standards.

MR. BLAIR: That true. And we are part of HIPAA.

DR. ZUBELDIA: But I think that what I'm trying to convey here that we're looking for PMRI standards to get to the same level of implementation guides that we have administrative simplification.

MR. BLAIR: Clem, were you able to hear that?

DR. MC DONALD: Yes. Maybe we can just go further. I'm not sure what I'm troubled by.

DR. COHN: I think that's actually okay. We might just want to talk about HIPAA I guess administrative and financial transactions; that may be what we are talking about.

DR. FITZMAURICE: Clem, I think your implication is that this says there aren't very many implementation guides out there.

DR. MC DONALD: No, I think there are more than you think. What we are trying to do in health care is standardize everything like no one ever tried to standardize before. No one standardizes all the vocabulary in the universe. They have a place to put in free text. We don't know where it all ends. And we have the privacy requirements. We've got all these other things that go on and on.

So for a particular standard, you've got implementation guides, but you still have to worry about how you get it across the Internet. The vocabulary kills you every time.

DR. FERRANS: Clem, when you talk about there being more implementation guides than we think, for message format standards is there an issue as to the quality or specificity varying between the guides?

DR. MC DONALD: It's specificity within that context.

MR. BLAIR: Could we get that phrase then into the sentence?

DR. MC DONALD: The problem with that is this becomes metaphysical. Just saying it is good. You want to have implementation guides. You want to be as specific as you can be. Then a new test comes along which has some other variant to it.

MR. BLAIR: Well, actually, Clem, put it in the context of the fact that this is introductory wording to help the reader understand the problem so that when we give our recommendation a little bit further on, which is encouraging implementation guides and support for implementation guides, that they would understand why we are making that recommendation.

So if you could just help us with the wording so that it is accurate and balanced, so that the reader can understand what the problem is.

DR. MC DONALD: I think maybe I'm wrestling with myself here. I think we should say we want implementation guides. There is no question about it. There is nothing wrong that. They are good.

DR. FERRANS: Clem, I actually had a different question for you. I see six paragraphs listed under message format standards. Because the bottom part after that says recommendations, these six things sort of represent our issues, observations, and assumptions about message format standards. I guess my question to you is, is there something we're missing here?

DR. MC DONALD: No. You mean these six paragraphs?

DR. FERRANS: Yes.

DR. MC DONALD: No, I think they're okay.

MR. BLAIR: Now the six paragraphs, aren't they the recommendations?

DR. FERRANS: No, because recommendations come right after it. So by default these are the issues, observations and assumptions. I just wanted to make sure we had captured them.

DR. MC DONALD: The conformance standards almost needs a little more work. It could use more space, because it's so important. But one just says there are a problem, but again, the reader doesn't know what they are.

DR. COHN: Are we on to the next paragraph now?

DR. MC DONALD: Do you know what I mean? That would be worth expanding that just a little bit, saying standards are -- if there is a way for users to verify that a vendor has adhered to a standard, that would be nice. And the conformance testing lets them know that. It keeps people honest.

DR. COHN: Well, since we're on the issue of conformance testing now, I thought that the issue with conformance testing is that you really needed detailed and comprehensive specification of the standard, at which point then you could test for conformance.

DR. MC DONALD: No, the limit to conformance testing is not solely the limit to the standard. There are political limits. They don't want to do it. They can't get anybody to do it. The time hasn't been invested. If one vendor does it, then how do the other ones trust them? So conformance testing lacks -- it's not simply a consequence of -- you can conformance test any standard within the constraints of what they specify.

Three years ago we would see message standards with the units in the wrong field. It's flagrantly -- it wasn't valid. It was not that the book wasn't real clear about it. They just didn't read the book or something.

MR. BLAIR: Clem, I have a sense that you agree generally with the issues and the recommendations. And there is just some words there somewhere you still feel a little uncomfortable. Do you feel like you need to get that done today, or is that something where you could send Margaret and email with a modified sentence that would correct it?

DR. MC DONALD: I would just like to get a sense of the group. I think that the conformance testing is more -- just give it a little more understanding to the reader.

DR. COHN: Do we need to explain a little more what conformance testing is?

DR. MC DONALD: Yes.

DR. COHN: We basically just sort of say it's an impediment.

DR. MC DONALD: What it is and what good it does, because without it people just can assert compliance with a standard when they flagrantly are not anywhere near it.

DR. FERRANS: I would use DICOM as a very good example of that. All vendors put conformance statements on the Web, but they are not required to do conformance testing. And when the people who are trying to implement those systems have a great amount of difficulty, because they don't support -- each vendor doesn't support say 10 percent of any particular part of the standard that is random. So it leads to --

MR. BLAIR: In the interest of time, could we leave it, Clem?

DR. MC DONALD: I can pass if there will be some time we could do a little bit more editing.

MR. BLAIR: Absolutely.

DR. ZUBELDIA: Clem, for my education are you talking about syntactical conformance or semantic conformance, or both?

DR. FERRANS: A lot of it is syntactical conformance.

DR. ZUBELDIA: Syntactical, because that's what we see in X12. There is a lot of syntactical misunderstandings, and you can do semantic if the syntax is not correct.

MS. AMATAYAKUL: So somebody is going to send me some stuff on this?

MR. BLAIR: Yes. Now is it necessary for you to read us through all of the other six paragraphs? Is there general comfort level with the next three paragraphs, just in the interest of time?

DR. FITZMAURICE: I'm uncomfortable with the sentence that reads, "Development of message format standards in the private sector is responsive to market needs." I'm saying, therefore, it needs no government attention? I don't know what the point is.

DR. FERRANS: That's a good point.

MR. BLAIR: I think it tends to be driven by market needs. Maybe responsive is a good word.

DR. FITZMAURICE: But is there a problem that needs to be addressed?

MR. BLAIR: Well, it wasn't saying that it was a problem. I think it was an observation that they are responding to the market needs. They are not being done because the government says this is what we want. It's responding to the private sector. I think that's the intent of that sentence.

DR. FERRANS: I would strike it.

DR. MC DONALD: Well, what you could say, you probably want to reinforce that it's supposed to be principally a private sector activity. You could say something like is guided principally by market forces, and that's good. I guess you've still got the problem then of how do you go to the next step.

MR. BLAIR: Well, what if we were to say -- because I hate to lose the concept that is there -- could we wind up saying principally responsive to -- maybe we could say responsive to market needs and government regulations.

DR. FITZMAURICE: Well, I like what Clem said, development of message format standards in the private sector is guided principally by market incentives or market forces. So the government, if they throw money at it and say do this, here is the response. Market forces, I guess. It doesn't obviate then the fact that the market fails in a lot of cases to do as much as it should.

DR. COHN: Actually, I have an interesting question here, and I don't know if we want to bring this up. Clem may go ballistic. But we could say guided principally by market forces and members of standards development organizations, since I think there have been some issues having to do with obviously these things are just reflective of whoever is at these meetings participating in the process.

DR. FITZMAURICE: But that's part of market forces too. The market pays your way or it doesn't pay your way.

DR. FERRANS: It depends on how you define market. I would disagree, because 80 percent of the health care market is small business, and they are certainly not as representative, because they don't have the wherewithal to participate as much. I think on a proportional basis you would probably see the larger health care institutions, and the larger vendors participating. So I'm not necessarily sure in that sense of the market. In the commercial market it's definitely true.

DR. FITZMAURICE: But even there they don't see the value enough in standards to take two days off of their business practice or their medical practice and go to a standards meeting.

DR. FERRANS: I would say that if I was going to add any caveat to the statement, I would say although development of message format standards in the private sector is responsive to market needs, the process by nature is not fast. And the market is fragmented, which makes it difficult for them to address all those needs.

MR. BLAIR: Clem, are you fragmented?

DR. FITZMAURICE: Because all the other paragraphs had raised a problem that a recommendation was going to try to address, and so does this one. I like it better.

MR. BLAIR: Do we have any other concerns or comments then about the discussions of these paragraphs that precede our recommendations?

DR. FERRANS: And the market is fragmented, not the process is fragmented.

MR. BLAIR: I think we are ready for recommendations.

MS. AMATAYAKUL: "One, to accelerate the selection of message format standards to achieve interoperability without the need for bilateral agreements. The secretary of HHS should designate an entity which will utilize the guiding principles for the selection of PMRI standards for adoption."

DR. FITZMAURICE: I've got a problem with this one. I don't know what action is called for by the secretary. And I don't know what 'selection' means.

MS. AMATAYAKUL: Let me make one comment before we take some other discussion, that might be helpful. These recommendations, there are six of them here in this sequence, and they build on another. So the first step is to figure out selection.

MR. BLAIR: Criteria for selection.

MS. AMATAYAKUL: Right.

DR. ZUBELDIA: How did we address the bilateral agreement terminology earlier? Can we change that to whatever we did before?

DR. MC DONALD: Actually, the complication here is the first thing is you should designate a power. And then later on you say that power does certain things. I think this first sentence is just all tangled, because you don't really care if they achieve -- if they achieve perfect interoperability, we don't care what they use to get it.

Secondly, we're telling them to select something for adoption. That's like saying adopt it for adoption, because they are sort of synonymous, and there is no subjects in most of these things.

MR. BLAIR: Could you read the sentence again for us, Margaret?

MS. AMATAYAKUL: "To accelerate the selection of message format standards to achieve interoperability without the need for" however we describe bilateral agreements above "the secretary of HHS should designate an entity which will utilize the guiding principles for the selection of PMRI standards for adoption.

MR. BLAIR: Okay, can I rephrase this a little bit? After interoperability we don't even have to say to reduce bilateral agreements. Just leave it with it's to promote interoperability. And the other piece is the intend of this, as Margaret indicated, this is the first piece, is to wind up saying we would be using the guiding principles for PMRI as the criteria to select which standards would be adopted in a future process by an unnamed entity.

DR. MC DONALD: Couldn't we do it more directly and say that the department will use PMRI standards towards selecting the message standards for adoption?

MR. BLAIR: The key thing here was the use of the guiding principles as the criteria for selection.

DR. MC DONALD: But who is the kicker here? I mean don't you want HHS to use those guiding principles?

MR. BLAIR: I think some entity within HHS, yes.

DR. MC DONALD: Well, then why don't we just say HHS, and let them figure out --

DR. FERRANS: It's not specified that it's in HHS in this. The secretary could select the UCLA Department of Informatics.

DR. MC DONALD: The whole purpose here is to get HHS to pick and use a set of standards. That's one of the purposes of this early stuff, and then have it cascade out. So wouldn't we just want to say to accelerate the adoption of message format standards, we would suggest that HHS pick a set of standards based on guiding principles.

MR. BLAIR: That works.

DR. FERRANS: That's perfect.

DR. COHN: I guess the other question I have, and I'm constantly looking at this stuff to make sure these things are actionable, and obviously most of them are still too high level. But I mean do we also think that the process should be similar to the process that has already occurred for the HIPAA administrative and financial transactions? Is that the type of process we are talking about, or do we have recommendations?

DR. MC DONALD: Well, I don't know that we could define it ourselves, and whether we have to. But that wasn't bad.

DR. FERRANS: Shouldn't that be a separate recommendations? That we recommend that the process used be similar to that used for the HIPAA administrative --

DR. MC DONALD: Why don't we do two recommendations. So we first say they should use the guiding principles to select standards so that they will accelerate the adoption widely for their own use. In the second one we would suggest that one set of processes that worked well within the ones, et cetera.

MR. BLAIR: The last time we went through this process, the NCVHS made the recommendations for the selection. And why are we in this case not recommending that we do the same for this? We just want her authority for us to do that.

DR. FITZMAURICE: Can I suggest a beginning to this? My suggestion is it could read to provide national leadership to monitor and to accelerate the selection of message information standards, and then whatever you want the secretary to do. But the reason is this area calls for national leadership. It calls for somebody to look it over, and it calls for some action to accelerate.

DR. MC DONALD: But you've got to be careful. What you can say is that -- all of the sentence, except for you said for the adoption of. You can accelerate the adoption. They can select.

DR. FITZMAURICE: The problem with adoption --

DR. MC DONALD: Well, there are two different issues. We are trying to accelerate the general adoption, and they can themselves select their own, and that will help. So I don't know how to put them together.

DR. FITZMAURICE: I would make that another recommendation. First of all, I want the secretary to be interested in standards.

DR. FERRANS: Getting to Jeff's part, I think Jeff was more specific when he suggested that the NCVHS be the entity. Is that correct, Jeff?

MR. BLAIR: I sort of feel like we ought to have a little more substance to this than just saying an unnamed entity.

DR. FERRANS: With the future process.

MR. BLAIR: So I feel as if it is within reason, unless the committee feels uncomfortable with this, that we wind up asking her for the authority for the NCVHS to perform that selection process.

DR. FITZMAURICE: Then you become a government agency with regulatory powers.

MR. BLAIR: Not the selection, but to do the recommendations like the NCVHS did.

DR. MC DONALD: Well, if we could break out the discussion to first get clear what we are asking. We are asking -- this is a question. We are suggesting that HHS should accelerate the adoption of message format standards by selecting a set them itself. Isn't that correct? For its own use. Now there is a separate step of who does it. I think the risk of combining them together is that we can't get them to make choices. If they decide they want to do it differently, then they throw out both of those options.

MR. BLAIR: So what are you suggesting?

DR. MC DONALD: Well, I actually think we don't have to suggest ourselves in a public document. It sounds self-serving. The law says they are supposed to look to us.

DR. COHN: Clem, that's actually why I was referencing the HIPAA process. If you remember the process itself is pretty complex. There is a relying on, there is a consulting with, within the HIPAA framework of how things get decided. That was why I was referencing -- I don't know that we really are asking NCVHS to be solely the arbitrator of all clinical data standards.

DR. MC DONALD: If we took it one step at a time, if we simply said HHS should select standards for its own use, using the guiding principles, isn't that a good statement to make?

MR. BLAIR: That is a recommendation that is down below. That's one of the six.

DR. MC DONALD: I think the first thing is that's what we want them to do.

DR. FITZMAURICE: No, I'd say the first thing is we want the secretary to take national leadership. To recognize a responsibility to the nation.

MR. BLAIR: I think even before an agency selects it, we still have to reference what would be the criteria for selection. I think that's the first point that this makes.

DR. MC DONALD: The guiding principles.

DR. FERRANS: The guiding principles and the HIPAA process?

DR. MC DONALD: HIPAA doesn't have these in it. We've got to give them some simple idea. We're telling them take leadership, select a set of standards using the guiding principles. Then that's one idea.

MR. BLAIR: I think we ought to take that exactly as you said it right there.

DR. COHN: I think, Clem, that you are right on the money here. I think what we're all saying is that number one is the secretary of HHS should utilize the guiding principles.

DR. MC DONALD: You should pick them. You should pick some as examples or show leadership, and you should use the guiding principles to choose them.

DR. COHN: That's right. And then I think recommendation two gets to be this issue of the process, which I think is what you are suggesting.

DR. MC DONALD: Yes. And if we separate those out, we can get them cleaner.

DR. FERRANS: Let me ask a separate question, but it's related. When we talk about the secretary or the department taking leadership, because HIPAA asked the department to study clinical standards, does the department need to assert authority or something along those lines?

DR. MC DONALD: Do you want them to?

DR. FERRANS: Well, to put it to you this way, if we are going to through and make all these recommendations of all these things, it sounds to me like the department ought to declare itself, and say we have done the administrative standards. We have studied the clinical standards. Now we are going to do the clinical standards, and here is the process and the entities and the framework that we're going to do to achieve that.

DR. MC DONALD: For whom and to whom? What cope were you thinking?

DR. FERRANS: Well, the scope can be anything for their internal use, to use for people who are reimbursed by Medicare.

DR. MC DONALD: Okay, within their scope.

DR. FERRANS: Within their scope.

DR. MC DONALD: I don't know if that says any more than we are going to adopt -- this is under the message standards heading. It's not the whole HIPAA law.

DR. FERRANS: But to me, there is a fundamental principle that we need to ask the department to step up to the plate and say we are going to action on clinical standards.

DR. COHN: I actually agree with you, Richard. Margaret is trying to get a word in edgewise.

MS. AMATAYAKUL: I think it might be helpful to just look at the major content of each of the six items. If I could just read the key points of each of the six items, because I think you are trying to put all these six items into one recommendation here.

DR. COHN: But I think we are talking about a very important first recommendation that I think we have been missing, which is saying that we are recommending the secretary -- I think there are better terms -- but step up to the plate to deal with this.

MR. BLAIR: I feel as if the group has kind of agreed on splitting out that first recommendation into two. Yes? I think that I can almost make a stab at the wording for those two. Is that useful? Should I do that?

MS. AMATAYAKUL: Yes.

MR. BLAIR: I'm stealing from everybody. The first one would be the Department of Health and Human Services should assume leadership to improve the interoperability of message format standards by:

- utilizing the guiding principles for patient medical record information to select standards for their adoption; and

- authorize the NCVHS to continue in its role of advising the secretary in this process of standards adoption.

DR. ZUBELDIA: I must be missing something. Under the administrative simplification part there were nine transactions. There was a procedure for selecting the standards that would be applicable to the nine transactions. In here if we define these guiding principles to select the standards, are we recommending that the secretary say follow the guiding principles? Adopt say HL7, and then everything, HL7 becomes automatically adopted?

Or do we need to at some point -- somebody needs to make the list of messages and the list of items like we have code sets and identifiers on one side -- the list of items that need to be standardized? And then given that list of things that need to be standardized, use the guiding principles to select the proper standards for them?

Are we doing it upside down? Because in the administrative simplification side it's very clear you have the standard, you use the guiding principles, and then you select the standards that meet the guiding principles for those nine transactions for the code sets for the identifiers. And I think we are skipping that step.

DR. MC DONALD: You broke up there at the beginning.

MR. BLAIR: There was a reference to the inventory of standards.

DR. MC DONALD: What are discussing? The thing that Simon just said, or the bigger principle? I'm lost where we are.

DR. ZUBELDIA: Are we recommending --

DR. MC DONALD: Which thing by what he just said, or in general?

DR. COHN: Clem, I think Kepa is asking if there is something even before this.

DR. MC DONALD: This is just my way to get clear.

DR. ZUBELDIA: Before the secretary uses the guiding principles to select a standard, do we or does somebody need to tell the secretary the standard for what? Because the automation of the PMRI is not something narrow. It's very wide. So should we or HHS define what are the parts of the PMRI that are going to be standardized? Unless the parts of the PMRI that are going to be standardized are defined, then use the guiding principles to select the standards that would be useful there.

We are skipping that step. We are saying here are the guiding principles. And then if you use the guiding principles, you are going to come up and say okay HL7 is a standard to be adopted, and DICOM is a standard to be adopted.

MR. BLAIR: Is that because we skipped the section where -- the previous section before we got to the message format piece, the recommendations, we wound up indicating the overview of standards that are out there, and the status of standards that are out there related to PMRI. So we kind of have identified those that are there.

DR. ZUBELDIA: But I think we need to be a lot more specific. And the same as in X12 there are several hundred standards, and only nine of them were named in the administrative simplification side. Now that those nine have implementation guides in place, there is other work being done in X12 to create implementation guides for other things that are not those nine, but would be useful.

I think in the medical record area we probably ought to follow a similar process, because if the secretary uses the guiding principles and says HL7 is to be the adopted standard, how is that going to happen? It's the whole HL7 set going to be allowed?

DR. COHN: Kepa, I guess I'm confused here, because --

DR. MC DONALD: Well, I think it gets control, because as I understood what we were saying is, we're not saying that HCFA is going to tell the world what they must use. That won't work in this country, right? Or are we thinking it would?

DR. ZUBELDIA: No.

DR. MC DONALD: What we're going to say is that HCFA, as they do communications, they adopt the standards according to the guiding principles, which include things like what is out there, and all the rest. And what they are choosing to communicate would focus the specifics.

DR. COHN: But Clem, what I'm hearing from Kepa -- and maybe I'm a little confused -- is he is saying, well, are we just going to say all HL7 standards become standards, and that's a level at which we deal with it? Which I guess I'm surprised at him saying that, since he was just referencing the fact that that is not what happened with the X12 standards. But I guess I'm maybe missing some important point that he was making.

DR. ZUBELDIA: I think at some point, somebody, either NCVHS or the HHS needs to make a list of standard functions that need to be adopted. And those standard functions need to be adopted using HL7 or DICOM or whatever is most appropriate, using the guiding principles.

DR. FERRANS: I think he's saying start it out with a list of functional -- things that you want to transmit, and then say here are the candidate standards that would accomplish that, and then go through the process. Is that what you are saying?

DR. ZUBELDIA: If we want to make it parallel to what has been done with administrative transactions, yes.

MR. BLAIR: I agree that that is rational and a logical thing to do. Maybe the reason that many of us jumped to this point is that we went through those discussions to a large extent as we went through I guess eight iterations of the work plan as we were just trying to decide what would be the focus areas that would make up standards for PMRI. And in the document, in the work plan itself it winds up elaborating on these to a certain extent.

And then the other thing was that in June, and I don't know if you were here, we had a 600 page document which had 78 profiles of standards and terminologies and data sets related to this area. Each one was 6 to 8 or 10 or 12 pages that the SDOs and terminology developers contributed. Now maybe that is not adequate, and maybe that is not sufficient, but at least in my mind I think that may be why we wound up thinking that we kind of have this stuff in place.

DR. ZUBELDIA: From a pragmatic perspective, that inventory standards, and say out of this inventory the HL7 section of the inventory meets the selection criteria.

MR. BLAIR: We have had about eight different contributions from HL7. It might have been even more than eight, where they broke down specifically the different message formats that related to clinical information. And they described each one in a profile which indicated market acceptance, which indicated description, which indicated relationships to other standards, which indicated relationships to other code sets.

DR. COHN: I actually sort of agree with Kepa though. That's something that needs some process. In the initial legislation, because we are not going to say all 78 are going to be implemented. We need out to start out somewhere and finish somewhere. Now the reality is that we are probably a little late in this process.

We should probably think about it. We could hold a set of hearings. We could ask HL7, DICOM, and others to come and present based on the guiding principles, and the implementation guide. Explain what it is that should be at the top of the list.

DR. FERRANS: My question to you is -- and this gets back to my original thing, which was something overarching. The secretary should assert leadership or whatever. If they do that, then step one of the process would be for the NCVHS -- I really see that as the early part of this future process that we are going to define. If we put it here saying, should identify an entity, whether or not it is named or not again is a political question.

And then that entity would take the inventory of standards, identify them. Apply the guiding principles. Apply the process that was successfully used for administrative simplification. And come out with standards that would be recommended for these incremental levels of adoptions. Something like that.

DR. COHN: So what you are saying, which I think is where I'm coming to, is that we probably in the next six months can't do the initial hearing that I think Kepa would like to have that would allow us to put a listing of the 20 functions.

DR. ZUBELDIA: A listing of functions that need to be standardized. Then you apply the guiding principles to those functions to come up with standards.

DR. FERRANS: What is interesting to me about doing that is that we could actually hear people argue about now we get into business case stuff, and now actually we go through a useful process of saying you know, we really ought to do this first, because if we did this, this would allow us to do decision support, or this would allow us to eliminate these duplications or save costs. We could find out where the low hanging fruit is, or where the best return on investment is, and go about it that way potentially.

DR. MC DONALD: If we get real complicated, and we want to accelerate it, we would be better off staying out of it altogether federally and let the market do it. Because we are going to end up with a bunch of struggles at a high level area that isn't going to help any. The feds are not going to enforce with severity, clinical message standards. The only way they can do it is in their own area. They are already making choices in their own areas in terms of the VA and the DOD.

DR. FERRANS: You bring up a good point. Again, what I would ask this question to the chairs, what is the secretary's authority in this area? Can we define what the secretary can do?

MR. BLAIR: I think it was Bill Yasnoff who in November had suggested that with the way our mission was written in the law, we didn't have as much authority as the NCVHS had in recommending that specific standards be adopted for the financial and administrative transactions. Ours was somewhat less. It said study and recommend. And it was a smaller section. It had less specificity.

So if I recall correctly, Bill's suggestion was that we make recommendations and we ask for the additional authority instead of being presumptive. And that would also reflect the fact that we are heading into an election period. If we wound up being too aggressive, then it may be hard for us to get acceptance of all the recommendations.

Bill, did I characterize your statements correctly?

DR. YASNOFF: Yes, I think you've got it right. But I would add that I don't think, since we can make recommendations for legislation, we don't necessarily have to limit ourselves to the existing authority of the secretary. But I share Clem's concern that we need to limit our recommendations to those things that are going to be widely accepted, because otherwise the likelihood of the political process in Congress ratifying these recommendations in any form is very low.

DR. FERRANS: Well, that's what I don't understand. I guess I was saying, yes, we're going to ask for the authority. That's why I was saying that we recommend that the secretary assert the authority or step up to the plate, or however the appropriate definition is. My question is then, does the secretary have the authority to do these things, or is this something for Congress? I just frankly don't know.

