DR. LUMPKIN: Good morning. It's been a very busy summer. I know that many of the committees have been working very diligently. It's time to review some of that work, so we'll get going.

Let's start as usual with some introductions. Let's do the announcement first, and then we'll do the introductions.

MR. SCANLON: We're very pleased the Secretary has signed off on three new appointments for the National Committee and two reappointments. She signed off on Friday, and all of the prospective new members have already agreed to serve. Let me tell you who they are.

First all, we are having Simon Cohn has accepted a reappointment, as well as Kathleen Fyffe. We're happy to welcome them to reappointments.

Then in terms of new members we have good geographic distribution here as well. From Texas we have Mark Rockstein(?), who Bob, I think you and others nominated. Dr. Rockstein is a professor of law and director of the Health, Law, and Policy Institute at the University of Houston. He would bring us expertise in privacy, health law, and ethics. So that's a very good addition to the committee.

In addition, Dr. Kepa Zubeldia, who we talked to this morning as well. Dr. Zubeldi has been appointed. Tepa actually lives in Utah, so he is our first member from Utah. Tepa holds many hats. He has testified before the committee before. Among his current jobs is the vice president of technology at the Envoy Corporation, which is probably the largest or second largest health care clearinghouse in the United States. He serves on a number of standards bodies and other institutions as well.

Finally, Dr. Andy Kramer, who is a professor of geriatric medicine at the University of Colorado Health Sciences Center in Denver. Dr. Kramer, you remember, was nominated by several members of our Population Subcommittee and other folks in HHS. Dr. Kramer is a leading expert on long-term care, particularly in the areas of quality and outcome measures. We're happy to fill the complement of the committee.

I think Tepa was able to be here today, but Dr. Kramer and Dr. Rockstein were unable to come. They will be here for our November meeting, probably for subcommittee meetings before then. So we are happy to welcome all of those folks to the committee today.

It's probably not early to begin thinking of the next of reappointments, probably for the 2000. We'll probably have four appointees as well.

DR. LUMPKIN: Thank you. We're certainly looking forward to the new members starting. We have plenty of work. So welcome.

We'll start off with introductions.

[Introductions were made.]

Okay, on our agenda we've got three items which are scheduled for action tomorrow. As is our practice, we would like to get those introduced, see if there are any issues that the subcommittees may want to address, that the full committee would like the subcommittee to address. They have them on the agenda of their meetings.

So Lisa.

Agenda Item: Report on Medicaid Managed Care Data Collection and Reporting, Action Item 9/28 - Dr. Iezzoni

DR. IEZZONI: Well, we have these two reports that we'd really like to get off of our desk at this point. It feels like years, and it has been since we've been working on them.

I'm not sure what each of the people who are not on the Subcommittee on Populations has, but I think that you have a copy of the Medicaid managed care report. I don't know if you have a copy of the islands and territories report. I guess you don't.

Well, those are the two action items that we're hoping to have your input on tomorrow when we vote. So perhaps we should make sure that people get a copy of the islands and territories report.

MS. GREENBERG: I didn't realize that was actually coming up for a decision, as well as the Medicaid managed care report. It was basically approved at the last meeting to be sent out to the participants for comment. So I think unless there are significantly changed.

DR. IEZZONI: Again, I wasn't here at the June meeting, and so maybe I missed some of the nuances of the decision that was made for that.

DR. LUMPKIN: Has it gone out, and now it's back and ready to go?

DR. IEZZONI: Well, it has gone out, and we have gotten a few comments. We got some fairly lengthy comments from HRSA. And we got a laudatory comment I think from Palau.

Dale, perhaps you could come to the microphone and just give us an update on where we are in terms of the comments coming back on that. This is the insular areas report again.

MR. HITCHCOCK: We just got back comments. Some of them came in last week. We really haven't had time to incorporate them. None of them really address, except for possibly the HRSA one, the recommendations that we made. And HRSA was one of the last ones to come in, so we need to think a little bit more about that, and decide whether it will result in any changes that need to come back before the full committee or not.

Beyond that, we got comments from Puerto Rico, from CDC, some interesting comments and some thoughtful ones from Joe Wiser(?), who was the regional health representative who came and talked to us, and gave us some really interesting comments on the report, some of which I need to follow up with.

Basic things like the title of the report, that we had referred to the Pacific Islands as insular areas. Joe was saying that's not in common usage. We should talk about jurisdictions, and we should talk about freely associated states versus flag territories. We've got some semantics to deal with.

DR. IEZZONI: It's a very long title of the report.

DR. LUMPKIN: Let me see if I understand. We do have a report that we have approved for release. And I guess you don't need to bring it back if you like it the way it is.

DR. IEZZONI: I guess let me just ask for an opinion. Do we need to bring for now, the insular areas and the Puerto Rico and Virgin Islands report back to the full committee?

DR. LUMPKIN: Let me suggest that your subcommittee tell us that.

DR. IEZZONI: Our subcommittee what?

DR. LUMPKIN: Tell us whether or not, based upon the comments, you think it needs to come back to us, or you are comfortable with it the way it is.

MR. HITCHCOCK: I think that's the way we left it. Basically, I think we were not really required to bring it back unless the recommendations changed substantially, and I don't see that.

DR. IEZZONI: Then we won't bring it back.

At today's meeting, this afternoon you guys, Barbara, Elizabeth, and Paul, we want to make a decision, so you might hear about it tomorrow, but hopefully we'll consider it done, providing that we make the revisions based on comments from the field.

So the Medicaid managed care report, just to reprise for you all, this initiative started two years ago. We went out to the field to Arizona and Massachusetts and we heard from a lot of people in Washington. We had a subcontract with people at GW to look at the state of regulations around data reporting for Medicaid managed care organizations, and the perspective of state officials and other stakeholders around data for Medicaid managed care.

Again, I wasn't at the June meeting, but I understand it was a fairly exciting time when you all started talking about this Medicaid managed care report. Based on what I understand happened at that meeting in June, we made the decision to separate the draft contract language, which Sara Rosenbaum and her colleagues at GW were drafting.

We made a decision to take that off and put it on a side table, and decide what to do with it later. But to try to get approval for the report, which basically describes what we heard from the field. What we heard in our hearings in Arizona and Massachusetts, around the table here in Washington, and describes what the GW people heard in their survey that they did of the Medicaid managed care people and the stakeholders in the states.

That's what you see before you now, is the Medicaid managed care report stripped of the draft contract language, which we will make a decision about how to deal with that separately.

So unfortunately, the staff did not have the time to prepare the executive summary, and so you have the report. The executive summary will be a wordprocessed version I suspect, just basically copying the recommendations, with maybe a paragraph or two introduction at the beginning of it.

So what we are here to do today I guess is to get comments from you all on the recommendations. Again, the summary of the report findings start on page 40, and the recommendations start on page 42. Our subcommittee will be talking more about this later today I think in our breakout session.

DR. LUMPKIN: Are there any comments or concerns that people would like to put before the committee?

MR. GELLMAN: I appreciate that the contract language has been dropped. However, I still oppose the report. Basically, what it looks like to me is the classic NCVHS report; collect more data, share it with more people. The report includes basically only the merest tip of the cap in addressing privacy, but not in any way that would interfere in any manner with the full, complete exploitation of patient data for every purpose that could be imagined.

I don't find any evidence in the report that the community of people concerned about privacy was consulted. There are a bunch of people that we already know, people that have talked to this committee before. I don't see any of them referenced in here. I don't know whether they were or they weren't.

The section in the report on consumer representatives on page 24 doesn't reflect a single consumer representative that made a single objection about privacy, and my suspicion is that the people that drafted this report only talked to people that want to exploit data.

I don't find any discussion in the report of the consequences of the recommendations for privacy. I don't find any place in the report where a recommendation for more data sharing was changed because of privacy concerns. I don't find any recommendations for additional privacy protections because of the recommendations that are being made.

I don't find any consideration of technological or administrative procedures that might allow use of data in a manner that fully protects patient privacy. And I don't find any analysis of loopholes in existing law that would place data at greater risk for privacy because of the recommendations of this report.

I'm not arguing that this report doesn't put its finger on a problem. But I think it is one-sided. It says take data and share it with people, and don't pay any attention to privacy, and I don't think it's good enough.

DR. LUMPKIN: Other comments? Simon, you had some concerns with the last iteration.

DR. COHN: I will apologize. I actually did not receive the copy of the report in advance of this meeting. So I wanted to comment I was just going to reserve the right to make comments tomorrow after I had reviewed it tonight. Other than that, I'm hoping that this is a much improved version.

DR. LUMPKIN: Any others? For those of you who do have concerns, although the subcommittee is meeting tomorrow at --

DR. IEZZONI: The first meeting will be discussing this today.

DR. LUMPKIN: Today.

MS. GREENBERG: And tomorrow.

DR. IEZZONI: Tomorrow I had hoped we were going to discuss our next initiative. At 3:30 p.m. we're hoping to talk about the Medicaid managed care report.

DR. LUMPKIN: Given the fact -- because I know some people may not have gotten their packets before they left, I was just wondering if it would probably just be fair to the subcommittee if people have concerns, that they would get them to you, so at least even though it's not on your agenda tomorrow morning, you would have some heads up.

DR. IEZZONI: Yes.

DR. LUMPKIN: So I would ask that people, if they do have the opportunity to look at them, and if they want to consider at least cruising by and sharing them at eight, so that the committee can then allot their work, and decide whether or not or how they want to bring this back.

MS. GREENBERG: Right now I think the agenda is to start at 8:30 a.m. The privacy and confidentiality, on the other hand, is meeting at 8:00 a.m.

DR. LUMPKIN: So since many of the individuals who may have concerns, but are not on your committee are also on the privacy subcommittee, they could perhaps just sort of fade away at 8:25 a.m., and let Lisa know if there are any concerns.

DR. IEZZONI: And if you have specific language that you would like to replace the context with, please give it to us. And we are happy to consider any changes at this point.

DR. LUMPKIN: Okay, thank you. A letter of progress report to the Secretary on standards for computer-based patient records.

Agenda Item: Letter/Progress Report to Secretary on Standards for Computer-based Patient Records, Action Item 9/28 - Mr. Blair

MR. BLAIR: We would like to present that today. I'm saying 'we' in the sense that I have discussed this, this morning with Simon. He is in a position to help you go through this much better than I am as a blind person. So I'm going to turn this over to Simon.

I think the only comments I might make before I do to help you go through that is we have gone through several drafts of the progress letter. It was distributed electronically at least within our Subcommittee on Standards and Privacy and Security. And it was in the briefing book.

However, if you haven't had a chance to read the briefing book, Simon will take you through it now. Let me turn it over to Simon.

DR. COHN: I guess this has to do with the desires of the chairman, if he would like us to just read it and go through. It's a short enough document that people may have already had a chance to review it.

DR. LUMPKIN: Have people had a chance to review? Has anyone not had a chance to review it? Is this available to the people on the Internet?

DR. COHN: Maybe I should just read through it then.

DR. LUMPKIN: Yes, why don't you just read through the letter.

DR. COHN: Everyone should be aware the context of this is this is just meant to be a progress report to the Secretary, just sort of alerting her to the progress of the activity related to uniform standards for patient medical record information, and the work of the Work Group in identifying the focus areas, and what the Work Group intends to do between now and next August.

The letter starts out, "Dear Secretary Shalala, On behalf of the NCVHS I am pleased to inform you of our progress on the next report we are preparing for you as mandated by the Health Insurance Portability and Accountability Act of 1996."

Now hopefully, there are no changes on that, but as we move into the meat of the area, we can take things in a paragraph by paragraph basis if people would like.

The next paragraph is, "HIPAA directs the NCVHS to 'study the issues related to the adoption of uniform data standards for patient medical record information and the electronic exchange of such information,' and to report to you 'no later than 4 years after the date of the enactment of the Health Insurance Portability and Accountability Act of 1996 recommendations and legislative proposals for such standards and electronic exchange.' The Computer-based Patient Record Work Group within the NCVHS's Subcommittee on Standards and Security has the responsibility for studying the issues and preparing the committee's report by August 21, 2000."

Comments or otherwise? No, okay.

