Thomas Salon
Washington Marriott Hotel
1221 22nd
Street, Northwest
Washington, DC
Committee Members and Participants:
Lisa I. Iezzoni, M.D., Chair
Hortensia Amaro, Ph.D.
Lynette Araki
Olivia Carter-Pokras, Ph.D., OMH
Patricia Golden, NCHS
Richard K. Harding, M.D.
Ronald Manderscheid, Ph.D., SAMHSA
Vincent Mor, Ph.D.
Carolyn Rimes, HCFA
George H. Van Amburg
M. Elizabeth Ward
Page
Briefing on Medicare Outcome and Assessment Standardized Information Set (OASIS)
Steve Clauser, HCFA 8
Liz Mauser, HCFA 13
DR. IEZZONI: This is the meeting of the Subcommittee on Population Specific Issues, is that what we are? Yes? You can see that we are not as popular as the other two subcommittees, so this will be a very intimate afternoon and hopefully, we will have a chance to have a dialog about some important issues.
The first thing that I wanted to was just review for people who came yesterday to the meeting and for Vince, since he was not here yesterday, what I thought I heard about what the role of our subcommittee was going to be. Then what we could do is not talk about what you hear right now but just kind of be pondering it in the back of your head. Then we will hear from the HCFA people again, and then afterwards, we will spend some time talking about any corrections that you might have to what I am about to say.
We will talk about Georgia's piece that we want to vote on tomorrow, and then we promised ourselves that we would try to find a date for July for us to all get together again. That will be the last item on the agenda. If we get done before 5:30, we will quit.
DR. AMARO: I met this morning with Dr. Sondek, and I think our discussion is relevant to our business, so at some point, I would like to just share that.
DR. IEZZONI: Okay, let us add that to -- right down after George and right before we kind of come up with a date.
All right. Yesterday, we talked about the fact that we have two types of business, old business that we are wrapping up and new business. The old business -- I hate to call it old, because I think it is going to be ongoing, but it the OMB Directive 15. We heard some interesting presentations yesterday from the Bureau of Labor Statistics and the Census Bureau. The outcome of this is that Hortensia will be working with Olivia to draft a response to the Federal Register proposal that OMB will probably be coming out with around July 1st, and that the Bureau of the Census will also be coming out with. We will, as a subcommittee, look at this response when we get together in July. We will, by e-mail, try to iterate a file conclusion of it so that Dawn can send a letter out in response by the end of August. That is item number one on the old business.
George has item number two on the old agenda that we are wrapping up, and we will deal with that. Item number three on the old agenda was the core data sets. We heard from Ron Manderscheid that SAMHSA is actively coming up with encounter and enrollment data approaches for mental health, substance abuse. What we will do is we will hear a presentation from him when that work is done in conjunction with Barbara Starfield's committee, to try to bring it back to the full committee. Is that what we heard? Okay.
The next core data elements, Vince, you will be happy to hear that we have authorized full payment to you. What we have said that we will do is we will ask Caroline and Judy Kasper to coordinate getting you final comments, that you will redraft that based on the final comments that you will get, and it will be wrapped up. It will be wrapped up as of that point, and we thank you very much for that document, for the background that it gave us, but we feel that the paradigm which was kind of implicit in the document was different from the very core, stripped down administrative encounter type of paradigm that the broader core data elements project used and that mental health core data elements project used. So, at this point, we are planning to move on because we do not feel that we have a sense of where a core data element would fit for disability and long-term care issues in the broader context.
What we do want to do is keep track of coding for long-term care, how coding differences might be manifest. Look at the ICIDH again. Look at how the Bureau of Census and Social Security Administration will be thinking about disability as they are going to be conducting a variety of new surveys. We will have some presentations on that, probably in the context of breakout sessions at future meetings. Okay, is that what we heard, people? Okay. All right. So, that is all for old business.
For new business, we have two types of new business. One is kind of this being nimble to respond to immediate issues that arise. One of the immediate issues, although it is not -- well, it is kind of immediate from what we heard yesterday was the issue of data systems for the territories and islands, Puerto Rico and the Pacific Islands. What we have decided to do, because these places get block grants and a variety of other federal sources of money that do not have systems to track their need or how in fact health is affected by the implementation of block grants. What we will do is to hold a one-day information gathering session in September specifically about Puerto Rico, other territories, learn about the issues and think about whether we need to do anything more or whether that one-day session is enough for us to be able to draft some recommendations to the Secretary about data systems.
DR. AMARO: Did you say September?
DR. IEZZONI: September. Yes, I did say September. DR. AMARO: So we need to come up with that date?
DR. IEZZONI: We should probably come up with that date, or we could say it would be October because we are having already two days of meetings in September, so we might want it to be October. The point is early fall. So, that is a very good suggestion, Hortensia. We will come up with a date.
DR. CARTER-POKRAS: [Comment obscured by previous speaker.] money. September would be this fiscal year. October would be next fiscal year. So, if we have to travel anybody, that may be an issue. We need to get somebody in there to give us some feedback on that.
DR. IEZZONI: That is a very good point, Olivia. We did not hear that. Is Lynette somebody who could answer that for us?
DR. CARTER-POKRAS: We will have to grab somebody. I know that sometimes there is a problem with planning October meetings because we have to get the budget approved before we can travel --
PARTICIPANT: We should make it a little colder in this room though.
DR. CARTER-POKRAS -- the end of the fiscal year is easier than the very beginning of a fiscal year.
DR. IEZZONI: Are you okay?
PARTICIPANT: I am okay.
DR. IEZZONI: What we are going to move to right now is that the second issue which was the nimble kind of respond to immediate things, is what we are talking about today. This is the -- you know, what we are here this afternoon to talk about is the fact that we have just learned -- a number of us have just very recently, within the last couple of weeks, learned that HCFA is planning or has written a notice in the Federal Register proposing that there be a new data collection procedures put into place for home health agencies.
What we wanted to do as a committee was to hear about this. Long-term care disability and the type of population that I think will be addressed by home health is one of the populations that we would be interested in learning about. Hearing about it, and then thinking after we hear what it is that is being planned, we might want to talk as a subcommittee about whether we want to hear more from the industry people who are out there who would be affected by this. So, what I think our guests will be doing today is telling us about this. We would also like to hear from you about whether we have run out of time to respond as a subcommittee, which I think we might have within the Federal Register timing. It was something that we did not know about.
Okay, so could you each introduce yourselves.
MR. CLAUSER: Steve Clauser. I am currently at Research at the Health Care Financing Administration. Our office sponsored the development of the work that Peter Shaunessy did on developing performance measures and a quality improvement system for home health, which is really the basis for the development of OASIS.
MS. MAUSER: I am Liz Mauser. I am also in the Office of Research and Demonstrations, and I am now the Project Officer on the Oasis Demonstration. It is ongoing.
DR. IEZZONI: So, are either of you involved in the implementation --
MS. MAUSER: The implementation actually goes across all of the bureaus of HCFA are involved, so I was involved in terms of writing the notes of the proposal we are making.
DR. IEZZONI: Okay, I am afraid that people are going to have to speak up because it is actually a bit noisy in here, so it is going to be hard for us to hear. Maybe we should go around the room and have ourselves introduce each of us, so you all are on equal footing and fair footing. George, do you want to start?
MR. VAN AMBURG: George Van Amburg. I am a Senior Research Fellow and Commissioner with Health Institute.
MS. WARD: I am Elizabeth Ward, Assistant Secretary for the Washington State Department of Health.
DR. MOR: I am Vince Mor. Who are you? She is my project officer.