DR. YASNOFF: I think when we discussed this before, we decided that we didn't need to know that. That we could make whatever recommendations we wanted, and we can say this is what we think ought to happen. And either the secretary should do this, or propose legislation to get the authority to do this.

DR. FERRANS: That answers the question.

DR. ZUBELDIA: But in our recommendations to the secretary, somewhere in those recommendations I would like to see a recommendation that would follow the same process that has been used before of identifying the functions first, and then identifying the standards that meet each one of the functions.

MR. BLAIR: Could we add those two sentences that I suggested there?

MS. AMATAYAKUL: How about what I've been doodling with is the secretary of HHS should assert leadership in the selection and adoption of message format standards through: (a) identifying from the NCHISB, an inventory of standards, the PMRI communication functions that need to be standards; (b) utilizing the guiding principles for PMRI to select standards for adoption for use in HHS; and (c) authorizing the NCVHS to continue in its role of advising the secretary in the process of standards adoption.

MR. BLAIR: Could I just extend one piece on that, and that is using the inventory and other sources.

DR. MC DONALD: What was the first phrase? I think it's already gotten long. Sometimes it's just better to make one vote, one agreement, and then we move on to another one. What was the first clause in that? I didn't hear it.

MS. AMATAYAKUL: The first thing is the secretary of HHS should assert leadership in selection and adoption of message format standards through.

DR. MC DONALD: Why don't have a period, and then say they should. Because you can do leadership without any of those things.

MR. BLAIR: Just a minute. The through was a colon, and then she had three sub-bullets underneath that as to how she would assert leadership. Continue.

MS. AMATAYAKUL: (a) is identifying from the NCHISB inventory of standards and other sources, the PMRI communication functions that need to be standardized; (b) utilizing the guiding principles for PMRI to select standards for adoption for use in HHS; and (c) authorizing the NCVHS to continue in its role of advising the secretary in the process of standards adoption.

DR. MC DONALD: Now is this going to be all three recommendations or all five, six? What is this replacing?

MR. BLAIR: Replacing that first recommendation.

DR. MC DONALD: I think it's too convoluted. I just say they should assert leadership. And then say as part of the leadership, they should do whatever. Just make separate ones. We can just agree on them separately. We all agree they should assert leadership. These are like the house that Jack built. We keep adding these clauses and phrases.

MR. BLAIR: I think to just say assert leadership without saying how.

DR. MC DONALD: No, we believe that all by itself. Then we can provide more supportive -- Mike, you know how this goes. Are you there?

DR. FITZMAURICE: Here I am, Clem.

DR. MC DONALD: If you analyze it, we're tangling stuff up. They should give us authority, which we already have. You can't take it away from the law. You've got another one where you are saying that they should pick them out from the inventory. Well, the inventory doesn't help you. That's everything. It's the whole universe. I'm not sure they shouldn't pick it out on the basis of what they have to do next, rather than by trying to do everything. You get it all tangled with all of those things.

MR. BLAIR: I thought that we had finally built consensus on these items here.

DR. FERRANS: I think this is more a question of style. I think he is saying break this out. I think what Clem is saying, the important number one point is that we should assert leadership, and we shouldn't dilute it by adding a lot of sub-bullets as to the mechanism of it. And then we should say --

DR. YASNOFF: What you do.

DR. FERRANS: Exactly. That's what he is saying.

DR. ZUBELDIA: Asserting leadership.

MR. BLAIR: So are you saying that the other three sub-items should be separate recommendations?

DR. MC DONALD: Well, I'm not sure all three of the other sub-items really make sense. The first and middle one does. The last one, I have the problem that we are asking to give authority to something as best I can tell, is in the law.

DR. FERRANS: Authorizing us to continue our work.

MR. BLAIR: Could I suggest this? What if we just went with what is there? We could make them separate recommendations, and when we get to the full committee, we could wind up looking for some guidance or thought on whether each of these are relevant or not.

DR. MC DONALD: I didn't hear anything like this one in all the discussion we had. What I heard were a couple of variants, but not that one.

DR. FERRANS: I think because this is the recommendations part, which is really the meat of the proposal, we probably ought to knock it out here. My problem with number two I guess is that I don't think the secretary should identify --

MR. BLAIR: What is number two?

DR. FERRANS: I'm sorry, where we say the secretary of HHS should identify from the NCHISB inventory of standards -- I don't think the secretary should do that. I think there is something about the designation of an entity got lost somewhere in there, and it's not necessarily the secretary. It should be whoever is going to do this, should do that.

DR. ZUBELDIA: You know what? I think that the industry expects the NCVHS to identify that.

DR. FERRANS: So then we should put that, not the secretary.

DR. COHN: I guess I'm sort of wondering, we have to think about whether the HIPAA is the right process. And we could actually at that point say applying the HIPAA process as the way that these get identified, and with whatever wordsmithing we want to.

DR. MC DONALD: But saying we have to identify what we have to do sounds like we don't know what we are doing yet, and that we're setting ourselves back.

MR. BLAIR: I agree, that's a piece that I feel uncomfortable with. But I feel like we have gone a long way to hearing from the 91 testifiers, and the inventory, and other stuff. I feel like we've gone a long way to identifying what are the likely candidates.

DR. FERRANS: Let me just see if I can take a stab at it. The secretary of HHS should designate NCVHS as the entity that will go through the standards adoption process, or something along those lines? And then after that say the NCVHS will utilize the guiding principles and the HIPAA process in making these determinations. Something along those lines.

DR. YASNOFF: How about combining that with the original recommendation and say the secretary should take a leadership role by designating an entity responsible for promoting the adoption of PMRI standards.

MR. BLAIR: We are back to the original.

DR. YASNOFF: It's not the original, because you are not saying -- we got rid of the interoperability and bilateral agreements. And we also say that agency should take a leadership role, and what the goal of that is.

MR. BLAIR: But we're back to entity.

DR. FERRANS: To be honest with you, I would say as a general recommendation before we get to message format standards, there ought to be a general recommendation that the secretary should assume responsibility, leadership, designate authority, whatever for PMRI standards in general. And should designate the appropriate agency, entity, or entities to work on this. Because it may not be the same entity every time.

DR. FITZMAURICE: Could I suggest that the secretary would not want to direct NCVHS to do something. The secretary might ask NCVHS for advice. We could recommend that the secretary do things with consultation with NCVHS. Now what that does --

DR. FERRANS: How did it work with the administrative standards?

DR. FITZMAURICE: That was with the consultation with NCVHS.

DR. COHN: A lot of people rely on the recommendations in the law.

DR. FERRANS: Then that's probably a good way to wordsmith this. But I think it should be broader, because what we are going to end up doing is wordsmithing in each different area we recommend that the secretary assume leadership or whatever. And what we're really saying is across the board.

DR. FITZMAURICE: But that's all right, since we have broken it up however we have broken it up. We're consistent across there. It's just we can't direct an advisory council to do things. But we can do things acting with the advice or under consultation or relying on the recommendations of a national advisory council.

MS. AMATAYAKUL: Can I ask a question? Why do you have to make a recommendation for the secretary to assert leadership in this area, when it is already in HIPAA to address this?

DR. FITZMAURICE: Because it's a good idea.

DR. FERRANS: Not for selection and adoption of PMRI standards, it's just for the study.

MS. AMATAYAKUL: But it's also to make legislative proposals.

DR. YASNOFF: I think what we are getting at is that we essentially have found through our study that this is an important issue that requires continuing attention by the secretary. And that is what we were really trying to say. That essentially our finding is that this is very important. It's an obstacle to progress in all the ways that we have outlined, and therefore something should be done besides filing our report and forgetting about it.

DR. FITZMAURICE: Well said, Bill.

DR. COHN: And Bill, I think what I'm hearing from Richard and others is that maybe before this message format standard, maybe there is a paragraph that says something like that with a high level recommendation one, that this is an area that the secretary needs to exert leadership in X, Y, and Z, from which everything else sort of falls.

DR. FERRANS: One way to handle that very interesting comment that you made about legislative proposals is that where they have regulatory authority to do so, and where Congress needs to be involved, and work in consultation with the NCVHS to make those legislative recommendations.

MR. BLAIR: The secretary should assume leadership to address issues related to interoperability -- no, I'm sorry, should assume leadership to what? To promote uniform standards for patient medical record information?

DR. FERRANS: To accelerate the widespread adoption of those standards in the U.S. health care system. That's the goal. At the end of the day, we want everybody using standards.

MR. BLAIR: So the secretary should assert leadership to accelerate the development and widespread adoption --

DR. FERRANS: I don't know if it's development.

MR. BLAIR: Well, some of it is.

DR. MC DONALD: It's adoption.

MR. BLAIR: Okay, to accelerate the adoption of uniform standards for patient medical record information?

DR. MC DONALD: Yes.

MR. BLAIR: Okay.

DR. FERRANS: That's actually the thing that all the testifiers agreed upon, the government should help facilitate the widespread adoption.

DR. ZUBELDIA: The secretary should take steps to accelerate the adoption.

DR. MC DONALD: Can we vote on that one and get it done? That sounds like a good one.

DR. ZUBELDIA: Margaret has been trying to catch up with us.

DR. FITZMAURICE: The act of asserting leadership is important, because someone can always ask you what have you done to assert leadership.

MR. BLAIR: Is the word 'leadership' not in there?

DR. FITZMAURICE: Yes.

DR. MC DONALD: Let's freeze it. That at least sounded good. Let's get it written down. If we keep whacking at it, nothing ever looks right to anybody.

MR. BLAIR: Give Margaret time, and then she'll read it back to us.

DR. COHN: Should we say by both regulatory and as needed legislative means? No. Okay, whatever.

DR. FERRANS: Appropriate steps.

MR. BLAIR: Margaret, can you read that back to us so we can say yea, verily?

DR. MC DONALD: Are you changing it again? I can't see it. I can hear you guys well. I still can't see you well.

DR. YASNOFF: You can't see it, because it's presented in a non-standard format.

DR. KOLODNER: Clem, next meeting we'll use Net Meeting.

MR. BLAIR: Margaret, are you able to --

MS. AMATAYAKUL: I think so. The secretary of HHS should adopt appropriate regulatory steps and make legislative proposals to accelerate the widespread adoption of uniform data standards for the electronic exchange of PMRI.

DR. MC DONALD: What happened to leadership?

MR. BLAIR: That was different than what I had.

MS. AMATAYAKUL: Well, I had suggested first like a paragraph at the beginning. Something to the effect that the NCVHS --

DR. MC DONALD: If you lead with regulatory, you often get negative responses.

DR. FERRANS: Yes, I agree.

DR. MC DONALD: That leadership phrasing was perfect, but I can't remember it exactly.

MR. BLAIR: Should I give it to you again?

DR. FITZMAURICE: Yes.

MR. BLAIR: Okay. The secretary should take a leadership role to promote the adoption of uniform data standards for patient medical record information.

DR. FERRANS: How about to accelerate?

DR. MC DONALD: No, it's perfect. That's not what got written down.

MR. BLAIR: And I don't care whether we have accelerate instead of promote; either one is fine.

DR. FITZMAURICE: So something like, the secretary should assert leadership to promote the adoption of uniform standards for electronic exchange of patient medical record information for the nation.

DR. MC DONALD: Period. It's a perfect sentence. It is rhetorically perfect.

MS. AMATAYAKUL: The secretary of HHS should take a leadership role to promote the widespread adoption of uniform data standards for the electronic exchange of PMRI.

DR. MC DONALD: Who said that out loud?

DR. FITZMAURICE: Margaret just did.

DR. MC DONALD: No, the previous voice.

MR. BLAIR: Me, Jeffrey.

DR. MC DONALD: You said the same thing?

MR. BLAIR: Well, it wasn't exactly the same, but some of the modifications --

DR. MC DONALD: But I liked yours.

MR. BLAIR: All right, should I say it again?

DR. MC DONALD: Didn't everybody like yours?

DR. FITZMAURICE: Yes.

DR. MC DONALD: Why do we keep mutating it?

MR. BLAIR: Okay.

MS. AMATAYAKUL: Sorry.

MR. BLAIR: The secretary should take a leadership role to accelerate the adoption of uniform data standards for patient medical record information.

DR. MC DONALD: Good.

MS. AMATAYAKUL: So you don't want electronic exchange in there?

MR. BLAIR: I don't think it's needed.

MS. AMATAYAKUL: The secretary of HHS should take a leadership role to accelerate the adoption of uniform data standards for PMRI.

DR. FITZMAURICE: Should we have a vote?

[Several yeses.]

MR. BLAIR: Abstentions? Negatives?

DR. KOLODNER: That opens it for paper, as well as electronic. It covers information.

MR. BLAIR: Could we slide that then down to within message formats. Given that we now have this recommendation in place --

MS. AMATAYAKUL: Do you just want to start this area with this sentence?

DR. FITZMAURICE: Make it a recommendation.

DR. FERRANS: Stay in the broad.

DR. COHN: There needs to be a paragraph that goes along with it?

MS. AMATAYAKUL: It seems like there ought to be some introductory paragraph, and then this is a recommendation. Then you get into methods formats.

DR. FERRANS: We have identified it as being extremely important. There has been a consensus among the testifiers, blah, blah, blah.

MR. BLAIR: I'll tell you where the lead in sentence might be, repeating the summary from the end of the general rationale piece.

MS. AMATAYAKUL: Okay.

DR. FERRANS: My question is, before we go on to the individual focus areas, are there other broad recommendations such as below this, the secretary should rely on the advice and counsel of the NCVHS in making these determinations? The secretary should use the guiding principles to promote the adoption of standards? Those are the two obvious ones. But I think those really cut across the board, and we ought to include them at this high level. I don't want to have a big, cluttered list of high level ones, but I think a few of them are useful.

MR. BLAIR: Does everybody agree that especially those examples are overall type supportive recommendations.

DR. MC DONALD: I didn't hear clearly that last --

MR. BLAIR: I think he was winding up saying that this is an overall recommendation that is not within a focus area; that is broader than a single focus area. And then he wound up saying that using the guiding principles is also broader than a single focus area. And the role of the NCVHS is broader.

DR. MC DONALD: The only problem is we have to find a place to put it.

MR. BLAIR: Margaret, the second sub-item that we had had there about using the guiding principles, I think that people felt fairly okay, close to okay with that wording as a item. The third one, which was authorizing NCVHS to continue, maybe if we paraphrase that and reworded the way Don Detmer used to reword things in terms of the NCVHS is available to assist you in this process, or something like that.

DR. YASNOFF: Do we not want to recommend that the secretary designate somebody, some entity to be responsible for this?

DR. FITZMAURICE: I think that's a lower level initiative.

DR. FERRANS: And it might vary by focus area. If we were going to put something in there, whether the secretary would designate an entity or entities. I just don't know whether it would be different for terminology, for example. It's hard to say.

MR. KENTSMITH: This is Dave Kentsmith. I just have a question about this. How is this unlike setting up a standard for choosing pounds over kilograms or 120 volts that we use in our homes, or 60 cycles or what's the gauge of railroad ties? Isn't there a process in place for that, and is this similar to that?

DR. MC DONALD: We still have miles and meters.

DR. FITZMAURICE: And often it's the industry that has agreed on a standard, and comes to the government to enforce the standard.

MR. BLAIR: If the marketplace can come to consensus either de facto or by cooperation, that works. And if that doesn't happen, then sometimes the government steps in to promote it.

DR. FITZMAURICE: That's right.

MR. BLAIR: Margaret, are you able to read those?

MS. AMATAYAKUL: What I have so far is that there will be an opening paragraph that discusses that NCVHS has identified this as an extremely important area. There was consensus among testifiers. We'll repeat the summary from the general rationale. Then we have three general recommendations.

MR. BLAIR: And they are?

MS. AMATAYAKUL: They are, the secretary of HHS should take a leadership role to accelerate the adoption of uniform data standards for PMRI. Two, the secretary of HHS -- and then I had a question -- should designate an entity that will utilize the guiding principles for selection of the uniform data standards for PMRI?

DR. FERRANS: I said the secretary should utilize the guiding principles.

DR. MC DONALD: Yes, that's what I say.

DR. FERRANS: I just don't want to get into the entity selection until we understand all the different focus areas, and whether that really is appropriate for one entity.

MS. AMATAYAKUL: So the secretary of HHS should utilize the guiding principles for the selection of the uniform data standards for PMRI. And three, the NCVHS is available to assist the secretary of HHS in providing advice relative to uniform data standards for PMRI.

DR. YASNOFF: Is that really a recommendation? I don't think so.

DR. FERRANS: It's not phrased as a recommendation.

DR. ZUBELDIA: At what point is the functional list plugged into this?

DR. COHN: What functional list?

DR. ZUBELDIA: The functional list for the standards to be adopted.

DR. COHN: Let me actually make a suggestion here, because I think it's not a general recommendation. What you are asking for, which was made easy by the legislation was a list of what it is we are going to start with to do. Once again, I think that gets down to the next message format standard.

I just have a thought, and Clem, I would be curious about your thoughts on this one. If we sent a draft after our February meeting of both our requirements and the issues and all this to a number of our already identified standards organizations and asked them for what their views were on the high priority items that should be the focus of immediate standardization, I'm not at that point asking for the standard, but what are the topic focuses or the areas.

That might actually basically allow us to pick the recommendations, and in the message format standard area say that we recommend that these areas be immediately investigated for possible standards that could be adopted. That's sort of a process. Once again, Clem, do you think a communication like that would make sense?

Dr. McDonald?

DR. MC DONALD: I'm sorry? I got distracted.

DR. COHN: I was just asking you a specific question. I'm sorry you were distracted.

DR. MC DONALD: No, it was a very important one. I think I heard some key words in there.

DR. COHN: What I was suggesting is that after the February meeting it might make sense for the NCVHS to send a communication to a number of the standards development organizations that we have identified, along with potentially even a draft of the report, asking them for recommendations on priority areas, where basically functional areas like Kepa was commenting on, where there should be immediate investigation for possible message format standards.

We could take their reply in terms of the functional areas, not standards per se, but functional areas represented by those standards. Include them as recommendations for the areas that should be immediately investigated.

MR. BLAIR: If we do that, can we do that in a manner where we're asking them for the functional areas for us to focus on, as opposed to saying -- because we don't want the answers to come out, yes, recommend HL7's order entry and results reporting piece. And NCVHS comes back and says recommend mine, recommend mine. I think we have to craft the letter specifically to what you and Kepa are asking for. What are the functional areas that need government support in standardization? Simon, am I changing your thought?

DR. COHN: I'm not sure which ones should go forward, but I those that are of high value, that would be candidates.

MR. BLAIR: How is that different from the question we asked everyone that testified, where we asked them first of all, what were the problems, and then what should be the role of the government to address those problems?

DR. COHN: I think Margaret is shaking her head no, and I don't remember them getting that specific. I think we were always at one or two levels higher than that.

MR. BLAIR: So now we're getting specific to saying what are the functions?

DR. FERRANS: And they were sort of on camera, representing their organizations. Now we are just asking them a specific question.

DR. MC DONALD: If I wasn't part of this committee, I would think that what we are really trying to do is keep ourselves as busy as we can. This is not going to make the standards move faster if we are going to have another two years of hearings. What would make it move faster is tell HCFA to commit to some standards and get out of the way. They are not going to commit to standards if they don't have a need for it, just where they are doing stuff.

DR. ZUBELDIA: But if we come up with a list in this report that says this is the low hanging fruit. These are the things that would produce the most return for the investment in automating the PMRI, I think that that will cause the adoption of the items on that list faster than items that are not on the list.

DR. MC DONALD: Well, then we could do both.

MR. BLAIR: I'm kind of sympathetic towards what Clem just said though. I think a lot of folks are looking to this committee and our activity to accelerate the movement of standards.

DR. FERRANS: If you take that view, and if you play devil's advocate here, you say, well, we're talking about message format standards, and I think HL7 was mentioned once and only in parenthesis. And its adoption is fairly widespread, if you want to go to that. But I think recalling previous discussions that we had, we had at least thought at that time that we weren't going to come out and say pick this one, pick that one.

There is a tension between recommending that we know flip the hat and say secretary, give us the authority to do those kinds of activities, versus saying we recommend that you adopt these based on what we already know. It's a very important decision.

DR. ZUBELDIA: I would not recommend use this specific HL7 message. But maybe with this report we should have a list of the functional areas that need to made standard. And I think it should be as part of this report. If we need to send a mailing to the standards organizations that have testified before the committee and say which are the functions that you would like for us to recommend to the secretary as being targets for standards.

I think that the industry is expecting the NCVHS to come up with such a list that would be kind of the second round of HIPAA, and simulate what was in the first round of HIPAA, which was some functional items that needed to be standardized. Then there would be debate, like there was debate between X12 and UB92 and NSF about which one to adopt for that function.

DR. MC DONALD: There is a different model in the clinical area, I think. And instead of having a bunch of discrete messages, there is going to end up being a model. I know there is in X12 too. This discrete message is not necessarily the way you want to think about this stuff in the world of clinical care.

DR. ZUBELDIA: Clem, that's why I'm talking about a functional list.

DR. MC DONALD: It gets tangled.

DR. ZUBELDIA: The function is for instance, blood banking, as a function that needs to be automated, then there will be a series of messages that flow from blood banking information that needs to be automated.

DR. MC DONALD: I'm not sure that's right, because then you end up with all these stove pipes again that you have to cross-talk from, because blood bank gets an order, just like radiology gets an order.

DR. ZUBELDIA: But if the function is lab reporting, whatever the function is, there will be more than one message that addresses those functions, or that interrelate to create that complete function. Whereas in X12 each of the functions was addressed by one or two messages, and there was a one-to-one map. I don't think in HL7 you are going to find a one-to-one map, but if that's the function, that is the low hanging fruit to automate. There may be multiple messages that address that function, and they all need to be implemented.

MR. BLAIR: Can I make an argument to support Kepa's suggestion? Clem, I'm going to try to tie it to your suggestion too that we focus on acceleration. Because Kepa is saying we ought to identify the functions, and do it in this report, and some of them are messages. Some of them are maybe standards for content of PMRI, which has not been well formed yet. But that's an area where we do need some standardization. Others are standards in terms of medical terminologies in different areas.

And you know I think to be honest with you, I really feel like this work group has the knowledge and the expertise and the familiarity that we could come up with the functional areas. Maybe we focus on 10 or 12 functional areas. And we can include them in the report. And that way our recommendation could be more meaningful in saying we want to accelerate the selection and adoption of standards.

And that we get back to those two points. One is that we recommend that the secretary rely on the NCVHS for guidance in this process. You can rephrase it that way, rely on the NCVHS for guidance in this process. And the second point would be that the process of selecting those standards to be adopted would utilize the guiding principles.

And therefore, we accomplish several things when we do that. Number one, we get Kepa's point in here, which I think is right. It is included in the process. Number two, we can do that, and without delay. So we do it in March. And we accelerate things, and I think we converge on that recommendation.

DR. MC DONALD: I don't want to be belittling, but I don't think we have the expertise. And I think this would be government versus industry all over again. We are going to end up with an NSRD standard. We are going to end up with a biostatistical standard. We're going to end up with 5,000 standards, which is contrary to what we are trying to get to.

MR. BLAIR: We were saying about 10 or 12 functional areas.

DR. MC DONALD: I know, but we're going to argue about that for six months. Is it blood bank a function, or is it reporting a function? Is it tall people a function, is it small people? We have not mentioned this in two years of discussion, how we are going to get something organized like this.

DR. ZUBELDIA: Why don't we ask the SDOs or HISBs to give us that list.

DR. FERRANS: I think my issue with this is I agree with Clem. I think that we could get probably do 80 percent, but that last 20 percent is the same kind of stuff that slows down the SDOs, which is the details. And there is a lot of analysis to do -- and correct me if I'm wrong, Clem -- there are always a lot of trade offs that have to be made.

Are we going to nail down some kind of detailed spec as to what we are recommending? If that's what we were going to try to start accomplishing, then I think we might be in over our heads, unless we had some technical support, and people from the SDOs working with us who are the real subject matter experts.

DR. ZUBELDIA: I don't think we can do that between now and this summer. But I think we can come up with a list of what are the functional areas that need to be automated. And if the list is not perfect, and some of them cannot be done right away, we still don't have the first report of injury, which is part of the administrative simplification. Nobody is complaining about that.

So if we come up with a list of functional areas that need to be automated, that would be the basis for moving forward and accelerating things.

DR. FERRANS: I think it starts with a list. And here is what I don't want to see happen. And I agree with you, Kepa. What I don't want to see happen is that the secretary says come back with a report of recommendations and legislative proposals. And then we come back with a report saying this is important. These are the areas.

But if we said, and here is a list. And if you give us the authority, we will pull the trigger and start the work, that's our proposal. I think that that's a good one.

DR. MC DONALD: You just described some things that are insurance industry issues, rather than in the PMRI issues. But I bet you we could argue about that. There is more work to be done. But we set out here to write five or six broad proposals, recommendations. And we have been over this twice now. Now we are not even doing this, we are doing something else.

DR. COHN: Actually, Clem, I think we are doing that. I think the question gets to be making the recommendations actionable.