"We believe this report will be important to you and the nation because it will make recommendations about standards that will lead to significant improvements in the efficiency and effectiveness of the health care system for the delivery of high quality care. This reflects the first of ten guiding principles for selecting patient medical record information standards," and there is an attachment that lists those, Attachment 1. "These principles are based on the guiding principles for selecting standards for HIPAA."

Comments? Good.

"This report will address the following six focus areas as they relate to patient medical record information." And further information is in Attachment 2.

Message Format Standards

Medical Terminologies

Business Case Issues

Standards Necessary to Support NCVHS's Vision of a National Health Information Infrastructure

Standards for Data Quality, Accountability, and Integrity

And finally, Effects of Inconsistencies Among State Laws

"In gathering information for this report, so far we have heard from 79 testifiers during five hearings over a total of nine in 1998-99. We plan for additional hearings during the next few months."

"So far testimony has shown some areas of significant accomplishment in standards for patient medical record information by both the private and public sectors. However, the witnesses believe that we need additional areas to be covered by standards, as well as more widespread adoption of existing standards. First and foremost, this would improve direct patient care, such as by fostering decision support systems to reduce adverse events. Second, these advances in standards are essential for addressing health care system needs in areas such as clinical efficacy, effectiveness, performance measurement, and research. The witnesses also believed the government can find ways to play a constructive role to advance progress. The committee is currently developing recommendations on how best to proceed."

Comments about that paragraph?

"Although it was not included within the scope of this work effort, many testifiers stressed the importance of legislation to protect the privacy and confidentiality of health care information."

Comments? Final sentence,

"The NCVHS looks forward to delivering a cogent report on time with the recommendations and legislative proposals. We welcome any comments."

So that is the letter. There are two attachments. I don't want to necessarily read both attachments completely. The Work Group and the Subcommittee will be reviewing this, this afternoon. I think there are a couple of wordsmithing changes in the attachments area.

One I caught specifically had to do with Attachment 2 under medical terminologies, where it says in the second sentence, "It will include issues related to convergent medical terminologies." It should be changed to convergence of medical terminologies. Other than that, I thought the attachments, at least to my eye, looked fine.

Do people have any comments about either the substance or style of the letter?

DR. LUMPKIN: Actually, I have two comments. The first is that one could read this letter and assume that there is nothing going on, and that really what the recommendations of the committee are not to generate or create this whole industry of standards for electronic medical records and their transmission, but in fact to try to rationalize the process so there is some consistency between what may be accepted by one sector of the industry versus another.

So I think there may be some way to say that. And then the third is that actually as I read the scope, the issues of privacy and confidentiality are within that scope, because it does say issues related to. And so I think that perhaps that introductory sentence might be changed just a little bit.

DR. COHN: Okay, so you are referencing the sentence that has the testifiers stressing the importance of legislation?

DR. LUMPKIN: Right.

MR. BLAIR: The reason that we phrased it that way, and it's up to you if you wish to alter that, was that at one point we had had data security among the focus areas for the Work Group. And there had been a Work Group decision to not include that because of the privacy and confidentiality work effort that was separate. So it was stricken from the focus areas on the Work Group.

That may be different than what you are referencing now in terms of the overall scope. That was the rationale for why it was said.

DR. LUMPKIN: I think there is a difference between what we think are issues, and what the subcommittee may be tackling itself in reference to earlier activities by the Committee, earlier activities by the Institute of Medicine, a report on computerized patient record. I think many of those documents may adequately describe the privacy and confidentiality issues. But I think it still is germane that our report would note that that is one of the issues related to the electronic medical record and its transmission.

DR. COHN: So I'm hearing a suggestion to change the introductory part of that sentence to more fully state that it's of note, or that we should emphasize that many testifiers stressed this as an important issue?

DR. LUMPKIN: Right, and that it will be part of the report. Again, it may be by reference to other documents.

DR. COHN: The first comment, I sort of missed what to do with it. You were making a comment about the fact that -- and I think we agree -- that a lot of this Work Group and the recommendations have a lot to do with trying to bring perhaps more convergence into the area, as well as provide a little leadership in the overall definition of standards?

DR. LUMPKIN: Actually, now that I reread it, it is covered in the last paragraph.

DR. COHN: That was what I was thinking.

DR. LUMPKIN: Never mind.

DR. COHN: Other comments? Kathy?

MS. COLTIN: I wasn't certain what you were including when you talked about convergence of medical terminologies. But the one area that I didn't see explicitly mentioned, and it seems to me medical terminologies is the focus area where it might fit is consistency with, or compatibility with administrative transactions.

Because I know that one of the efficiencies that health providers are looking for is to be able to actually generate the administrative transactions from the electronic medical record system. That may mean mapping one coding system to another, but it seems to me that it was an issue that ought to be included in one of those focus areas. I wasn't certain that it was.

MR. BLAIR: We did have more detail in the letter which alluded to that issue, and a number of others. And in the conference calls that our Work Group did have, there was a decision to try to keep this at a high level. This afternoon in our Work Group will could revisit that if we want to begin to add greater specificity to the description of the issues that were raised. But that was why that level of issue identification wasn't there.

DR. COHN: Actually, just to further clarify also, I think if one looks in Attachment 1 under the ten guiding principles, I think the intent of Principle 3, which is to bring consistency and uniformity to the use of other HIPAA standards to their data element definitions and codes, and was meant to begin to address that issue.

But I'm hearing from Kathy is some sort of a comment that we should make as with the focus areas, that has to do with consistency with administrative transactions, which I think the Work Group will consider a possible change to the Attachment 2. We may want to wordsmith that.

Kepa?

DR. ZUBELDIA: I have a question whether the security issue should be one of the bullet points, or you are assuming that security will be covered under the administration side of HIPAA? I'm not talking privacy, strictly the security components. Because the security for the administrative transactions is not the same as the security for medical records, although HIPAA is supposed to contemplate both. Should that be some specific focus in here?

MR. BLAIR: The focus areas that are referenced there come out of the work plan that was created during last year, and was the guide for how we did our information gathering. So data security at one time was a focus area, and had been removed I think about nine months ago. That's why it's difficult for us to put it back as a focus area now, because the focus areas were the area where we gathered information, and we did not ask for witnesses, and specifically gather information on data security.

I think we can mention the importance of it, and the fact that there were comments that were added by witnesses when they were addressing other topics, that addressed their concerns about privacy and security. But I feel like it's difficult for us to say that that one of the focus areas that we had in the work plan.

DR. LUMPKIN: I also think that we need to reference the earlier document that we produced, because the intent of that earlier recommendation was to cover both data at rest, as well as data in motion. I think that ought to cover the scope of what we will be discussing here.

DR. ZUBELDIA: Just a reference like that would justify having it out of a document.

DR. HARDING: I just have a clarification of what the thought was of what you were going to do with that next to the last paragraph? Is that going to be left intact, or is there a therefore that comes after that? It states that many testifiers stressed the importance of legislation to protect privacy of health care information, therefore.

DR. LUMPKIN: I think therefore the committee will address it.

DR. HARDING: It just kind of leaves it. It's a dangling sentence.

DR. LUMPKIN: We're actually not going to wordsmith this today.

DR. COHN: We would appreciate any help the committee would like to provide, so we don't have to wordsmith it tomorrow. So I guess the question is, the point of this sentence was a comment that obviously within HIPAA there is already the requirement that Congress act by August 21, or the Secretary will come up with recommendations. I think this was just a comment stating that it is still very important for legislation to occur.

I don't know what therefore there would be at this point, since Congress is already on the hook at this point. Dr. Harding, do you have a comment about what you would like to see there?

DR. HARDING: I just got this. We could state that. Therefore, we are awaiting Congress' action. Therefore something. That's a funny sentence to just be there. It's just a statement of fact, without a how does that affect anything.

DR. LUMPKIN: If you have some suggestions that may come to you. I think what we are really thinking about at that particular point is some assessment by the committee, and that would be in the ultimate report, so we don't have to get it necessarily. The committee looked at privacy and confidentiality concerns, and feel that they were adequately covered by the following document. Or that additional work may need to be done prior to the adoption of these standards.

It doesn't have to be a really in-depth expose of the privacy and confidentiality needs of electronic medical records and their transmission. To the extent that they have been covered by other documents, I think that's appropriate to do it by reference or referral.

MR. SCANLON: Since privacy and confidentiality fills out the picture of what the HII would look like, and it's so critical, the committee may want to add a sentence or two that it stresses that obviously the full potential of standards and medical records technology would depend on adequate privacy and confidentiality protections, and then cross-reference and urge support for the legislative activities, and regulatory as well.

I think the point is to sort of acknowledge actively the privacy framework needed, and include some sort of reference in there as well. It doesn't have to be a lot of detail.

DR. STARFIELD: I'm not sure I understood the response to Kepa's comment about the security standards, which are really quite monumental in this whole issue of computer-based patient record, and how are we going to deal with that? At least we have to say how we're going to deal with it.

DR. COHN: I would try to make an initial comment on that without it being a final comment. I think we are all expecting that there will be a final regulation related to security of medical information that should be coming out sometime in the near future. And at such time as that is released, the Work Group and Subcommittee will review that document to evaluate its adequacy for further clinical information standards work.

I think the presumption right now is since we don't know anything more, is that we're hoping that it will be adequate. But if it's not, then we will have to consider that in the context of any report either for August or subsequently.

DR. STARFIELD: I think that has to be said somewhere.

MR. BLAIR: Could I support Simon's comments right now? Because please keep in mind that this is a progress letter which is happening at a time when we have yet to finish the information gathering phase, and the Work Group during the end of this next month will just begin to deliberate the issues that are observed from the information gathering. And then by December begin to, for the first time, start to formulate our recommendations.

So I think that we want to be careful in this progress letter to not jump ahead and start making recommendations, but to just identify that these are the things we have heard that we find are important, that we could report at this particular time. There are some issues like confidentiality and security, which clearly is a high enough concern that John, as you indicated, that we will be giving it additional attention. We will have some recommendations, or some statements of support in the final report.

MS. FYFFE: Let me try and get some clarification here. The proposed rules that came out in 1998 about security and electronic signature, did they not primarily deal with the administrative transactions?

DR. LUMPKIN: No, actually those rules really governed security in the broader sense.

MS. FYFFE: Thank you.

DR. COHN: Other comments? I want to personally thank the full committee, because you have made some very valuable recommendations to improve the substance of the letter. We will come back to you tomorrow afternoon with some modifications to the letter.

I think what I'm hearing is that the modifications will be primarily around the next to final paragraph, and will expand some issues around privacy and confidentiality, as well as make a comment on security.

I'd like to thank everyone.

MR. BLAIR: Thank you, Simon.

Agenda Item: Committee Process for Addressing Issues Between Meetings, Action Item 9/28 - Dr. Lumpkin

DR. LUMPKIN: Thank you.

The last item is under Tab F, which we have seen before.

MS. GREENBERG: Some e-mail traffic yesterday resulted in the version that is just being passed out to you. It actually in content, is intended to be identical to what's Tab F, but to clarify the two scenarios. There is identified a need to make committee recommendation or comments between meetings.

Do you want me to walk through the document?

DR. LUMPKIN: No.

MS. GREENBERG: Do you want to give people a few minutes to read this revised version?

DR. LUMPKIN: Well, actually, what I'm going to suggest, just because we have spent an adequate amount of time on this particular document, and we have plenty of committee work to do, and there is no grave urgency to get this document approved, what we will do is if there are concerns about it, so we can give people a chance to read it.

If there are concerns about it, when it comes up for adoption tomorrow, we'll just take those concerns, and bring it back to the next meeting.

DR. COHN: Well, I don't think that there is a grave urgency between now and November to have this concluded, I would speak that we actually do have an urgency in November to have this approved, recognizing that there will be NPRMs, as well as some final regulations coming between the November and March timeframe we believe. And we need as a committee to think how we are going to able to respond to those in a timely manner.

There is a long time between November and March. It will be fine if we don't have it until November, but it can't be something at the end of the meeting in November, which is only a one day meeting, that we wind up deferring to March for further discussion.

DR. LUMPKIN: Given that, again, the process would be is that between now and tomorrow, when people have a chance to read it, if they have concerns, bring those to me or Marjorie. We can then make an assessment of how much time we will need. If it appears to be an excessive amount of time, then we'll postpone it to the November meeting, to be decided certainly.