DR. IEZZONI: Okay, good. A relationship exists then. Lisa Iezzoni. I am at Beth Israel Medical Center in Boston.
MS. RIMES: I am Caroline Rimes. I get to work with these guys through tomorrow.
DR. AMARO: I am Hortensia Amaro, and I am at Boston University School of Public Health.
DR. CARTER-POKRAS: Olivia Carter-Pokras. Office of Minority Health, Office of the Secretary.
DR. IEZZONI: Why don't we get started? Let us hear from you.
MR. CLAUSER: I thought it might be useful to break it into kind of two pieces, one to give you some kind of an understanding, from a policy context, about how HCFA got to the point of dealing with OASIS. Then Liz can talk a little bit more about the development of OASIS as an instrument and its use in our current HCFA Demonstration Project which is really testing its applicability in a real life programmatic setting. I will talk a little bit about policy, and Liz can talk about the instrument.
The development of OASIS really, in most respects, goes back almost 12 years to a research study, and Liz is going to talk more about that development effort. When we talk about it from a policy context, about how HCFA really got focused on this, I think we really go back to about 1994. Bruce Vladek, our HCFA administrator, initiated what he called the Home Health Working Group. It was a real interagency group of experts from the agency in the areas of human health, public policy, quality assurance, program integrity, and operations, all of the areas that have some impact on the home health program, to really kind of do a cross cutting, kind of a ground up assessment of the home health benefit, what is it doing for our beneficiaries and how effective is our current policies in each of those areas that I mentioned.
As part of that effort, the work group really spawned what was called the home health initiative. Part of that was really to reach out also to external communities, to get input from providers, researchers, policy makers, on aspects of the home health benefit to find out kind of what works, kind of what does not work, and to get some of their assessments about the short-term and long-term policy directions that we might want to consider in improving the way that this benefit provides service for our beneficiaries in the program.
One of the arms of this initiative had to deal with quality assurance. In a meeting that we had with a lot of the provider community, we really got a sense from them that there was a lot of support within the industry for an assessment instrument in home health, particularly for quality assurance and performance improvement. But they did not want an instrument as extensive as the MBS in nursing homes. From their point of view, they thought it would be much more promising to develop what they considered a core assessment instrument that could be used by agencies for assessment and other purposes.
Kind of in follow-up to that, HCFA convened a work group of experts in clinical assessment to really kind of look at the issue of doing assessment instruments in home health. That included representatives from the industry and national associations of home care providers, which really even went beyond a bit even our traditional Medicare home health agencies. This group also suggested that they thought a core assessment instrument was the way to go instead of a comprehensive instrument. They were very concerned at the time that a single instrument really could not capture the broad diversity of patients that the Home Health Agency serves, both from technologically dependent patients, very acute oriented patients, all the way to those who have largely needs for kind of skilled management of maintenance kinds of services.
The recommendation was that HCFA develop a core instrument of some type and try to build that into something that agencies could use in their own comprehensive assessment of patients under the program. I think it was also part of the same group that also recommended the use of an instrument that had been developed by the Office of Research and Demonstrations, a research initiative with the University of Colorado. You know Peter Shaunessy at the University there, who was dealing with assessment as part of a project that we had to develop outcome based quality measures for home care.
There were a number of assessment items that this group recommended be put in in addition to the core assessment process that Peter had put together for our research study. This data set is really the basis for our national demonstration project and the outcome and assessment information set for home care. Liz is going to talk about the instrument in our demonstration in a minute.
The other thing that he just mentioned was that, and this is really the next step in kind of the policy development, is the publication of a notice of proposed rule making, and that was done on March 10th. This would require agencies to collect the OASIS data as part of the conditions of participation to participate in the Medicare program and provide services to Medicare beneficiaries.
Now, the comment period for the MPRM has closed, and the comments are currently being reviewed as we speak. I think our understanding is that the number of comments that we received were relatively small for the kinds of condition notices we make this area. I think there were like 90 comments on the OASIS itself.
MS. CLAUSER: 142.
MR. MAUSER: 140 to 150 comments on the entire conditions of participation. OASIS is part of the whole MPRM, which really deals with the conditions and in many other areas. That was, at least from our perspective, I think that makes us hopeful that we will be able to move to a final rule and hopefully implement the system based on the comments and an assessment of what we received in response to that MPRM.
Now, the most important part of the MPRM, I believe, is that agencies will begin to collect the standard data on the OASIS tool. I think the important thing from our perspective that we try to emphasize is that we realize that while we really expect that we have a core assessment instrument go into the implementation of the conditions of participation. Over time, like all assessment instruments, the OASIS is going to evolve. There will be a need to reevaluate data items, wording of data items not only to adapt to the changing nature of the home health industry but also -- and individuals who receive home health services, but also in terms of the reliability items as we get more information over time. Therefore, we expect that there will be iterations over time, and this thing will be an evolving process like all of the other instruments that we have.
Now, that is really kind of the key pieces of the policy step that we have to do. What I would like to do is to turn it over to Liz to talk a little bit more about the development of the instrument itself and what we have done in the context of our demonstration to learn about its utility in the home health program.
MS. CLAUSER: I have -- actually, I will pass these out. These are some handouts about the demonstration and also in case anyone has not seen the Federal Register notice.
I want to start by talking a little bit about some of the developmental work. In 1988, HCFA sponsored a study called the Development of Outcome Based Quality Measures for Home Health Services, and the Robert Wood Johnson Foundation also sponsored a companion study called, Indicators and Measures to Use Assessing the Quality of Home Health Care.
This project, which began in 1988, was mainly to develop and test outcome based measures or indicators of quality for Medicare Home Health Services. At that point, we were going to consider whether these measures could be incorporated into Medicare's home health quality assurance programs and approaches.
The first phase of the study was really a developmental phase, which I will explain a little bit about. The second phase of the study was a general feasibility assessment to really determine which quality measures would be appropriate to investigate further in the final empirical phase of this study. This study ended, I guess, in about 1993 or 1994.
MR. CLAUSER: Yes, I think 1994.
MS. MAUSER: 1994. Down there. The developmental work really first involved the review of existing classification and taxonomies of patient care needs and conditions. There also were extensive reviews of the literature on indicators of quality of care. The University of Colorado developed an initial taxonomy of care needs of home care patients, and they began to initially specify indicators of quality care for home health patients.
There were a number of different clinical panels that were convened to review the taxonomies of care and also the quality indicators. They were really trying to get the perspective of clinical care home health providers.
During the developmental work, there were several different iterations in terms of developing these quality indicators and then having these clinical panels review the quality indicators. I guess sometimes people -- the wording of these is a little bit different. When I refer to quality indicators, I am really talking about attributes of care or of a patient, not rigorously the sign that can be used to gauge or assess the quality if it is precisely defined. The quality measure is really once that quality indicator is precisely defined with a numeric value.
Once this developmental phase was over, we began a feasibility stage. Really the purpose of this feasibility stage was to assess the comprehensive set of measures that were developed during the developmental phase to look at the burden of data collection, to look at possible sources of data, to look at different approaches for collecting the data, to look at whether this was practical for the Medicare program, whether they could use existing data from the HCFA program or from accreditation programs. They were trying to look at some of the accuracy of information if they used it from existing sources. They were also looking at whether the system of measures that were developed were comprehensive or not, and they were trying to identify whether there were certain quality of care problems that were excluded from the system that was development.
I am just going to go through very quickly some of the criteria that were used initially for choosing outcomes to measure, and this is on your sheet. One of the things, they wanted to make sure that the outcomes that were developed, outcome measures, would be something that were really measurable. They wanted to make them as simple as possible.