DR. FERRANS: We are prioritizing the list of things that we would make recommendations on.

DR. COHN: Exactly. Richard is commenting can we get a little more substance here, and how far can we dip down. And I think we are sort of trying to deal with that issue.

DR. MC DONALD: I think we're looking for jobs on the committee, rather than trying to get the committee work done.

DR. COHN: Clem, what did you say?

DR. MC DONALD: We just defined more work for ourselves, which is good if that's our jobs. But we have in front of us two pages of recommendations, and we have only talked about one of them, and it's 5:30 p.m. What in the world are we doing?

MR. BLAIR: What do you suggest, Clem?

DR. MC DONALD: Well, we should try to reform the ones we had, rather than start with new ones. We've got the one about required implementation guides to support standards. That's a good recommendation. We haven't got to it yet. Require conformance testing. We haven't gotten to it yet. We've got some good hits here.

DR. FERRANS: Clem, I think the way that we got here, sort of looking back at this, is we said we started out with we should select an entity, and that was one of the recommendations. And that sort of morphed into we're going to be the entity. And then we sort of said, well, if we know we're going to be the entity, we might as well try and prioritize the things that we're going to need to be working on, and why should we wait until after the election to start that process, when we can send a letter out to the SDOs now, asking them their advice.

DR. MC DONALD: We could do that anyway as a separate path if we wanted. But I'm discouraged by our progress and our process.

DR. FITZMAURICE: I think Clem has some wisdom here that we can always do things that will advise the secretary. But we need to focus on the recommendations that we have here.

Also, I want to interject the fact that it is 5:35 p.m., and I'm willing to stay here, oh, no longer than two o'clock this morning. But we need to have the audio visual people on notice to leave. Jackie will be leaving, and we need to consider the person who is here to support Jeff.

MR. BLAIR: It's kind of hard here. We seem to have some divergence here. Let's see if we could wind up agreeing something, at least for the interim, okay? Clem, I'm trying to be responsive to what you are saying so that we can move forward a little bit more quickly.

Margaret, you have those three global ones right now. The role of asserting leadership, and the one on using the guiding principles. And the third one is relying on NCVHS for assistance in the process.

DR. FITZMAURICE: For advice.

MR. BLAIR: Could I ask the committee, I understand that these are not exactly where we want them to be at this stage. But could I ask, unless somebody feels very, very strongly, that we kind of accept those at the level of granularity that they now have, and move on to the next recommendation? Is that okay?

DR. COHN: Which is message format standards?

MR. BLAIR: Within message format standards. Is that okay?

DR. COHN: That's fine.

MR. BLAIR: Kepa, is that okay?

DR. ZUBELDIA: That's fine.

MS. AMATAYAKUL: May I ask one question? Are we going to stay past six o'clock?

DR. COHN: No.

MR. BLAIR: Are you available?

MS. AMATAYAKUL: Yes, I'm available.

MR. BLAIR: We have kind of moved up that first recommendation within message formats up to a global one, so maybe we need to go on to a second one.

MS. AMATAYAKUL: So you want to strike the original first recommendation, which was to accelerate the selection of message format standards to achieve interoperability without the need for bilateral agreements. The secretary should designate an entity which will utilize the guiding principles for the selection of PMRI standards for adoption.

MR. BLAIR: I think we have those rolled into the three global.

MS. AMATAYAKUL: Except we don't have designating an entity, which we said was going to be more specific, and would be something we would put into message format standards.

MR. BLAIR: I think we replaced that with the notion of relying on NCVHS.

MS. AMATAYAKUL: Okay. So then the next recommendation is to insure compliance with interoperable PMRI standards, the entity that is designated responsibility for selecting the message format standards for adoption should --

DR. FERRANS: Then that would read either NCVHS.

DR. MC DONALD: You can go back to HHS.

DR. FERRANS: HHS in consultation with the NCVHS.

DR. MC DONALD: Why not just HHS for each of these?

DR. COHN: Yes.

MR. BLAIR: Okay, say HHS.

DR. MC DONALD: Well, HHS would not so much require conformance. It would support conformance testing, and with somehow a verb there.

MS. AMATAYAKUL: This recommendation relates to selection of message format standards. And then under it there is implementation guides, conformance testing.

DR. FERRANS: Is there a problem with requiring standard guides? What that is saying is if HHS is going to pick a standard, there needs to be a guide with it that's a requirement. I think that's an absolutely reasonable requirement for a federal agency.

MS. AMATAYAKUL: So the first recommendation then basically is HHS --

DR. MC DONALD: Why don't we say HHS will require -- never mind, I don't have it.

MS. AMATAYAKUL: HHS should require the development of standard implement guides to support the message format standards that are selected.

DR. MC DONALD: Does that mean that they have to have them before they select them?

MR. BLAIR: No. For the standards that are selected, we would require the development of.

DR. FERRANS: It's not a prerequisite for selection, but it's a requirement for --

DR. MC DONALD: Of whom?

MR. BLAIR: Clem, I'm not sure in your question, when you said of whom?

DR. MC DONALD: Who is the object of the requirement? The only thing I can think of is you could require the standards developers to have implementation guides. Or you could require HCFA to develop implementation guides. I could like either of them. I'm just not sure what you mean.

DR. FERRANS: I don't think we should specify. I think we're going to try and stay at a higher level here.

DR. MC DONALD: How about require the availability?

MR. BLAIR: I think we said require the development of.

DR. MC DONALD: How about for the standards that are selected, rather than to support the standards?

DR. FERRANS: Yes, for the standards that are selected. That's good. And then I think the same thing for conformance testing, and however we can keep this -- how we sync these up in terms of --

DR. COHN: Require conformance testing to be performed by an independent organization.

DR. FERRANS: For the standards that are selected.

DR. COHN: Maybe we should require the implementation of a process for conformance. Because you aren't really conformance testing the standard. You are conformance testing information systems.

DR. FERRANS: Require conformance testing of health care information systems. This is kind of an interesting thing, because do you provide a disincentive for people to use the standard, because then they are going to have to do the conformance testing? I'm just playing devil's advocate.

DR. COHN: What has been your experience with the dot.com standard on that?

DR. FERRANS: Well, there's no requirement. If there was a cost, I suppose the vendors will just pass it on to the users anyway. It's sort of cost of development, if you think about it.

DR. COHN: I think the marketplace wants to hear somebody say they implement the standard, but they don't know if they actually do or not. I just thought that the radiology systems were required to produce evidence that they conform.

DR. FERRANS: It's a document. You are supposed to publish a document saying that you conform.

DR. MC DONALD: A conformance test is a test.

DR. FERRANS: Right. But there are conformance statements that are required, but I don't think conformance tests are.

MS. AMATAYAKUL: So we want to require conformance testing to be performed by an independent organization for the message format standards that are selected for PMRI?

DR. FERRANS: No, we have a problem there. For the information systems that use the --

DR. MC DONALD: No, conformance testing really applies to the messages they deliver. You need a conformance test. So somebody has to develop a conformance test. That's the thing that HCFA could really help, because they could help fund the development of conformance tests by one of these organizations.

MR. BLAIR: Let Margaret read it again. I think the wording is okay.

MS. AMATAYAKUL: Okay, so require a conformance test --

DR. MC DONALD: No, I was just trying to explain it. You want to have conformance testing be required of the vendors. But you need to develop a conformance test to be able to do it.

MS. AMATAYAKUL: So require the development of a conformance test and require conformance testing?

DR. MC DONALD: I'm not helping with that. It's two separate ideas.

DR. ZUBELDIA: Require conformance testing implies that there is a test.

MS. AMATAYAKUL: Require conformance testing to be performed by an independent organization on the messages -- of the messages --

MR. BLAIR: Selected for adoption. Actually, why don't you just say of the standards selected for adoption.

DR. MC DONALD: Yes, that's good.

MS. AMATAYAKUL: Of the message format standards?

MR. BLAIR: No, of the standards. Get rid of message format. Just say of the standards selected for adoption.

MS. AMATAYAKUL: Okay, but this is under message formats?

MR. BLAIR: I know it is, but Clem has pointed out quite correctly that many of the problems with conformance goes beyond the message format to the specific codes that are within there.

DR. FERRANS: It should be selected for adoption, not selected for PMRI.

MR. BLAIR: At this point I have been informed that we need to make a brief pause and interrupt while the telephone lines get switched. Apparently after six o'clock -- Clem, and Bill, and Ken, they need to switch things over in terms of both the Internet and your telephone lines. So there will be a brief pause.

[Whereupon, the meeting was recessed at 5:50 p.m., to reconvene the following day, Tuesday, February 1, 2000, at 8:30 a.m.]

P R O C E E D I N G S [8:50 a.m.]

Agenda Item: Call to Order and Introductions

DR. COHN: The purpose of this meeting is to both have a briefing on the current status of the regulations and implementation, review the subcommittee work plan and the NCVHS report to Congress on implementation of administrative simplification. That is what we will be doing this morning.

I think it is expected that after we finish, we will go back as the work group and continue with various discussion items related to recommendations to the NCVHS on clinical data standards. So, that will be probably happening late this morning.

With that, let's introduce people around the table and then in the audience.

I am Simon Cohn. I am chair of the subcommittee, the national director for health information policy for Kaiser Permanente and a member of the committee.

Jeff.

MR. BLAIR: I am Jeff Blair, vice president of the Medical Records Institute and a member of the committee.

DR. BRAITHWAITE: I am Bill Braithwaite from the Office of the Assistant Secretary for Planning and Evaluation at HHS and staff to the committee.

DR. FITZMAURICE: Michael Fitzmaurice, senior science advisor for information technology for the Agency for Healthcare Research and Quality and government liaison to the committee.

MS. TRUDEL: Karen Trudel, Health Care Financing Administration, staff to the subcommittee.

MS. BALL: Judy Ball, Substance Abuse and Mental Health Services Administration and staff to the subcommittee.

MS. GREENBERG: Marjorie Greenberg from the National Center for Health Statistics, CDC and executive secretary to the committee.

MR. ZUBELDIA: Kepa Zubeldia, vice president of ENVOY Corporation and member of the committee.

DR. COHN: Would those in the audience please come to a microphone and introduce yourselves.

MR. GRODOCK: I am Doug Grodock, Blue Cross/Blue Shield Association.

MS. JACKSON: Debbie Jackson, NCHS staff.

DR. COHN: Thank you.

With that, let's proceed on to the briefing. Dr. Braithwaite, would you like to take the lead and Karen Trudel?

Agenda Item: HHS Briefing

DR. BRAITHWAITE: Okay. We are going to give you an update on the tentative schedule for publication of the various rules that we have been working on administrative simplification, talk a little bit about the enforcement team that is getting together to put together an enforcement regulation.

We are going to talk about our implementation plans as far as we have gotten with those, a memorandum of understanding between the Department and the various standards developing organizations and data content committees that are working on these standards and a little bit about the plan for collecting information so that this subcommittee will be able to evaluate the implementation of HIPAA standards as we move forward in time so that we can create the report that we are required by the legislation.

Given the fact that we have published now five notices of proposed rulemaking, just to give you a flavor for where we are with those, we have already passed the dates on which we had expected to publish the final rules for those -- at least the first four of those. The transactions and code set standards were -- which was the first one that we had hoped to publish in final.

We don't expect to get that out now until March of this year. The national provider identifier, we are putting in expected publication date of June and the national employer identifier also in March. The security rule, I suspect, will not be out until May or June of this year and the privacy rule, which is still open for comment until February 17th, we -- since we extended the comment period until February the 17th, we don't really have -- we haven't made a decision. We haven't heard of a final date for publishing that final rule yet. So, that is still unknown.

We have other NPRMs in development. The national health plan identifier is in development and we are hoping to publish that NPRM in April of this year and the claims attachment NPRM, which is already into the clearance process that we hope to publish in March.

As you know, the national identifier for individuals is on hold, pending implementation of privacy protection. So, we are not -- we don't have a date for that. And then the final round, the NPRM for enforcement, I will talk a little bit more about.

All of the regulations, the rules that I have just talked about, are accompanied in the legislation, at least, by penalties, civil money penalties for failure to meet the standards and criminal penalties for failures of maintaining the privacy of the information that is associated with individuals.

It is clear that the Justice Department will be enforcing the criminal penalties and writing lots of rules and regulations in place for how they do that operation. So, I don't know if they will come out with something particular or special for violations of privacy, which are the things that trigger the criminal penalties. But that is up to the Justice Department and we won't be involved except peripherally in that regulation.

However, for the civil money penalties for the violation of the standards that we are putting out in these regulations. We will be involved. The sections that are referred to are typically implemented by some branch of the Department, like the inspector general's office or the Office of Civil Rights, which is used to handling that sort of thing. We think at this point that the Office of Civil Rights is the appropriate because this is, in fact, most analogous to a civil right, the right to privacy.

So, we expect that our central and regional offices will be handling that enforcement. We have put together a team of federal employees with not just HHS, but also some folks from other federal departments to work on this regulation and we don't have a target date for when that will be published, but it is not a standard. It is a regulation for the enforcement of the other standards.

So, we believe that it is not subject to the two year delay after effective date. So, we expect the effective date to be equivalent to the first date on which the first standards are required to be complied with, which is two years after the effective date of our first rule, which, as I said, would be sometime in March of this year. So, that would be the effective date for compliance. The requirement would be May -- yes, May of 2002, because there is a 60 day delay period after we publish before the effective date.

So, we are working hard. We are meeting regularly on enforcement and coming up with all of the rules and regulations. We are trying to decide first of all of the regulations, all of the standards should be enforced in exactly the same way or whether there should be some differences between enforcement of security and privacy versus transactions, for example.

There are lots of questions to be answered in this process. So, we are moving forward and I think that is about all I can tell you about that process.

Karen, do you want to talk some about implementation on the MOU?

MS. TRUDEL: Yes.

DR. COHN: Bill, do you want to just break and let's talk about -- ask questions about enforcement for a minute?

Jeff, did you have a question?

MR. BLAIR: Yes. Bill, the only date that you gave that was not exactly what I had expected from recent rumors was for health claim attachments and you said March of this year we would have the NPRM for health claim attachments. Is that right? Is it March or is it May?

DR. BRAITHWAITE: No, it is not quite right. What I said was the tentative expected potential publication date for health claim attachment NPRM was March. It is a guessing game. We are just trying to give people a signal about what we expect, but there is absolutely no way to nail down these dates.

DR. COHN: The question actually about the enforcement piece, which I think is obviously an important part of all this, things are just starting now. So, it is a little much to ask for expected completion dates. But is that generally thought of as something that will be completed this year in terms of the regulation for that?

DR. BRAITHWAITE: I don't know, Simon. It is possible we could get the NPRM out this year. There is no real pressure to get the final rule out, you know, a couple of months before we actually have to enforce something. So, there isn't the pressure on this particular regulation that there is on the others. We want to take it slow and get it right. I don't want to predict a date at this point.

DR. COHN: Okay.

Kepa.

MR. ZUBELDIA: Again, on enforcement, I have heard about various no budget for enforcement or for this for enforcement. Is there going to be a budget for enforcement?

DR. BRAITHWAITE: There is no appropriation in the HIPAA language for any of the HIPAA implementation, but there will be a budget for enforcement, as there is a budget for all of the other activities. We just have to take it out of the appropriations that we have received from Congress for everything else.

DR. COHN: Any other questions?

All right, Karen.

MS. TRUDEL: Okay. I will talk about the memorandum of understanding first. There have been a number of discussions about how to best implement the ongoing process of maintaining and changing standards over time. There have been discussions underway between the three content committees that are mentioned in the statute, which is the National Uniform Billing Committee, National Uniform Claim Committee and the American Dental Association and also three of the standards developing organizations that will be involved in HIPAA standards, which is at the 12 end, health level 7 and the NCPDP for prescription drugs issued.

Those groups got together and we facilitated some of their discussions and they talked through a process for involving all of them and set up this process to be a focal point for requests for changes to standards and they have set up a protocol for how those will be considered, how they will be processed, who will be involved in the process, the rules that they will use, ways that they will publicize and involve the public in these processes.

They have developed in concert a memorandum of understanding, which each of them would sign and it indicates what each one's role is and their interest and willingness to participate in this process over time. This is what we think is the optimum means of maintaining the standards over time. Because they are industry standards, we want industry input. We would like it to be a very collegial process where all of the groups involved have an opportunity to contribute their expertise to the process, but we also wanted to make sure that it was not so cumbersome that we would never be able to change a standard because the amount of time involved would be much too long.

We think that the process that these groups have come up with meets those requirements. It obviously will have to be tested in reality to find out how it works and how well it works and whether there are any problems that haven't been foreseen.

The Department, as I understand it, will sign the MOU, but will be a liaison, an observer to the process, will not be an active leader in the process, simply make sure that this process continues to carry out the set of ten guiding principles that we established in the regulations to begin with.

The MOU is now being reviewed one last time by our general counsel and we expect that as my staff goes to the X12 meeting next week in Denver, they will be able to carry the news back to that group and to the NUBC and NUCC in following weeks, that the MOU is approved and that these groups can go ahead and start the process of refining it.

So, I think that is a very big step forward. I didn't think we were going to get there this time last year or even in August, but I really commend all the groups that were involved. They did a really remarkable job.

Are there any questions on that?

MR. BLAIR: When might we be able to have a copy of the memorandum of understanding?

MS. TRUDEL: I would think as soon as we have the general counsel's approval.

DR. COHN: Karen, just for me to understand the process a little better, is the MOU going to be signed by all the parties without modification efforts being reviewed by the general counsel? Are we at that stage now?

MS. TRUDEL: Yes.

DR. COHN: So, it is not likely that as it goes back to any of these groups that there will be last minute modifications and changes that have to go through another cycle?

MS. TRUDEL: I never say never, but there has been quite a bit of review. We have made a number of changes based on the requests of the various organizations and at least informally I understand that as it is now written, the groups are all feeling that they can sign it as is.

DR. BRAITHWAITE: I think, just a comment, this is really a major achievement given that HIPAA was passed without any appropriation and no money to motivate any of this to happen. The fact that various previously competing bodies in the private sector were able to get together in one room and agree on a rapid process for things that they have disagreed with and competed about in the past is remarkable and a real achievement in moving forward with a cooperative standard setting approach for the future.

DR. COHN: Yes. I guess I should probably just take this moment to inform the subcommittee that, hopefully, either February or March, depending on how things proceed, there may actually be more of a formal discussion related to the MOU with some of the parties involved, just because I think the NCVHS is going to wind up working very closely with the data content and standards organizations listed in the MOU. So, once that all gets -- begins to get settled, we can begin to have that conversation.

MR. BLAIR: I was sort of waiting to see if there were other questions on the topics we just covered.

My question is related to them and it is a little bit of an extension. You know, both of you have been immersed in going through the NPRM process and then coming out with the final rules and I guess that you are now experts, if you haven't been before in what it takes to navigate through the political process and the Department of Health and Human Services process.

So, here is my question. This subcommittee is working on an additional work effort, which is a report to the Secretary due in August of this year, which is on uniform standards for patient medical record information, that is going to hit in August of this year, which is like what, four or five months before new elections. Clearly, we are really putting a great deal of effort into trying to make this a meaningful report that moves things forward.

But it would be really helpful if we could have guidance from both of you with respect to either the message that is in there or messages or the style or how we characterize that. I know that you have been busy. You haven't been able to take a look at the draft to this point. Will it be possible like in our February meeting, will you be there and have an opportunity to critique this report at that point? Because it would be helpful. Our next chance for a full NCVHS meeting is June.

So, I am asking hopefully that we could have your guidance at that point.

MS. TRUDEL: I am planning on being at the February meeting.

DR. COHN: Are you referencing what participation might be there?

MR. BLAIR: Yes.

DR. COHN: At the full NCVHS meeting?

MR. BLAIR: Yes, and I am hoping we might be able to read the report that we send out prior to that meeting, so that you could give us some guidance later this month. Bill, would you --

DR. BRAITHWAITE: I am planning to do that. I have actually read the draft and --

MR. BLAIR: You have?

DR. BRAITHWAITE: Yes.

MR. BLAIR: Oh, good.

DR. BRAITHWAITE: I am quite pleased with it actually. There is some tweaking to do, obviously, but the general message of the need for standards for the exchange of this information and the need for a process to bring those forward and maintain them is a very good message. I am not quite sure yet how we are going to implement that message within HHS. The more advice you can give us about that, the better.

MR. BLAIR: Okay. Well, thank you. I am pleased to have feedback. Thank you.

DR. COHN: Are there other questions on the topics that we are discussing?

MS. TRUDEL: I would like to talk a little bit about our plans for implementing the standards for Medicare. We have been doing a lot of thinking about that very recently. Although the final rules have not been published at this point, we are aware that the implementation guides themselves, because they are industry guides, they have been balloted. They are final. They are available on the Web for anyone to look at. That represents a low risk in terms of beginning to think about how to implement.

So, we are going ahead with beginning to develop our instructions for implementing the transaction standards. We are beginning with the claim and we will work our way through in hopefully easy stages, trying to do this in a way that doesn't put a huge work load at any point in time and also gives us the ability to work this work load in with other priorities that were backed up and waiting as a result of Y2K. We need to work around the implementation of prospective payment systems and some other major initiatives that HCFA has underway.

But we have already prepared and are beginning to clear an instruction for the implementation of the professional claim, the A37-40-10. It is in our review process right now. We are getting comments back from a variety of folks around HCFA and that will be -- we expect the first thing that we roll out and we are hoping to begin to work on that in the fall.

We will then proceed with the institutional claim and probably some of the standards that we already use in X12 formats, like the remittance advice and we will work our way through that process very gradually.

We have gotten as we go out and speak to people a lot of questions about what is Medicare going to do. When can you actually share your plans? When can you tell us what the dates are? Obviously, this is of interest for everyone's planning needs and we are mindful of that and we are working at this point to clear through HCFA senior staff at least a very high level plan with some dates that will allow the industry to do some planning.

We are also in the process of scheduling some training. This would be for Medicaid state agencies, for Medicare contractors, carriers and fiscal intermediaries and for some of the regional people. We have a syllabus. We are talking about basically a three day session that would include an intro to HIPAA and then break out sessions that talk about how to go through an implementation guide, how to read the implementation guides for the various standards and will give people not all of the information that they need to implement these standards, but will certainly get them on their way.

There will be a three day course in, I believe, nine different locations and we would very much like to share the course material when it is completely prepared with anyone who thinks that it would be useful. So, we would like to make everything that we do to implement something that can be ported out to assist others if they would like to utilize it.

We also have a Medicare HIPAA newsletter that has been prepared. I think we have done two different editions of that at this point to Medicare state agencies, to explain to them what is going on with HIPAA and what they think about and just a variety of issues and answering questions and we will be doing more of that on the Medicare side as well.

So, I think that kind of sums up the Medicare plans right now. Are there any questions about that?

DR. BRAITHWAITE: Just before the question gets asked. Yes, we are going to post the educational materials on the administrative simplification Web site as soon as they are available.

DR. COHN: Karen, maybe I will start with a couple of questions here. The relationship between Medicare obviously, HCFA, the nation's largest payer and these various standards is obviously an intriguing one. Do you plan to have separate complete implementation guides for Medicare for each of these standards or are you -- what is it that you are going to be doing different than is already going to be in the standards guides? Maybe you can clarify that.

MS. TRUDEL: We will be referring to the implementation guides and referring to the Washington Publishing Web Site. Some of the things that we will be doing that are a little different will be providing some cross walking between our own formats, like the NSF, that we are using now, and the version 4010 so that all of our contractors don't have to do their own mapping.

There also are some operational issues that are Medicare specific that we need to cover with the contractors in terms of how they are going to do testing and essentially it will not be a different implementation. The whole point of HIPAA is that there would not be a different implementation. This is simply a way to work this into our own programmatic flows.

DR. COHN: Okay. Now, I do -- I was sort of taken by your comment about the fact that there were a number of initiatives going on in HCFA at this point, many of which have been delayed because of Y2K and I really applaud HHS, again, for having their data council to help coordinate a lot of the various activities going on. Is there similar coordination going on now at HCFA in relationship to the various data requirements occurring -- that are being asked by HCFA because of all these delays and HIPAA coming on board and prospective payments and sort of -- et cetera, et cetera, et cetera.

Is there some other sort of oversight occurring within HCFA?

MS. TRUDEL: It is happening at a number of different levels, yes. The priorities are set at an executive level and then there are various groups that make sure that those policies are carried out and then made operational.

I participate in a group that actually does the scheduling of some of these various things and make sure that the priorities are carried out and that we are within our resources.

DR. COHN: Okay.

Agenda Item: Review of Subcommittee Work Plan for 2000

DR. COHN: Okay. Now, are there any other bits -- I want to talk a little bit about what we are going to be doing this year, but -- and which all of you are, I think, really part of. I think this is an occasion to among other things talk about when we are having hearings and sessions for the rest of the year, which I hope that you are all available for.