But if we think that they are items that we can address within the timeframe, then we will try to get it accomplished tomorrow. But I just don't think it's fair to ask people to comment on a document that they just got.

MS. GREENBERG: Well, as I said, the document actually is the same as the content as the one that is in F. On the other hand, it's my understanding, and I apologize, a few people did not get their agenda books either. So some haven't even had a chance to review that. I think deferring it until tomorrow is very appropriate.

MR. SCANLON: It is likely that there may be an NPRM dealing with confidentiality protections before the November meeting. And the committee tomorrow will be briefed on where things stand. But there probably will be a need for the committee to weigh in before the full committee meeting possibly on privacy. So as you are thinking about the process, or even scheduling meeting --

MS. GREENBERG: The comment period would not.

MR. SCANLON: The comment period would be 60 days.

DR. LUMPKIN: We would be able to comment at our meeting then?

MR. SCANLON: In November probably.

MS. GREENBERG: Or agree to a procedure to develop comments during the comment period, which would end before the end meeting, which is the end of February.

DR. LUMPKIN: Right, but if it comes out between now and November, November is only five weeks away. Our meeting is early November.

MS. GREENBERG: November 3.

DR. LUMPKIN: So that's like five weeks. It would be 35 days. So we would be well within the comment period, even if it were published tomorrow or the day after tomorrow.

Okay, we'll ask everyone to take a look at that, and get any comments to either me or to Marjorie.

So we're ahead of schedule, just a little bit. Okay, this is unanticipated. Let's take a 15 minute break. For any of you who would like to -- because we will have some time after that. So having now looked at that, if anyone would like to during their 15 minute break take a look at this letter, we could raise some issues after that, because our guests are not asked to return until 10:30 a.m.

MR. BLAIR: Dr. Lumpkin, could I make a suggestion, that if it turns out we are a little bit ahead of time on the agenda, that you protect that time so that there might be a little bit more time in that lunch break for the work on the NHII activities, to be able to have their deliberations. So being an opportunist here, maybe this is a good thing.

DR. LUMPKIN: That is true, but unfortunately, our speakers coming at 10:30 a.m. may not be movable. So if people can take an opportunity and look at the letter in this break, we will try to get together at 10:15 a.m.

[Brief recess.]

DR. LUMPKIN: We're going to get started. Just one item before we get started. I'd like to ask, because we should have done this when we started, are there any members who have conflicts of interest with any items on the agenda? Okay, good.

The next item is a briefing on quality of care data activities. John Eisenberg, Administrator at AHCPR, who has been here a couple of times before. Welcome again. He has agreed to come down a little bit early to get us started, since we are going faster than before.

Janet Corrigan will be here, and then we'll put her on when she arrives.

John, welcome.

Agenda Item: Briefing on Quality of Care Data Activities - John Eisenberg, M.D., Administrator, AHCPR

DR. EISENBERG: Thank you. Thank you for letting me come and join you. I want to thank you for my first CDC/NCHS name plate. I will cherish it, Marjorie.

What I understand you want me to do is to brief you on what is going on with some of the progeny of the President's Quality Commission, namely the QUIC, the Quality Interagency Coordinating Task Force, and the Forum, and I would happy to do that. I also figured I would take advantage of this event to make an announcement of something that the agency is releasing, something to do with quality, but not a lot.

And I actually left the press release in my office, so somebody is bringing here. I didn't realize I wasn't coming in from Rockville. Just as an aside, I still teach some at Georgetown, but the law is that since I have to take a leave of absence in order to do my hour of teaching at Georgetown so that it's not a conflict of interest, I didn't go from my office. I'm on leave this morning until about nine o'clock teaching. But I'm starting to understand the federal rules.

Well, first let's talk about the QUIC. By way of background let me just remind you all that in the 1996 campaign the President said that were he elected, he would appoint a commission to deal with the issues of health care quality and consumer protection. Of course he was elected, and so of course he appointed the group, the presidential advisory group called the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry.

And that commission started meeting in the spring of 1997, and then issued its first report in the fall of that year, and its final report in the spring, April 1998. So we've had about 18 months since the commission's report was issued.

What the commission recommended was a wide variety of innovations in health care quality and consumer protection. The first part, the consumer protection part, had led to the patient's bill of rights. As you know, there has been a fair amount of political disagreement over the bill of rights. But if you look at it very carefully, there is more that the two sides are agreeing than they are disagreeing on. Janet I think is the staff person for that commission, and Sec. Shalala and Sec. Herman just did a magnificent job of generating consensus around a number of issues.

In addition to the recommendations about the consumer's bill of rights, the patient's bill of rights, there was a second part of that report, that second part, which came in April 1998. It had more to do with quality of care, quality measurement, and quality improvement. It had a long list of recommendations that I won't go through, because you can get them if you want. The website is available, and Janet probably carries copies of the report with her wherever she goes. They are actually a collector's item now.

So what I want to do is talk about two things that happened as a result of the commission report, focusing in on these two. If you want to ask questions about other progeny of the report, we can do, and since Janet's here, you can do that as well or better than I.

But the first was the QUIC. The story on the QUIC was that the commission recommended that there be a national advisory group that would bring together the public and private sector. They would do a report on the status of health care quality in the country, but it would require legislation.

That legislation, although offered, really has never made it very far in the Congress. Some of it got woven into AHCPR's reauthorization, which we expect is going to be passed by the House tomorrow, and has been passed by the full committee in the Senate. A lot of what our reauthorization says was influenced by the President's task force.

The night before the press release, Chris Jennings was working on a title for this, which was sort of a substitute for what the commission recommended. In the absence of legislation, the sense was there ought to be some way at least of getting federal agencies who are working on quality together to collaborate and to make the whole greater than the sum of the parts. So Chris came up with this nickname, this Quality Interagency Coordination Task Force, which we call the QUIC. It was then announced when the President received the report from the commission.

So it was established by executive order in March 1998. It is chaired by the secretaries of health and human services and the secretary of labor, the two co-chairs of the commission. They have asked that I serve as what we call the operating chair, which basically means that they come and meet about twice a year with the task force of QUIC, and in between that we have monthly meetings, and a number groups that I'm going to tell you about.

It's actually a very exciting idea, I think, and has been quite constructive. The mission of the QUIC is to enable federal agencies with health care responsibilities to coordinate their activities to achieve the goals that are described here: better measurement and improvement of the quality of care; providing beneficiaries with information to help them make choices; and developing an infrastructure that would be needed to improve the health care system; including knowledgeable and empowered workers, well designed systems of care, useful information systems.

What I found fascinating about this was that we had a meeting, and we just put out a call to all the departments in the federal and said, if you are interested, come join us. We met upstairs in Room 800. And lo and behold we had some of the usual suspects like the VA and DOD and a number of agencies within HHS -- HCFA, AHCPR, FDA, CDC, and SAMHSA and others.

But we had some surprises too. In addition to labor, we were pleased that the Office of Personnel Management came, because they run the federal employees health benefits plan, and they have been very, very active in the QUIC, but the Coast Guard, the Federal Bureau of Prisons, even the FTC.

I asked the FTC why there were coming. They said well, we're responsible for being sure there is competition. If you guys are telling us that we're going to compete not just on the grounds of price, but on the grounds of quality, then we better understand how you measure quality, which I thought was a very interesting perspective from the FTC, and they have continued to be involved.

OMB was there, the Department of Commerce, and the National Highway Traffic Safety Board.

So what the QUIC has been doing is to basically collaborate wherever it looks as if it might be useful, without trying to get in the way the normal operations all of these agencies, and be value-added, rather than just another element in a bureaucracy. So where that collaboration looks like it is most useful is where there are people who are covered by federal programs, by the VA, by DOD, by HCFA, by the Coast Guard, and so on.

Places where we can get our own work done better, where the quality of the product or the services produced that can be enhanced, or where we can minimize the burden or confusion for consumers, providers, patients, and so on. One of the places that we hope that we could come together is to try to find some common measures and common activities so that we aren't all reinventing the wheel in different elements of the federal government.

So there are five groups. What we did initially was to go around the room and ask everybody what they thought their highest priority was for, and then tried to condense, collapse those into five general categories. These were the five categories that people in the federal government think are the ways in which all these different agencies have opportunities for collaborating, benefiting from one another.

One of them is patient and consumer information; getting better information to the folks. I will give some examples of what these are working on in a moment. Responding to key opportunities for improvement. Improving measures. Enhancing the work force to improve quality. And improving information systems.

So what I'm going to do is go through each of these work groups briefly, tell you what they are working on, and then I'm going to summarize the quick part of this presentation by giving you some projects that we updated the Secretary about last week. So what you are hearing is hot off the press.

The Patient and Consumer Information Work Group is co-chaired by HCFA and the Office of Personnel Management, which is not surprising, since the two of them have very direct responsibility for getting information to people about the quality of care. What they wanted to do was to help to understand first what the current status of efforts to assist consumers to make decisions was. And the first thing we did was just have everybody talk to one another about what they were doing.

It was fascinating that Labor was trying to put better programs together for union members, for workers and businesses. OPM was trying to help employees. HCFA was trying to help beneficiaries. One thing they had in common was using the Consumer Assessment and Health Plan Survey, I was happy to say. But there weren't a lot of things that they had shared prior to that date. What we were able to see was a fair amount of collaboration among the federal agencies, just in looking at what they were doing.

And then trying to develop a common framework for measuring and reporting quality so that there was a common language. Getting a website for consumer access to federal information on quality. That's been done. We have a button on consumer.gov, which is the FTC's website. We are currently constructing a website that would be specific for the QUIC, but that others could link into.

And then following up on the bill of rights, there was no vehicle, no mechanism in the federal government for each of the departments to talk to each other about how they were complying with the consumer bill of rights, even though the President has asked us all to comply, and we have to report to the White House on how we're complying.

This was a way for the different agencies to share ideas about they were complying with the bill of rights. The idea was if we are going to ask the private sector to comply with the bill of rights, we ought to be complying ourselves.

So the second work group, is the Work Group on Key Opportunity for Quality Improvement. The VA and DOD are the co-leads here. That also shouldn't be surprising, because they have the most intimate relationship to the delivery of service of the federal agencies who are involved in the QUIC. So they have been focusing, along with a number of other agencies -- these are the two co-leads -- but on most of them there is somebody from every federal agency that is interested in health care quality.

So we are focusing on improvement efforts to improve care in several areas. We started with diabetes because it was something that was already in the course of progress, and that is that AHCPR had sponsored a project at New England Medical Center. Shelly Greenfield and colleagues had developed a set of accepted measures for quality in diabetes.

HCFA and the VA as I recall, had already started to pick up on that with what was called the DQIP project, the Diabetes Quality Improvement Project. What we did was to try to get other agencies involved in DQIP, and we have been able to do that. Depression will be second, and we're thinking about perhaps congestive heart failure or cancer as the third.

The NCI has recently decided that it is going to start a major program in quality based upon an IOM report in large measure. So they are bidding to make cancer one of the other focus areas that will get multiple agency collaboration going.

Developing criteria for an adequate formulary is controversial, because people read that and they said, oh, there is going to be a federal formulary. That's not what it is intended to say. What it is intended to say is that VA and DOD already have a formulary, and yet they haven't had the opportunity to look at the evidence that surrounds the appropriate selection of drugs.

And as others, like the Coast Guard and Bureau of Prisons look at formularies that they are thinking about developing, the idea is that we'll have an access to information about effectiveness of pharmaceuticals that they can use, although we anticipate that there will be multiple formularies.

Improving patient safety and medical error performance is something that several of the agencies have interested in. AHCPR has been funding some of this research. The VA has taken the lead by developing a National Patient Safety Partnership as a link to the National Patient Safety Foundation. So that's another area.

The third big area is developing better quality measures. The leads here are HCFA and AHCPR. Again, that probably wouldn't be surprising to you that those are the lead agencies. First, to look at what's in the tool box currently, to develop a compendium of what's in the tool box, identifying risk adjustment measures that are in use. If you read that literature, you know you get to Iezzoni when you can't find anything else. But we figure we've got to help Lisa out a little bit here.