They looked at some statistical properties of the outcome measures. For example, they wanted to avoid very rare outcomes or very common events. They also wanted to make sure that all of the individual measures conveyed unique information. They wanted to look at whether the measures that were developed provided some utility for assessment and care planning purposes. They wanted to make sure the measures that were developed were not very gamable by the home health providers. Finally, they wanted to look at whether the items and measures could be used for clinical assessment, management, administrative, fiscal and reporting purposes.
In developing the outcome measures, one of the first things they did is to define what the University of Colorado calls Quality Indicator Groups or QUIGs. This was really -- they developed this because there was a need to develop homogeneous groups of home health patients. Since there is a wide variety of home health patients, they wanted to try to classify them as a first step for risk adjustment. These quality indicator groups are really based on diagnosis, they are based on the requirement for specialized care, and they are also based on functional problems.
The University of Colorado ended up developing 25 different groups or QUIGs. There are 16 QUIGs that are more acute care oriented and 9 which are more chronic care oriented. Just to give you a few examples for acute QUIGs, they have things such as orthopedic conditions, neurologic conditions, terminal conditions, oxygen therapy and IV infusion therapy. Some examples of chronic QUIGs are dependent in living skills, dependent in personal care, impaired in mobility, someone who has chronic pain. These are just some examples.
For the work, they defined an outcome as -- three different ways, actually, they defined an outcome. One is a change in health status between two or more time points. Another way is a change in behavior, emotions or knowledge that can influence end result outcomes. So, this might be compliance to a medication regime as an example.
The final type of outcome is a health care utilization that reflects typically a substantial change in patient health status. Some examples of outcomes are improvement or stabilization in ambulation, improvement or stabilization in management of oral medications, acute care hospitalization for any reason and improvement or stabilization in total number of pressure ulcers.
As part of this feasibility study and to really help with the validity assessment of the chosen outcome measures, a survey was done of home health providers, and the survey asked the home health providers about frequent quality problems in their agencies. Some of the quality problems that home health providers mentioned were family caregiver stress, inadequate exercise or diet control, increased symptoms like pain, poor medication compliance, decreased abilities in activities of daily living and instrumental activities of daily living, institutionalization for care, poorly controlled hypertension, inappropriate medication. These are just some examples of what agencies mentioned.
Other considerations during this feasibility phase for selecting outcome measures was they were looking for measures where a reasonable amount of change actually occurs for the measures of interest. There is also -- for these measures, there is a potential for change. Finally, they were looking at the independence of a measure relative to other measures included in their system. During this --
DR. IEZZONI: Liz, can I just ask you how they evaluated the gaming? During this initial phase study, did they evaluate the gaming issue?
MS. MAUSER: I am not sure. I was not involved in the developmental phase. I am not sure exactly how they did that.
DR. IEZZONI: Thank you.
MS. MAUSER: I can find out for you, though. During this feasibility stage, they also examined existing data sources such as the HCFA 484, 485 and 486. They looked at clinical records and existing data sets.
They ended up developing data items for the sole purpose of quality assurance and performance improvement. During this feasibility phase, there were a series of reliability tests done. Generally, for these reliability tests, two assessors did the assessment within 24 to 48 hours of each other. Once these reliability tests were completed, they revised or eliminated items if there Capas (?) or Pierson czars (?) were lower than .75. This was really the first set of testing in terms of reliability, although there have been a number of different studies since then.
During the empirical phase of the developmental work, this phase really focused on the additional refinement of the measures, developing risk adjustment methods, really refining the approach, this approach to quality assurance and quality improvement -- I will go into defining this approach a little bit more in a few minutes -- as well as doing additional reliability testing of the instrument.
During the -- initially during this empirical phase, they did reliability testing at three agencies in Colorado. During these testings, there were two assessors on the same visit filled out the assessment. Here, during this initial reliability testing, it turned out for the activities of daily living and instrumental activities of daily living, their scales, their Pearson's (?) correlation coefficients ranged from .54 to 1, averaging around .8. The only scales that really were below .7 were the ability to manage equipment and transportation. Besides that, they were all above .7. In terms of variables that were used to define membership in a different quality indicator group, the Koan's Kappa (?) on average was about .81.
Once all of these reliability tests were done, the University of Colorado reviewed all of the results. Then they revised data scales as needed if they had low reliability. Then they conducted the reliability test again. Some of the things that they did when they were looking at variables with low reliability, in some cases they adjusted the scale or collapsed two categories. So, the final variables that are in the OASIS from this developmental work were variables that had the highest reliability after all of these different tests were done.
DR. IEZZONI: Can I just ask this. The OASIS is administered by a home health nurse?
MS. MAUSER: It is either a nurse or a physical therapist also.
DR. IEZZONI: Okay, so in the future, as it is used as a quality improvement or quality assessment tool, it would be the nurse employed by the home health agency --
MS. MAUSER: Right.
DR. IEZZONI: -- rating patients.
MS. MAUSER: Right. Yes.
DR. IEZZONI: And the gaming was not determined?
MS. MAUSER: Yes, they are going to be building -- once OASIS is -- the notice of proposed rule making would require agencies just to begin to collect the OASIS data, the OASIS items. They would not be reporting them to HCFA. You want to give agencies an opportunity really to learn how to collect these items, to try to integrate them into their assessments. Once these data have to be reported to HCFA as part of the conditions on participation surveys, we are going to have to go out and do audits of these surveys in some cases. They might visit a patient later on in the day and do another assessment. So, there will be things.
DR. AMARO: Along the lines of the data collected, it looks like some things might be done by observations but other things -- other items take interaction with the client or the patient.
MS. MAUSER: Yes.
DR. AMARO: So, is this done in the patient's language?
MS. MAUSER: Yes.
DR. AMARO: So, English, Spanish.
MS. MAUSER: Whatever it is, right.
PARTICIPANT: Whatever?
MS. MAUSER: Whatever, yes. Well, the home health provider -- I mean, the home health provider, however they are communicating with the patient.
DR. AMARO: Oh, but the instrument is in English only.
MS. MAUSER: The instrument is in English.
DR. MAUSER: So, it depends on who is available and how they happen to translate the items?
MS. MAUSER: I am not sure. I mean, that is something that our surveyors will be dealing with. We are not specifically dealing with that. I am not sure if they have translated these instruments or not. That is something that is more operational.
DR. IEZZONI: Should we say that is an issue?
DR. AMARO: Yes.
MR. CLAUSER: It may or may not be an issue. I do not know exactly what they have put in there.
MS. MAUSER: It may or it may not. We just do not know.
DR. AMARO: We have moved toward recommending, and I think other data systems have moved toward trying to provide the instrument itself in a translated form for the most important or largest number of language groups rather than to depend on impromptu translation because you have gone through all of this testing and then suddenly it all goes out the window.
[Ms. Mauser and Mr. Clauser speaking at the same time.]
MS. MAUSER: Again, I am not sure how --
MR. CLAUSER: I am not sure what people might need. I have a copy if you want to look at them.
MS. MAUSER: I do not think it says it in the -- I do not think so.
DR. AMARO: Well, if you had gone through a translation process, you would know it, right, because the instrument would have been translated through the normal process?
MS. MAUSER: This is not a final rule. This is a proposed rule. So, I am not sure what they do in the final rule for it.
DR. IEZZONI: It sounds like a final rule is about to be written.
MR. CLAUSER: They have to assess the comments.
MS. MAUSER: It is not going to be out next week.