Now, there is as you know a fair amount of overlap with the work group, which luckily has the same membership of the subcommittee, but it is a good happenstance. There are actually a number of things that are, I think, on our work group. Now, I have not revised the work plan per se, only because all the things we are talking about are really already on the work plan. Certainly from a high level overview, as we know, the subcommittee's responsibility is to respond to the NPRMs as they are produced.

There is also the responsibility to develop the annual report, which we will be talking about in a couple of minutes. Then I think as we begin to move to implementation, a major focus for us has to do with these implementation and enforcement issues, which we have just been talking about.

We have just mentioned industry readiness and we are going to have to go into that further this issue. The issue of identifying and resolving implementation issues, monitoring implementation, monitoring early implementers and then identifying the need for new and revised standards. Those are sort of all the various pieces that we somehow need to fit into our activities this year.

Now, first of all, as we know, our next meetings are March 30th and 31st. There is a work group on computer-based patient records to, I think, do our next revision on the recommendations after the NCVHS meeting and then on March 31st, we expect another meeting of the subcommittee.

Now, the agenda for that is not finalized. If we, indeed, are able to get people to talk about the MOU in February at the NCVHS meeting, that would be on the agenda for March. If that somehow doesn't happen, then we will obviously bring that up and spend some time exploring with the MOU -- people who have signed the MOU, the nature of the MOU and how we can all work together.

That may be a February activity during our breakout at the NCVHS or it may be a March 31st activity. Similarly, if we are luck enough to have any of the NPRMs out by the end of March, it will also be an occasion to occasion to actually develop at least a draft response to be discussed by the full NCVHS in relationship to either of the claims attachments for other NPRMs that are created.

So, that is the meeting in March and April. Now, the next session of the next meeting of the overall group is going to be June the 1st and 2nd. June 1st will be, once again a -- I think the intent is to be a meeting of the computer-based patient records work group, hopefully, our final look at the recommendations prior to the end of June NCVHS meeting.

Hopefully, this will be a happy and short session, but then again I am known to be an optimist. But I think that we should keep that on the calendar. I don't think we will be cancelling that. Now, on the second -- obviously, the main priority for that meeting is to make sure that anything that needs to happen to that report is completed, but it is also an occasion to, obviously, take care of any further subcommittee business that we may have, which may include if we need to meet with Faulkner & Gray representative earlier, may be a good occasion for that if we feel we need to do that before the July meeting.

I have made notes here and I can't even read them. Now, by July, I think we are going to be looking at spending full sessions dealing with implementation issues. We have identified July 13th and 14th as a set of hearings for the early implementation.

Actually, let me go back for a second to the May meeting, to the subcommittee and NCVHS meeting. Somehow in those hearings, either the hearing or the full NCVHS meeting, there will be some discussions related to coding systems and preparing them for changes, as in hearing from people, you know, if we do begin to move towards future coding systems, what the industry needs and what the issues are likely to be. I don't know if that will be a subcommittee issue on the first or whether it will be a full committee issue, but I know that Marjorie Greenberg and I are talking about that and trying to figure out where it makes the most sense -- having missed that, I knew there was something that we were going to be dealing with right then.

The 13th and 14th is the early implementers session, either here in Washington or I think in New Jersey, I think, with some discussion potentially.

MR. BLAIR: That is July?

DR. COHN: That is July 13th and 14th. I think at that point we would be expecting to really get into this issue of what is the status of implementation. I think we have all already observed that many different organizations see very different parts of implementation and have very different parts of implementation and have very different views on what the status of implementation and we are likely to hear different things from Faulkner & Gray than from the AMA, than from WEDI, than from X12, than from NCPTP. But I think we need to begin to hear from all of them to begin to get a complete picture of really where we are with implementation.

I think we will spend some time focusing on that, as well as obviously hearing from anybody that is out there trying to implement the systems and trying to make them work and what are the issues they are beginning to observe.

Do people have other things that they want to bring up? Bob has had time to do a little more planning, but that is -- I think, will be the focus of that session. It has got to be a good meeting or else people aren't going to show up on the 13th and 14th, in the middle of summer, either in Washington or otherwise on the East Coast.

Comments about that session? Okay.

Now, the next session will be, I think, in late -- likely be in late September. I would ask people to hold the 21st and 22nd of September, which were the two days after the NCVHS meeting. I think we are still hearing from subcommittee members to make sure that we have a quorum for that session. But if it doesn't go then, it will go right around then likely. I think there is a recognition that what we need to do is to have a yearly session to talk about the issues around revisions to standards, new standards, et cetera, that need to be recommended for the Secretary.

I think one of the things that we will be talking to the MOU signers about will be is September a good time for a session that might explore that. My sense is that it probably is a good time of the year to be talking about it. I think that there is probably going to need to be a couple of months after recommendations come from the NCVHS for the Secretary to deal with them. So, this may be the appropriate time. But they also may have other suggestions, based on their calendars and cycle and, of course, when the final regs come out.

So, this is a session that we will reserve, but if we begin to conclude as the year progresses that September is too early, we can certainly move it to October or November.

Now, I think I have finished up the fiscal year. To my view, that is really what we need to be doing this year. I think the question that I have for the work group, the subcommittee and others is does this sound about right? Are we missing anything? Is there something else we should be doing around implementation that we are missing or that we should be doing to make this more effective?

Silence. Okay. Well, I am glad that we got this on tape so I can remember this.

But I think that this -- this once again is, I think, what we have come to. I mean, we have talked about this in the work plan. It is actually referenced as we begin to look towards the -- we will see Jim Scanlon a little bit -- we will begin to elements of this in the third annual report to Congress on implementation of administrative simplification.

Certainly, if any of you have any other thoughts about how we need to be either monitoring implementation, how we need to be identifying issues, how we need to be resolving issues, I think that needs to be an ongoing discussion.

I didn't mean to be so definitive here. Anybody have any other questions about any of this? Well, actually, I think our next item is to talk about the first draft of the report on implementation. I think maybe we ought to take a ten minute break and find Jim -- and have Jim Scanlon join us for that since he has put a tremendous amount of effort into this report and we can begin to get into it.

So, it is now 9:55. Why don't we take a ten minute break and we can come back at 10:05.

Thank you.

[Brief recess.]

DR. COHN: Let me call us back in session. The topic is the review of the first draft of the NCVHS report to Congress on implementation of HIPAA administrative simplification.

I want to thank Jim Scanlon for joining us and I also want to thank him for his work to help create the draft of what we are reviewing today.

Jim, do you want to -- do you want me to introduce the topic or do you want to --

Agenda Item: Review of First Draft of the NCVHS Report to Congress on Implementation of HIPAA Administrative Simplification

MR. SCANLON: Let me introduce the requirement itself and the topic and then we can open up the discussion. You will recall that in HIPAA not only does the law give new responsibilities to NCVHS but it also requires that the NCVHS submit an annual report on the status of implementation of the administrative simplification requirements, as well, beginning one year after the enactment of the law.

The committee has submitted two previous reports. In a way, they were dealing largely with preparing for implementation and the extensive concentration process and comments and the adoption of what standards should be adopted themselves.

This is the third now of the annual reports to Congress. We are still in the pre-implementation stage, of course, but things have moved along to the point where the standards are known and progress is working its way through on security, as well as on privacy. So, there is more to report there, but I think the committee -- the subcommittee itself thought that we may want to begin looking at some of the issues now relating to implementation and readiness and so on and what the committee would want to focus on and that maybe we would highlight those in the report itself.

So, you have before you really what we all regard as the first draft that tries to pull together the factual information in terms of where things stand, but it also kind of looks ahead to -- I think there were six or so issues that related to preparing for implementation that the subcommittee discussed at one of our previous meetings and wanted to include in the report itself.

The report itself -- well, I think in terms of the overall process, the subcommittee hoped to present this report, assuming we have agreement, to the full agreement at its meeting towards the later part of February for consideration by the full committee and then on the assumption that it would be approved or approved with further editing, we would hope to actually send it up probably March or so or depending on how long the -- we could do it right after the February meeting or we could do whatever we are submitting or editing would be.

Hopefully, it won't last -- hopefully, we will be able to finish it fairly soon.

DR. COHN: So, Jim, you are suggesting that the process is for our review, hoping the full committee would suggest editorial revisions, have them finally approved by the executive subcommittee or some other group and then going in as the final report.

MR. SCANLON: Yes. And I think if we followed that approach last year, the only -- we had a complicating factor last year because some of the members wanted to submit separate views and presumably we will allow for that as well this year. It is just that we had to establish a process last year and by the time it was all worked out, it took us back to the full June meeting of the national committee last year and then we didn't actually get it out until after June.

So, hopefully, we can -- now that we have a process for considering other views, we will simply include them in the report. I think we can -- you know, clearly we shouldn't take as much time.

So, the report as it stands now pretty much reflects the discussion of the subcommittee at our meeting back in December, I think, in terms of the issues we wanted to highlight, the issues the subcommittee sort of wanted to project for where do we want to be prepared for the year ahead.

And, of course, it also it also describes where things stand in terms of each of the standards. I think Bill has already given you a -- Bill has already told you where each of the standards stands now, including the privacy standard.

So, what I can do if there -- see if there are any other questions on the overall process about -- what we can do then is to just -- I can give an overview of the report. I don't think we want to do line editing today though we are clearly open to line editing after -- in terms of anyone getting -- having comments. But I think we wanted to agree that this is what the committee wanted -- this is the basic framework and these are the issues or the areas that the committee wanted to emphasize.

There may be additional issues. There may be areas that the subcommittee would want to state differently, but that is kind of where we would be.

There is an executive summary that actually turned out to be about eight pages. So, it is kind of a long summary, but -- and then there is a fair amount of detail in the report itself. We have included in the -- at least in the first draft some of the material that we have reported previously in terms of process and requirements, largely for documentation's sake. We may want to turn those over to an appendix or even just reduce them. But it is sort of this

-- it is a fair amount of detail.

DR. COHN: Let me suggest this process, only because I think it is -- I noticed, for example, that this came out recently enough that not everyone has had a chance to review this thoroughly. Yet, I agree with you. We don't want to do line editing. I think, however, there needs to be a little bit of a balance in terms of how we would review this. Now, first of all, I don't want us to focus on the executive summary. As I reviewed this document and I have looked at this -- for the subcommittee to really try to move this forward.

I think the executive summary is redundant and needs to be significantly rewritten. I expect that by the time we are done, it will be three to four pages as opposed to eight pages and, once again, it is one of those things where every -- I think there were a lot of things that got put together that probably could be simplified and brought down significantly.

However, I actually thought that the body of the report itself, once I started getting into that was actually very good, from the writing and from the content. Now, I think we look at it and see if there are other things we need to put in. So, I think that we need to focus on the actual body of the report, recognizing that the executive summary will reflect the body when we are done. I think that we can have confidence that Jim and I can review it and anyone else who wants to review the executive summary can do that, but obviously the content is the important part here.

Now, I think with that, I think that maybe what we can do is to actually just sort of walk through the sections and maybe you can talk briefly about what is in each section. If there is something that is not quite -- just looking at the table of contents, but it briefly reviews what is in each section without line editing with the view generally that if any of you have reviewed it and have it and more importantly, if there are content pieces that are missing, we can all kind of make sure to include that.

Everyone okay with that? Jeff, Kepa? Okay.

Do you want to just comment about these little pieces of paper that you used?

MR. SCANLON: Yes. There are two -- we have actually circulated the draft within HHS to the Data Standards Committee for comment and we have been getting comments back. You have before you two suggestions for addition.

One of them deals with inclusion of the HIPAA security summit, you know, a little description of what the HIPAA security summit was. As an example of industry taking the initiative in some of these areas. So, there is a paragraph here that describes that that we would include and, in addition, there is another paragraph suggested from the standards committee that describes the memorandum of understanding process that I think Bill and Karen described earlier this morning.

This is for identifying the need for new and revised standards and what will this process look like. So, those would be fairly -- those would be good additions to the report itself. So, you will want to take a look at those, but they are proposed for addition as well.

Let me go to the -- the beginning of page 9 is the table of contents. It is fairly detailed. We could clearly cut this back if desired, but it is a fairly extensive documentation of pretty much what is in the report and it breaks it down into the subheadings.

Let me go into the report itself. We started out with -- on page 11 with basically the background. Why did HIPAA get passed and what is the issue HIPAA administrative simplification was trying to address.

So, there is basically in a few paragraphs in terms of background sets the stage for why was HIPAA enacted and what is the general purpose of HIPAA. It is followed then by a brief paragraph that says what the purpose of this report is and that includes both meeting the legislative requirement, as well as kind of a report to HHS and the Congress and the public and the industry about where the committee sees this situation -- progress and where the situation -- what the situation is currently in and what it will look forward to.

Then the content of the report -- there is a brief paragraph that describes the content that will follow the report and then we go on to the requirements of HIPAA itself. This is language you have seen a number of times before, what HIPAA requires in terms of the administrative simplification.

There is more detail then on page 13 and I think we are open to any -- you know, any editing or suggestions for shortening, but this is more or less standard, taken from the law itself and other documents that the committee has written and HHS has written in terms of what the specific requirements for standards are.

The next section deals with the timetables that were required in the law. Here, again, we just repeat what was in the Act itself and the timetable that was specified in the law. Then we begin to describe -- and maybe this can go somewhere else -- we begin to describe what proposed rules have been -- have already been issued. Let me come back to that. It is kind of a summary here in terms of timetables.

Then on page 15, there is a discussion of the expanded responsibilities for the national committee, which is largely taken from the law. Again, we may not want to -- we don't necessarily have to include this in the report. We may want to put it in an appendix or refer to it, but for at least the first draft, it is included.

Overall, Chapter 2 here describes the implementation process both what -- the process set up in HHS, as well as the consultation process and, again, we can cut this back, but this basically describes the role of the data council, the implementation teams, the data standards committee, the whole Federal Register process and how everyone could have input into the process and then the plans for low cost distribution for the standards and implementation guides themselves.

Again, we can shorten that, but more or less factual information in terms of background. We included as well, following that, the guiding principles that HHS and the committee adopted for adoption of standards. Remember, there were ten guiding principles that everyone thought we should guide the adoption of the standards. Again, we could include those in the report refer to them or include them as an appendix.

MR. BLAIR: With the guiding principles -- well, you know, actually that one does refer to the ones that were in -- with the financial administrative ones. So, the comment I was about to make was that we have revised them for standards on patient medical record information, but that is not going to be relevant to what you are presenting. So, never mind.

MR. SCANLON: The guidelines that Jeff referred -- guiding principles that Jeff referred to are followed by a short section on consultation and this simply describes, as we have in previous reports, how the industry and others can provide input and comment into the process. There were seven steps here.

That is followed on page 18 -- and here we get into the actual -- to the report on progress itself. There were -- and this follows previous reports. There is a section describing what the NCVHS had done in the way of hearings during the past year, 1999.

DR. COHN: Yes. Actually just one modification here. You mentioned standards for computer-based patient records. It is actually --

MR. BLAIR: Standards for patient medical record information.

Actually, Jim, we consider that an important distinction.

MR. SCANLON: Sure. We will put that in.

Then there were other hearing you will recall on the flow of information in the pharmaceutical industry in disclosure of prescription information, employer use of health information and those involve panel discussions.

Then the other issue is here we would indicate that the NCVHS -- well, we actually would -- we would refer to the comments on the NPRM for privacy, just say that they are under development or that the committee was -- began to develop comments on the privacy NPRM as well.

DR. COHN: You mentioned some hearings and not others for 1999 and I was sort of struck, for example, that there could be, for example, a comment having to do with, for example, the work around statistics for the 21st Century. I mean, you had a whole section here for outreach for public health and health services research. But you didn't mention statistics for the 21st Century. I was just curious about the decisions about what was in and what was out in this section.

MR. SCANLON: I think the basic cut was -- and we can do this either way -- the basic cut here was hearings related to HIPAA, HIPAA requirements, not all activities of the NCVHS. Those are covered in other reports. This was meant to be just focus on HIPAA-related -- maybe we should say that, HIPAA-related --

MS. GREENBERG: The update of the 45 year history or what will be the -- the 50 year history will include all 1999 activities.

DR. COHN: That is right. Think about the outreach. The outreach was really specifically around the uses of HIPAA.

MR. SCANLON: Even that was related to HIPAA and trying to draw in the participation of the health services research and the public health community there. That is the next paragraph. There is another section dealing with the following dealing with a very brief NCVHS comments on the NPRMs. Here, we more or less refer to what will be on -- what is already on the NCVHS Web site.

Finally, a -- again, this is all in the nature of background and legislative requirements and what happened but the next section, 3, actually talks about where each of the standards currently stands. We just go through each of them starting with transaction standards and code sets in terms of where they stand and we will put in -- we could put in the projected dates, I guess, that we have now got on the Web site. We could actually use the month and the dates. So, we have projected publication dates as well.

So, the first is the -- the first is the transaction in code sets. I think we would hope to have that issue that is the first of the final regulations relating to the standards.

The first report of injury, we did not include this, remember, in the first set of standards. We may have to look at this wording to see where that may stand. I will ask Bill and Karen to look at that. We may want to revise the wording there.

We then go through each of the standard identifiers in terms of where it stands, beginning with the provider identifier, then the national employer identifier and the plan identifier. Unique health identifier for individuals, we simply say here that work has been suspended as a result of the Congress's and the White House's directions to us to hold up until privacy protections are in place.

MR. BLAIR: Is that an important word for us to lock onto because the word I had heard up until now was

"deferred" and is "suspended" something that everybody for political purposes has adopted and that we should be careful to use as well?

MR. SCANLON: I don't think so. No special significance, I think. It is just -- I don't think we have any special wording. And the language of the HHS appropriations act -- that is what matters. In fact, we shouldn't even be talking about this. At any rate, that is the -- there was just no further work there. That is extended into this year's appropriations as well.

DR. COHN: I was going to say -- this actually -- appropriations language is actually stronger than previous ones, I mean, isn't it?

MR. SCANLON: This is the same as the --

DR. COHN: -- legislations enacted specifically approving the standard. I thought it was just -- that there wasn't a requirement, that they are saying they are actually going to do legislation on it.

MR. SCANLON: It is stronger than the White House language, which left a little wiggle room. But this is exactly what is in our current appropriations as well.

MR. ZUBELDIA: Jim, this requires legislation. So, even after the privacy final rule comes out, there is still no legislation for individual identifiers, right?

MR. SCANLON: They would -- yes. The adoption of an -- in their language, the adoption of a unique identifier for individuals would require literally an act of Congress.

DR. COHN: I guess the new process would be if we identify an approach for a standard for this, we would have to be recommended to Congress for legislative approval.

MR. SCANLON: I would think so or they would. Though I doubt they would initiate something on their own, but literally it would require the opportunity to -- it would require some sort of enactment on their part.

DR. COHN: -- the issue comes up from time to time.

MR. SCANLON: Yes.

And then, let's see, the next standard I think that we review the status of is security and electronic signatures. Again, Bill reported on where we are and I think we gave a projected date there as well. Now here we do say that we are at least harmonizing -- I guess I used the word "coordinating" -- the security rule with the privacy standards and I don't know if that is the best word, but there is no -- it just means that they would be -- they would be looked at each other so that they -- where necessary, they were harmonized. Maybe "harmonized" is a better word. I don't think it --

DR. FITZMAURICE: "Coordination" sounds pretty good to me.

MR. SCANLON: "Coordination."

DR. COHN: Question. This has to do with the electronic signature part of this one. My understanding was is that that was being deferred. Should we make a comment about that or is that --

MR. SCANLON: In fact, Karen gave me some suggested language about -- we will add that to -- to just simply say that that has been deferred -- we are referring to NIST, I guess, on the electronic standards.

MR. ZUBELDIA: I have been asked several times about what happens if the privacy comments indicate a displeasure of some of the changes when the security be uncoordinated from privacy because I understand security is now being made to be in alignment with the definitions in privacy and so on and what if some of those definitions need to be changed again? Will security be once more delayed to be recoordinated with the new changes in privacy or will security just move ahead with whatever it has and have to be corrected later?

MR. SCANLON: It is too early to tell. Bill or Karen, you can hop in, too. Until we see the extent of the need for change, I don't -- it is hard to predict.

You are talking about should the privacy comments result in changes back to security as well?

MR. ZUBELDIA: Bill suggested that we may have security in June, final rule, and privacy may not be ready by then. Are we going to always have them out of sync or do we always want to keep them in sync and, therefore, delay security until the privacy is also ready, too.

MR. SCANLON: I don't know that we can answer that until we see sort of exactly what the privacy comments look like. There is no -- it is hard to predict exactly what will happen here. This is largely new territory, as you all know, and, of course, there is the -- the process itself allows for revision of the standards, but we will have to see how -- what the comments on privacy look like in terms of how they would affect the -- how they would then affect the final version of privacy, how would it look like in terms of -- in relating to -- in relation to security.

Obviously, we don't want conflicts. So, we may have to -- at a minimum, we would want to make sure that they were not in conflict, but I wouldn't want to project a date or anything like that or what it may ultimately look like. I don't think we really know until we see the comments on privacy.

DR. BRAITHWAITE: There is no procedural reason why we can't put out a final rule for security and then come back with a final rule for privacy later that tweaks some of the things that were actually put out under security. It is common. It happens all the time. There is no procedural reason to hold one up for the other. You just don't want to publish two things closely together in time that are wildly divergent.

MR. ZUBELDIA: And in that sense, I would encourage to have the security published as soon as possible, rather than just wait.

DR. COHN: Thank you for that input.

MR. BLAIR: Simon, you mentioned that there was something about a deferral on electronic signatures and you acknowledged something about NIST and -- could you tell me what that is?

DR. COHN: Karen, why don't you -- Karen is the expert.

MS. TRUDEL: In the course of looking at the comments that we received on that regulation and also of reassessing some things that are some additional technological things that are going on in the area of electronic signature, NIST had requested that we allow some additional time for them to do some reevaluation and rather than hold up the entire regulation, we decided to split the two apart, proceed now with security and especially considering that none of the transactions now require an electronic signature of any kind -- prompted that request, but that is what we are essentially doing.

So, we will either publish an electronics security final rule by itself or couple it with one of the subsequent final rules that comes down the road.

MR. SCANLON: We will write it up that way in the report.

The next standard that is described in the progress report is the claims attachment and here again we

-- as you remember, we still are to issue a proposed rule on this standard. I guess we are hoping to have one this spring. I would like to say late winter, but we -- and, so, again -- and we simply describe what the status of that would be as well.

Now, the relatively new section here is on privacy protection standards because here, while we have reported on the status of the other -- the HIPAA EDI standards previously, the privacy standard, here, a number of things have happened during the year and we are just describing what happened here. You will recall that the -- as HIPAA laid out this process for privacy, the first step was that the Secretary would issue her recommendations. She did so in 1997. Congress then set for itself a date by which it basically set up a trigger.

If they did not pass a privacy law by this past August, then HHS was required to issue final regulations to protect -- literally this is the way it is written -- the information transmitted in connection with the HIPAA standards by February of 2000, this month, actually.

So, the August date having passed, that triggered this other requirement that HHS now issue proposed rules for health information privacy and as you know, these were issued in November. The comment period is now open until February 17th and there is every expectation that a final rule would be issued during this year.

DR. COHN: Just very quickly, there are two wordsmithing things. First of all, since August has passed, it is does not enacted -- it is actually did not enact private protection.

Actually, the question is -- you mentioned this occurrence triggered the HIPAA requirement. Actually, I don't think the not doing something is really an occurrence. It is probably lack of an occurrence. It is a wording issue, but I think --

MR. SCANLON: Yes.

Let's see. I guess I want to reserve most of our time for the implementation issues because these are really -- they are largely new issues for the report itself. So, the final section, I think, here, Section F, on page 22, talks a little bit about other aspects of implementation, including the arrangement for publication of the implementation guides and so on and some communication efforts and educational efforts and the reference to the Web sites where all the information is available.

DR. COHN: I think Kepa has a question here.

MR. SCANLON: Sure.

MR. ZUBELDIA: One part of that is not here, is the coordination of benefits and I understand coordination of benefits has been approached in the past as part of the claim. But the coordination of benefits, we probably should look into other things, other than just the claim. Not for this year, but maybe for next year we need to start looking at what is the progress of that coordination and whether there is an implementation and the process for coordinating benefits, not just the standard, the model for coordination of benefits.

DR. COHN: Why don't you put that on the list for our September hearings.

MR. ZUBELDIA: And those are part of the process of the progress report for next year.

MR. SCANLON: For next year. Okay.

The next section of the report -- and unfortunately, it is the last section of the report, so we clearly want to move -- you know, we want to make sure we do a good job on the executive summary. This is the section where the subcommittee and the full committee wanted to identify potential issues or areas of emphasis for the year ahead, given that this is where the status is and you will recall that there were about half a dozen issues that the subcommittee wanted to identify.

Let me briefly review these and these are obviously the areas where the subcommittee wants to make sure this is the way we want to say it and that these are the right issues. Let me describe the issues first. The first one, I think, dealt with the issue of industry readiness and there may be another way to describe this, but it is basically the issue of given where things stand, given that the basic framework for all of the standards is now known, well, for most of them is known, given the security framework and the emerging privacy framework, attention now turns to, well -- and given that the Y2K crisis is over, how ready are those covered entities in the industry for this?