Then you list needed measures or improvements in measures, collaborate on development, improvement risk adjustment measures for quality comparisons, as well as for other uses, and developing culturally competent measures of quality. So that, as you can see, is a very big task for that task force.

Developing the work force is one that the Department of Labor was very interested in, as you might imagine, and HRSA because of their interest in the work force. So they are the co-leads on this one. People look at the work force very interestingly, from very different parts of the health care system, through very different prisms.

One of the ways in which we're going to approach this is to explore the impact of the health care workplace on the quality of work life, with the assumption that if the quality of work life is better, the quality of care will be better. We have a conference that is scheduled for mid- October, and we are looking at all the things that make for a better workplace.

Now some of the workers are mostly interested in staffing ratios. Some of the managers are interested in things like art in the workplace, and the degree to which that improves the quality of care that is provided. The head of the National Endowment for the Arts, for example, is going to come to the conference. He is very interested in the movement towards art in the hospital, arts in the health care workplace, and what does to the workplace itself.

But we are also going to be exploring effective means for assuring that the workers themselves are appropriately credentialed and skilled providers of care. There is a joint credentialing program going on within the federal government. You all know about the National Practitioner Databank.

If you haven't read the book that just came out called The Blind Eye by James Stuart and the Michael Swango(?) affair I would urge you to read it. When you finish that, you will agree that there is a need for a national credentialing system, so that we don't have people going from state-to-state with new names wrecking havoc.

But this is one for the federal government at least. Some of this is surprising. You would have thought that the VA and the DOD and the Bureau of Prisons, and other federal agencies that hire doctors would have had a collaborative activity before in credentialing, but there is a lot entropy in the federal government, like there is in all the places that you all work as well. So it hadn't happened. So this is an effort to get federal agencies together to use a standard credentialing system.

Then finally is improving information systems. If you haven't ever seen the state-of-the-art VA clinical record, then I would urge you to do that. Visit the one in Washington, for example. But the VA and DOD had already gotten started with the Indian Health Service on a common model for an electronic record. This was an opportunity for other agencies to work with them, and to learn from them, to facilitate electronic sharing of clinical information to be used in improving quality of care while treating patient respectfully.

Obviously, the confidentiality issues are very dominant here. What we are trying to do is to figure out how we can help at least these providers be sure that they are preserving confidentiality in a way that this group has expressed the importance that that be done.

And share information on telemedicine uses is another. The VA and DOD have done a lot in that area.

Let me turn to what we mentioned to the secretary the other day. This is a different cut at what the QUIC is doing. I just presented the five task forces to you. Now what I want to do is tell you some of the thing that we have done so far in the first year that the QUIC has been in place, and we have categorized them somewhat differently.

This is several efforts to improve current patient care practices. I mentioned to you that diabetes was the first one. The VA and DOD had created a common guideline. I already mentioned the DQIP to you. We put together a conference to identify successful strategies. And we now have an agreement among federal agencies that will collect and report the performance of providers on the DQIP measures. So we will now have a standard metric across federal agencies on the care of people with diabetes, and we can do some comparisons and benchmarking and performance feedback.

Depression diagnosis and care I mentioned was next. The issue of reducing errors is one that we are thinking about. I can't announce it, because we haven't made the decision finally, but we are thinking about a multi-agency activity to look at ways in which errors can be reduced. And then I have already mentioned this project on working conditions and quality.

The second big area is efforts to create quality improvement tools. This cuts across many of the work groups as well. I have mentioned the common credentialing effort. That's really moving along very, very nicely, and it's about ready to start.

Information on measures on risk adjustment methods in use is something that we have done by pulling together a compendium that will be, once it's ready to be released, will be released and available to the general public, as well as to federal agencies.

The formulary guidance is something I have mentioned.

And then we also realized that as we were starting to have these meeting, that different agencies had different terminologies for the same thing. We agreed that we needed to have at least a common language to overcome what Greg Meyer(?) calls the tower of babel in health care quality. So this sounded simple, but it's been a lot harder than we thought it was going to be, to develop a taxonomy of quality improvement terms that people in the federal government can use.

Then the last thing we had about the QUIC is about informing Americans about the quality of care that is available by serving as a gateway for consumer information that is available for federal agencies. All these agencies have websites, and they all have information the public might find useful, but there wasn't an easy way to get to it previously. I have mentioned consumer.gov, and we also are going to probably use Healthfinder, which is an HHS website as a vehicle for getting people to the right places.

The common terms for the public is different from the common terms for the quality wonks. And a guidance for producing report cards is something that we have made some progress on as well.

So, John, I can just go through the other parts of the what I was going to say, or stop for questions now, whichever you would prefer. It might be better to go through, so we don't go into Janet's time?

DR. LUMPKIN: Thank you.

Agenda Item: National Quality Forum - John Eisenberg, M.D., Administrator, AHCPR

DR. EISENBERG: Let me talk a little bit about the National Forum. The Quality Commission recommended that in addition to there being this advisory federal group, that there also be a private sector group which Janet et al. called the Quality Forum. It is now called the National Forum for Health Care Quality Measurement and Reporting. So you can see why we call it the Quality Forum.

The Quality Forum was announced by Vice President Gore after the commission report. But he made it very clear that what the federal government was doing was kicking this off. It was not intended to be a government program. It was intended to be a private sector program, but we wanted to be sure it got off to a good start.

It's purpose, therefore, is to be a private, non-profit entity that will develop comprehensive quality measurement and public reporting strategies to adjust priorities for quality measurement for all stakeholders consistent with national aims for quality improvement in health care. Remember the National AMES(?) thing, because that was one of the recommendations from the commission, that it hoped that the advisory council would take on. But now it looked as if it needed a natural home.

So the major tasks for the Forum as they were put together by a planning that met over the course of the past year were to develop a framework to coordinate and to promote quality measurement and reporting; to develop a plan for public measurement, data collection, and reporting, to endorse sets of quality measures; and to promote standardized measurement collection, verification, and other tools and analytic tools.

So it's a very, very big job, but one that is going to hopefully bring some symmetry in the private sector to the way in which we talk about quality, and the way in which we report quality, and the information the public has.

Now hopefully what you're going to see is that the head start that the federal government has through the QUIC will help the Forum, and won't constrain the Forum, so that as we develop a common terminology within the federal government, that might help the forum, and maybe would be modified by what the Forum does for example.

The organization of the Forum is pretty straightforward. Its first meeting with its new director, which I will mention in a moment, is going to be October 6. There is a Forum board, and I will tell you a little bit more about the Forum board in a moment. And the Forum board has reporting it to an executive director and a staff. We are expecting that the budget will be probably a couple million a year, maybe three.

The Framework Board is a board which will serve the purpose of developing those national aims for quality improvement. We are also hoping that the Framework Board will do some other things in terms of vision for the future of health care quality. But it's intended to be a small group of people who are thinking about the future, who are looking at where quality is headed, whereas the Forum board will be much more oriented towards the operations and the actual activity of the Forum itself.

The Forum will have four councils. Any organization that wants to join, can join. There are dues, and they will see in that brochure that I handed out that they range from around $15,000, but less for some organizations. Every organization will pick one of the councils in which it will have its primary membership, but it can be a member of any of the councils, go to the meetings of any of the councils. But it will be on a consumer council, a purchaser council, a provider and health plan council, a research and quality improvement council.

It was very clear that the Forum planning group wanted the consumer or patient perspective, and the perspective of purchasers to have at least half of the emphasis of the Forum, and not get too controlled by those of us who make our living in quality basically. It was really intended to be much more focused on the users than the providers of either health care, or of quality information. So we are happy we still have a seat at the table, but we are reminded regularly that this is a very user-oriented group.

The composition of the board is that there are to be 17 members on the board of the Forum, and they are intended to be national leaders in patient or consumer advocacy, business, health care delivery, quality improvement of health care public policy. Four of these would be chosen by the council; remember those four councils I just showed you. So probably the chair, but not necessarily the chair of each of the councils will become a member of the Forum's board, one of the 17 members.

The others are selected by the board itself, with a majority of the members representing consumers or purchasers. So 9 of the 17 have to represent consumers or purchasers, and the others can represent providers or quality improvement organizations.

The current Forum board so far, these are the people who have been announced. Gail Warden chaired the planning group, and is going to be the first chair of the Forum board itself. Michael Cook from Deloitte and Touche, myself, and let me just ahead and show you Nancy and Nida Pearl(?).

HCFA and AHCPR have positions on the Forum which go to their directors, and is sort of a permanent position I suppose you could say. There is this person named Iezzoni who is on the board; Patricia Powers; Bill Roper; John Rother(?); Jerry Shea; Mike Stockard; Marina Weiss(?).

What's not on here is that the QUIC has a position on the board as well. So the two secretaries will choose a member of the QUIC most likely other than AHCPR and HCFA, who will serve on the Forum board as a representative of QUIC, and that is going to be Janice LaChance, who is the head of the Office of Personnel Management, who runs the federal employees health benefits, and has been very, very active in this program.

So the four councils have not named their members, and there are a few other slots that remain to be named. There are also some liaison positions, non-voting, but to be sure that the Forum is not separated out from the organizations who are doing a lot of the quality measure activities, JCAHO, AMAP, which is the American Medical Association's accreditation program, and NCQA, and I already mentioned the QUIC are going to have positions which are liaison positions on the Forum board.

And the staff -- this was announced last week -- the executive director is Ken Kaiser, who was the recent director of the VA. And the Framework Board director will be Tracy Miller, who is a lawyer, who was working with Jim Talon(?) in getting the Forum off the ground. She is really outstanding. Ironically, she was Nancy and Nida Pearl's classmate at Harvard Law School, as these things tend to happen. That was really truly coincidental.

Then when Sec. Shalala announced this last week at the QUIC meeting, her comment was you can be sure that people are taking the Forum seriously. And it's going to take itself seriously if it has Ken Kaiser as its director. And I think that really is true, that Ken will make this thing work.

Then finally, the Framework Board will have 6-8 people on it, who are going to be national leaders in managing health care quality, and quality measurement and reporting, public policy, quality improvement in other industries. These are going to be people committed to quality improvement, people who are able to assess the current state-of-the-art and advance it.

They are going to have to be able to commit a fair amount of time. We are anticipating that they will spend on average 20 percent of their time. That boils down to four or five days a month, which is a lot of time for busy people. But we are hoping that this will be where the new ideas come from for the Forum.

So what I'd like to do, if you don't mind is to do my little announcement, take advantage of the time that I'm here and mention to all of you that AHCPR has put together a new program which is going to be available to the public. We all thought what better place to mention it than the NCVHS. I'll just announce it today. This is the official announcement.

It's the announcement of making hospital data easier to get for people. AHCPR has been collaborating with a number of states, 22 states now in our health care cost and utilization project. This is not a survey that we do. We basically contract with and agree with the states that the data that they have about hospital use and services affiliated with the hospital, like emergency and short-stay surgery, ambulatory surgery will be sent to a common place which AHCPR organizes in order to make it talk to each basically, so that the states can do cross-comparisons and benchmarks.

This was the Hospital Cost and Utilization Project. It is now called the Health Care Cost and Utilization Project, because of the fact it is more than just the hospital. But it's a relatively inexpensively way frankly, for the federal government to get data that is available to the states to do cross-comparisons, and also available to the research community to do research.

So they are doing two things simultaneously. One of them is to develop ways in which it can be used to answer questions. For example, we have 33 quality indicators that we have developed, and that we are now reporting back to the states on those 33 quality indicators, how do they compare with other states. I suspect there are far more than 33 that we could use, but the states have found it very useful.

New York and Utah for example have reported that they are already using it to give information back to hospitals about how they compare to other hospitals in the state.

But one of the issues about the database is that in the past if you wanted to do research on the database, you had to go back to each of the states to get permission to use the data rather than having a common place where you could go to get the more intensive database. So we have talked with the states and developed something which we are calling the SID, the state inpatient databases, and now making that more public, with privacy concerns being paramount here.

I think we've got something that's really going to be a real gem for health services researchers and people concerned about the general area of quality and utilization.

The 1995 and 1996 data are available for 22 states right now. What this represents is hospital inpatient databases set as part of the HCUP project. And it's the university of the respective hospitals' discharge records. The data is in a uniform format. Those 22 states represent more than half of the U.S. community hospital discharges. So it's a terrific database. It's not the whole country. It can't be interpreted as being representative necessarily of the whole country. But by and large it is.