DR. IEZZONI: Well, I guess the question is, do we have a chance to comment? Will we have a chance --
MR. CLAUSER: Clearly, the formal comment period is closed. I mean, the obligation of the government, the notice of proposed rule making, comments that get received within that legal time period, we have a legal obligation to take serious consideration and justify in the final rule exactly how we address those comments in the context of the ruling process. We always want comments, I mean, in terms of feedback on whatever we are doing. The motivation of the agency is to try to do the best job they can, and to the extent that you are -- you know, you have an interest in providing information, I can tell you exactly who to provide it to.
DR. IEZZONI: Why don't we deal with this whether we want to write a response with some of these items after we have heard more of your presentation. Okay.
MS. MAUSER: I guess I will really basically describe some of the developmental work. Throughout the developmental work and even now, the University of Colorado has been reviewing existing data items from other data sets including the FIM, the SF36, MBS (?) the draft of the uniform needs assessment instrument. They have been looking at established scales for activities of daily living and instrumental activities of daily living. They have been looking at pro quality screens, state level home care quality measures. They have been looking at some emerging data sets in managed care, and they have been really reviewing a lot of data systems that individual agencies are currently using. In their work to date, they have reviewed over 3,000 clinical records at numerous agencies across the United States. So, they have continued to look for different variables to refine the OASIS, and in the demonstration, we are continuing to do that. I will discuss that in a couple of minutes.
I guess one thing I just wanted to stress was that the data set developed by the University of Colorado -- and this is a little different than some of the other data sets that have been developed -- really resulted from the process of first specifying the outcome measures and associated risk factors and then, for each outcome measure, developing the data items that would go with it.
Probably most of you are familiar with the different types of items included on the OASIS. In the Federal Register notice is a copy of the OASIS.
I am going to now spend just a little while talking about the current demonstration that we have ongoing. The real purpose of the demonstration is one, to have agencies integrate the OASIS into their clinical records. One thing that we have been encouraging for all home health agencies using the OASIS, and we encourage it in the notice of proposed rule making, is for agencies, if they are collecting similar items that are on the OASIS and probably most agencies are collecting those items or they should be collecting those items -- that they replace the OASIS items for the items on their assessment for similar items so they are not duplicating their assessment process or their data collection process.
DR. MOR: Liz, I would like to ask a question. OASIS as you have just described, very nicely described, was developed for the purpose of outcome measures. It was not designed as an assessment instrument.
MS. MAUSER: Yes.
DR. MOR: But now as part of the notice of proposed rule making, you are suggesting that agencies take these items and incorporate them into their assessment process.
MS. MAUSER: A lot of the items on the OASIS are items that they are already doing for assessment. These are items, for example, that may be are asked a little different way, and the agency really feels that it makes a difference in terms of how they assess the patients. In that case, the agency may make the decision that, okay, we are going to do it the OASIS way, and we are going to do it our way also in those cases. Those are comments that we got back from agencies.
I do not know what the comments are yet, I have not seen them, in terms of the OASIS. Agencies have looked at it and said, Oh, well, you are asking it this way, and we really think it is more useful to ask it that way. It is something that we need to look at and see if maybe we need to modify it. Those are also things that we will look over time, are agencies having trouble incorporating this in terms of their assessment process and do we need to make modifications as a result of that. That is one of the things that we are looking at in the demonstration.
DR. IEZZONI: It does seem that there was a research effort specifically to develop assessment measures.
MS. MAUSER: It was -- the research effort was to develop outcome measures for quality assurance and performance improvement.
DR. IEZZONI: [Commenting during previous speaker, not individually distinguishable.] -- assessment measures.
MS. MAUSER: No. In the demonstration, we are trying to also implement and refine Medicare's approach to outcome based quality improvement. We are going to be implementing as part of the conditions of participation, and we really want to develop a foundation for a national program for outcome based quality improvement.
In the program, we are trying to develop for the Medicare program and in the demonstration, the outcome based quality improvement is really based on two stages. In the first stage, there is outcome analysis. Agencies in the demonstration and once we implement this in the Medicare program will be receiving risk adjusted outcome reports. That is really the first stage of this process. The second stage of this process is to look at these outcomes and to review areas where the agency is doing very well and also areas where they are not doing so well and develop plans of action to either improve care in cases where they are not doing very well and also to develop plans of action to reinforce care for areas that they are doing extremely well in.
DR. IEZZONI: Liz, let me just -- I am sorry to keep interrupting you but I am back on this gaming issue. You know, most of what I have done my research on has been risk adjustment for hospitalized patients. New York State, as you probably have heard, implemented this coronary artery bypass surgery reporting system. The providers submit the information about patients, and then it is produced by the state to produce a risk adjusted mortality profile.
There has been some debate with the state agency people denying that this occurred, but some compelling evidence that in fact since providers are the ones who are reporting the information that they are manipulating some of the data. For example, in the New York Heart Association, functional class is one of the data elements that is reported. Unless you go back literally and reinterview that patient or are sitting there in the room while that patient is examined, you cannot test the accuracy of that.
So, I guess I am a little nervous about having the agency's nurses or home health providers be evaluated by information that they, themselves, are reporting. Yes, I hear that you are going to send out auditors periodically, but I suspect that there is going to be enormous incentive to game these data.
MR. CLAUSER: There is gaming in terms of actual fraudulently trying to misrepresent the status of the patient, and then there is also -- you know, some people misinterpret as gaming when there is appropriate coding which then starts making populations look different over time as people get better at doing what they are doing. That is going to be -- that is a hard thing to disentangle in a lot of areas.
DR. IEZZONI: HCFA had to deal with that when they implemented DRGs (?) and tried to figure out whether code creep was due to increased accuracy and completeness of coding or changes in the patients that were admitted to the hospital. A lot of this is, as you say, very subtle, especially functional status. There is going to be, I think -- you cannot necessarily call it fraud because you are not saying that somebody is now running the Boston Marathon when in fact they are in wheelchair, but subtle shifts in what people call people in terms of ambulation and other functional status measures, especially if they view themselves as being rated on this. I mean, it is just going to be human nature.
MR. CLAUSER: Some of that you can pick up in the demonstration, right. Going back in and redoing it and seeing at least over some period of time exactly what happens to raters as they get more comfortable in the change.
DR. IEZZONI: But in the demonstration, the motivations are quite different. It is a research enterprise.
MR. CLAUSER: But other than doing it, it is hard to --
DR. IEZZONI: It is also burdensome on patients having second people come back in and physically examine them and talk to them to do the auditing process. I mean, when the government audited the medical records for the DRG creep (?), the OIG (?) did that. It was just a medical record. You know, that is not a burden, but it is a burden on patients having to come back and have auditors look at them. Maybe I am just talking aloud about things that immediately are worrisome to me.
DR. MOR: I actually think those are generic issues in general. Really, the extent to which this particular instrument and its implementation, it was designed initially as a quality measure, and now it is in an assessment context. This is a more or less an issue because it is always going to be an issue.
DR. IEZZONI: Well, that is the -- I was reacting to the criteria for choosing the measures. Avoiding gaming. That was one of the explicit items, you know.
MS. MAUSER: To the extent possible. I mean, you are not going to avoid it completely.
MR. CLAUSER: I mean, to the extent function drives as we know in this field -- to the extent function drives a lot of power in terms of understanding the clinical and health status of the individuals that are in these care settings, you cannot avoid function even though you have some concerns about gaming. Now, there are things that you can do to try to address some of that gaming to some extent but I agree that it is a generic problem. It is true in nursing homes, and it is true in any setting that has to deal with function as a major variable.