I think there the issue would be through hearings or through other means, to sort of look at the issue of the industry readiness. A secondary would be how to -- the issue of if during implementation issues arise, how do they become identified and what is the process for kind of bringing them to the attention where they can be resolved.

A third area is the whole area of how do we monitor the success of implementation? A fourth area deals with how do we actually enforce the standards and a fifth deals with, I think, Kepa's idea of learning from early implementers. In other words, even though each of the standards will have a 24 month implementation period, there will be some health care organizations that may -- that will start to implement before that and those are the areas where you could learn about how it is all working and we would want to bring them in for hearings or other experiences.

Then, finally, identifying the need and revised standards, as we move towards actually implementing these standards, most likely there will be needs for new standards or revisions and so on that come up and what would be the process and what would be the nature of the standards for moving forward there.

So, those I think the group may want to spend a little more time on. Those were the six areas, as I am remembering and in each of the areas, it is basically a short description. Maybe we should just go through that to make sure everyone is comfortable.

In terms of readiness, I think -- industry readiness, the first area here, I think the point here is that the attention is now turning towards actually having requirements and standards to implement. Presumably, the industry has been gearing up for these. We don't really have a good measure of or a good sense of, on a systematic basis anyway, of how ready people are. According to the overall EDI industry analyses, there clearly are some sectors of the industry that are much further ahead than others, but -- pharmacy, for example, and certainly hospital claims more so than ambulatory claims and certainly providers, individual providers, much less than the institutional providers, but I don't think -- even there, the information is not systematic and clearly even in that group, it is not clear the extent to which the exact standards that we are proposing are currently being used or what their readiness is.

So, I think what the committee wanted to say here was that we would -- the committee would want to focus in the year ahead on perhaps some hearings where the various sectors could be brought in to talk about what they see as how ready, how ready is everyone and are there issues that are anticipated and what shall we do, you know, if there are some barriers to overcome?

Now, the readiness is -- obviously, that is an implementation issue, but there are other -- even aside from that, the next topic here talks about all sorts of implementation issues. It really sort of outlines -- it says that the committee, obviously, wants to assist in this process and would hold hearings.

DR. COHN: Jim, since -- I know Jeff hasn't had a chance to review it and I know --

MR. SCANLON: Sort of reviewing it.

DR. COHN: This area, since you are focusing in on it, you might want to just -- starting with this ready -- identifying and resolving the implementations use, it might be as fast just to read the page and a half or so that specifically relates to this.

MR. SCANLON: Okay.

DR. COHN: I agree with you. It is really --

MR. SCANLON: This is the new --

DR. COHN: -- the crux of really the things we are talking about for the coming year, just to make sure everybody is comfortable with it. It probably would not take any longer than trying to describe it.

MR. SCANLON: Should I just read -- let me read verbatim. I can go back to the industry readiness here actually to start.

So, under "Industry Readiness," this is what the draft currently says. "The HIPAA data standards will apply to health plans, clearing houses and providers, who transmit health information electronically. These covered entities will have 24 months from the effective date of the final rules to come into full compliance. Small plans will have an additional 12 months to comply. It is currently difficult to assess industry readiness for HIPAA implementation, although the use of EDI to support administrative transactions in health care has been increasing for several years, concerns about the century day change and other issues may have diverted attention from the HIPAA effort and baseline levels of EDI use in claims and related transactions vary decidedly among types of providers and health care organizations.

"The NCVHS is encouraged to note that many sectors of the industry itself have been very active in the HIPAA standards adoption process and in educating and preparing their respective constituencies for implementation. The NCVHS plans to examine the issue of readiness in the year ahead with public hearings planned to focus on readiness and other potential implementation issues."

So, that would be the first of the --

DR. COHN: Okay.

MS. GREENBERG: We were talking a little earlier about the hearings and I know you were saying in July possibly meeting with the early implementers.

DR. COHN: Right.

MS. GREENBERG: Now, were the discussions with Faulkner & Gray at the June meetings -- sort of related to industry readiness. I guess I am not quite sure what hearings are planned to address industry readiness. I mean, I am just trying to be concrete. It says that here. So, what would we point to?

DR. COHN: Well, I think that the -- both the early implementers and sort of the status hearings in July, I mean, to me, the issues of identifying and monitoring versus identifying --

MS. GREENBERG: Yes. I had a hard time sort of seeing these things as separate to some degree.

DR. COHN: Yes, they tend to merge. But you are right. In the sense that if you hear that an industry is 80 percent implemented, you know they are ready and then some. On the other hand, if you know they are zero implemented, I think that is a strong statement.

MR. SCANLON: Yes. Readiness is different, though, than implementation. You can be ready and still --

MR. SCANLON: Well, I guess we will have to make sure that we ask that question as begin to --

DR. COHN: Maybe we need just to reflect to make sure that that question gets asked, as well as status of implementation, like, you know, how ready are the constituencies. I think that is what you are bringing up.

MS. GREENBERG: Yes.

MR. SCANLON: Again, this is a continuum here. The second major issue here would deal with identifying and resolving implementation issues. So, in addition to the readiness idea, let me read what we have as a draft on this topic.

"Once the final administrative simplification standards have been adopted, the health care community will be encouraged to notify the Department or the NCVHS in writing or through our respective Web sites of any issues or concerns with the implementation of the new standards. In addition, the committee will conduct a number of public hearings to obtain additional input from a broad cross section of users in both the public and private sectors. Based on this input, the committee will notify HHS of any problems that are presented and will provide recommendations and how to deal with those problems."

That is all for that.

MR. BLAIR: Okay. You are not looking for wordsmithing at this point. You are just giving us a background.

MR. SCANLON: Yes. I think this is more the issues and the content.

MR. BLAIR: Right.

MR. SCANLON: The third major area here deals with monitoring implementation and this is probably -- this is one of the longer sections, but I think we -- let me read this as well.

"In addition to accessing industry readiness for implementation, the NCVHS plans to devote increasing attention in the year ahead to how it may best monitor implementation of the HIPAA data standards at baseline and subsequent to the issuance of the final standards. The committee is considering several approaches to monitoring the progress of implementation, including both quantitative and qualitative approaches, using industry sources of information, as well as public hearings.

"In this manner, the NCVHS expects to identify how well the overall effort is proceeding, identifying any problem or obstacles and recommend ways to overcome them to meet the requirements of the law."

That is the first paragraph.

The second paragraph, "The NCVHS plans to obtain information on the extent to which the adopted standards are being implemented and to solicit reports on the progress of standards implementation from the industry, as well as federal and state agencies for the health care programs under their jurisdictions. These agencies and representatives from the private sector will be asked also to provide public testimony at NCVHS hearings, where appropriate, at which they will be asked to indicate the extent of standards usage they have observed.

"The committee will also make substantial use of industry data sources to assess major trends in the application of information technology and health care. In addition, once the final standards have been issued, the health care community will be encouraged to notify HHS or the NCVHS in writing or through our Web sites of any issues or concerns with implementation. We will also ask the applicable standards development organizations to provide regular status reports on the implementation of the new standards. We would encourage them to provide advice as to how to increase the rate of compliance, if necessary."

And the final paragraph in this issue, "Since security is a primary concern to the public, the industry and the committee, we will also ask the appropriate private sector certifying bodies to monitor the status of the security measures that will be adopted and to ensure that adequate safeguards are in place to protect individually identifiable information."

So, again, we are sort of premising hearings and, well, largely hearings and expert testimony, as well as sort of quantitative -- whatever, systematic quantitative measures, more or less like the Faulkner & Gray, but possibly some other areas, as well, in terms of what the actual penetration is.

That concludes the monitoring implementation section. Any --

DR. COHN: Bill, go ahead.

DR. BRAITHWAITE: I just had one comment. There is a little bit of confusion there in the third paragraph that talks about having people notify us of issues or concerns, which is exactly what the previous section was about. It seems to me that we should monitor the implementation before we identify and recommendation resolution for the issues for the issues that we have discovered in the monitoring.

So, I would change the order of the sections a little bit and move monitoring up one and try and distinguish the three a little more carefully because they all kind of blend into one thing. We are going to ask people what is going on and then report to HHS is what it amounts to.

DR. COHN: Jeff.

MR. BLAIR: The area of readiness, is the purpose of that just so that we have an understanding of a baseline against which to measure implementation progress or was the thinking behind that section that we were going to uncover problems that the user community has, whether it is acute care, ambulatory care or health plans, where they have -- they don't have the information infrastructure in place to take the next step or what was the purpose of the information that we expect to get out of readiness?

MR. SCANLON: I will start the answer, but Kepa actually suggested this idea and I think everybody thought it was a good idea.

I think the readiness issue was the one that can be looked at this year because I think -- and I think it is -- to some extent, we will get -- to some extent, we will get a very basic kind of a baseline, but it will be fairly crude, I think. I think there was some concern, if I am reflecting Kepa's thoughts and the other committee members, that while some of the industry appears to be well -- very knowledgeable about the requirements for the standards and is moving along. There are some sectors that at least anecdotally appear to be less knowledgeable about the very requirements themselves, about the standards themselves.

I think the issue here would be to see where exactly this all stands and what exactly are those sectors and what issues -- I think the answer there, if there is one or two sectors or others of the industry that are not familiar with the requirements, not taking any steps to prepare for implementation, the issue there may be more education and information and working with the right industry groups.

In terms of penetration and monitoring implementation later, first of all, that comes later in the process in terms of when we actually have standards to adopt, but the medicine there, the remedy there may be a little different.

But, anyway, Kepa, I would defer to you. You raised the issue.

MR. ZUBELDIA: An anecdotal incident. I was on the panel on Tuesday last week, the Nashville Health Care Council. The health care council had about 200 people attending the session. These are people involved in health care at the CEO, CIO level, very high level. We asked them how many of you are actually doing something about HIPAA and less than five hands came up. Two of us -- two of the hands that came up were from my company.

MR. SCANLON: And those were fairly large organizations.

MR. ZUBELDIA: So, out of 200, five people were actually doing something about HIPAA. So, that is, I think, something to monitor.

But let me say something. One thing that I think has been extremely effective in increasing the awareness of HIPAA in the last two years was a power point presentation that was taken on the road by Leo and Gary Beatty and three or four people and basically it was the same message that was taken over and over and over everywhere. And that was extremely effective.

I would like to see what can we do to help the implementation, not just the awareness, now the implementation, to the same kind of level. I think we have a very acute problem in our hands. A couple of weeks ago, I was in the RSA security meeting, very large security meeting. Two of the prevalent themes or the two prevalent themes in the meeting were security and portable devices and health care security and HIPAA.

There were over 5,000, maybe 6,500 and the security experts in the country. So, he can say, okay, there were about 6,000, 6,500 people, security experts. If you go to an X12 meeting and you will find what, three, four hundred X12 experts. I mean, that is a big gap and if people think that security is in high demand, they haven't even looked at X12 and EDI as being in very, very high demand and there is a tremendous lack of experts.

So, as we were talking her, I have been thinking of -- monitoring the implementation. You mentioned a Web site to monitor the implementation. I am wondering if it would be effective to have some sort of discussion group or chat room, not real time chat room, but some sort of discussion group in the NCVHS or in the administration simplification Web site, to talk about the technical aspects of implementation and then would be monitored by some of the X12 and NCPDP experts.

So, they could answer questions as it goes by and there will be all kinds of people that need assistance with X12 implementation and maybe we can organize a team of volunteer experts to help implementation because if we don't proactively do that, I don't think it is going to happen very quickly.

That would also serve as the compliance window to see how the implementation is going and let us peak into what these experts are talking about. Is this going well? Or are they asking very basic questions? Is anybody asking any questions? That kind of window into the real live system.

I don't know if there are resources to do something to do something like that in our Web site or in the Department's Web site or the administrative simplification Web site, but I think it would be very useful.

I think especially it would give us a window as to what is happening out there. I think it would be useful for the participants, too.

MR. SCANLON: And actually, Kepa, it would be these kinds of suggestions, I think, that would come up at the hearings as well. You know, what could HHS, NCVHS and the industry do to promote better awareness of what the requirements may be.

I think the two year ramp up, to some extent, has people, you know, more or less, feeling more comfortable because they know whenever the final standard is issued, they will still have 24 months to comply but that may not be -- you know, there are a lot of things to do in order to be ready. But I think that 24 month sort of ramp up period to some extent has people feeling that it is still far away.

DR. COHN: I guess I should comment also. It is sort of hard to prepare for something that you don't know for sure what it is, which is the whole point of the final rules. I mean, you know, people can speculate, you know, I mean, is the security NPRM the same as the security final rule? Is it different? Are there some minor differences? Are there major differences.

It is hard -- you know, some of these things have big impacts. So, it is hard to gear up to do a major security fix at your organization when you don't know what the final rules are going to be.

Having said that, I think people are beginning to gear up right now. I actually think that the issue that Jeff brought up, though, which is an infrastructure issue, is something that we need not lose sight of because it is one thing that you have done things electronically. You have computers. You are sending things electronically and, gee, now you need to know how to deal with X12 standards.

It is a whole other thing when you discover that 80 percent of the transactions are -- and I think that is a whole other level of readiness. I think if administrative simplification is ever going to meet the vision, it has got to be persuading people that have been working the paper to move to electronic environments. That is where the value is going to be. It is not going to be moving people from their proprietary formats to more standard formats.

So, we should not lose sight of that issue.

MR. SCANLON: And that would be part of readiness. I mean, it is a little bit beyond the HIPAA mandate, per se, but the idea of --

DR. COHN: It is a monitoring of readiness issue. You are right. I don't think we have funds to persuade everybody to move from paper to electronic, but I think that -- once again, that may get into an area that we haven't really touched on, which is communication strategy and Kepa was commenting on that, just reminiscing. Once again, it is hard to do communication strategy -- a communication plan if you don't have final rules to communicate it.

MR. SCANLON: That is right.

DR. COHN: But we probably need to keep that on the -- I don't know where we put that. It is easy enough to put in the back of my mind, but it is probably something that -- I mean, you mentioned it a little bit in the implementation report, I think, some communication issues. But that probably needs to get revisited as the final rules come out.

Jeff.

MR. BLAIR: I would like to suggest that that topic of readiness be something that we do prioritize very high on our list because, at least in my mind, when I think of a baseline to measure our progress and implementation, that that baseline needs to be established very, very early. So, I tend to see it falling underneath that topic of readiness.

So, whether that is something that we do with Faulkner & Gray or by some other method, I do think that the baseline portion of the readiness is something we need to do before people start implementing this thing so we can measure progress. Does that make sense?

Simon, do you have similar feelings or --

DR. COHN: Well, I think that is what we have been talking about, the quantitative and qualitative measures ever since last September, though it is a little bit different than readiness. Status of implementation is different than readiness.

MR. BLAIR: Okay.

DR. COHN: So, I am not sure that we are going to have qualitative metrics as easily -- actually, quantitative -- well, we will have good qualitative metrics, but in terms of quantitative metrics on the concept of readiness, but I think you are saying that both need to be done as a high priority, which I think -- once again, I think that July hearing is really meant to be focused on that and I think realistically we can't get in too far to it until then only because our plate is already full with the CPR and work group recommendations.

Realistically, there is only so much that we can do. But I think that is -- and I see Judy is nodding her head on things that need to be done.

MS. BALL: One of the thoughts that comes to my mind, though, comes on the heels of the discussion this morning. If Faulkner & Gray is skimming cream and if people who come to our Web site and might be able to provide discussion and insights on our Web site are probably more cream and folks who could actually participate intelligently in a chat about security mechanisms and implementation sounds like cream to me, too.

I think we are going to have to think rather creatively on how to get to the body of the health care system that doesn't know about HIPAA, doesn't know that they need to care about HIPAA and, as you said, may or may not even have computers. I don't have a solution.

MR. SCANLON: Yes. They are unlikely to be participating or respondents even in a Faulkner & Gray type of survey and, in fact, it would be hard to get them even to come as expert witnesses. But I think you could -- we could probably think of the areas where we think there are soft spots or relative lack of awareness and maybe there are representers from those groups.

I am thinking small provider offices, for example. We could actually ask the MMGA, the Medical Management Group Association, to come in and talk about what they see as -- at least in the group practices. There may be folks at AMA or other places, there are other organizations.

You probably need -- you need to get folks who at least are the gatekeepers in those areas and then come in and that would help. And, recall, just as in Y2K, there was sort of a first stage of awareness. I mean, before there were any issues -- before there were issues of actually implementation and correction and so on. I think that was the concern in the readiness that -- you know, are the necessary covered entities even aware and if it varies among sectors, what are they and what are the potential barriers there?

DR. COHN: Shall we proceed?

MR. SCANLON: Okay. The next topic -- again, this was raised by the subcommittee at the December meeting -- deals with enforcement issues and this is literally the enforcement of the standards once they are adopted and the compliance date has come. This is the exact wording.

"Because of the extensive consultation among HHS, the NCVHS and the industry that has characterized the HIPAA effort and the issuance of proposed rules, the requirements for the standards themselves are well-known." Maybe we need to think about how we say that.

"However, there are a number of issues and details relating to enforcement and compliance with the standards that remain to be specified. The NCVHS is pleased to note that HHS has established an internal working group that is focusing on enforcement issues across all of the HIPAA requirements. The NCVHS plans to devote considerable attention to this issue in the year ahead as well."

DR. COHN: Next section.

MR. SCANLON: The next section deals with learning from early implementers.

"Although HIPAA provides a 24 month implementation period for the standards after the effective date of the final standard, clearly some health organizations will begin to proceed with implementation long before that date. The NCVHS believes that feedback from these early implementers will provide an invaluable source of implementation information and potential guidance for further implementation.

"Accordingly, the NCVHS plans to focus specifically on these efforts and organizations to gain insight into national implementation."

Now, the next area deals with -- and this is the final of the new areas -- identifying the need for new and revised standards.

HIPAA requires the Secretary of HHS to review the standards and adopt modifications to those standards, including additions, as appropriate but not more frequently than once every 12 months. The NCVHS expects that monitoring and evaluation of HIPAA readiness and the progress of implementation will identify needs for additional standards or future revisions to existing ones.

"Consequently, as part of its monitoring efforts, the NCVHS will seek input to identifying any additional standards that may be appropriate, as well as the need to modify existing standards and will provide timely recommendations to the Secretary."

Those are the six areas.

Those would be -- and that is the exact wording -- those are the six areas that I think the subcommittee wanted to highlight for the report itself. Then HIPAA, you are reminding me that we would include as part of that last identifying the need for new and revised standards, we would include the paragraph that Karen provided that talks about the MOU process.

Should I read that as well? It is a short paragraph. This would be a second paragraph under "Identifying the Need for New and Revised Standards."

"The Department has been negotiating with several organizations for them to serve as the focal point for requests for revisions to the standards and for additional standards. These groups have agreed in principle to work together to review these requests and suggest revisions to the standards. The groups are the following: X12, HL7, NUBC, NUCC, NCPDP and the ADA.

"Any person or organization will be able to request the revision or a new standard through a single entry point, via the Internet or on paper. Each of these organizations will consider the request and a consensus recommendation will be made. On a to-be-determined cycle, revisions will be presented to the NCVHS for consideration and then on to the Secretary for issuance."

So, this is the --

DR. COHN: Where did you think that should be?

MR. SCANLON: I think this was suggested --

DR. COHN: I don't think it is after --

MR. SCANLON: That is where it was suggested. But we could find any other place.

MR. ZUBELDIA: I would make a separate entry for coordination of standards or revision or standards maintenance, rather than new standards.

DR. COHN: I think this has -- I mean, this probably is a different section rather than --

MR. SCANLON: This could go back into the --

DR. COHN: Now, let's sort of finish up with this. Actually, I have some comments about the final section here.

MR. SCANLON: The final section -- and, again, the committee may not want to include it this year. This was included last year as sort of a section where there were some other issues that could be raised that didn't fit neatly into the HIPAA standards progress report. To some extent it continues the issues that were raised last year and it may be that the subcommittee doesn't want to raise these same issues this year.

But it basically states that the committee has identified a number of special privacy and security concerns that it wishes to highlight for the Congress and the public. That was the way it was stated last year.

The first of these is comprehensive federal health privacy legislation. Here, I can read this, but the basic

-- the basic point here is that even with privacy regulations that HHS is developing, there is still a need for national legislation that provides comprehensive systematic and balanced health information privacy. Again, I think that the subcommittee probably wouldn't want to make that point.

It concludes with, again, the NCVHS again urges the Congress to enact a comprehensive federal health information privacy law this year.

Second, again, was the point that was made last year and you may or may not want to continue this point but it was the idea that in addition to the need for privacy and confidentiality protections, there was still need for antidiscrimination measures, based on health status. The language here is comparable to last year's.

Again, I think the full committee is making this point in its privacy comments, comments on the NPRM for privacy. The subcommittee may want to make these points as well. Again, this goes beyond the HIPAA, but it is sort of another point that, you know, the need is not diminished for actual antidiscrimination legislation.

A third point deals with security -- I am sorry?

DR. COHN: Let's go through all four.

MR. SCANLON: The third section deals with security and I think here the point was to emphasize the need for -- it was to add emphasis to the idea of the need to have a comprehensive security framework as well as the standards and privacy.

I don't think -- let me see what we -- here, I think, the committee -- we say that the committee believes that the proposed rule for security standards that HHS has published for public comment provides the basic framework to ensure that all health care entities safeguard the integrity, confidentiality and availability of their electronic information.

But, again, we close here with the idea that the committee plans to monitor industry compliance with and the development and maturation of security technology and standards. So, it is simply another push.

The final point, again -- and the committee may not want to include this year, this is the idea of the need to consider the linkage of the individual health identifier to privacy protection. This was the point you remember that was made last year. We may or may not want to continue with this.

DR. COHN: Let me just make a summary comment here and get input and then we can talk about individual sections.

I mean, first of all, I am not sure that we even need this?

MR. SCANLON: I was thinking the same thing.

DR. COHN: If we do, it probably should at least to my view, I would include the comprehensive federal privacy legislation and the antidiscrimination measures. I think the security comments are redundant with the earlier section, the securities and NPRM. I sure don't think that we need to end this report on a linkage of the individual identifier to privacy protection and especially with the final sentence, which is inaccurate, which is the NCDHS agrees with the conclusion of both Congress and the Executive Branch that work on the adoption of a unique health identifier for individuals be related to health information, privacy protections are assured, which is actually false.

So, I think that it is -- you know, it is once again a wholly inaccurate statement. I don't think we would get anywhere considering we have identified individual identifiers separately. Now, the question I have for the committee is do you sort of agree with the way I am going? Does it even make sense to have this section here? If it does, should we be asking the privacy and confidentiality work group to provide any other areas?

I mean, I think, for example, after the hearings on the 25th, that that whole Internet issue may turn out to be a big issue because I think we are all beginning to identify alarming gaps with -- in health care privacy around Internet and, then, once again, not covered by the HIPAA legislation, but which needs to be beyond that and it may provide an opportunity to highlight that, but whether -- does it even fit here?

Comments, questions, statements? Kepa, do you want to start out and then, Judy, you can go after.

MR. ZUBELDIA: I agree with you the security part, I think, should be part of the security section that is up here. And the individual identifier issues being made part of the privacy section that is up here. There are privacy protection standards that has already two paragraphs. Maybe you could have a small third paragraph that talks about patient identifiers.

DR. COHN: There already is, I think --

DR. FITZMAURICE: I generally agree with your observations.

DR. COHN: Okay. Judy, do you have a comment?

MS. BALL: Yes. A couple of things.

One is I agree with your comment on security but I think security needs to be identified specifically back in the section about industry readiness, that it is not just the standards, but it is also the kind of level of security that is already in place for health care information. I think that is one of the ideas that came out of your hearings earlier.

The second comment I had is the 5(a) and 5(b) on federal privacy legislation antidiscrimination measures, I think it -- this would be strengthened by tieing it back to the privacy NPRM, that the -- you can state factually that these issues were addressed in the NPRM and there was agreement that these areas cannot be addressed simply by regulation and that these things are still needed. Anyway, tie this conversation back to what the Department has come out and commented on.

DR. COHN: I guess the question is -- I think we are all in agreement that this section is if it even exists, it should be modified significantly. I am hearing -- the security part, you are right, needs to be reincorporated in the -- as some comments about the security readiness and security monitoring and thanks for reminding us that there is a whole different set of issues around security, which I think we have mentioned before but had somehow neglected in this discussion.

MR. ZUBELDIA: There is a hole.

DR. COHN: There is a hole? In relationship to security?

MR. ZUBELDIA: In relation to security. It is not just a whole set of issues. There is a hole.

DR. COHN: Thank you. I think that is an important issue that we especially need to focus on with readiness.

Jeff.

MR. BLAIR: Jim, in the past these types of reports, do they generate action?

MR. SCANLON: Not necessarily. I think the action would be in what the -- first of all, I should say you will never make -- you will never earn a fortune trying to protect what Congress will do in any given year. I don't think the report itself or many annual reports to Congress will necessarily do anything per se in terms of Congress enacting a new law or anything like that.