We see it as a companion to the database the National Center for Health Statistics puts together, which are a survey. Ours isn't a survey. Theirs is a sample frame that can be demonstrated to be representative. Ours is not necessarily representative, but it is able to go a little deeper into the data that we can get hold of.

So what data elements are there? These are some of the data, typical discharge abstracts data are listed on this overhead. To some extent of course it depends on the states. Some of them have additional variables like birth weight, some of them enter data like race, and so you can tell the racial distribution of hospital discharges and the care that people get. For some states, hospital and county identifiers allow you to link to the American Hospital Association's annual survey and the area resource file.

These are the states that are in it. You can say it's a substantial number of states, and a lot of big states where that data is available. The ones that are starred have their data from 1995-96 already available, and the 1997 data will be available in the spring of 2000. The lag occurs because of trying to clean up the data and put it into a common format.

So for those of you who are interested in using it, or who want to spread the word about this database being available, this is how you can get it. This is an application for purchasing it. It's a relatively low cost -- I should know exactly how much it is, but it's low cost. For descriptions about how to obtain this, it can be obtained at that number, which is the group that we contract with to operate it at Medstat.

So I think it is related to -- although I have sneaked in here in the presentation on quality, it is related to quality, because what I think it's going to allow us to do is to get a better sense of what's happening around the country in various hospitals in the quality of care that's been provided.

So we've got some follow-up from the President's Quality Commission, and I think it's been terrific. I think Janet should be proud of the work that she did, and the leadership that she showed in getting this thing together. Sometimes along the way we weren't so sure it was going to happen, and at times along the way there were compromises made, and people agreed that we needed a consensus. So there were some things that some people wanted that didn't get in there.

But I think given the retrospect now of almost a year and a half, what's clear is that it really set a framework for patients' rights, and also for quality measurement and improvement, but we still have a long way to go to achieve the gauntlet that was thrown down as one that we're going to have trouble meeting, but I hope that we can.

So thank you. If there is time, I would be happy to address people's questions.

DR. LUMPKIN: Thank you. We have time for some questions. Paul?

DR. NEWACHECK: Thank you, John, that was an excellent presentation. I do have a question about the overlap between the work that is done at the QUIC and the National Forum, and some of the private, non-profit groups, namely the National Committee on Quality Assurance, and also the Foundation for Accountability, which are in the process of developing consumer-based information systems and such.

Can you tell us a little bit more about how you are addressing the issue of overlap, and how you are trying to perhaps develop hopefully synergies between these organizations, and creating common frameworks in the standards?

DR. EISENBERG: For the Forum, the formal mechanism is a seat at the table, although it's true that FACT(?) does have a seat at the table. That frankly, was something that the Forum planning group considered in great depth, and decided basically because FACT doesn't do reporting that that made it different from the other two organizations.

But there are other emerging organizations like URAC(?) that need to be considered. So although having that liaison seat on the Forum was an advantage because of the more well established organizations now have a mechanism of communication, we want to be sure that doesn't preclude communication for the other organizations that do what you described. So that's one way.

The second way is that we are hoping that there will be interlocking activities so that if a program is being undertaken by NCQA to develop a quality measure, that it is linked with the quality measures that are being used elsewhere. I think to some extent that's a responsibility for us at AHCPR as we start to fund people to try to link them together as much as we can. And the CAPS survey is probably an example of how it can work. Maybe we can build upon that success, as you know well.

So if that is a model, then our hope is that we can use these as forums for people to understand what each other is working on, and try to overcome the issues of ownership and propriety. Those are natural issues that everybody will always have to deal with.

I know that the AMAP and NCQA and JCAHO set up an organization called a Performance Measurement Coordinating Council, or PMCC, which is sort of a parallel mechanism for collaboration with the Forum. And I think what we're going to have to work on is being sure that they don't go off in different directions.

DR. NEWACHECK: That's going to be a real challenge I think.

DR. EISENBERG: Yes, it's is, but it's also a challenge not to assume that we have the answer, and therefore only one solution is the correct solution. That's just as a risk as having poorly coordinated activities, as to assume that well, let's just pick one and go with that.

I think my own view of this is that what we need is a reasonable number of approaches and then test what their outcomes, but you would expect me to say that, and we ought to test it seriously. So there is going to be a balancing act between letting 100 flowers bloom and the tower of babel.

DR. LUMPKIN: Other questions?

DR. ZUBELDIA: With QUIC one of the projects is to do a credentialing effort. Have you looked at how that could be used for non-federal agencies, specifically maybe Medicaid, the Blues, commercials? Because the credentialing problem is not only federal.

DR. EISENBERG: Right. Well, having been the chief of a service at a private hospital before I took this, and knowing how big a hassle credentialing is, I agree with you. It's also a serious issue for managed care, because as you know managed care organizations often have the responsibility of credentialing physicians. In some markets there are multiple managed care organizations asking the physician to start the credentialing process over every time he or she starts with a new managed care organization. It's really torture.

So our hope is that we can set up a federal model, and if the private then says, yes, that works, and wants to adopt it, that would be fine. If they say this works and we want to modify it, then that would be okay too. But I suspect that what will happen is that we'll test it out in closed systems like the VA and DOD, Bureau of Prisons, and the other delivery sites within the federal government, and shake it out, and then see if it's available. It will certainly be available for people in the private sector. It's up to them in terms of whether they want to us it.

DR. LUMPKIN: I have a question in relationship to the QUIC, and that is to what extent do you see this committee working and coordinating with the work of the QUIC? To the extent that I think we have some concerns in relationship to quality as it relates to the collection of data, and the standards that may become de facto standards, and the extent to which they may agree or contradict standards that are developed in other areas such as HIPAA. So what role do you see the NCVHS playing with the QUIC?

DR. EISENBERG: Well, I hope one of being a beacon, a guiding light. In my role as co-chair of the Data Council I have been very impressed at the degree to which the NCVHS serves as a mechanism for us to get ideas about what people outside of the federal government think we ought to be doing. We take the recommendations of the NCVHS very seriously.

The challenge is for you to stay ahead of the curve though, because in order for you to deliberate a topic sufficiently well and then give us advice, you've got to have a good sense of what the issues are going to that are in front of us 6 or 12 or 18 months from now. So I think what we probably ought to do is to sit down and talk about the topics that are not the ones we have just finished, but the ones that we're going to be taking on, and see if the NCVHS could help with that.

I think you also could serve in a role similar to that of the Framework Board by telling us what you think the issues are that we ought to be dealing with. If you think that there are some hot topics, or some very important topics that we have neglected in the inventory that we're putting together, then it would be helpful to know that as well.

Let me just say as an agency that is a member of the QUIC, I think that you ought to feel comfortable going to any of the constituency agencies and saying that we think you ought to be doing this or that. I know that your project on information systems has influenced the way in which AHCPR has shaped its research agenda for information systems through Mike Fitzmaurice's activities with you.

There are other places where you might look at an individual agency and want to reach into the agency to give it advice. You could do that through the quick. You of course could do that independently. I think those are at least three different ways in which this could take place, John.

It might mean a smaller meeting of a subgroup of this group who wants to look at where things are going, and give us some advice.

DR. LUMPKIN: We do have a quality subcommittee, and that may be a good place for that activity to occur.

DR. EISENBERG: That would be terrific, and I would be happy to come and join you to talk about it.

DR. LUMPKIN: Great, thank you.

MS. WARD: I don't have a question. It would be nice to have copies of the overheads.

DR. EISENBERG: Okay, I can do that.

MS. COLTIN: I have sort of question/suggestion. One of the things that I found historically as we have been working on measures is we keep running up against the inadequacies of current data systems. What that does is force the data collection methodology into medical record review of patient surveys. And there is a limit as to how many patient surveys you can implement.

One of the things we have talked about in the quality work group is trying to identify what are the most important areas where current data systems are inadequate for constructing measures of quality and for implementing and monitoring quality improvement activities.

I didn't know as you were building you SID database, and looking at the kinds of quality measures that you were able to construct from that, what kinds of limitations you were running up against, and whether that's an area where we might be able to provide some direction as well in terms of both the future of the administrative standards, and what elements are captured in the next iteration, as well as the common surveys and the inadequacy of information that might be needed to supplement what can be done from the administrative data.

And I think this is true not just for hospitals. It's certainly true on the outpatient side as well. But that was an area that we had identified to try to focus some of our work. I think if you have any comments or ideas along that line, we would love to hear them.

DR. EISENBERG: Well, I do. I think about it, because if there is one place where my responsibilities with QUIC, and my responsibilities with the Data Council, and my responsibilities at AHCPR intersect, it's this one, better data on quality that we can use to improve the health care quality.

There are so many issues here, Kathy. I think one of them is survey integration within the department. We have some places where we have multiple surveys looking at the same thing, and then other places where we have no data at all. As Jim will tell you, we're trying to push the Data Council towards being a more effective mechanism for getting some survey integration done within the federal government. We can come and talk with you about where we are, which isn't very far, but where we hope to go with survey integration.

The second is the issue of how we can gain access to private sector data without violating confidentiality. I think the HCUP project is a nice example of that. It's not just private sector data. It's state data as well as private sector data. But your ideas about how we could move in that direction I think would be very helpful there as well. That's not just the quality. That's going to be a serious for Healthy People 2010 when we look at the gaps that we have in the federal databases for answering the Healthy People 2010 questions.

The third issue is this, that the Quality Commission, when it wrote its report said that there ought to be a national report on quality. I'm not sure that those terms were used, but that the advisory council should monitor the quality of care in the country. Because of the fact that -- well, for a lot of reasons, including the fact that Bill Frist wrote it into our reauthorization language, AHCPR is going to take on the responsibility for doing that reporting, and present that data to organizations.

It could be presented to you. It could be presented to the Forum. It could be presented to the QUIC. There are a lot of places where an annual report on what's happening in quality of care could be presented. He has asked that it be presented to the Congress and to the Administration. But I think having a vehicle where a national report on health care quality could be presented, and also some advice on where you think we ought to get the data for that, and how we ought to synthesize the data would be extremely helpful.

We know that AHCPR's databases are going to be a first step, but they are inadequate. Even NCHS and AHCPR's databases are the first and second step, but they are inadequate. So what we need to do is to get our arms around all the available data that we could use to paint a picture about what's happening to quality in the country. I think the NCVHS committee would be a great help to us in doing that.

I don't know if Greg Meyer has come to talk to your group or not. He has, so you know the general idea of what we're doing.

DR. LUMPKIN: Well, once again, thank you very much. I think for many of us, we're thrilled to see that the work is progressing. Our biggest challenge as a committee, and I think also with this work is how we put together what I describe as the left brain and the right brain. The left brain being the activities related to health care, and the health care being the population-based activities. Certainly we will look forward to working with you.

I'm particularly thrilled to see the formation of the QUIC, which does allow some structure for the population-based, and the person- and health care-based system to begin to look at the issue of quality in a much broader arena. It's very exciting.

DR. EISENBERG: Thank you. Thank you very much. I appreciate it. May I stay and listen to part of Janet's report?

DR. LUMPKIN: Please, you're welcome to. Janet?

Janet Corrigan is the Director of the Division of Health Care Services at the IOM. We're very pleased to have you with us.

Agenda Item: Briefing on Quality of Care Data Activities, IOM Initiative - Janet M. Corrigan, Ph.D., Director, Division of Health Care Services, IOM

DR. CORRIGAN: Thank you. It's a pleasure to be here.

I brought a small brochure describing our largest quality initiative that is underway. It doesn't look as nice as the Quality Forum though. I was really very impressed. For an organization that is just getting off the ground, it's a very nice piece of work.

You may also notice that some are in color and some are in black and white, and that's because the color printer broke down. So now you can see how primitive our technology is. The contents are the same, so don't worry which one you get.

What I wanted to talk to you about today is a whole set of activities that the Institute of Medicine has underway. The most significant one is the Quality of Health Care in America. That's the one that is described in the brochure that I'm passing around.

The IOM has a long history of working in the quality of care area. It really goes back many years to Kathy Lura's(?) days, when she was the director of the Health Care Services Division, and did a great deal of work on Medicare issues related to the quality of care.