DR. IEZZONI: But I think that --
MR. CLAUSER: Well, yes, that is true, anything that is collected by the person who is being evaluated.
DR. IEZZONI: That is right.
MR. CLAUSER: Physicians, anybody.
DR. IEZZONI: Fine, it is a generic issue, but it is important. I am just concerned about the provisions that you have for addressing that and making sure that you are getting meaningful data.
MS. MAUSER: Yes, the provisions, I do not think we are ready to speak about that today. That is going to be part of some future notice of proposed rule making, and so --
DR. IEZZONI: We should try to make sure that we are informed about all of this, not that it is your fault that we did not know, but we should as a committee try to get some process so whenever we have these kinds of situations, we are not in a situation where are trying to react too late to be useful.
MR. CLAUSER: I want to emphasize, I think any comments you provide would be useful. The question of -- I think that agencies are always interested to hear from interested parties who have useful things to add to the deliberations.
[The following comments were simultaneous, small portions not individually distinguishable.]
MS. MAUSER: And then comments, too, about --
MR. CLAUSER: I do not want to discourage you in at least making an effort to try to get some communications to us if you have something --
MS. MAUSER: And also comments about the gaming issue or maybe even things that you would think --
MR. CLAUSER: I do not know but the language thing may already be accounted for, but if that is a concern, that should be raised.
MS. MAUSER: Yes. The thing is about the gaming issue, if you suggest things you can do, other things like that, I mean that is something we will take into consideration as it proceeds up that path.
DR. IEZZONI: Right. You just have to understand that we just spent the entire day talking about administrative simplification, and this does not sound simple. So, we are kind of coming from, you know, six hours of having talked about --
MR. CLAUSER: Simple in what context. I mean, a lot of the -- at least some of the work -- I do not want to jump ahead of you, but some of the work we are seeing in the agency leaves us to be somewhat optimistic that this is not a significant burden on the agencies in terms of what they are normally doing in terms of the kind of assessments that have.
DR. IEZZONI: But I hear about patients being examined a second time due to auditing.
MR. MAUSER: Oh, in terms of auditing.
DR. IEZZONI: Why don't we let you go. Go on.
MS. MAUSER: As I was saying before, the outcome based system is really a two stage process. In the first stage, there is outcome analysis by the different patient groups and also some global outcomes are analyzed. All of this is risk adjusted as needed. The outcome reports really trigger specific groups or outcomes to examine.
In this second stage screen, there is case review for the triggered groups and outcomes. We looked at some -- the agency looks at some processes of care to see why they are doing poorly in an area or why they are doing very well in an area. They develop actions to change or reinforce behaviors.
Further demonstration, there were 50 agencies that were phased into the demonstration beginning in January 1996, and it is a three-year demonstration. One of the basic features of the demonstration are that data are collected at the agency level for each adult patient. It is important to realize that OASIS was developed for adult patients. It is not for pediatric patients, for example. At the start of care, every 60 days thereafter, which coincides with their recertification period, and at discharge.
In the demonstration, the data items are incorporated into the day-to-day agency recordkeeping so that agencies are not providing information beyond which they normally require for patient assessment and care planning.
The data are computerized so we can calculate risk adjusted outcome measures for the individual agencies. In the demonstration, outcome reports are produced to compare an agency's outcomes to the outcomes of the demonstration agencies and also to be able to compare an agency's outcomes in one year to their outcomes in a preceding year. That is actually one of the most interesting, I think, comparisons is for an agency to be able to see how their outcomes change over time.
In the demonstration, we are right now in the second year of the demonstration, and agencies are focusing on specific outcomes to reinforce or change care behaviors through developing this plan of action. For this second year of the demonstration, all agencies are working at trying to look at re-hospitalization rates. Since that is a major problem for a lot agencies, we asked all agencies to look at that outcome measure. And then all agencies picked another outcome to look at and develop plans of actions and to implement ways to improve care. Basically, it is a continuous quality improvement cycle where you get these outcome reports, you develop plans of actions to change care, you get another round of outcome reports, and it continues over time.
As I said, before -- 50 agencies are participating in the demonstration. The agencies that were chosen is really a leadership sample. We were looking for the agencies participating in the demonstration, that there was some administrative stability over time, there were some organizational support for quality assurance activities. They were flexible in terms of implementing these changes for the demonstration, and there was at least some staff interest.
During this demonstration, we received close to 300 applications for the 50 slots, so there was widespread interest. In some of our demonstrations, it is hard to find enough providers to participate, but in this case, it was not difficult.
We also tried to get agencies across the United States. I listed the different states. There are 26 states covered in the demonstration.
So far, the agencies that are participating have felt that incorporating the OASIS into their assessment care planning processes helped them really to focus more on precision. A lot of these variables they were already collecting but they were not collecting in a very precise manner; they were kind of just writing it in their record. They also have felt that using -- in implementing the OASIS as part of their assessment that it has really helped them in their assessment process.
There was a provider meeting, I guess last November. I am not sure how many of the agencies said that they really felt that they were doing improved assessments after implementing this standard instrument. I do not know whether it is -- I think a lot of agencies right now are not collecting a lot of these items in standard ways, so I think using the OASIS or whatever OASIS eventually becomes after iterations, I think it just helps agencies really focus what they are doing and what they are looking at.
All of the agencies also said that their care planning has been enhanced since incorporating the OASIS, and they also felt they were better able to identify, at least initially, patients that are home bound.
Last fall, we did a time survey to find out whether using the OASIS really increased the time of their assessments. We found that it did not increase the time of the assessments. We did a test in 11 agencies and about 60 providers. We looked at agencies that had branches, one using the OASIS and one not using the OASIS. We asked them to time the sort of care assessments and also the last phase or the discharge visit. The time difference was maybe a few minutes. So, it did not increase the time.
In the demonstration, we started out with OASIS-A. Right now, agencies are using OASIS-B. Really, the changes between OASIS-A and OASIS-B were based on care provider feedback and reliability tests done during the first year of the demonstrations. Changes were really intended to clarify specific items and increase the ease of the use of the OASIS.
Right now, we are doing more reliability testing of OASIS-B. Just last week, actually, the University of Colorado completed some initial reliability testing with 40 home health patients, and the nurses are doing two assessments on the same day of these patients. Right now, Colorado is analyzing these data.
We are also going to be doing some additional reliability testing throughout the summer. We want to look at the reliability at the different data collection points, looking at the initial assessment, looking at the follow-up periods and also looking at the discharge assessment. Those will be continuing throughout the summer. Any changes from these reliability tests will be incorporated into future versions of the OASIS.
The activities in the demonstration for this year, one was to integrate OASIS-B into their assessment process, and that has been done a few months ago, to continue all of the data collection activities, to review the outcome reports that they receive from the University of Colorado, to analyze care for target outcomes, direct plans of action, to attempt to change care behaviors and change patient outcomes.
Just to -- and before I turn it over back to Steve, there has been widespread interest and participation in the development of the OASIS. Approximately 500 agencies have been involved in the research in different stages of the research process. Right now, there are seven state associations sponsoring activities related to the OASIS, and this includes Washington, Indiana, Massachusetts, Minnesota, Tennessee, Ohio and Florida. Additionally, California is just beginning some activities. New York State is also sponsoring a demonstration with roughly 25 certified and licensed agencies. Also, there is a consortium in New England; they are also sponsoring some OASIS-related activities.