Clearly, the advice of the committee will be pulled to reinforce probably any new development, but I don't think this necessarily will change anything. It is a report on implementation. I think the whole idea here is to provide a vehicle for monitoring and, hopefully, the committee would either, you know, ask the Secretary if that were the appropriate place or work with the industry or work through some specific means.

The committee could ask the Secretary to propose legislation, for example, which you may very well do in terms of the clinical data standards.

MR. BLAIR: So, this is really not a vehicle for us to propose that Congress do something as much as it is a report to Congress on here is what we have been doing. Is that correct?

MR. SCANLON: And what you will do, what you propose to do in the year ahead.

MR. BLAIR: But you are giving -- you can use the vehicle of such a report -- if we are going to ask Congress to do something in this report, it needs to be probably pretty targeted and be like in the summary or be right up front. Somehow it needs to stand out. Is that correct?

MR. SCANLON: Yes, I would think so. For example, apprehensive privacy legislation, if the committee wanted to go on record -- and I suspect the full committee will -- you know, of the need for federal privacy legislation -- that it has not diminished and continues, I think, you know, you would want to say that. So, again, I think -- the section here was included last year because I think the full committee wanted to emphasize certain things, given the state of play and this year the subcommittee and the full committee may not want to --

MR. BLAIR: Well, then let me refine my questions here a little bit.

DR. COHN: Jeff, I am not sure. What are you thinking?

MR. BLAIR: Well, I am thinking that maybe if there is a portion of this, which is an opportunity for us to send a message to Congress that we want them to act on something, that either that be in the summary or a list of concerns, where it is clearly identified. These are concerns where we would like Congress to either look further or help -- you know, or pass legislation or whatever and I just don't know whether or not as a subcommittee, you know, that is what we want to do with this report or not.

DR. COHN: Yes. I think the question gets to be a question of almost vehicle also. I mean the committee has gone on record more times almost than I can count at identifying the need for comprehensive federal health privacy legislation.

This is not the first time the Congress has seen our support of this topic. So, I mean, we just need to be aware of that. That is not to say that we shouldn't do it again, but it isn't as though that is new.

Now, yes, we could open this up to -- I mean, the question is is whether we end at what we are going to be doing and sort of leave it at that, implementation, and have that be sort of the last thing that they remember or do we want to add some other stuff at the end and what can we say there that is important enough that would cause them to actually look at that section and do we want it so important that they forget everything else?

MR. SCANLON: We don't put it at the end if you are -- you are right.

DR. COHN: Well, no, I mean, I think, for example, if we -- if there were some -- if, for example, the privacy and confidentiality group subcommittee has hearings on February 25th exploring the issue of Internet privacy and there is some major issue that comes out of that. We could choose to put it here, but it also might overwhelm the whole rest of the report. And does that help the report? Does that help the issue? Does it expose the issue?

I am actually as we are talking becoming more and more convinced that maybe we need to really end at the end of implementation. These other areas need to be somehow incorporated back into the body of the report.

MR. SCANLON: Sure. That could be done easily.

DR. COHN: And then maybe -- we were talking about privacy. We talk about once again the need for comprehensive federal health privacy legislation and we talk about the need for antidiscrimination measures and we put it in there. Given that we are already doing all these other things and we have another letter going to the Secretary February 17th saying that there needs to be federal privacy legislation and that maybe this is not --

MR. SCANLON: I think that is fine. I think we have already said in this draft earlier in this report, where the privacy proposal is discussed, that while we applaud the proposed rules on privacy, we continue to believe that, you know, they are limited in certain ways and we continue to believe that the privacy law is needed and urge Congress to act and we may just want to say it there.

These were included last year, again, because the full committee and the chair, I think, particularly -- these were points they wanted to emphasize especially or concerns and maybe that they are no longer so separate that they --

MS. GREENBERG: -- there was still hope that Congress would meet its deadline. So, the committee, I think, wanted to encourage that. The current draft letter on the privacy continues to support comprehensive legislation. I think folding these issues back into earlier in the report makes a lot of sense.

DR. COHN: I think we have reached consensus on that. Okay. Well, with that, we are actually done with this report. Is everybody comfortable with the revisions that we have talked about? I mean, we obviously will have a chance to see this again, though, as members of the NCVHS and maybe with the opportunity on -- at the end of the first day to revise this if needed or whatever. But, hopefully, I mean, I will work with Jim to make sure that the executive summary is short, to the point, reflects the things that we have identified.

And once again, if any of you can provide -- I will have the opportunity to wordsmith it whatever, but it is -- I am sort of looking towards a three page executive summary as opposed to an eight page executive summary.

MR. SCANLON: We have to be careful. Sometimes the executive summary is all that many readers will read. So, on that assumption, you make sure --

DR. COHN: But it should not be longer than the report, though.

Okay. Are we comfortable with that?

MS. TRUDEL: I just wanted to ask if you wanted to set a deadline for any editorial changes so that a final draft can be prepared and circulated to the subcommittee before the next full committee meeting?

DR. COHN: For the report?

MS. TRUDEL: Yes.

DR. COHN: Yesterday. Tomorrow. I mean, we are now at three weeks before the --

MS. GREENBERG: Our goal would be to send out the next version.

MR. SCANLON: It is really about a week or two anyway. The full committee meeting is February 23rd.

MS. GREENBERG: Right. So, we have been asking for any documents that would be included in the agenda book by like the 10th or the 11th or whatever. We will be sending out the agenda books the following week.

DR. COHN: I think the question got to be is would we have another version for the subcommittee to review and comment on prior to that going out. I think that was what I think Karen was referencing.

MR. SCANLON: That is ten days.

DR. COHN: I know.

MS. TRUDEL: That is why I asked.

MR. BLAIR: What would be the purpose actually? Do we think it would be that different from the -- aren't we allowing the full discussion at the NCVHS meeting?

DR. COHN: Let me tell you what I am going to suggest. I think this is going to have to be sort of a two page -- I think what I have heard from the committee is -- from the subcommittee is that we are comfortable basically with the report; that is, with the modifications that we have made. I think what we can do is to make those modifications, try to clean up the executive summary. What we will do is when we send it to Marjorie, we will also send electronically copies to all the members of the subcommittee and staff with the idea that additional changes can be made. What we may wind up doing is when we actually meet with the full committee, we will go through with them, we actually may have a marked up version. Once we get that version out on the 11th, any changes will be shown like we have been doing with the CPR work group as the change is actually on the copy and allows us to make improvements to it, bring them and go over it with them and the full committee and we say, gee, these are the changes we made. Here is the new version. Here is the marked up changes, expecting they have read the original version and have whatever changes we have incorporated and allows us to sort of work up until the meeting.

So, does that work for everyone in terms of modifications and otherwise? I am hoping there won't be much.

MR. BLAIR: Question. This weekend I am going to have somebody able to read it to me if I send an e-mail to you Monday, Tuesday or -- to Jim, you know, with any additional comments that I might have. Is that still in time? Would that be okay?

MR. SCANLON: This weekend, sure.

MR. BLAIR: Okay.

DR. COHN: Actually, I doubt we will get a whole new version out on that.

With that, I think this is the end of the agenda for the subcommittee. I think that we will -- I guess we reconvene as the work group on CPR to see if we can finish up the recommendations.

I actually want to thank the staff for their help on this. This has been a lot to do.

With that, why don't we break for about five minutes.

MR. BLAIR: Let me ask you this. What do you think about the possibility of -- since we are getting close to -- people might want to bring their lunches -- should they bring their lunch down?

[Brief recess.]

Agenda Item: Reviewing the Recommendations from the Work Group on Computer-Based Patient Records

MR. BLAIR: This is the second episode of our review of the first draft of the report to the Secretary on uniform data standards for patient medical record information.

For those of you who were with us yesterday, we got through a good portion of the document. We are going to continue on today.

This is Jeff Blair. I am just going to real quick, you know, go around the folks that are here to introduce everybody. I am Jeff Blair, chair of this work group.

DR. COHN: This is Simon Cohn with Kaiser Permanente, a member of the committee.

MR. ZUBELDIA: Kepa Zubeldia with ENVOY Corporation and member of the committee.

MS. BEBEE: Susie Bebee, staff, and I am with the National Center for Health Statistics.

DR. FERRANS: Dr. Richard Ferrans and I am staff with the VA and LSU Health Sciences Center.

MS. AMATAYARUL: Margaret Amatayarul, contractor.

MR. BLAIR: Do we have any guests? If so, come to the microphone and announce your presence, identify yourself.

Anybody.

MS. TRUDEL: Karen Trudel, Health Care Financing Administration.

MS. JACKSON: Debbie Jackson, National Center for Health Statistics.

MR. BLAIR: Well, we are going to turn it over to Margaret Amatayarul, who is going to lead us through the next section, which I believe is quality, accountability and integrity.

DR. YASNOFF: Jeff, do you want us on the phone to say "hello," too?

MR. BLAIR: Oh, I apologize. Yes, please, would you announce yourself as well.

DR. YASNOFF: This is Bill Yasnoff from CDC on the phone.

MR. KENT-SMITH: This is David Kent-Smith from the Government Computer-Based Patient Record Project. I am the chief clinical officer on the phone.

MR. BLAIR: Thank you, Bill and David, for joining us.

Margaret.

MS. AMATAYARUL: Okay. This is data quality, accountability and integrity. Jeff, do you want me to read the prefatory comments to the recommendations or do you want to go right to the recommendations?

MR. BLAIR: I think in the interest of time, let's go right to our recommendations.

DR. COHN: Can I make one wordsmithing comment about the data quality, accountability, integrity area? And that has to do with your comment about use of proprietary codes. You mentioned in the actual body of the discussion areas, a comment about proprietary codes. My belief is that is an inaccurate use of that term. I think what you are talking about are home grown or local codes and calling them proprietary codes specifically means owned.

MS. AMATAYARUL: Can you point me, Simon, to the paragraph?

DR. COHN: I am looking at the last -- it is on my page, I am looking at page 26, line 45, where it says "use of proprietary codes."

MR. BLAIR: Can you just read the sentence so that we have --

DR. COHN: Well, it is a bullet. It says, "Use of Proprietary Codes. Some health plans require that their providers use home-grown diagnoses or procedure codes, which hamper comparable performance measure." I just don't think that that is what proprietary codes are.

MR. BLAIR: What is a more appropriate word, do you feel, to convey that --

MR. KENT-SMITH: How about "non-standard"?

DR. COHN: Yes. That would be fine.

MR. BLAIR: Non-standard. Yes, I think that is a good suggestion.

DR. COHN: Sounds good. Thank you.

DR. FERRANS: But then the bullet after that has modification of standard codes, which would sort of imply non-standard, too. Is there --

MR. ZUBELDIA: That is even a bigger problem.

DR. FERRANS: Is there any way that we want to bracket this?

DR. COHN: Well, actually, I think they are fine being together like this. Actually, it makes them more likely -- one is non-standard codes and then one is even if you have standard codes, you are modifying them inappropriately. I think that is a -- at least from this view, it is going to be okay.

MS. AMATAYARUL: Okay. The first recommendation in this section is to promote quality, accountability and integrity of electronic PMRI. The Secretary of HHS should utilize the data quality features and characteristics referenced in the guiding principles for PMRI when selecting message format standards for adoption and in the construction of conformance tests.

MR. BLAIR: Any questions or comments?

DR. YASNOFF: I think it is fine but isn't it redundant?

MR. BLAIR: This is in quality now.

DR. YASNOFF: I mean, I don't object to it, but I mean we already asked the Secretary to use the --

MR. BLAIR: Well, I think we are heading at a little bit different tact with the data quality and integrity. So, the wording is slightly different for a purpose.

DR. YASNOFF: I understand and I don't object to it.

MR. BLAIR: Let me just explain because maybe we need to improve the sentence so it is clearer.

We are not really in this case looking for a separate data quality standard or integrity standard. We are really looking for the characteristics and features that improve quality, data integrity and security to be integrated within the message format standards and if we wind up coming up with content and structure standards, that would also, you know, apply there.

There already is a work group within HL7, for example, with that title, with that mission, but they may need a little bit of help to get this topic higher on the radar screen because business interests very often have this as a lower priority. So, that is the intent of this recommendation. Do you feel like we need to strengthen the wording to communicate that or do you feel like it does?

DR. YASNOFF: Essentially what you are saying to the Secretary is be sure to pay attention to quality issues when you do standards. Is that right?

MR. BLAIR: Well, as we go down these recommendations, I think we are going to be stronger. We are going to wind up trying to put incentives in place to encourage the SDOs to build quality features and characteristics into their standards. Okay?

DR. YASNOFF: Right. I understand that, but in this recommendation, you are essentially saying Madame Secretary, be sure to pay close attention to data quality when setting standards. That is really all you are saying, which is okay. I don't have any problem with that.

DR. COHN: Bill, you are wondering whether we just don't say that? I guess that was the question I was trying to figure out. Bill, are you there?

DR. YASNOFF: I can't hear you.

DR. COHN: Can you hear me now?

DR. YASNOFF: Yes.

DR. COHN: Okay. I was just wondering if are you wondering whether this should just be reformatted just to say that?

DR. YASNOFF: I am not quite hearing you completely. Are you asking whether we need to change the wording?

DR. COHN: Yes. Were you suggesting that or not?

DR. YASNOFF: No. All I am saying is that this may be redundant, but I think the emphasis is worthwhile. So, just -- let's go on.

DR. COHN: Okay.

MS. AMATAYARUL: 16. To accelerate the implementation of PMRI standards incorporating data quality, accountability and integrity features and characteristics, the Secretary of HHS should create incentives for improving data quality. These may include establishment of a minimal set of critical quality measures and a minimum required data set to support derivation of the measures. The data set would require adoption of (a) uniform units of measure, (b) uniform data dictionary, (c) interlocking set of structured vocabularies.

DR. COHN: Can I make a comment on this one?

MR. BLAIR: Yes.

DR. COHN: I found this one to be a very odd recommendation. I think we are somehow in the same paragraph confusing data quality with quality data. I actually think that the approach to this -- it is an approach to acceleration of I think PMRI standards and using PMRI standards to support quality data, as opposed to data quality.

We talked about this yesterday in terms of that medical terminology recommendation, that there ought to be -- let's see, I am trying to think where this was and maybe I am mistaken -- I guess this is --

MS. AMATAYARUL: It is right here.

DR. COHN: Okay. Basically the issue of providing incentives for using the standards in a way that made it not necessary -- not necessarily do you have to do chart abstraction and other things in relationship to that, which I think it makes a lot more sense than what this is talking about.

MS. AMATAYARUL: This is not intended to do that. This is --

DR. COHN: Well, but that is what this says.

MS. AMATAYARUL: Okay. Well --

DR. COHN: This says improving data quality and the next sentence is "These may include establishment of a minimal set of critical quality measures."

MS. AMATAYARUL: Yes. The intent of this recommendation came from several testifier, who talked about the fact that one way to incent use of terminologies to achieve data quality was, in fact, to set up quality of care measures.

DR. COHN: Well, I think we are talking about the same thing exactly then. You are talking about data quality and then talking about quality data. And I am saying that what you want to do is to deal with quality measures, which you are just talking about. Then the way you incent that is you don't go around asking the government to establish additional -- ala addition, the HEDUS additional to QUISMC and other groups, other additional quality measures, just to tweak people.

What you do is you figure out ways to allow those things to happen in a more cost efficient and effective way by utilizing these standards to communicate this information in a way that doesn't require chart abstraction, which is typically the HEDUS issue and every other quality organization's issue right now.

So, I think that there might actually be a business case to be made of, gee, if you could transport -- let's talk about HEDUS, for example. You could transport blood pressures or you could transfer other measures electronically in a way that didn't require chart abstraction, there actually might be dollar savings that could be used as part of the incentives.

But this seems to be just sort of an arrow out to the right.

MS. AMATAYARUL: Yes. And, Simon, I am only trying to report what the testifiers said, that they weren't looking -- my understanding was that, yes, there was ORICS(?) and there is HEDUS and OASIS and so forth, but they wanted more than that. They didn't want to just look at those and strengthen those. They actually wanted more.

That is what I was trying to convey here. Now, that is, I think a decision your work group has got to make is do you want to focus on what existing data sets there are and improve the data quality therein, which is different than what this is because this really did mean go outside of those.

DR. FERRANS: We are confusing quality of care measures with data quality.

MR. BLAIR: Actually, can I suggest here that it is important for us to make that distinction. In this case what I think it is trying to say is that in order to improve data quality, if you put incentives in place for quality of care, that will drive improved standards for data quality.

[Multiple discussions.]

-- double linkage. That is two linkages there.

DR. FERRANS: Simon, here is what I would recommend. I think that a reasonable recommendation from the work group would be that when the Secretary has any future, you know, reporting requirements placed, that they look to the standards established to make sure that we are using, you know, the appropriate terminologies, message formats to ensure data quality.

DR. COHN: Yes. And I think beyond that I would say that there would be the issue of potentially providing incentives or additional reimbursement if these data sets -- if these required data can be produced using information systems as opposed to having to use chart abstraction.

MR. BLAIR: Could I get back to what Margaret was pointing out, though, because I think if I recall during the testimony when people were saying we needed to have incentives for quality of care on the part of HCFA and on the part of other payers, so that the incentives in place were not just reimbursement. Are you winding up saying you don't want to convey that message here or are you saying that we just didn't convey it correctly or what?

DR. COHN: Well, I think that this actually, by my memory, is a combination of two different testifiers. One is the concept of paying on the margin, as I -- well, that is what it looks like to me. We were going to be incenting and paying on the margin for people to adopt and use terminologies and then the other piece had to do with quality measures and somehow these things got connected.

I was at the hearings. I don't quite remember recommendations that called for people to -- I am just trying to -- I guess I don't remember anybody calling on the Secretary of HHS to establish additional clinical -- critical quality measures in addition to what already exists for health care.

MS. AMATAYARUL: I think it was Blackford Middleton that made the largest case for it.

DR. COHN: Additional quality measures? Additional to what already exist. Okay. There was a consensus there?

MS. AMATAYARUL: Well, I am not saying one person is a consensus. That person stuck out in my mind. I wouldn't want to say that there were or were not others.

MR. BLAIR: I think Al Buck from JCAHO was also struggling and the JCQA -- let me just finish this one thought here -- part of it was that the HEDUS measures and the JCAHO accreditation process, they were struggling -- and part of their testimony even indicated that they couldn't measure quality very well because the data wasn't there for them to measure anything that was clinically meaningful or clinically specific. It was too general.

So, they were looking for incentives on the quality to -- for quality of care to drive down to try to put pressure on the standards groups to have more clinically specific information to support those measurements.

Okay. Bill or --

DR. YASNOFF: Jeff, aren't we really wanting to say that the quality of care measures should use PMRI standards or should be required to use PMRI standards that would minimize the need for chart reviews and so on and would improve the quality of data.

MR. BLAIR: That is, I think, implied or assumed but I think that the additional point that the testifiers were making that Margaret is referring to is they were winding up asking the Department of Health and Human Services to place more incentives on measuring quality of care to try to press the issue.

DR. FERRANS: Actually, let me support what Bill just suggested and the reason is if the first step is to require that those reporting measures are using PMRI standards, then once that happens, that incentivizes people to have systems that, you know, collect and store the data that way because then they can essentially do EDI to those groups.

So, from the standpoint of what our goal is, that would certainly make sense. I am not -- I am still sort of struggling a little bit with the quality issue and I think if we are talking about data quality, we need to make more specific mention of it in the data quality part on page 24, where -- I mean, we are talking about chart abstraction being inefficient and at times inaccurate and that is a data quality issue. So, automation of that would make sense.

We don't state that explicitly here. So, I think we should.

MR. ZUBELDIA: This has two separate issues in it. One is to use PMRI to gather data that has good quality, that will not require -- that will therefore improve the reporting because it is good quality data.

The other issue is to refine the gathering of quality data, data that measures quality of care and to refine the gathering of that kind of data. They are two separate issues.

MR. BLAIR: Both of those issues are true, but I think there is a third issue, which is, I think, what this point was trying to make, is that in addition to those two, this is also saying that we need something that will provide incentives by the payers, like HCFA, for measuring quality of care in order to push forward the development of those standards so that you could measure quality better.

DR. COHN: Well, Jeff, and I think that was the point that I was trying to make because I think there are different ways of doing that. I mean, I think, one way to incentivize what you just were describing is to incent by, you know, having these things which are supported by PMRI standards be sent electronically and you can actually pay more for that if these things are developed electronically and sent electronically.

We should be talking about that proposal. We should not be talking about a proposal that includes establishing data quality measures, data sets, data dictionaries, et cetera, et cetera. Because as I said, I think -- you know, once again, it may be that Blackford Middleton made this comment. I don't know of any organization that I can think of that is actively advocating for the Secretary to be developing additional quality standards that need to be implemented on a nationwide basis at this point.

I think most people think that they have enough quality measures as it is. They are struggling to meet those quality measures, wishing that they didn't have to do expensive chart abstraction and would really look towards this leadership in a way to get them out of that --

MR. BLAIR: Let me try to refine this because I think we heard -- maybe we heard something different. Okay? If it is just what you are saying, then it is winding up saying use the standards that are out there to ensure quality and the messages that I heard, especially when Al Buck was testifying and when NCQA was testifying, both of them wound up saying they have reduced dramatically their requests for quality information because the data isn't there.

So, they were winding up saying -- if we wind up simply saying we are going to ask for what is there today, but not put an incentive in place for an improvement, then, yes, what we will do is we will automate what is there today and we will not have a higher standard of quality --

DR. COHN: Can I comment in response to that because I have gotten pretty familiar with, for example, the HEDUS measures. Now, some HEDUS measures are based on administrative data and those are really the ones that HEDUS is having trouble because there is only so much administrative data. There are a whole bunch of other sets of measures that are based on either manual abstraction or survey results, both of which are very expensive to do.

For example, the blood pressure measure really is based on manual extraction of the chart. So, they are proceeding into the areas where they don't have automated systems to do it, but it would be wonderful if we could support them in that as opposed to saying, well, gee, no, what you are doing really isn't enough. We need to have the Secretary do something else.

I think the strategy is to try to support those efforts, make them easier to occur and then allow them naturally through their consensus process in the same way that standards developers develop standards through consensus processes to expand the processes, while at the same time paying on the margin or providing the incentives for them to computerize these things, which is I think what we have -- at least what I have been talking about -- I am not sure I need to argue this with you but I guess we need to figure out what the work group wants to do in terms of recommendation and

what --

DR. YASNOFF: Jeff, could I suggest some language?

DR. COHN: Bill Yasnoff has some language.

MR. BLAIR: Yes, Bill.

DR. YASNOFF: What do you think about this for language? "The Secretary should establish incentives for reporting quality of care measures that use PMRI standard and ensure comparability of this data by establishing requirements, including the A, B, C we have listed."

MR. BLAIR: That is probably pretty good. Read me the A, B, C.

DR. YASNOFF: Uniform units of measure, uniform data dictionary, interlocking set of structured vocabulary.

MS. AMATAYARUL: Bill, could you read the first part again?

DR. YASNOFF: Yes. I knew you were going to ask me. So, I wrote it down.

MS. AMATAYARUL: Hold on one second. Let me scroll up. Okay.

DR. YASNOFF: Okay. So, we say, "The Secretary of HHS should establish incentives for reporting quality of care measures that use PMRI standards and ensure comparability of this data by establishing requirements, including..." And then list A, B and C.

MR. BLAIR: I feel comfortable with that one. How about the rest of the committee.

DR. FERRANS: Can you scroll back down so I can see it again?

DR. YASNOFF: Simon, does that align better with your thinking?

MR. BLAIR: I think it is a good compromise wording.

DR. YASNOFF: Do you need me to read this again?

DR. COHN: No. We actually want to see it on the screen.

MR. BLAIR: Simon and I are locked in an arm wrestling here.

DR. COHN: No, no. I think the -- this is actually getting a lot better. I am still wondering what we get --

DR. FERRANS: Existing in future or are we just talking about future ones or are we talking about new ones? Could somebody just be a little more specific?

DR. COHN: Well, you see, I think the existing ones could benefit from this as well as future ones. At least that is my view. And that is an easy win.

MS. AMATAYARUL: Could I -- I have been trying to capture what your thoughts were as you were talking and I think maybe I could even include what Bill had just proposed as well. "To promote enhanced data quality through adoption of PMRI standard medical terminologies in the private sector, prior to their being regulated, the Secretary of HHS should require quality of care measures to use PMRI standards that would minimize chart reviews and enhance data quality, (b) support refinement of the gathering of data that measures quality of care and (c) consider providing incentives, such as paying the marginal cost for reporting specific data."

DR. YASNOFF: That sounds pretty good to me.

DR. FITZMAURICE: I have a question about the Secretary requiring quality care measures to use PMRI standards. There might first want to be an investigation of do we already use PMRI standards. I suspect that many of the quality measures aren't associated with information systems. Somebody going through chart review is going through a lot of torture and to require them to use PMRI standards, maybe message transmission standards, they don't have that capability.