Prior to my joining the IOM a little over a year ago, after finishing up with the President's Commission, there was another project underway called the Quality Roundtable, which produced a very significant piece of work, a statement about the urgent need to improve the quality of health care. That was published in JAMA one year ago, in September of last year.

It was very significant I think for a couple of reasons. First of all, it very carefully reviewed a great deal of the literature on overuse, underuse, and misuse of health care services. And it represented I think a big step forward in terms of bringing together a group of experts, really the best around the country I think in a whole set of issues related to quality of care, and issuing a call or a challenge that really basically indicated that when it comes to the quality of health care, we have fallen far, far short of where we should be. And that there is a very big need that really requires national attention.

In that sense it was really very consistent with the message in the Commission's quality report. The nice that it also did for the effort that I have been working on over the last year or so is it allowed us to start from the place of everyone being in agreement that quality of care is very seriously jeopardized right now. That we have millions of people who are not receiving the quality of care that they should be, and that it's doing significant harm.

So the Quality of Health Care in America project, when it got rolling in June of last year, a little over a year, the overall objective of the effort is to put together a plan to produce a threshold improvement in quality over the next ten years. This effort is chaired by Bill Richardson, who is the CEO and President of W.K. Kellogg Foundation.

The Kellogg Foundation is not funding the effort, and according to the Academy's rules actually they can't provide any contribution to the project. So he is very much serving as an individual with many decades of experience in the area.

You will see from those listed on the committee that it really is a very strong group that we have pulled together here. In addition to the individuals listed, there are two subcommittee and three major technical panels that are also working on components of the effort.

When we first started to organize our work for what is going to be almost a three year long project, a little bit less than that, we planned to have it all wrapped up at the end of year 2000. We pretty much decided that were sort of two major areas of concern.

One of them was to look carefully at the various forces in the external environment that is driving the health care industry, and identify the critical ones that right now represent major impediments or facilitators, and then to analyze those in-depth to try to figure out where we would have the greatest leverage in terms of improving incentives for quality, the ability of health care organizations and providers to improve quality.

Then the second major area of activity -- that first effort is being co-chaired by Molly Joel Coye and Cris Bisgard. Molly Joel Coye used to be with state government for many years as a regulator, and is now with Lwelleyn West(?), and Cris Bisgard is with Delta Airlines as major purchaser. He is also a physician.

They are co-chairing a sizable committee which draws on members of the Quality of Health Care in America Committee, but has other individuals too. So in terms of everyone who is involved in this effort, I think we're probably at about 55 or 60 individual across the various panels and subcommittees and full committee.

Then the second major area or domain that we are looking at is to take a look at what needs to be done to improve the ability of health care organizations and provider groups to improve quality. That subcommittee is duped Building the 21st Century Health Care Chassis. It really takes its name from a comment that Dave Lawrence of Kaiser made a couple of years ago, that the health care chassis is really broken.

We don't know how to deliver high quality health care, and our CEOs of health plans and leaders within the medical profession to some extent feel that their hands are tied behind their backs. What we have is tremendous inertia out there, with recognition at that level of the quality of care problem, but at the same time an inability to move forward. And we don't fully understand why we are not able to make more aggressive progress on the quality of care front. That particular subcommittee is being chaired by Don Berwick.

So when the committee first came together, it identified a series of reports that it was going to be producing over the next two and a half years. Our first report is going to come out in this coming January. This is a report that really required the input of both subcommittees and the full committee, and it's going to be on patient safety and medical errors.

We selected this particular area. We took a look at the overuse/underuse/misuse categories and for the most part, the medical errors and patient safety falls into the misuse category, although not exclusively. And we decided that it was a good place to begin, in part because the evidence is very strong and substantial. That we are looking at very large numbers of people who are harmed as a result of medical errors.

Most of you have probably seen the Lucian Leape and Don Berwick publication in the British medical journal that just recently that what we're really looking at is numbers of people dying from errors committed within hospitals annual that far exceed breast cancer and AIDS combined in terms of a mortality toll annually. So this is a serious problem that ranks right up in terms of leading causes of very preventable death.

So at any rate, we took on the medical errors/patient safety initiative, and that has consumed a lot of our efforts in the last year and a half. There is a report that is coming out in January. I'm sorry, I can't tell you much more. According to the Academy rules, we don't release draft copies or indicate what recommendations are.

But I can give you a flavor for the areas that the committee has examined. We took a very comprehensive view on the patient safety/medical error issue, and have examined the need to build a much stronger research base to support patient safety. As you see in other industries like the airline industry, the nuclear industry, elsewhere where there have been substantial efforts to really identify prototype systems and build a stronger research base.

And we also took a look at a whole set of issues related to the regulatory system, and the role that it essentially plays, the state regulatory processes or federal, or whether it's sort of a quasi-regulatory; the accreditation programs and others.

We spent considerable time looking at error reporting systems, both mandatory systems, voluntary systems. There are some very good voluntary systems out there, but tend to be very narrowly defined.

We took a look at a variety of the efforts with some help from the JCAHO and supplemented the survey that they done of states that identified 20 states with adverse event reporting systems that are primarily attempting to look at adverse events attributable to medical errors.

We also took a very close look at a set of issues related to credentialing and recertification of providers, and the extent to which errors issues are reflected in that, and patient safety concerned. We look at medical education.

We convened a group of a small roundtable, a group of about 20 leaders from the specialty and subspecialty groups about a month ago to basically get their input on what kind of leadership can the professional groups provide in this area, whether it's the AMA or those that are involved with education, continuing education, certification, as well as the subspecialty groups themselves in terms of educational initiatives and communication initiatives.

We also had a very nice focus group with leaders from the states on the regulatory side and the legislative side that Trish Riley helped us from the National Academy for State Health Policy. Trish sits on one of the subcommittees.

And we got the input from states and from the legislators as to their perspective on this issue, and the kinds of efforts that they either had underway, or were planning, or thought that they could put in place.

So we gathered a huge amount of input from outside, and there were many, many individuals who testified before the committee on different efforts. We then took a close look at some of the kinds of things that have to happen internal to health care organizations for patient safety to improve. Issues of medical culture and leadership and patient safety programs, some of the data-related issues, but not too extensively in terms of detailed data-related issues. And good examples of safety initiatives that are in many ways best practices and things of that nature.

So the report at the end of this year, the early part of next year really will be a synthesis of what we have learned in all of those areas, as well as what the committee has concluded in terms of its overall findings and the recommendations that it comes forward with.

We also are planning a series of other reports that will not be nearly as lengthy as this particular one. This is a full report, a full volume of several hundred pages. The other reports will have a series of white papers that come out over the next year. Those white papers are going to address what our External Environment Subcommittee has identified as critical issues, or sort of policy levers or enablers that we think are important issues in that external environment that can really push quality forward.

One of them is a paper that will deal with communication issues, communicating with the American public around quality of care issues. To the best that we can tell, the American public isn't really aware of how serious the quality concerns are within the health care industry. Some of us who have worked in this area for a little while -- I'll speak for myself -- are frankly surprised that there isn't more press attention or awareness of the quality of care issue.

Consumer protection has gotten a tremendous amount of attention, and the bill of rights has, but there is another whole major piece here in terms of quality of care, and that doesn't get picked up in the press. And doesn't really get the attention that we think it should given the magnitude of the problem.

So what we did was four or five months ago we convened members from the print and broadcast media in a full day workshop that the California Health Care Foundation helped to fund. And we entered into a dialogue with them. It was a wonderful showing. We had about 20 members from primarily national media, but to some extent local as well.

Susan Denser(?) from the McNeil-Lehrer program, Robert Pare(?), The Wall Street Journal, all the major newspapers were represented, and they stayed the full day, which actually surprised us. There was a wonderful workshop, and we learned a lot about why there isn't more attention focused on the issue than there has been in the past.

And we also learned a lot about how complex and difficult the message is to communicate to the American public, in part because right now we don't have a strategy to really say this is what you should be doing. The comparative quality data aren't out there. We don't know how to tell people where to go to get the best quality of care, or even if we do, some may think that they do, but it's not readily available or understandable to anybody. So the strategy is a little bit difficult.

At the same time, if we don't begin to raise general awareness of the issue, you find yourself in a situation where there is a lack of support for policy initiatives and others that really are trying to advance the field in this area.

So we are producing a white paper on that effort that is also going to include an updated synthesis of the literature on quality, which Mark Shuster and his colleagues at Rand produced for us, which was an update of an earlier effort that they published.

Another major part of our effort is we have a workshop that is coming up next week actually on information technology and quality issues. That workshop, Don Detmer and Brent James and Jerry Grossman, and Andrew Ballist(?) helped us put together as part of a planning committee. Here what we are trying to do is to understand why we haven't seen much more advancement in the information technology infrastructure of health care organizations and professional groups.

We want to first of all, look at how information technology has transformed some other industries. We have taken banking as a model, to think how there might be a similar paradigm in health care that would really allow that to take place very rapidly.

We also though, want to take a look at the way that information technology -- and we think the answer to this is yes -- the way that information technology will enter the industry, and the most important applications may well have changed as a result of the tremendous development of the World Wide Web and the Internet.

And we are specifically interested in trying to understand whether the absence of capital or lack of capital is really that significant of an issue anymore. There has really been a belief that one of the reasons IT hasn't moved through the health care industry more rapidly was the lack of capital.

And that the capital sometimes being in the hands of perhaps health plans or companies that are for profit and have access to the equity markets, but sometimes you need the investment to really be made more at the medical group level, or the provider group, and oftentimes there isn't a one-to-one relationship or contractual situation between them.

We realize that that's an impediment, but we also wanted to look closely at whether or not with the World Wide Web and the Internet, there are just so many Internet-based applications, that it opens up sort of new world, a new window for many medical groups and providers that are in smaller settings, as opposed to very large ones. We're going to question that assumption.

We also want to take a look at what we think are some of the most promising applications in the area of quality of care, improving quality of care. And see if we can identify what the impediments to those are. And whether part of the problem is as some people have asserted, that there is no business case for quality. You just don't make money off of putting these systems, and we're addressing that in another workshop as well, from another angle, because we hear it from so many people. We don't full understand that, but we want to try to sort through it.

And then lastly, the workshop will deal with some of the policy implications in the afternoon. We will be releasing workshop proceedings and the committee's recommendations as a result of that effort.

Another major external factor that we're going to try to dissect which is related a little bit to the first one, we are going to be doing what is called the payment/cost/waste workshop. It's a horrible name for a workshop, but in the early part of next year. There we are going to try to hit head on this issue of the business case for quality by looking at different payment systems.

And then taking a series of examples where particular quality improvement initiatives have been put in place, either patient safety or maybe increased beta blockers on the underuse side. In terms of the overuse side, to decrease the overuse of antibiotics; for certain types of surgeries, hysterectomies.

And we're going to try to trace those through and see whether or not -- it is assumed that some reimbursement systems and payment systems allow the health care plan to get a greater return out of their investment in those quality improvement efforts. In some cases in some of the examples we have turned up, there is a negative return. Which isn't to say that hospitals or providers or health plans are not purchasing quality because they are making money off of errors, they are making money off of poor quality.

But at the same time, if you haven't aligned the payment system, it is going to be very difficult to really get a push behind it. It's not clear to us to the best that we can tell, it seems like capitation provides for whoever is making the investment to reap the return on the investment a little bit better. So we want to take a look at what happens in systems when there is mixed payment; when it's part of fee-for-service, part of capitation.

How capitated do you have to be to somehow then make it a viable option for the board of directors or the CEO or whomever to make a decision to really to turn an organization around and get it oriented towards better quality care. So what is that payment dynamic?

We also want to try to take a look in that workshop at sort of what the window for turning an organization around. Some people call it the window of hell, where you really try to begin to encourage development of many different quality improvement efforts within a major institution, a medical center or elsewhere. And it may take 2, 3, 4, or 5 years before you really begin to get a return and you see the results.

The problem we have right now is that some organizations that have really embraced the quality side of it, and were trying to encourage the development of those innovative projects, the CEO doesn't last in their position long enough to be able to carry through on it. So we want to look at that as well.