We do not have an estimate of the number of agencies that are currently collecting the full OASIS or a subset of the OASIS. We know it is hundreds of agencies out there are doing it. Also, we have had up to this point widespread industry support for the OASIS and for developing and outcome-based continuous quality improvement system. NAHC has -- the National Association for Home Care has been sponsoring numerous sessions on OASIS at their meetings and have been disseminating information. This was probably one of the few times since I have been HCFA that we have gotten widespread support from the industry, and the National Association of Home Care has really not put forth any major complaints with it. So, that is surprising that they like it so much at this point.
MR. CLAUSER: I would like to just say, unfortunately, this day is the D-date for our reorganization in our agency, and I have 60 people that I am desperately concerned about. I am going to have to leave in a few minutes because I have to get on the phone and make sure these people are taken care of in the reorganization. So, I apologize the need to have to leave, so I thought instead of saying any more, maybe I can stay for a few minutes in case there is a dialog.
MS. WARD: I think my concern is that it is going to take a lot more conversation than we have today, and that is -- I guess I was sitting here trying to find a way to describe my concerns. I live at the stage agency level. We have a mandate to standardize and to do quality improvement and to have multi-state agency collaboration with outcome evaluation and with the private sector. I am very much aware of -- I have office -- I have employees who are working with OASIS.
My concern is you are perfecting -- I do not know if this will translate. You are perfecting a plane that will fly at 5,000 feet, and I think that is great. I need a plane that will fly at 10,000 feet. I do not know if we are ever going to talk to each other. At some point, there is an airport out there, and I am going to be flying in a 10,000 plane because I have to build it regardless at my state agency level. We may or may not -- we may crash, or we may not be able to land at the same airport.
It is getting into that kind of interaction. I was surprised to find our state licensing -- facility licensing person who is as also concerned about what this means to them. She is getting to the point where she also needs a plane that flies at 10,000 feet. So, it is just -- I think those are the conversations I think --
MR. CLAUSER: What is the difference in altitude?
MS. WARD: I need something that measures patients not in the box of home care. We have people who are going in and out of care. Washington also has -- a more peculiar in that we have some of the lowest numbers of visits per home care.
MR. CLAUSER: If I would have had the time, I would have gone into it a little bit about that ourselves. I mean, I think as many of in the agency recognize, it is much more beneficial to be looking across provider groups and thinking about ways that -- and program tools enable us to integrate and facilitate flexibility in the program. One of the things that in the agency we are currently looking at is the concept of kind of post-acute care data sets. It will enable us to do a number of things in trying to look at how we integrate our benefit structure and creating systems in a way that enable. Instead of our program being so provider-centered, to have it be more beneficiary-centered so that beneficiaries may have a lot more flexibility in terms of their choices of location where they may end up receiving services, whether it be a nursing home or a home health agency, to try to facilitate information that will be more useful for both providers and beneficiaries. To say that gee, here we are seeing that these seem to be more optimal sources of care for these sorts of conditions and these sorts of situations so that we can do a little bit better in terms of developing both practice standards and kind of clinical pathways to take up terminology. It is really used in a different field.
We are in the process of looking at that now. Quite frankly, I do not know if such an instrument can be developed, but I think it is something that -- and a lot of it is going to depend upon what your objectives are for what you expect from that instruments in terms of, you know, what things does it have to do -- performance improvement, resident assessment, eligibility for benefit. There are a number of conventions that have to fall in there. The issue, I think, is going to be can we create an instrument that is small enough that it can be efficiently used, or does it get so big because of all of the expectations that we build on it that it becomes unwieldy and it creates the kinds of problems that you were referring to earlier, Lisa. That is a research question, and it is something I think we are interested in the agency. But at the same time, we are committed not to waiting for it to go. We want to move forward and try to improve care.
MS. WARD: I think my concern is to not have to say to you, you should not implement OASIS, because you have a tremendous industry support. You will learn from going forward. There is this other issue that I think it out there.
DR. IEZZONI: George, did you have any comments?
MR. CLAUSER: I have some comments on the -- you can ask them.
MR. VAN AMBURG: What happens now? How fast is the train going? What are the next steps given the reorganization. Just really practical things. What groups and how are the decisions going to be made about integrating any changes to something that is going to go forward? It seems to me that you still have demo in your way. You still have a bunch of other features underway that could really form the final proposed rule, plus additional work. I do not know where you stand on the final.
MS. MAUSER: I guess right now they are reviewing all of the comments that came in. From that, there will be an interagency work group that will review all of the comments. We always brown nose (?) the proposed rule makings; the whole agency is involved no matter what it is. So, the research people will be involved, the operational people, everyone. It is actually a department-wide group that reviews the comments and will develop the final rule making.
The way, though, that we are trying to do the OASIS is that they are trying to figure a mechanisms to easily implement over time changes to the OASIS. So, there could be just like a Federal Register notice saying okay, and I am not sure of all of the regulatory terminology, but I know it will say, okay, we are changing these data items. So, it would be easy over time to make changes. There is a lot of work, especially as you know, Vince, going on with the case mix and other things going on in the demonstration. So, changes are definitely going to be made over the next several years. It will probably be some time before agencies start reporting the data to HCFA. I think they are trying to --
MR. CLAUSER: This is just a requirement for the agencies to collect the data.
MS. MAUSER: Right. They are trying, I think, to get agencies reporting the data to HCFA by October 1, 1999, so we have it for a per-episode prospective payment system, but those dates can change. Who knows what is going to happen. But, I think the thing they are trying to build into whatever they do is some flexibility to make these modifications over time because we realize modifications will need to be made. As Steve was saying, there is a post-acute care work group that is looking at some of these data instruments, looking across the instruments, looking at differences in the wording and seeing whether maybe we should be implementing changes or maybe we should not be, or how does this impact developing some type of data set that goes across the different settings. So, I think the most important thing is that this is going to be a pretty fluid process and there will be chances to change items over time.
DR. MOR: The world of experience in the MBS side is that there are lots of agencies that operate on very low margins, and they will want to invest in software and other kinds of things that the market will not be very sensitive to your desires for changes, and that is going to be an issue. There is always this battle between do you go forward and have it iron clad or do you wait until it is more right or what have you. Just recognize that the little guys out there, who are getting clobbered anyway, could get it between the eyes.
MS. MAUSER: We are trying to warn agencies, too. In the Federal Register, I think there is a paragraph or so about that because if you are looking at a vendor, to try to look for a vendor that will be flexible over time to change items realizing these items will change.
DR. MOR: The post-acute work group, is that --
DR. IEZZONI: Yes, I just wrote that down. That might be a group we should hear from.
MS. MAUSER: It is more of an informal group at this point. Different components at HCFA have been --
MR. CLAUSER: This is not like a chartered group like the Home Health Initiative was.
MS. MAUSER: Yes. Right, yes.
MR. CLAUSER: It is really people who are doing it more informally at this point. You know, with internal discussions among staff who are really interested in these issues.
MS. WARD: Is there a point of contact?
MS. MAUSER: At this point, it might be --
MS. CLAUSER: With the reorganization, I do not know where everybody is. I will know better tomorrow, I hope.
MS. MAUSER: If you contact us probably maybe in the next month or two months --
MR. CLAUSER: Give us a call in a week or two when we see how things settle down, to see where people end up in the reorganization. I mean, people are moving all over the place.
DR. IEZZONI: Hortensia has a comment and then George.
DR. AMARO: A brief comment. Your ethnicity question you might just want to look at when the new recommendations come out because it does not follow the Directive 15.
DR. IEZZONI: And George, quickly.
MR. VAN AMBURG: I am more interested in how the data will be used than collecting it. Is there a contact person for that?
MS. MAUSER: For how these data will be used in terms of developing outcome measures or?
MR. VAN AMBURG: No. How do you expect the home centers to use the outcome measures?