So, then it falls down to the content and use the same definitions. That would be good, but I am questioning our recommendation for the Secretary to require this without the Secretary having some background in what is actually going on out there. Do they currently use PMRI standards that exist? Are they compatible, at least, with them even if they don't come from information systems and what can the Secretary do to promote the use of information system reporting of quality of care measures, which is not just PMRI standards, but also how do you collect the numerator, how do you collect the denominator? It is a set of rules as well as the PMRI standards.

MR. BLAIR: There are four or five thoughts there. Could we sort of take them one at a time? I think the first comment that you made was concern about --

DR. FITZMAURICE: That the Secretary require --

MR. BLAIR: Now, I was okay with either Bill's statement or Margaret's statement. Margaret's statement that she has up there, I think, says require these things, I think, prior to adoption of PMRIs. Is that right, Margaret? That is what you added?

MS. AMATAYARUL: Well, initially -- the lead is was to promote enhanced data quality through adoption of PMRI standard medical terminologies in the private section prior to their being regulated, the Secretary -- but then it says the Secretary of HHS should require quality of care measures to use PMRI standards.

DR. FITZMAURICE: I don't know that the quality of care measures are going to be regulated by the Secretary. So, I wouldn't want to make that assumption.

DR. COHN: That is why I have been reacting the way I have been.

MR. BLAIR: What was the general feeling on what Bill Yasnoff recommended?

DR. COHN: Where is he talking about that one? I mean, it actually makes more sense than -- the question here is, I think, I am supportive of the first part of the sentence, where it says the Secretary should establish incentives for reporting quality of care measures that use PMRI standards.

I am just not sure about the second part of the thought there, where it says "and ensure comparability of data by establishing requirements, including uniform units of measure, uniform data dictionary, interlocking set of structured vocabulary.

I am trying to figure out what the value added of the rest of that thought is.

DR. FITZMAURICE: Simon, suppose we replaced "ensure" by "promote" comparability by publishing not requirements but by publishing guidance of some sort. Now, it waters it down, but it also doesn't have the committee saying we want you to regulate this.

DR. COHN: Well, I guess, I am just -- once again, you have to help me with how quality measures occur out in the real world, at least the real world as I know it. I don't know how the --

DR. FITZMAURICE: -- real world better than I do, Simon.

DR. COHN: -- is is that typically there is a sort of a negotiated activity that occurs, for example, around HEDUS, where, you know, it is a public private interaction that produces these measures. So, it isn't the Secretary necessarily publishing guidelines on all these things, to my knowledge. Maybe she does. The Secretary said she also wants to have that measured for Medicare, but typically most of these measures that are out there in the community are sort of self-developed, self-generated --

DR. FITZMAURICE: And licensed and copyrighted.

DR. COHN: That is right. And they actually include uniform units of measure. They include data dictionaries, at least to some extent. They probably don't include interlocking sets of structured vocabularies. So, that actually is part of the process of developing these quality of care measures. So, I am trying to think of the value added or what we are describing there as opposed to the issue of incentives of having the quality people develop these things using these PMRIs and people reporting them that way in a way that would provide some sort of incentive in the marketplace for that to happen.

MS. AMATAYARUL: Simon, you know, I agree that HEDUS and those other groups provide definitions of terms that they want you to collect, except nobody conforms to those definitions of terms and there is no way to ensure that they are using those definitions. I can provide you with specific examples from specific institutions where they actually subscribe to two or three different data collection places each with different definitions of terms and they aren't complying with one or two or three of them.

So, they are there, but they are not being used.

DR. COHN: Well, but that is the whole point of the data dictionaries. It is there but you choose whether to use it or not. So, is that what you are --

MS. AMATAYARUL: No, I think what we are trying to do is say, hey, where are the data dictionaries that are out there and comply with them.

DR. COHN: No, actually, I thought what we were trying to do was we were trying to encourage the adoption and use of PMRI standards for collecting quality data.

[Multiple discussions.]

MR. BLAIR: But there is a different piece because in many cases, the quality features and characteristics are not in existing PMRI standards. We need to have some incentives to develop those characteristics and features and get them part of the existing standards in order for the data to improve.

Maybe I ought to give an example so you will understand that this is different than the other things we have talked about so far.

For example, a data integrity issue is that right now if you take an HL7 message, the whole concept of that message is that it is point-to-point. There is no recognition in the fact that in an integrated delivery network, it may go through three or four or five different servers and there are no audit trails that you have lost information or that the translation between one thing and another was done accurately. Those are the kinds of data quality and data integrity things that we need to encourage.

I may be out of sequence here because maybe that is on another one of these recommendations here, but at least that is part of what was in the back of my mind as I was thinking of this.

DR. FERRANS: What I really hear is that we are again sort of mixing up data quality and quality of care measures. I do think that the issue of quality of care, we have talked in the report about being able to measure outcomes and measure the quality of care and, in fact, the

-- we tied in so closely in the beginning of the report about how we said that there was a strong linkage between quality and -- I am trying to think back to -- but in any case, we might want to separate out and have the section dealing with quality of care and then look at it from the perspective of in order to measure quality of care, you know, sort of taking a different spin on it, here are some issues about message format standards. Here are some issues about this.

Here are some issues about information systems that don't necessarily have to do with the standards themselves, but have to do more with the systems.

DR. COHN: I have a slightly different suggestion, though. I do agree with you that we have had just a terrible time walking the rope between data quality and quality data. I wonder if we may just want to just retitle the section to include -- I mean, as opposed to trying to continue to make the differentiation, maybe there should be data accountability, integrity and quality data. That maybe should be the title of this section since we seem to want so badly to put them altogether.

DR. FITZMAURICE: Could I suggest that we really want quality of data and that using for quality of measures is an example, but an example of promoting good quality data -- economy or for the nation is quality measures. We would encourage the Secretary to develop this guidance. We might secondly encourage the Secretary to obtain these measures working in conjunction with the Office of Personnel Management from the health plans that service the federal employees.

In other words, what is it that is under her control or that she can do in partnership with a federal agency to serve as guidance, to serve as a leader and to find out how much does it really cost to do this.

MR. ZUBELDIA: And in doing so, I think that the first sentence that says establish incentives, that probably needs to be separated from the rest.

MR. BLAIR: I really agree with what Kepa is saying and what Richard has said. I think -- and Simon is saying the same thing in a different way. I think we have to separate out the recommendations for incentives to improve -- incentives to improve quality of care, which in turn would drive improved data quality from the other recommendations of how we would do that.

DR. COHN: That is cleaner.

MR. BLAIR: Okay. What if we had one --

MR. ZUBELDIA: Or just PMRI standards period.

MR. BLAIR: Could I suggest one recommendation where we will separate out the incentives to improve the quality of care? I will probably wind up --

MR. ZUBELDIA: I am sorry. Let me have -- where I think it should be cut. After the PMRI standards, right here, put a period and that is the sentence.

MR. BLAIR: How does that read?

DR. COHN: Yes, I think the only change I would use, rather than use PMRIs is say utilizing PMRI standards, only because people may have a choice for awhile about whether they are using PMRI standards or not and we want incent people to be utilizing it when they have another option.

MR. BLAIR: Could you read me the sentence?

MS. AMATAYARUL: The Secretary should establish incentives for reporting quality of care measures for utilizing PMRI standards.

DR. COHN: No, not for. Just utilizing.

MR. BLAIR: Now, the only thing in there is it doesn't say anything about those incentives for developing better data quality of PMRI standards.

MR. ZUBELDIA: And that is a different topic.

MR. BLAIR: That is a different topic?

MR. ZUBELDIA: And the Secretary should also provide incentives for developing quality of care standards, quality of care data standards.

MR. BLAIR: To improve the ability of PMRI standards to measure quality of care. Is that what you are saying?

MR. ZUBELDIA: Sure.

MR. BLAIR: So, that is a different -- maybe you want to tell Margaret how that would be phrased?

MR. ZUBELDIA: There are incentives for reporting using PMRI and then there are incentives for improving the ability of gathering the data using PMRI.

MR. BLAIR: Excellent, excellent.

DR. COHN: Okay. But that is not what is up there now.

DR. FERRANS: It says for quality of care data standards -- it is incentives for standards. That is the problem.

MR. BLAIR: So, it has to be incentives for reporting with or utilizing or --

DR. COHN: Wasn't this one the one that had to do with developing quality of care measures, utilizing PMRI standards?

MR. BLAIR: That is the second one you are suggesting?

MR. ZUBELDIA: That is developing the standards for quality of care data.

DR. COHN: So, it isn't reporting. So, it is actually developing the standards or developing quality of care measures or refining or improving them, whatever.

MR. BLAIR: Let me ask you if this wording would be okay. I am working on the word "developing" and instead -- so that they don't think we are suggesting that they develop totally new standards. What if we had the phrase for incorporating data quality characteristics and features into PMRI standards to improve their ability to measure quality.

DR. COHN: I actually think that they are probably fine right now. I don't know if that is the problem.

Mike has his hand up. I have probably spoken too much.

DR. FITZMAURICE: A suggestion about the first one. It currently reads, "The Secretary should establish incentives for reporting quality of care measures utilizing the patient medical record information standards." I would suggest the Secretary should establish incentives for using patient medical record information standards for reporting health care measures, including quality of care measures. Our focus is on PMRI standards. Our focus is on whenever health care measures are reported and particularly important in our economy is quality of care.

MR. BLAIR: Does everybody feel comfortable with Michael's addition? Good.

MS. AMATAYARUL: Let me make sure I have it then. The Secretary should establish incentives for using PMRI standards for reporting health care measures, including quality of care standards.

MR. BLAIR: Including quality of care measures.

DR. COHN: There probably needs to be some where a statement in all of this that this is actually -- at least the idea would be is that this would actually save the industry money in the long run by reducing redundancy and producing data flows from computerized systems as opposed to manual chart abstraction.

I don't know if we say that anywhere here but we probably need to put that rationale somewhere.

DR. FERRANS: Let me just ask this question as long as we are on the subject and this is not somewhere that we have really discussed, but when we talk about incentivizing people to automate collection of clinical data, not just to buy information systems but we have talked about paying on the margin. Are there any other mechanisms that people are aware of that -- other incentives, that could -- other mechanisms for incentives better, you know, because I would be just interested in discussing that if anyone has --

DR. FITZMAURICE: One example would be when the Health Care Financing Administration through the Medicare program collects data for the PROs. It has, I think, four contractors. You might collect more detailed information and require that or encourage that to be in -- using PMRI standards, by making an extra payment if it is in PMRI standards to the CDACS(?), they are called.

MR. BLAIR: The other piece that -- at least this is my understanding, so if I am not precise on this, then, you know, correct me. I have the impression that JCAHO has tried for a long time to put in place continuous quality improvement measures and without the data to be able to show continuous quality improvement in outcomes, they have tended to fall back to continuous quality improvement in terms of simply what is implemented in an institution because they don't have the data to really do the continuous quality improvement for outcomes.

So, that, I think, is a second area where if we have incentives for continuous quality improvement of clinical outcomes, that is going to be hard. But that is where we want to drive these standards to be able to support that. Yes? No?

DR. FITZMAURICE: Well, let me try the standards and we also want to drive systems and part of this has to be, you know, an evaluation of the benefits compared with the costs of putting things into PMRI standards. So, some of these are -- we are talking as though they are foregone conclusions, but they are not, rather than direct, let's say, have the Secretary direct HCFA to collect all this data in PMRI, direct her to investigate the benefits and the costs. The benefits may be being able to say more about the quality of a particular population of patients. The cost may be very expensive if the hospitals don't already record things, using PMRI standards.

DR. FERRANS: I will be -- I guess I will come out with one other suggestion and it is not -- is that the only other way, since they provide funds, reimbursement through Medicare, the only other way to get hospitals, acute care settings and others to invest in information systems would be to provide some kind of tax break or something like that and that would fall under legislative proposal. I don't know whether we would want to recommend that they would make that legislative proposal, but it is within, you know, the scope to recommend legislative proposals.

MR. BLAIR: Richard, with your question, I have the impression that you are trying to take the first recommendation that we have there and say what those incentives might include, such as paying on the margin, such as incentives for continuous quality improvement or clinical outcomes and you have other things as possible tax incentives or financial incentives. Is that right?

DR. FERRANS: Yes. And I guess it is just as I have been thinking about this, the issues of data quality don't necessarily

-- don't exclusively have to do with the standards. It also has to do with just the automation of clinical data collection, which is difficult to do at the point of care in a timely manner.

MR. BLAIR: So, these three items would be subsets underneath the first recommendations. Correct?

DR. FERRANS: Yes. I think having a statement of incentives may include we will just show the Secretary here are a few ways you might think about doing it.

MR. BLAIR: Richard do you want to let Margaret know how that would --

DR. FERRANS: I think she has got it.

MR. BLAIR: You have got it.

MS. AMATAYARUL: Mike -- can I get back to Mike's comment on the Secretary should investigate the benefits and costs of using PMRI standards? Is this where we want that or this another general recommendation? And doesn't that apply to everything?

DR. FITZMAURICE: It does sound a little more general.

DR. FERRANS: That sort of brings up a question. If we go through this process and the Secretary gives the authority to or says go ahead and start recommending standards or putting them in, do we fall into that situation where there needs to be a cost benefit analysis done.

DR. FITZMAURICE: At some point when you -- if we were to recommendation, for example, standards and the Secretary would say, all right, I am going to adopt these under HIPAA or under some new legislative process, if the impact is more than a hundred million dollars, you must do an impact analysis and publish it in the Federal Register. And it is probably wise to do it even if it is less than a hundred million dollars because it is something that is new and will impact some people. It will probably will have more than a hundred million dollars worth of impact.

DR. COHN: I was just going to comment about the underlined section here where the Secretary should investigate the benefits and costs of using PMRI standards. I think that is what she was asking us to do. So, probably an early recommendation -- it is probably not the wisest recommendation to say, well, we spent three years studying and we think you ought to investigate benefits and costs of doing what we are recommending here.

So, just a thought on that one. Probably there is a way to put it that is not quite the way you have just described that might make a little more sense.

But I think that -- or do you mean using it for quality measures specifically or --

DR. FITZMAURICE: No. I am looking at -- let's suppose you tell hospitals if you put your clinical data into a PMRI standard format then we will give you the payment that we would have paid the data collectors to put it into PMRI format. So, you buy the products that the systems produce to give them the incentive to have systems that will produce that.

DR. COHN: I guess I -- unless we can somehow change this one around a little bit, it sounds to me like what the first 25 pages are really all about, not the costs but certainly the benefits.

DR. FITZMAURICE: This is more certain information than we have. That is what I am saying.

DR. COHN: Well, before you decide that, I think you need to figure out it gets modified so --

DR. FITZMAURICE: We can call it research and benefits and the resources --

DR. COHN: Further research.

DR. FERRANS: When we have looked at specific standards, like HL7 or SNOMED, to name a few, there has never been any testimony about what would be the cost of implementing that standard nationally. I doubt that there is any data on there and any study of that would be of the sort of here is a list of here is a list of assumption types, such as the one that was done to support what would be the cost of doing the privacy regulations. That was part of the --

DR. COHN: Okay. I know it has been a long time, but just the observation that this sounds an awful lot like what the legislation required us to do.

DR. FERRANS: I agree with you. I don't think that we should phrase it that way and perhaps --

MR. BLAIR: Could I echo that I also think that we probably don't want to go down that path because when we did the inventory of standards, the questionnaire wound up having a section on implementation cost, maintenance costs, ongoing costs and license costs and that was the area that had the least meaningful feedback and I don't think it was because people were trying to avoid the answers as much as they really -- nobody has ever really measured that and even the SDOs don't really know because it differs for every organization and it differs by what they are actually implementing and how they implement it.

So, it is really a murky area to start to get into.

DR. FITZMAURICE: Let me sound as someone who is going along with the general trend of let's get rid of that sentence. The difficulty I see with that as the way that I stated it is that it is easier to measure the costs, particularly the capital costs of putting it in. It is difficult to measure the benefits when you can't envision what might be done with the information within a known organization, how it might be combined and the new services and products you might produce and then estimate the impact on attracting more patients to your particular organization.

You have to see into the future more for the benefits than you do for the costs and probably that uncertainty alone accounts for a good part of a reluctance to invest in information systems.

MR. BLAIR: That is a very good point.

DR. COHN: I just need to do a little time check here and just talk to people for just a second. And, Jeff, I apologize if I am taking your territory here but it is 1 o'clock. I think this is an area where we ought to hold it and discuss it. I mean, we can reflect on it as we get into our meeting in March, but I don't think it should be showing up on our March discussion with the NCDHS particularly -- February discussion.

I guess the question that I have, though, is that we have obviously, I think, done some good work here. Admittedly, there probably is more left to do. Is our strategy for the next 45 minutes -- because I think we are going to break in 45 minutes -- to do it the way we have been or are we going to try to go over the remaining recommendations. We have got a couple more recommendations -- a number of more recommendations to see if they are good enough to at least show to the NCVHS in February, recognizing that they are not complete.

I guess I would suggest that we go to a slightly lighter touch for the remaining recommendations if we can.

DR. FITZMAURICE: That sounds like a good idea because we need to get through them and then Margaret and Jeff and others can work their will and if it is close to what we were talking about, we are better off than if we haven't gotten through them.

DR. COHN: Okay. Shall we move on then to --

MR. BLAIR: Our next recommendation.

MS. AMATAYARUL: The next set of recommendations is under "Diverse State Laws and Regulations" and the first one, No. 17, is "To ensure acceptance of digital signatures as the means to authenticate electronic PMRI in a consistent manner among all states, the Secretary of HHS should propose that Congress enact legislation requiring digital signature authentication of electronic PMRI."

DR. COHN: Could I ask an odd question on that one? Because I know that the regular HIPAA regs have an electronic signature feature to them. How is that different than this?

MS. AMATAYARUL: They are not required at the present time.

DR. COHN: Well, once the HIPAA comes out, will they be required?

MS. AMATAYARUL: Not -- I thought I heard this morning that that was going to be one delay because it was not -- because at the present time it wasn't required in any of the transactions.

DR. COHN: Well, no, but what I am wondering is has Congress already enacted legislation regarding digital signature that --

DR. FITZMAURICE: No. That got stalled. The House passed a bill yesterday that supports digital signatures.

DR. COHN: Okay. Well, how is electronic -- okay. I guess, is electronic signature different than digital signature?

DR. FITZMAURICE: It could be, but I would prefer digital to electronic. Electronic could be a picture of a signature.

DR. COHN: I guess the question I have is isn't this already in the HIPAA legislation is really what I am trying to ask and that is a question just because under "Security," there was security and electronic signature for a final rule.

DR. FERRANS: Under "Electronic Signatures," my understanding is that there were standards set for electronic signatures, but that there was not --

DR. COHN: There are laws and regulations. We are asking for a law here to enable the development of a regulation. My question is we know there is not a regulation for electronic signature. We are all in agreement on that. The question is is does the regular HIPAA legislation, which my understanding it does, already include the authorization for the Secretary to develop a regulation regarding electronic signature. At least, as I read it, it did. So, that was really my question.

If I am wrong about that, I apologize.

Yes, Karen.

MS. TRUDEL: My reading of the standing, it authorizes the Secretary to adopt standards -- a standard for electronic signature. It doesn't say digital signature. Digital signature was what we initially proposed, but it is strictly in the context of the transactions, as opposed to a broad standard that could apply to PMRI or anything else. So, it is strictly in the context of the HIPAA transactions and at this point the transaction standards that we are adopting don't require any digital signature.

DR. COHN: Well, I know that, but it seemed that at some point there might be one that does.

MS. TRUDEL: Yes. Absolutely.

DR. COHN: I guess I was just trying to figure out whether this was redundant with what was already going on, though it sounds to me like if we are going to recommend something, we ought to recommend digital signature authentication period and not just for PMRI but for everything.

MR. ZUBELDIA: The security NPRM says two things, that the standard for electronic signature will be that of a digital signature. It establishes that. Then it establishes that if a digital or electronic signature is used, it has to be used according to the standard.

What it does not establish is that a digital signature will be the means to authenticate electronic PMRI.

MR. BLAIR: There you go. That is the statement --

MR. ZUBELDIA: That is what this says is that the digital signature will be the means to authenticate electronic PMRI in a consistent manner.

MR. BLAIR: Then it gets back to Simon's question of do we have the ability to say that that should be a regulation or do we have to go back to Congress for that authority?

MR. ZUBELDIA: There are two different issues here. One is that the digital signature is the means to authenticate the PMRI and that is one issue.

The second issue is that it should be consistent among all states.

MR. BLAIR: Yes. Two separate issues.

MR. ZUBELDIA: That issue of consistency among all states is what is being debated now in Congress, isn't it?

MR. BLAIR: Yes.

MR. ZUBELDIA: But it also is implied in HIPAA because the HIPAA says -- the law actually says that the digital -- or the electronic signature adopted a standard, will be deemed to be in acceptance with all the states or something. There is specific wording that says that whatever is chosen as a standard for HIPAA will automatically be acceptable by all states.

MS. AMATAYARUL: Preempt.

MR. ZUBELDIA: No, they don't use the word "preempt."

PARTICIPANT: Will be deemed acceptable.

MR. ZUBELDIA: Will be deemed acceptable.

So, there are two different issues here. One is that the digital signatures will be the means to authenticate electronic PMRI and the other that may be redundant is the consistency in all states because that may be redundant because it is already expressed in the law, in the HIPAA law.

MS. AMATAYARUL: So, Kepa, are you suggesting that we separate these two points?

MR. ZUBELDIA: Possibly or that we forget about the second point of consistency among all states. It is already implied in the law. At least we need to assert that the electronic or digital signature is a means to authenticate the electronic PMRI. I would leave it at electronic signature because then the standard as is defines the electronic signature as a digital signature.

If you make this digital, it probably will end up having to be digital anyway, but if you make this digital here and then the technology changes in a few years, then you are stuck. Right?

MR. BLAIR: So, are we modifying then the recommendations there?

MS. AMATAYARUL: So, I have, "To ensure acceptance of electronic signatures as the means to authenticate PMRI, the Secretary of HHS should propose that Congress enact legislation requiring electronic signature authentication of PMRI."

MR. BLAIR: Okay. Do we have to go to Congress for that or can the Secretary -- well, I don't know.

DR. YASNOFF: Jeff, can I suggest that we not spend time debating how the Secretary has to do this and just say the Secretary should take steps to ensure that electronic digital signatures are acceptable for authentication, are allowable and acceptable for authentication in all 50 states and let the Secretary figure out what to do?

DR. FITZMAURICE: I like that better than requiring. Much better, Bill.

MR. BLAIR: Do we need to repeat that?

DR. YASNOFF: I can't repeat that. So, I hope you got it, except that I said "allowable" and "acceptable."

MR. ZUBELDIA: Yes, and still play the after PMRI.

DR. YASNOFF: I have the same comment about the next recommendation, that we should say the Secretary of HHS should take steps to ensure that and let the Secretary figure out what needs to be done.

DR. FERRANS: Right. And, for example, a minimal standard for retention is -- I think is not the good wording because right there you are recommending a federal floor versus a federal ceiling versus a uniform standard and those kinds of details becomes very important as was learned in the privacy debate. It is states rights issues.

MR. BLAIR: The problem here, the reason that it was specified as a minimum standard for retention is that as we start to head towards longitudinal lifetime health records and as we have more communications between states with health care information, some states have very short retention requirements and others are longer. The ones that are longer are not the problem. The problem is with the fact that there are short ones.

DR. FERRANS: It is probably what we are -- are we saying we want a uniform standard? Everyone with the same -- because if that is what we are saying, we should use the word "uniform." If we raise the floor by having a minimum, we will still have variability. If we want to eliminate variability, we should say "uniform."

MR. ZUBELDIA: We want a national standard.

MR. BLAIR: A national --

DR. FERRANS: Uniform national.

MR. BLAIR: Uniform national standard for retention.

MR. ZUBELDIA: And if there is a way to put the word "preemption" in big capitals, bold face, I would do it. That will attract attention.

MR. BLAIR: Okay. Next one.

MS. AMATAYARUL: Okay. The next recommendation is "To ensure that acceptance of electronic PMRI as a legal record of business is consistent among all states. The Secretary of HHS should propose that Congress enact legislation that recognizes the legality of PMRI in electronic form."

DR. FERRANS: My sort of gut reaction to that is that I understand the intent. I think the intent is good. Somehow there has to be some mention again of some sort of uniform standard because here we get into the data integrity issue and we are not -- I don't think we want to say that all PMRI should be recognized as a legal document. I mean, it has to have that certain quality.

DR. COHN: Look at what she has done over there. I think it actually looks pretty good.

MS. AMATAYARUL: "The Secretary of HHS should take steps to ensure that acceptance of electronic PMRI as a legal record of business is consistent among all states."

MR. BLAIR: That is pretty good. Okay.