Then the third part of that workshop is looking at the relationship if you sort of take the external payment system as given, what are the disincentives or problems that are encountered within a major health care organization or plan in terms of how the plan or the medical group pays the individual providers. So how do you align the internal compensation systems, whether they are salaried, or once again, fee-for-service or some kind of shared risk arrangement.

What types of arrangements have the best alignments in terms of quality improvement incentives at the level of the individual caregiver?

Another part of our effort has to do with looking at the volume outcome relationship. I think John mentioned earlier there was a major report that came out of our National Cancer Policy Board a little bit earlier this year that looked at the relationship between high volume providers and outcomes in the area of oncology and for different types of cancer care, and found a very strong relationship for at least four types of cancer in terms of practice makes perfect to some extent.

What we want to do in the volume outcome workshop, which is tentatively -- we're planning for March for this effort is to take a look at the volume outcome relationship in other clinical areas and see how strong it is, if it is strong. And also how far it extends. So how much volume do you need to be able to get the benefits of better outcome? So what clinical areas does it affect? How strong is it, and what are the implications of how high a volume you have to have?

Third, what the underlying drivers of the volume outcome relationship? Is it because that higher volume settings have specialized technology? They have really well trained interdisciplinary teams? What is it that is really driving it underneath the surface?

And then we will look at the policy implications of the volume outcome relationship for purchasing whether it's by major group purchasers or consumers and for health care delivery in organizations.

We have one other part of our work then, sort of turning to the 21st century chassis. Those were the major sort of what we see as the environmental or external factors that we hope to be able to influence. The 21st century chassis side is taking a look at two things. They first looked at characteristics of exemplary organizations and other industries, and whether there are things that we could learn from other industries. We did a fairly extensive literature review there.

But then we also decided with the help of the Robert Wood Johnson Foundation, to do a telephone interview survey of what are called micro systems. The term was coined by Paul Batald(?) and borrowing from some others in other industries. But he changed it a little bit, and he's really the one who has done most of the work on this, Paul Batald at Dartmouth.

Micro systems are essentially exemplary disease management programs or primary care programs. But we're down at the level of a group of providers with a defined patient population. So it's not a hospital. It's not a health plan. It's that much lower level where care actually is delivered, and you have a defined set of providers.

In that survey we have been trying to understand in the more exemplary ones, and we put together the exemplary list by talking to people who know a good deal about this. For example, Don Berwick from his IHI series knows a lot of the good programs out there, and Brent James and Steve Shortell. So we sort of networked into that group. If there is a certain amount of subjectivity, we built that expert knowledge. We are looking at primarily exemplary, so we're not sort of seeing the other side of the coin. That is recognized up front.

What we are trying to understand from those micro systems is what role does information technology play in their ability to provide what is believed to be higher quality care? What role does the training and interdisciplinary team dynamics play in the delivery of higher quality care? And to what extent do they really have more of a consumer-oriented focus or consumer directed care or whatever you want to call it?

How do they really relate to the patient? Do they involve the patient more actively in clinical decision-making? Is there more extensive patient involvement in actually directing their own care and patient preferences in the process, or taking certain responsibilities for certain aspects of the caregiving process?

Those are some of the areas that are trying to take a look at, both looking at other industries, and then the micro systems was our attempt to gather an evidence base as we try to produce evidence-based reports. It's kind of hard to do when you are looking ahead to designing a 21st century health care chassis. But those are two evidence bases that we have been able to draw into the thinking.

Now it's really up to the committee to try to synthesize a lot of that, and begin to identify what they think some of the critical characteristics of that 21st century chassis. That report will come out in the middle of the year 2000, by the end of the summer. The other white papers and more focused reports will all be coming out between now and the end of the year 2000.

In addition to that I'll just mention two other projects that I think might be of some interest to you. We have a project underway that is taking a look at -- it's a comprehensive evaluation of the Veterans Administration's national formulary system and the impact of that formulary on the quality of care, access to drugs, and cost.

That project has just gotten off the ground. The committee is being chaired by David Blumenthal and Roger Herdman(?) is the staff person. He's a very seasoned staff director. So we are very pleased about that. I think over the next year, year and a half we will learn a good deal about sort of not only the characteristics of that system, but we'll also be comparing it to other formularies out there.

And the extent to which it really uses state-of-the-art quality decision-making criteria, and what kind of improvements could be made to assure that the most appropriate drugs are on the formulary. And can it make a contribution to issues of patient safety by decreasing look alike-sound alike drugs and things of that nature, and ones that are more prone towards safety issues and adverse drug events?

We have another project too, the last one that I'll mention. It just released its final report, and it was a spin off from the Quality Commission's work. It relates to one of the components of the patient bill of rights. That was a project that we did for HCFA, a fast track project that was done in a little less than six months, which is almost unheard of in the Institute of Medicine. They are not accustomed to doing fast tracks, but we're trying to get them into that mode a little bit more.

That project was to take a look at the definition of what the Quality Commission termed complex or serious conditions. This was the term that the commission felt for those who had complex or serious medical conditions, the patient had ease of access to specialty care. As a result of the bill or rights when it came out, there was an executive order issued to the Administration to begin implementing it.

Of course HCFA has to figure out what kind of regulations should be written to provide guidance to Medicare plus choice plans on how they operationalize that term, complex or serious. That report has just been released. I think it really got into some fairly -- we had a workshop, and Lisa participated in that workshop and others, that provided a lot of good input.

The bottom line is that the committee really feels that there should be a bit of a narrowing in the definition. It should be complex and serious, not complex or serious. We need to start with those that they feel are really the ones that would benefit much more greatly from case management services and more extensive focus of health plan efforts.

And that complex and serious would take in potentially just so many people, many of who perhaps do not require detailed integration of services across medical and social areas, or even across different medical areas.

The committee also recommended that HCFA not attempt to incorporate into regulations, a detailed definition or algorithm that plans would then use to identify them. But they laid out in one of the chapters of the report, many different alternative ways that that can happen, and the critical issues that have to be considered in doing it.

But they did recommend that HCFA provide general guidance to health plans on this area. And they came up with language for general guidance that will help the plans to identify those that they believe would most readily fall into this category.

And then last, that they also felt there needed to be much more focus on what the case management and coordination services would be. That direct access to specialists in and of itself respond to the needs of this very high needs population. That what we really need are much more sophisticated case management programs. They laid out a lot of elements of what they believe to be a good case management program.

And then they talked a little bit about also how there might be some monitoring of health plans once they had been given the general guidance and they had their programs in place.

That's pretty much what we have underway at this point. Hopefully, you will see a lot of reports coming out. I'd be glad to answer any questions.

DR. STARFIELD: That's really exciting, Janet. I really congratulate with for the freshness of the approach and the framework on the overuse/misuse. There is probably another category of quality problems that doesn't fit any of those on the overuse/underuse/misuse, and that's sort of unanticipatible safety problems, because the knowledge base is so inadequate.

I remember being very struck by an article in JAMA about a year ago on deaths from medication use. It wasn't from errors. It was from unanticipatible errors. They said it was something between the fourth and the sixth leading cause of death, which is mind boggling, and has tremendous implications for the fact that our information systems can't now give you that on a routine basis.

So how are you going to deal with this sort of data need? This committee of course is very interested in data. And how are you thinking about that?

I have another question, something that you didn't mention, and that is the quality of care issues for different population groups. There has been a lot in the literature about probable differences of quality of care across the population groups, different populations groups, and of course the health objectives for 2010. They are going to focus a lot on equity. Is this is something that you are going to be able to think about?

DR. CORRIGAN: Yes, and I'll go to the second question first, if I may. I don't anticipate that the Quality of Health Care in America project will deal very much or very extensively with the issue of equity. However, we are in the process of putting together two major efforts at the Institute of Medicine that are precisely targeted at that area.

One of them, which has been approved and has funded related to communication issues with different populations when it comes to clinical information. We are assuming that to some extent we have a health care delivery system that doesn't communicate well with many of the different cultural groups that we currently.

And some of the differences that we see in terms of quality of care probably relate to this issue of inadequate communication, or appreciation of the specific values and things that are important to that population, and in some instances a lack of appropriate interface with more traditional medicine that might be very common for the particular group that you are talking about.

That effort is just in its early formative stages of getting a committee and identifying what specific clinical problem areas they are going to take on, and which in this case, ethnic groups or possibly also people with particular clinical characteristics, the disabled or those with a specific clinical condition, where for reasons that we don't fully understand, we're seeing serious differences in variability and quality. We think some of that has to do with communication.

We are also exploring and the IOM Council has had a workshop, and will soon be discussing in two weeks a major initiative on the uninsured. And looking at areas of a couple of questions that we're particularly interested in. I hope they will choose to go forward.

One of them is try to understand first of all, what we can say from the evidence in the literature on what care and quality of care do people who uninsured and underinsured end up getting? Some people think that the uninsured oftentimes make it into system and get care, and sometimes they do. Other people say they are not so sure they are getting into the system that well.

But clearly they are getting a different pattern of care, so we would like to understand what the implications are of being underinsured or uninsured for the pattern of care that you get, and in turn the quality of care and the outcomes that you are likely to achieve. The example there is always that you tend to end up more in the ED, and that's your point of entry, and you get care later in the process. But we are hoping that there is an even richer database out there, and we think there is, so that we can take that logic and thinking a little bit further to understand how the patterns of care differ.

And then in turn to get some implications and begin to think through what the overall costs to society are from the uninsured or underinsured in terms of in some cases what are probably high care costs as a result of the different pattern that they end up getting once they are in system. But also then those indirect costs that we pay in terms of lost productivity, because of poor outcomes and disability and other kinds of costs.

So that will touch a little bit I think on some of those differences, because some of those differences in quality of care tend to be racially or ethnically driven, and they tend to be associated with lack of insurance or uninsurance as one factor, but recognizing the communication issues and cultural issues are a part of that. Those efforts hopefully will begin to address it a little bit better. We're just going to touch on it in some of the work here.

The first question, some of the information systems issues on the patient safety side, we very much recognize that making a dent in this patient safety issue is going to require significant investment in information systems. There are numerous examples out there, and I think drugs are a very good one, where automated order entry systems really can lead to a great deal of improvement.

You are absolutely right about the studies that have put out on adverse drug reactions when they are using the WHO definition. They are trying to separate out errors up front, and they are just taking that other piece of that. Some people who come from the patient safety and errors perspective feel that a good deal of what falls into that category may well represent errors as well, because we failed to do much of the up front work that we needed to do before putting drugs on the market on a widespread basis. They question whether a good deal of that isn't preventable.

In our errors report we have opted to take the narrow definition, because to be very honest, we thought that there was just so much work that could be done in terms of the narrower definition of errors. We didn't necessarily see that we needed to get into that debate. So we really tried to focus on that part that is purely errors. But there is another whole area out there that needs to be dealt with in terms of the adverse drug reactions.

DR. STARFIELD: Especially in the ambulatory. Virtually the whole literature of the hospital, there is almost nothing in the ambulatory side.

DR. CORRIGAN: And the little bit that you can pick up on the ambulatory is a few studies of avoidable hospital admissions or encounters in the emergency department that you assume are on the ambulatory, or as you say, the adverse drug reactions. You are absolutely right. The only thing we have on the ambulatory at all pretty much is the drug side of it.

We do assume that -- at least our committee has tried to recognize that. So it's important to recognize that the statistics we have, or the extrapolations that we have made in terms of the toll that medical errors takes, all we've really got is the hospital side. So they were very conservative in terms of the overall estimate of what you would probably think this problem is contributing to for mortality and morbidity.

MS. WARD: This is another question related to medical errors. Are you expecting you will look at levels of education, training or personnel giving medications? I certainly know on the West Coast there have been major changes in terms of the types of personnel who have been hired, and the level of delegation down to lower and lower levels. I didn't know whether that would be a variable that you will be looking at.

DR. CORRIGAN: The one thing that has come out very much in our professionalism roundtable, when we convened many of the professional groups, and that wasn't just the medical profession, it was the nursing profession, pharmacy and others, was this issue. I didn't hear so much the message in terms of the delegation down to individuals with perhaps lesser training.