MS. MAUSER: Right now, agencies in the demonstration are using -- they are reading these outcome reports. They have received --
MR. VAN AMBURG: I am looking at one that I do not understand very well.
DR. IEZZONI: Liz, you said that you specifically chose agencies for the demonstration that were well endowed agencies, that were lead agencies, that were agencies that have resources. That is a very skewed population of home health agencies.
Again, it does not surprise me that the industry is delighted with this measure because they are rating themselves. You know, so this does not surprise me at all. If I were a home health agency, I would love to send my nurses out and say, Okay, this week this person can only walk five meters, but next week he can walk six meters. It is not within -- that is not necessarily fraud. I mean, that is kind of within the structure of medical art. But it does not surprise me at all that your industry is delighted. So, it would be very interesting to know how these places are really using this information.
MS. MAUSER: So far, agencies -- the demonstration and other agencies out there that are collecting these data and starting to use outcomes have not had a problem -- this is just an example of an outcome report. It is not exactly what the agencies are receiving. This was part of the developmental work. I just pulled the sheet out to show you the types of things they are getting. But they are not -- I mean, it takes a little while. They are probably not going to look at it the first time and completely understand it but once they have sat down and looked at it, the agencies have not really had any major problems interpreting outcome reports.
The data, too, that is being collected, as Vince is aware, we are doing a study to try to develop a case mix adjustor for a prospective payment system, and we are looking at the OASIS items plus probably about 40-something other items. There are a bunch of other items to look at whether we can some how combine the OASIS data collection with also data collection for prospective payments. On that study, we are doing agency recruitment right now and agencies will not start collecting the data until September of this year. There are a lot of different uses of these data.
DR. IEZZONI: Thank you. I just wanted to figure out, can you stay for a few minutes?
MS. MAUSER: I can just stay for a couple more minutes.
DR. IEZZONI: Vince, you had a comment.
DR. MOR: I would just like to comment. I know you are working on a variety of things, but personal experience, trying to figure out how academic integrated delivery system, which is now two hospitals, a rehab hospital, two home health agencies and now four SNIFFS (?). How they begin to think about the same information as they develop a discharge form. HCFA is thinking about this uniform discharge, whatever, Uniform --
PARTICIPANT: Needs assessment.
DR. MOR: -- Needs assessment instrument. That was just a heads up. That's why we have an academic around. Then they have the FIM (?) and then they have OASIS, and then they have an MBS, and these things do not come close to talking to everybody.
MS. WARD: That is the administrative simplification issue.
MS. MAUSER: I mean, I have really just started in the last couple of months have conversations about that, conversations about how these things are meshing, and there is going to be some additional work done. We are going to have to have additional work done trying to figure out what data items do we want across all of the settings. I mean, it might be fine for some of the data items to differ across settings, but it might be very appropriate that there are some core items that we might want collected across all of the settings.
I guess some of it we have to determine what we want these items for. One of the things that they are thinking about for this post-acute care system is that there will be -- that the beneficiary will get some type of payment. The beneficiary or the case manager or some type of advice will be able to choose if they want to go to a SNIFF (?) or a home health agency or maybe a rehab facility depending on the condition, but we will need some items to predict payment for them. We might want some items, I mean, just in terms of assessment items, from this core data set. We might want some items for outcome based measurement to assure quality across the settings.
These are all issues that are being discussed now, and we are trying to develop a strategy really to develop this instrument and to decide really what is the purpose of this instrument before we even start a lot of the work doing it. So, that is something that is going to be going on probably over the next few months to really determine how we are going to do this.
DR. IEZZONI: A quick question?
PARTICIPANT: Do you know if the question about language is one of the comments that was raised?
MS. MAUSER: I have not seen any of the comments. The comments, I think they were received June 10th, all of the comments. So, now our regulations staff has been going through all of the comments and consolidating them. For example, we got the same letter, for example, from social workers, and it was a form letter, they reduced that to one comment instead of how many comments we received. So, they are just really analyzing it now and trying to bring it down to something sensible that we can analyze. So, I have not seen any comments.
PARTICIPANT: Could we find out whether that issue was raised?
MS. MAUSER: We will find out as we start the review process, but I personally could not find out now, and I do not think the regulations staff is going to hand it over until they are ready for people to start reviewing it. That is a good point to make, and we can -- I mean, that is something that we will raise to them.
DR. IEZZONI: I think that is the basic point, that if it has not been raised in the comments --
MS. MAUSER: I mean, that is no problem. That is something even I can raise to the people --
DR. IEZZONI: We would request that you raise that based on our discussion this afternoon.
MS. MAUSER: I think that is something they should consider.
PARTICIPANT: As a footnote to that, have you looked at the World Health Organization's quality of life assessment, because they have translated that into multiple different national languages and have been coordinating across those different cultural as well as language groups so that you would have an internationally -- sort of level and way of assessing quality. Is that something that you would do?
MS. MAUSER: I am not familiar with that, but that is something I can raise to them.
DR. IEZZONI: Great. Well, Liz, thank you very much for coming and fielding all these questions.
DR. IEZZONI: I think that it would be good if we, as our little committee, just spent a few minutes talking about how we might want to proceed on not just the issue of OASIS but the 10,000 point issue that Liz brought in. I guess the first very concrete question is, it sounds as if that if got a letter to HCFA right now, they are not legally required to respond to it but it would be something that they would know came from the national committee and is not something that they could readily ignore, necessarily. So, I think that -- is the sense around the table that we should try to send in a letter?
DR. MOR: The question is -- I agree we should send a letter.
DR. IEZZONI: Okay, so, the first thing is we should send in a letter. Okay, the second thing is, what should we say. Why don't we just kind of brainstorm, go around the table and make a list of points that each of us kind of came away with. Is there somebody, Caroline or Lynette, who could just kind of scribe this down. I guess we will have the minutes, but we would want to have a list of this really quickly. I do not write fast.
PARTICIPANT: We will both do it.
DR. IEZZONI: Okay, both of you do that.
Okay, George, what would be your take-home message?
MR. VAN AMBURG: My interest is in the interpretation and use of the data, and it gets to the gaming issue that you are talking about. We really did not learn very much about it. This is a very strange example of an outcome report to evaluate, I will tell you. So, I need to learn more about that, but I think the whole issue of how people are going to use that data is a very critical issue, and we need to find out about it.
DR. IEZZONI: Well, I am just concerned that if we said in the letter that we do not know how you are going to use the data, they would say, well, that is your fault for not having talked to us about it.
DR. MOR: The notice of proposed rule has a fairly extensive description that might be helpful.
DR. IEZZONI: I guess on that topic though, George, it was curious to me that they started a three-year demonstration project in 1996 which is about how to use the data for quality improvement, and yet they are now moving forward with the rule before this demonstration project that shows whether these data are useful for quality improvement has really been completed. Vince, does anybody know anything more?
DR. MOR: That is a very good question.
DR. IEZZONI: Vince raised that, too.
DR. MOR: I really -- I am not sure I really understand the impetus, the rush of this. The MBS --
DR. IEZZONI: Why don't we write that down as one issue that we are concerned that there seems to be a rush, the demo is in progress, how to use the data is a big question for us given the burden. There is going to be an inevitable burden in collecting the information, both on patients and on the providers, and we just want clarification as to why there is pressure to move at this point.
MS. WARD: I think that would lead to my point which is knowing the health care delivery system has changed dramatically since they started designing this, and particularly because they actually started designing this 12 years earlier.
DR. IEZZONI: Yes, in the 80s.