MS. AMATAYARUL: Our next section is business case and there are two recommendations. The first one is "To encourage diversity of expert representation of PMRI standards development and to explore methods for reducing barriers to participation. The Secretary should (a) fund demonstration projects to explore outreach; (b) seek comments on development of implementation guides through the Internet and (c) make teleconferencing facilities available for participation in standards development."

MR. BLAIR: Comments?

DR. YASNOFF: Jeff, Bill Yasnoff here. I have two comments.

On (c), make teleconferencing facilities available, I assume what we mean is make existing government teleconferencing facilities available. I assume you we are not asking the Secretary to build specific new teleconferencing facilities for standards.

Then on the --

MR. BLAIR: Let me check that everybody else feels okay with that addition.

DR. COHN: Yes, we are fine, yes.

MR. BLAIR: Okay.

DR. YASNOFF: On (a), fund demonstration projects to explore outreach, can we say outreach to whom, like outreach to whoever it is we want outreach to, underrepresented groups, people who find it difficult to travel. Whatever it is we are saying, let's say it.

MR. BLAIR: Good. Excellent.

How about the rest of the committee? Feel okay with that change?

DR. FITZMAURICE: I don't know what letter (a) means. Fund demonstration projects to explore outreach. Does it mean to explore paying travel of private sector experts to get to meetings and see if that speeds up standards development?

MR. ZUBELDIA: I would change it to fund outreach projects, demonstration projects to explore --

MR. BLAIR: Outreach projects instead of demonstration projects.

DR. FITZMAURICE: I am going to give you my guess as to what I thought outreach was, but I am not sure that is it. I am not sure that anybody reading it will know what outreach projects are. Reaching out to somebody.

MS. AMATAYARUL: Fund outreach projects to underrepresented groups.

DR. FITZMAURICE: For participation in standards development process in PMRI standards development. I can tell you a recent private initiative that had some federal involvement we certainly helped defray travel for people who were -- who otherwise would not have been able to.

MR. BLAIR: I think the key word is "participation" because we are not saying that it should be funded for everybody to attend, but there may be a variety of ways to encourage participation without always having attendance.

DR. FITZMAURICE: Fund demonstration projects to explore methods for improving participation.

MR. BLAIR: Did you intend to go back to the word "demonstration projects"?

DR. FITZMAURICE: Yes.

DR. COHN: Why?

DR. FITZMAURICE: Because it sounds like a demonstration, to demonstrate that funding projects to get people to participate may be worth the cost. It may not be worth the cost. It is demonstrating the value of it or the lack of value of doing this.

DR. COHN: Maybe it is fund outreach and demonstration projects?

MR. BLAIR: Or fund outreach projects to demonstrate maybe. No?

DR. FITZMAURICE: I don't know what outreach is.

DR. COHN: Why don't we hold that question for next time?

MR. BLAIR: We have gotten far enough on this and, you know, we are close enough and we will wordsmith it some more at the next meeting.

MS. AMATAYARUL: 22 is "To promote the retention of open markets for U.S. health care information system vendors internationally. The U.S. must make sure that international standards for PMRI do not discriminate against U.S. interests. To do so, the Secretary of HHS should support U.S. participation in international standards development organizations and explore incentives or subsidies to U.S. organizations that serve as secretariat/provide technical assistance and the Secretary of the Department of Commerce should monitor the activity of U.S. health care information systems vendors abroad and take appropriate steps to correct issues."

MR. BLAIR: Correct issues?

MS. AMATAYARUL: That is what we said.

DR. YASNOFF: Jeff, you picked up on my comment. What issues do we want corrected? We have to be a little more specific than that. I think we -- we know what we want but it doesn't say it here.

MS. AMATAYARUL: Imbalances?

MR. ZUBELDIA: I would say to correct anticompetitive activities or something like that.

DR. FERRANS: Could someone give me a little background on what we are -- maybe I missed that testimony.

MR. BLAIR: Could I volunteer the background?

One of the things -- and I am going to try to choose my words carefully here -- there are many countries in the world that have looked at health care information systems as an opportunity for a new industry. A number of those countries have felt as if the U.S. dominance with health care information systems is a threat to a growing industry that they have.

While they have had difficulty competing directly with some of the U.S. vendors, among the things that they feel that they could use is if they have local or regional standards that meet their needs in their part of the world. If that could be, without making it an illegal barrier, it serves as a de facto to U.S. companies.

So, if we are not actively present with experts in those international standards meetings, there is a concern that those meetings would pass standards that are detrimental to U.S. interests.

DR. FERRANS: Okay. My other question was the language at the top about we must make sure that standards do not discriminate against U.S. interests, do we need language that is that strong or do we want to say something like so it is compatible with or in sync with, however we would say it?

DR. FITZMAURICE: I would go with "compatible." That is just what I have written down, rather than to make sure that they don't discriminate against us. Does anyone have any thoughts on that?

I think it reads a little publicly better as compatible, even if we know that the interest is, that we don't --

MR. BLAIR: What is the general feeling of the group?

DR. COHN: That is fine. It is cosmetic.

MS. AMATAYARUL: Next section is relationship to NHII and here we have -- the first one is "To ensure consistency with the recommendations made to the Secretary of HHS by the NHII subcommittee within NCVHS. This work group supports those recommendations."

DR. COHN: Is that a placeholder?

MS. AMATAYARUL: Well, I had a question about this because I thought this report was ultimately coming from NCVHS. Do we need to say this?

DR. COHN: No. I mean, unless there is some -- I mean, if there are particular recommendations that are appropriate, we could include it in here.

MS. AMATAYARUL: Well, there are some later that we

can --

DR. COHN: That is right, but I haven't seen any -- I mean, if there are -- there is something from the NHII subcommittee or work group actually, then we can include them as a recommendation. I just don't think they -- they haven't started making recommendations yet, I don't believe.

MR. BLAIR: Well, I think that by the time this report hits the Secretary, there will be the proposal for the concept of an NHII. As a matter of fact, I believe John Lumpkin is really targeting that by June we have a proposal to submit. This was intended to indicate our support for that.

DR. COHN: Well, Jeff, I guess I will have to make a comment. If the recommendation that the NHII subcommittee has is for a concept, I mean, that is fine. That is not an actionable item. If there are actions, then we can put things in here, but for the moment, it doesn't sound like there needs to be anything in here on this.

MR. BLAIR: Let me say one other piece and then if you feel like this still doesn't make the case, then that is fine.

The other piece is that the concept of the National Health Information Infrastructure with those three dimensions, the caregiver dimension is -- well, actually, the caregiver and the personal dimension are heavily focused on patient medical record information. There is a great degree of overlap and expansion and reinforcement there.

So, that was the only reason why we thought that we should indicate that we feel like those recommendations are in sync with everything that our work group is proposing. That is all -- do you still feel like it shouldn't be in there?

DR. COHN: I just have not seen anything yet that the work group is proposing that is in any way actionable.

MS. AMATAYARUL: I think we have another recommendation here that addresses those issues that Jeff talked about. So, if we delete that, I think the one that we have got would stand on its own.

DR. FITZMAURICE: Could I suggest that on one of these, letter C, that we might consider putting that under the business case issues that the Secretary should monitor international PMRI initiatives for their application to the U.S. health system and the health of its population. In other words, be aware of what is going on outside your own building.

DR. COHN: Good point.

MS. AMATAYARUL: Mike, will you repeat that for me. I was trying to move it.

DR. FITZMAURICE: The Secretary should monitor international PMRI initiatives for their application to the U.S. health system and to the health of its population.

MR. BLAIR: I heard kudos around the room, so, that is good.

MS. AMATAYARUL: Do you want me to read the rest of these?

DR. COHN: Yes.

MS. AMATAYARUL: To promote the development of a National Health Information Infrastructure, the Secretary should support basic health informatics research on data representation, data mining methods, work flow, change management and human computer interface, including for consumer interaction with their health records.

(b) Provide incentives for the use of health care information systems so that the cost of these systems is shared by all who benefit. All parties, including the government, should pay market rates for transactions. And (c) provide incentives to accelerate the development and implementation of U.S. NHII, including demonstration projects, test beds and/or networks.

MR. BLAIR: Comments.

DR. COHN: Actually, I have a comment only because I am not sure -- I am sure this is something that I have to look at Kepa to see how this sentence got in there. It says, "All parties, including the government, should pay market rates for transactions." I just wasn't sure what that -- I am just not sure what the issue is.

DR. FITZMAURICE: I don't know how we would define "market rates" exactly. Is it the lowest rate for a drug, the highest rate for a drug or the average rate for a drug?

DR. COHN: I am just not sure what the -- these are separate issues actually.

DR. FERRANS: Are we recommending transactional models for information systems?

DR. COHN: I think we are -- provide incentives for the use of health care information systems so that the cost of these systems is shared by all who benefit. I think that is fine. The second sentence, I am just not sure -- it seems that there is a hidden agenda there that I just don't know what it is.

DR. FITZMAURICE: It is not clear to me either.

MR. ZUBELDIA: I am not sure why it got included into this point.

MR. BLAIR: Margaret, can you --

MR. ZUBELDIA: When we talked about it was the fact that in today's environment, HCFA or Medicare is basically the only one that doesn't pay for claims transactions or for eligibility transactions. They are not paying for the cost of the data processing and communications. They are paying for the attended lines, but they are not paying for the cost of data processing. Everybody else is paying for it. So, there is actually a cost shifting with clearinghouses and vendors. In the EDI world, to file a claim to a commercial insurance company costs zero to the doctor, but if the doctor wants to file a claim to Medicare through a claim house or through another network or through a vendor, they have to pay. That is creating an imbalance.

MS. AMATAYARUL: I think that was the issue that was trying to be addressed here. Can you propose a recommendation to bring that into balance?

MR. ZUBELDIA: We have talked about paying the marginal cost in other places and I think that in those points where the incentive is for the Secretary to pay the marginal cost, I think that would cover this need.

MS. AMATAYARUL: All parties, including the government, should pay the marginal cost for transactions, that --

DR. COHN: What do you mean by "marginal cost for a transaction"?

MR. ZUBELDIA: Well, the cost of a transaction -- and we have talked about paying for the cost of reporting, paying for -- I don't know if we need something this specific in this section. I think that it has been already captured in the rest --

DR. FITZMAURICE: I think I would argue for deleting that sentence.

MR. BLAIR: It sounds like everybody is inclined to delete it. How about Bill and David, do you feel okay deleting it?

DR. COHN: I have a comment about C also.

DR. YASNOFF: I am okay with deleting that.

DR. COHN: I actually like C but it needs some additional wording that relates it to the other recommendations, I think.

MR. BLAIR: What does C say?

DR. COHN: Development of a National Health Information Infrastructure. This has provided incentives to accelerate the development and implementation -- I guess if you look at C and the topic, it gets a little redundant.

DR. FITZMAURICE: It is actually D isn't it, Simon?

DR. COHN: Oh, it is D, I guess. It is actually C up there. It just -- there somehow needs to be a little more linkage between the National Health Information Infrastructure and PMRI and all of this somehow is woven in here. It just seems like it is a gratuitous recommendation.

MS. AMATAYARUL: Why don't we take that back and work on it some more.

DR. COHN: Great. I am fine with that.

MS. AMATAYARUL: The next section is on confidentiality.

DR. FERRANS: May I make -- before I get to that one, may I make a recommendation. I know this is sort of the 11th hour, but, you know, in the discussions with Rob Kolodner about how to appropriately reference the GCPR, given the progress that has been made, it is important in this. I am wondering whether or not we can have a very brief section on relationship to GCPR, since it has been discussed. I believe it -- at least to perhaps three hearings, we have received testimony and just a statement of support of some sort, so that there is a clear understanding that here is a project involving the lead agencies involved in providing health care for the Federal Government that is trying to utilize PMRI standards. In fact, they are trying to lead the way and that the Secretary should support this.

DR. FITZMAURICE: How about something like this, we recommend the Secretary should monitor and/or participate in the work of the GCPR and --

DR. COHN: I was actually going to make a slightly more global statement where the Secretary is encouraging activities that help promote the infrastructure and somehow linking the fact that GCPR is a lead example of one of those. But there probably are others also. I guess that was sort of how I was thinking that it ought to use GCPR as an example of something which -- I think really is helping to create the infrastructure.

DR. FERRANS: I think the other reason is that there has been interest and a lot of things about whether HCFA and other agencies in HHS would formally join the GCPR project and to the degree, I think, that the committee thinks that this is a useful project that is helping to accelerate PMRI standards or certainly is trying to work on a lot of those issues to have interoperable data between two very large health care systems, I think it is appropriate that we should it in.

MS. AMATAYARUL: Would this be separate --

DR. COHN: I am sort of looking and smiling at Richard only because if this were not a government activity, he would be under the -- what is it -- not the antitrust, the conflict of interest act and you would have to be eschewing from these discussions or making this point, but since it is the government, it is okay to discuss.

Anyway, go ahead.

MS. AMATAYARUL: Privacy. To ensure -- okay, this is another one of these recommendations that maybe we don't need -- to ensure consistency, this work group supports the recommendations of the other group. Take it out?

DR. COHN: Take it out.

MS. AMATAYARUL: Good.

To ensure that standards for privacy and security of PMRI are not violated in domestic or foreign business processes, the public and private sectors should incorporate strict provisions to protect confidentiality and data integrity in their business partner agreements.

MR. BLAIR: Comments?

DR. FITZMAURICE: I think this is being debated over at Department of Commerce in dealing with the European directive. I am not sure what we have to say about this.

MS. AMATAYARUL: There is also -- the next one is to ensure consistency with the European directive for data security initiative, work with Congress and the HHS to promote adoption of policies, practices and standards for health care that are consistent with that directive.

MR. ZUBELDIA: On the previous one, I think it is already part of the privacy NPRM.

DR. FERRANS: You know, I have been thinking about this and my sense is even though it is being dealt with elsewhere, if we don't mention it in the report, it will look as if we are not cognizant of the tremendous issues of security and privacy surrounding PMRI. I would recommend that we are mentioning it even though it is redundant with the work of other groups within the committee. It is a report going to the Secretary. We should make sure that the Secretary understands that we recognize the issues.

DR. COHN: I also think that this is an area where we may want to have the Subcommittee on Privacy and Confidentiality specifically review this section to see what else they think is appropriate for adding and the March meeting is the perfect frame to make that point. Because I agree with you. We can't -- it is a critical part of the discussion.

MR. ZUBELDIA: I think if we are going to do that, when this is sent to the entire NCVHS as a draft, at that point it needs to go with some sort of cover letter saying that this section is left for the privacy subcommittee to fill in. Otherwise, we are going to get slammed by not having addressed privacy.

DR. COHN: Well, I think we have it filled in. I think what we are asking is a secondary review from them and I think we can do it at the March meeting at the full committee meeting. I think there is time for that.

DR. FITZMAURICE: I think my concern with No. 26 is that here we have the national committee telling the public and private sector what they should do with regard to confidentiality and integrity and that may be addressed in federal legislation. It may be addressed in the privacy regulation. It is the strict provisions. I mean, the regulation will do that. We might recognize that it is important and encourage the Secretary to keep on safeguarding the confidentiality of patient medical record information that is individually identifiable.

DR. FERRANS: How about the Secretary should encourage both the public and private sector to incorporate, I mean, something -- because --

DR. FITZMAURICE: But she already did that with a report back in September of 1997.

DR. COHN: I guess I am confused. What is your issue with that one? It seems to be pretty straightforward. It may be redundant with all the things that are going on, but what is -- do you have an issue --

DR. FITZMAURICE: What is the action for the Secretary?

MS. AMATAYARUL: Yes. This is addressed to the public as opposed to the --

DR. FITZMAURICE: How is the Secretary going to enforce or encourage strict provisions, other than what she has done? Put out a report. Put out regulations.

MR. BLAIR: Could you read the sentence for me, please?

MS. AMATAYARUL: To ensure that standards for privacy and security of PMRI are not violated in domestic or foreign business processes, the public and private sector should incorporate strict provisions to protect confidentiality and data integrity in their business partner agreement. This is the one relating to the issue of offshore transcription, stuff like that.

MR. ZUBELDIA: How about the Secretary should require the public sector -- the public and private sector to incorporate strict provisions?

MR. BLAIR: Is that satisfactory with everyone?

DR. YASNOFF: Take steps to ensure.

MR. BLAIR: Take steps to ensure.

DR. FITZMAURICE: But does that mean that the current privacy regulation is deficient and this should be a comment on the current privacy regulation?

DR. COHN: We don't have a current privacy regulation.

DR. FITZMAURICE: But there is a draft --

DR. COHN: We have a notice of a proposed rule.

DR. FITZMAURICE: So, should there be a comment on this point in the NCVHS comments on that privacy regulation, draft privacy regulation? I mean, is that the place --

DR. COHN: Probably.

MR. BLAIR: Is this our last recommendation?

DR. COHN: There is one final one here that I am --

MR. BLAIR: I am sorry. I didn't mean to cut this off. Was there any other comments on this one before we go on to the next one?

DR. FITZMAURICE: Nothing really. I have expressed what I think about it.

MS. AMATAYARUL: We will work on it.

DR. COHN: We will work on it. It is not done yet.

MS. AMATAYARUL: The last one is to monitor violations of privacy legislation/regulation. The Secretary of HHS should establish a center for health care privacy reporting.

DR. COHN: Yes. That one, I actually was trying to figure out where that one came from.

DR. FITZMAURICE: Does this overlap with the enforcement -- if there is an enforcement branch or an enforcement part of the inspector general's office or office of civil rights, would this be -- do we recommend that this is in a different place than where enforcement takes place for privacy? Is it a research function?

DR. YASNOFF: I think we need to be -- if we want to recommend this, we need to be specific as to what this center should do. I mean, it is implicit that it has to do with health care privacy reporting, but do we want this to be a place where information is collected and reported to the public or, as Mike has mentioned, do we want this to have to do with enforcement?

What is it that we want this to do? It is not clear to me.

MR. BLAIR: You know, maybe what we could do with this is -- Bill Braithwaite indicated that they were probably going to set up I think within the Civil Rights Department of the Justice Department the enforcement procedures. Maybe we could see if we could link and reinforce that type of plan with this recommendation so that it would be either a function that can collect the instances of violations to be passed on to the Civil Rights Department or within the Civil Rights Department. Maybe we could do a little bit more homework to flesh this out.

DR. FITZMAURICE: Are we asking for policemen or are we asking for public disclosure of violations?

DR. FERRANS: It could be something as simple as a site where people could report.

MS. AMATAYARUL: Like CERT(?).

DR. FITZMAURICE: But they are likely to have that anyway as part of enforcement. If I think there is a violation, then I am going to call the privacy police, not the research center.

MS. AMATAYARUL: Could I just make one other comment?

DR. COHN: I have got one other thing for the appendix, but go ahead.

MS. AMATAYARUL: I revised the message format in medical terminology and that was passed out to you. You have got a copy of that.

MR. BLAIR: I don't think I did, though.

MS. AMATAYARUL: It is to your left, Jeff.

MR. BLAIR: Thank you.

DR. COHN: I actually had one comment about appendix item, "Guiding Principles for Promoting Guiding Principles." There is something wrong with 11 and I think that it -- the second sentence is a problem, but if we are -- somehow a guiding principle at this level of specificity is almost more confusing. It says here, are consistent with the characteristics and attributes for clinically specific PMRI terminologies and then says these characteristics and attributes have been recognized within, I presume -- I don't know what scholarly in the industry, but --

MS. AMATAYARUL: Scholarly work.

DR. COHN: Scholarly works in the industry. Now, neither of those attributes -- and this is probably a place to either list those attributes and characteristics or footnote specifically which documents you are referencing or something because this one just sort of leaves you like --

DR. FITZMAURICE: It is not likely that they would be supported by a standard developing organization or even become a standard if they didn't meet those characteristics and attributes and if they didn't, the standard developing organization probably has some good reason for it and it is probably something that should be debated at that level.

MR. BLAIR: I don't quite understand what you are saying. Say that again, please.

DR. FITZMAURICE: It says are consistent with the characteristics and attributes for clinically specified specific PMRI terminologies. We don't know what they are at this point, but we can certainly believe that the standard developing organizations would have to consider them as they take a PMRI proposed standard and make it a standard.

DR. COHN: Well, actually, I think we know what they are. It is just that there is a whole bunch of things that we have identified and we either need to come up with a --

DR. FITZMAURICE: A desiderata?

DR. COHN: A desiderata or a -- list them or something because it is a little too high level to be -- I don't think it is a big deal.

MR. BLAIR: We can do that.

Is that our last recommendation? Then let me just discuss with you a little bit about, you know, our next steps here.

By the way, thank you, gosh, everybody. We worked until 7:30 last night. Folks hung in with us through all of this stuff and, as you could tell, we really thrashed out a lot of things, even though we have more to do. I have heard from so many people that they really are pleased with the document, even though the process is arduous.

Margaret, thank you especially for the way you have gone ahead and facilitated and enabled all this stuff.

MS. AMATAYARUL: You are welcome.

MR. BLAIR: I believe that -- was it Jackie or Margaret that asked for us to get the version that is going to be distributed at our full committee meeting to them by this next Friday. Is that correct?

MS. AMATAYARUL: Marjorie had said -- Marjorie Greenberg had said that things needed to be into her by February 11.

MR. BLAIR: February 11.

MS. AMATAYARUL: At least that is what I heard her say.

MR. BLAIR: Margaret and I will make sure that -- we have already touched base on our calendars. So, we should be able to get the updates in place for the next version so it will be out and distributed.

Marjorie, are you here?

DR. COHN: No.

MR. BLAIR: She is not. I am assuming that if she gets it by the 11th, that she will have it distributed probably a week before the full committee meeting.

DR. COHN: Send this to Jackie.

MR. BLAIR: Yes. Okay. Are there any other issues or concerns or processes with respect to the report to the Secretary that --

DR. COHN: I guess the only question -- the only thing that I have to just wonder about and that is the question of how we are going to deal with the two and a half hours at the NCVHS meeting. Are we going to have Margaret walk everyone through the recommendations?

Just an interesting thing to think about.

DR. FERRANS: Background and recommendations. There should be a high level review of the background and then a step by step of the crucial observations and recommendations, not necessarily all the observations, but observations and recommendations and then there should be a -- are there any red flags that members of the committee are worried about or is it more wordsmithing and sort of take a temperature after that.

DR. COHN: I think we should probably try to keep away from wordsmithing since this is not the final report, but it is more conceptual issues, things that we are missing, things that are too far off that we are misperceiving, et cetera, et cetera.

DR. FERRANS: I think, I mean, it would just be my perspective, is that if we walk them through all the observations and recommendations, they got through that and they are okay, then that certainly would be the kind of consensus that would allow us to go forward and just, you know, edit the report leaving things intact but wordsmithing at --

MR. BLAIR: I think that that is probably the most efficient way really for us to do it in two and a half hours. I think we need to probably give a little bit more thought to it in terms of how it is presented and what we focus on. They are going to get the information beforehand, but many of them may be overwhelmed by this document in the same way that I tend to be overwhelmed by some of the population and others from other groups.

So, maybe we could have a conference call during this next week or two between Margaret and you and me and we could try to think of the way to help the group digest that information so that they can make constructive comments.

Is that okay?

DR. COHN: Yes. I think that sounds great. I was just bringing the issue up because that is really the next big issue.

MR. BLAIR: Yes. No, good idea.

DR. FERRANS: My only last question was were we okay with this whole data quality, quality of care?

DR. COHN: Probably not, but we have chances to go through it again.

MR. BLAIR: Actually, I don't think we were okay with a bunch of the things. There is still -- that one happens to be probably be more muddy than the others.

DR. COHN: The good news is that we are not done yet. This is still in process. But it is clearly time to get the input from the full committee. I think if we went to them in June, having worked on it as hard as we are working on it, I expect them to pass it the first time. Chances are zero.

MR. BLAIR: My last comment is to thank Simon for making the extra available to us today and for, you know, helping us at every step of the way.

We are adjourned.

[Whereupon, at 1:55 p.m., the meeting was concluded.]

Department of Health and Human Services

National Committee on Vital and Health Statistics

JOINT MEETING OF SUBCOMMITTEE ON STANDARDS AND SECURITY AND WORK GROUP ON COMPUTER-BASED PATIENT RECORDS

January 31 - February 1, 2000

Proceedings By: CASET Associates, Ltd. 10201 Lee Highway Suite 160 Fairfax, VA 22030 (703) 352-0091

PARTICIPANTS:

Subcommittee:

Staff to the Committee:

Work Group:

TABLE OF CONTENTS

January 31, 2000

February 1, 2000

P R O C E E D I N G S (9:50 a.m.)

A F T E R N O O N S E S S I O N (1:05 p.m.)

P R O C E E D I N G S [8:50 a.m.]

JOINT MEETING OF
SUBCOMMITTEE ON STANDARDS AND SECURITY
AND
WORK GROUP ON
COMPUTER-BASED PATIENT RECORDS

Proceedings By:
CASET Associates, Ltd.
10201 Lee Highway Suite 160
Fairfax, VA 22030
(703) 352-0091