But some of the messages that really did come out very strongly were that public workshop was the issue of the need to involve -- there is strong evidence that if you can involve pharmacists in these efforts, whether it is doing ward rounds in hospitals or reviewing, that they can have a major impact, probably as good as automated entry systems can.

So there is no reason to wait for the technology if you can't get it in place. There are a variety of options that one has for dealing with the issue. But it was also brought out in that workshop that we really do have a problem with the lack of any kind of a core curriculum on patient safety for professionals and paraprofessionals of all types.

And then the third effort though is many of these are really systems problems. We have systems that are error prone, that are encouraging errors. When it comes to look a like/sound alike kinds of drugs, we don't have medical records that somehow pull together the relevant patient information from the variety of sources. So you don't know whether certain drugs are contraindicated.

We don't have simple ways of calculating appropriate dosages for people of small weight, like children, who have very high error rates when it comes to drug administration, just horrible error rates when you look at the literature on pediatrics I think. Maybe I'm too flippant, but I can't quite figure out why we can't tackle some of those problems. They don't strike me as ones that are just insurmountable in terms of quality improvement, and yet we just aren't seeing a lot of traction on the issue.

DR. EISENBERG: Well, I want to say about a year and a half ago there was in FDAMA, whenever FDAMA was, the Food and Drug Administration's reform, there was something called CERTS, Centers for Education and Research in Therapeutics, which was proposed. AHCPR was given the responsibility for them.

We have a couple of million dollars that we have allocated and they are going to announce probably this week actually, the award of four of these centers, the intent of which is to get -- this gets back to one of your previous comments, John -- to get a population base for looking at errors, adverse events, and to see how they might be prevented, to try to get some more scholarship in that area.

And hopefully we'll be able to get some money to have more than four of these. But it will provide some of the database that I think committees might be able to use for making further recommendations.

DR. CORRIGAN: That's great. To me one of the most exciting things about working in this area right now is that at the IOM we basically convene experts, and they think about the problems long and hard, and then we produce reports and send them out. Right now with the efforts of John and the efforts of the Forum, and with the QUIC and all of these different groups there are really talented people out there organized and ready to act on I think some of the recommendations and findings and reports that come out.

So my own sense is I'm a real optimist right now. I think we have a tremendous opportunity to reduce that threshold, improvement in quality over the next ten years precisely because we've got this infrastructure in place of people who are working together, and have the resources and the support within their organizations. As well as we are beginning to really see some of the bridge that we need between the public and the private sector to be able to get a real big boost here, which we haven't frankly always worked real closely together on some of these issues.

So I think what's in place is just critical. What we hope to really do with the IOM is to do some of that work with convening diverse groups, and getting different perspectives, and kind of thinking through what can be done, and what some of the most important issues are to focus on. And the hopefully, others can take it and run with it.

MR. BLAIR: Dr. Corrigan, I was very impressed with what you and what the Institute of Medicine is doing with its Quality of Health Care in America project. You mentioned I thought that it was next week that part of the initiatives that you are pursuing is the relationships between information systems and health care quality. I think you were saying that next week there is either a workshop or a conference.

Could you tell us a little bit more about that, and let us know whether that is either open to the public or open to NCVHS committee members?

DR. CORRIGAN: Sure, I'd be glad to. Yes, it's an IT and quality workshop. It's on Wednesday of next week. It is at the National Academy of Sciences main building on Constitution. Oh, I'm sorry, you're absolutely right. It's this week. Thank you, Kathy. I'm really sorry, I'm off by a week. I'm glad you reminded me. I'll show up.

It's Wednesday of this week, you are absolutely right. It is in our main building right in town. It is open to the public. The main workshop begins I believe it's at ten o'clock that it kind of gets going, and it will go up until four or 4:30 p.m.

I will say that it is probably going to be standing room only. We have had a tremendous amount of interest in the workshop. There are about 25 or 30 people who are going to be actively participating in a roundtable. The workshop is a blend of structured presentations and then a lot of discussion, which is really what we want, to kind of sort through the issue.

Most of our Quality of Care in America committee members are going to be there as observers. They will be sitting on the side lines. It's their way to immerse themselves in this issue. But others are more than welcome to come.

And in the morning we will start out with a presentation from someone from the banking industry to lay out for us what has happened in that industry, just as an example of how IT can transform an industry. Then we're going to move into a series of very specific I think presentations on how IT has been used as a facilitator for quality improvement at different organizations, Intermountain Health Care, Harvard Pilgrim Health Plan, and others; specific types of quality improvement initiatives. Some of those are overuse/underuse. Some of them are patient safety.

Then we're going to talk a lot about the Internet and the World Wide Web, and what doors it opens up for really bringing either a better evidence base to bear on practice. So that whole area of knowledge-based systems to get the evidence into the hands of providers in a usable fashion, so we can try to move towards evidence-based practice.

It will also take a look at some issues and some discussion about how the World Wide Web and the Internet can change the relationship the patient and the provider. There we are mainly taking a look at the issue of to what extent can the use of e-mail between patients and providers substitute for visits, improved quality of care, supplement visits for the purposes of quality of care. What is the whole role there of different kinds of interactions.

There will be some discussion of the issues of automated medical records, and automated clinical information. Then later in the afternoon there are one or two roundtables that will be addressing specific policy implications of what we have learned through the day. The policy implications for purchasers, for regulators, for legislative. The need for national standards in so many different areas.

We won't get extensively into the issue of standards for data collection, data transmission, privacy, confidentiality. Clearly, there are others with far more expertise in that area. I have no doubt it's going to come out as a major policy issue. It will be spoken to in the report.

But at the same time, it's more to extent is this more rapid IT development critically related to our ability to improve quality of care. That's the linkage we are trying to get at.

DR. HARDING: Thank you for that presentation. It was very informative, and both presentations. You made an aside that was kind of chilling to me, where you just happened to mention the issue of CEOs who spend money on quality aren't around the next year when the time comes for them to continue their work.

Of course that brings up the whole issue that we're in a pretty cut throat market here, with quality being run up against cost. And that cost, I think it would be fair to say has often won the day in recent years. Do you have some thought about we can philosophically or whatever, try to make quality a profit center instead of a cost center, so that people are demanding and expecting that from their delivery of care, as opposed to not really caring very much about it, being more concerned about what it's going to cost per month?

DR. CORRIGAN: There are two parts to your question I think. First of all, we do know of many areas where increased quality reduces cost. We have a lot of evidence out there about waste. That's what we call sort of the waste component of it. And it's hard to get some sense of how much waste there is in the system.

The Roundtable on Quality at IOM estimated that to be something like 30-35 percent of health care services that are delivered are unnecessary, and expose patients to more risk of adverse outcomes than the potential benefits that they get from the service. That's one way of looking at it.

Others say that it is much higher than that. That's the first thing. It isn't quality or cost. We have a lot of areas where higher quality is lower cost, but that's one of the reasons we are trying to get into that workshop, to understand if you are a provider under fee-for-service, and you come up with a way to improve quality that is going to keep people healthier, and reduce the number of visits, unless you have a lot of demand for your services, you may not be that likely to pursue it.

The other thing is that there are some improvements in terms of patient safety, for example in hospitals that may be under DRG reimbursement, and we know that problems related to adverse drug events or error-related lead to longer length of stay. But if it kicks you into a higher paying DRG, then it may not get that much attention.

So that's sort of this issue that given that we think there is so much waste in the system, how come the leaders within our health care organizations aren't going after that? In any other industry they'd be out trying to weed out that waste real fast and capture it. Nobody is saying that anybody is intentionally delivering bad quality. It isn't like that. It's just an issue of where you focus your attention.

And in an environment like this, with organizations that are struggling so much to operate in the black, and have just sizable problems right now financially, it isn't likely to rise to the top of the surface, really weeding out that waste and going after quality.

Then there are other areas where increased quality will probably increase overall cost. There that really leads to the second part of your question, which is yes, but how do you get the market to demand that and reward it, and to clearly send a message that not using those resources to get the higher quality is inappropriate? That's not what we want to happen.

And that is where we are frustrated too, and that's one of the reasons we did the communications workshop. And we sort of reached the sense that we have to find a way to help the American public at large understand. Because large purchasers, and you talk to some of the large employers on the private side, they say well, I look at some of the comparative quality data coming out. I look at accreditation status. I look at these other indicators. I look at the satisfaction surveys.

But to the best that we can tell, they look at them, but they don't do a whole lot more. When it really comes right down it, what's driving the decisions probably has more to do with premiums and the cost side. And it also just has to do with the established patterns that their enrollees have. Employees don't like to have a disruption in their relationship to their provider.

It's kind of a double-edged sword. The major group purchasers and employers aren't going to probably take a real aggressive stand in quality to the point of kicking out certain plans or encouraging certain plans to set up very different systems in the marketplace unless there is a clear message that comes from employees and from consumers at large that that's what they want.

So the demand has to be there, and we don't quite have that demand. We think some of it, our best guess, is lack of awareness of the quality problems, and how different the care may be in outcomes you get depending upon which providers you go to, which hospital you go to, which institutions. There just isn't an appreciation of that.

DR. IEZZONI: Janet, I share the other members' excitement about the projects that you are undertaking. I just wondered where the following fits into what you are doing. There are a lot of people with chronic illnesses that affect their physical function, and their ability toward their daily lives.

The one thing about which we have very, very little evidence in medicine is the role of physical therapy, the role of occupational therapy, the role of assisted technologies including quality of life. There are various activities that could improve people's ability to live functionally in the world everyday.

We also know that health insurers are typically refusing to pay for some of assisted technologies, especially, under the rubric of not medically necessary. And we know that they are cutting paying for physical therapy, especially if it is for maintaining function rather than improving function after an acute event such as a surgery.

I notice Chris Cassell is on your committee. She is probably the one member who might have a full, complete appreciation of these issues. But are these kind of issues being addressed by any of your various committee activities?

DR. CORRIGAN: No.

DR. IEZZONI: I was afraid of that.

DR. CORRIGAN: It's an issue that is just waiting to be done. I share your concern. One of the first things I came across when I went to IOM over a year ago was the Health Care Services Division has this very large project underway. It's been underway for almost three years and just got extended for a couple more that has to do with looking at the kind of research that the Social Security Administration is doing related to the definition of disabled.

They are doing several things. They are taking a look at how the nature of work has changed, because for people who get disability, the definitions have basically been around for many decades. There haven't been many changes in how you determine who is disabled, and who actually gets support.

But in looking at how work has changed, and needless to say, work doesn't require as much physical activity as it does mental in many cases, but they also I think have really surfaced the issue that unless you have things like voice enabling technology, motorized wheelchairs, good PT, good OT, the person has still got to get to work, and they've got to be able to function. Those kinds of things play a critical role in allowing someone who could take a job as a computer programmer or otherwise, to be able to do that, to gain entry.

So they very much did surface this issue of the relationship between benefits covered issues, and the definition of disability, who is defined and able to get benefits under disability, which it seems like it's an area that is just ripe for further exploration, but we're not doing it now.

DR. IEZZONI: Janet, on that particular issue there is a Catch-22 that Social Security, through the disability insurance program does not pay for assisted technologies. So even though people might be able to have gainful employment with them, Social Security won't. Medicare often won't pay, because it is not viewed as medically necessary.

DR. CORRIGAN: There is no coordination between Medicare, Medicaid, or private insurers decisions about what they will cover, and thinking through what the implications are on the other end in terms of people's ability to work.

DR. IEZZONI: Let me just point out that as the baby boom generation ages, this is going to become an issue that maybe even Congress will get very interested in. So hopefully, you'll have an opportunity through the IOM to do something about this in the future.

DR. LUMPKIN: Thank you. I would like to add my comments supporting the work of this committee. It's really amazing, the breadth of things that you have attempted to tackle, and seem to be doing a good job in addressing. We're all going to be looking forward to the work products from the IOM in this particular area. I wanted to congratulate you on your efforts.

At this point, thank you very much for coming. We're going to take our lunch break.

[Whereupon, the meeting was adjourned at 12:15 p.m.]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

Monday, September 27, 1999

Proceedings By: CASET Associates, Ltd. 10201 Lee Highway, Suite 160 Fairfax, VA 22030 (703) 352-0091

PARTICIPANTS:

TABLE OF CONTENTS

P R O C E E D I N G S (9:10 a.m.)