MS. WARD: That is the part that I have had the most trouble struggling with is that it is an out-of-date perception of how the world works. It does not take into account all of the things that we heard this morning about technology, standardization, and so you could tie that, why particularly are you rushing to implement something now that is going to be -- in my perception, it is already out of date in terms of how -- even Joint Commission is on a track saying we will demand hospitals and other health care providers be certified to have quality improvement, and we are going to go in and do it this way. They even have now said we cannot do it that way. That is not the way half of the world looks like. What we will do is have the hospitals and these providers tell us the quality improvement methodology that they are going to use that fits their environment, and we will go in and certify it.
DR. MOR: The JCHO is not certifying QI or quality assurance systems. The outcome measurement --
DR. IEZZONI: Oh, I know about the ONYX initiative. I am on their council. Performance measurement -- something that I tell you with great trepidation.
MS. WARD: And that may be also the wrong term, but at least it shows to me the ability of an agency that was on one train track to say the world is different --
DR. MOR: And a way to give people lots of options because there is no right answer.
MS. WARD: That is the part that just astonishes me, that they think that there is one single tool that can be used by everybody and that they are going to mandate a single tool. I just find that flabbergasting in today's environment.
DR. IEZZONI: Let us make that as our second point.
George or Liz, did you have any additional points to those two? Okay, Hortensia.
DR. AMARO: I was just wondering, just briefly, just to discuss it, but what was the history behind this getting to us so late?
DR. IEZZONI: We do not have a mechanism, I guess, to know when HCFA is doing this.
DR. MOR: The reason that it came up is because I complained to Lisa. I had separate agenda issues.
DR. AMARO: So, there are all kinds of things going on out there that --
DR. IEZZONI: Yes, and we do not know --
DR. AMARO: -- we are not being informed of and we are not going to be informed of --
MS. RIMES: And some things within the Center, too, you know certain surveys going through and things like that that you guys might want to look at, too. There are a variety of issues out there.
DR. IEZZONI: But I think once we get to notices of proposed rule making that that is a very definite stage at which we should be aware. I think though, Hortensia, you would agree that our third item has to be the language translation because --
DR. AMARO: Yes.
DR. IEZZONI: -- you are absolutely right. When you look at some of this, especially the mental health areas.
DR. AMARO: I think a lot of discussion to get this information from someone, including the person who is going to go verify it. How are they going to verify --
DR. MOR: I am going to put on a different kind of hat here because -- and just let you all know. I have a separate agenda open to designed as it relates to the nursing home work. In nursing home work in the U.S., there is a single language. In certain parts of the country, they did actually a Spanish language. The Spanish language version was developed by the people who were originators in the concept with the international folks, and it is used. Just as a matter of fact. The real issue is, as soon as you walk into somebody's home, outside of an institutional setting, where observation and continuing observation is not as much of an issue, you must have a more structured way of interacting with the client, in which case you need to at least have guidelines, language that is in the language of the person with whom you are interacting.
DR. AMARO: You mean your observations are going to be limited --
DR. MOR: You only have the one hour of interaction. You are fundamentally dependent upon that report and the reports of the persons confederate or other members because you are no longer -- you do not have the seven days of observation in an institutional setting. So, the whole nature of the assessment process becomes much more complicated, much more dependent upon the individual. There is no provision whatsoever in this instrument as designed, because it was designed as an outcome measurement on the assumption that you will go in, you will rate the person a 2 now and 60 days later a 3 that how that information is elicited. There are no instructions, no rules, no mechanism, no nothing.
DR. IEZZONI: Okay, item number three that you will write down is the language business.
PARTICIPANT: [Comment off microphone.]
DR. MOR: No, just the language, multiple languages for the assessment tool.
DR. IEZZONI: I also am concerned about -- Hortensia, how do you feel about cultural issues having to do with the mental health and behavior? Depressive feelings, problem behavior. Are these going to be cultural issues?
DR. AMARO: If it is going to rely on -- you know, people are just not going to look at it that way.
DR. IEZZONI: Exactly.
DR. AMARO: They are going to look at it as personality or it is just that way. They are not going to --
DR. MOR: These items are not behaviorally categorized. You cannot describe to the person, have you observed this kind of behavior and say yes or no.
DR. IEZZONI: Let us have that as a fourth issue because I think it is separate from the language. It is really cultural.
DR. AMARO: The whole issue of validity, too, because they talked about reliability, but they did not talk about validity. So, I wondered if any of their studies had look at whether they are being administered, other instruments tot look at the validity of this one.
DR. IEZZONI: Because I suspect that there is a lot of home health care agencies that are very specific to particular communities. Like the Portuguese community in Cambridge, Massachusetts, I suspect that there are home health agencies that cater to that particular community and the cultural issues that are raised in these kind of evaluations.
DR. MOR: I can only imagine but in Colorado, they should have had a lot of testing with Mexican-American community. I do not have a clue as to how it came out. There is no evidence in the published literature on this issue.
DR. AMARO: A very small percent. I mean, they only categorize as white or non-white given the demographics as shown, and it is very small.
DR. MOR: This is from a national profile. These are from all over. So, it is 11,000? This must be from the first year of the demonstration. I do not know.
DR. IEZZONI: But nevertheless, what Hortensia says is an issue.
DR. MOR: Yes. I assume that is in the demonstration that is all over the country.
MS. ARAKI: They have identified the agency. Are you looking a this?
DR. MOR: That is a -- Good Care, that is a fake agency.
MS. ARAKI: But it says agencies, so that is why I thought it would be an individual --
DR. MOR: Well, Good Care Home Health Services is probably just a substitute name.
PARTICIPANTS: [Simultaneous comments from other participants, none individually distinguishable.]
DR. MOR: I think the data are real. They are really from the demonstration.
MS. ARAKI: And you think this is cumulative data not individual agency data?
MR. MOR: This is 11,000 individuals.
DR. ARAKI: That is what I thought.
DR. IEZZONI: All right. Vince, next I will go to my issues, and I think you can tell what they are. The first is gaming. I think it is going to be just human nature that when you see a patient the second or third time, you think that they are getting better.
DR. MOR: Every instinct in the nurse's being wants to say that.
DR. IEZZONI: Right, will want to say that. Again, it does not surprise me that the home health agencies are thrilled with this kind of way of evaluating themselves because they are basically independently telling you what they are doing. The second thing is that when they do conduct audits, I think that that is burdensome for patients, having a second person come out and spend another hour with you.
MS. WARD: I do not think that is the important practice that we have to use regardless of whether it was for this or another thing. In mean, I have an agency that kind of an agency --
DR. IEZZONI: Is there any compensation that we can make to patients for that? Would you think that patients should voluntarily do that, be part of an auditing process?
DR. MOR: I think agencies have their own internal QA processes which are part of their system. I do not know what the Feds do on their survey certification. Do they do any home visits at all now?
MS. RIMES: I do not think that they do.
DR. MOR: I do not know.
MS. RIMES: I do not think so.
MS. WARD: That is part of why I was just so curious. Many of the state agency policy -- all of that is home care agency and not state agency driven. They are like a federal when they are going to go in and do an audit.
DR. IEZZONI: Why don't we just say generically that we need to learn -- understand better what the auditing issue, what the auditing procedures are going to be, thinking about feasibility, patient burden, et cetera.
Now, I saved the most important for last. Vince, are there any other issues that you think are not addressed by these five or six?
DR. MOR: Since the service delivery is changing fast, that would encompass the integrated delivery systems (?), so schizophrenia. The last comment that I would make is, and you called it gaming.
DR. IEZZONI: Because they have used the term gaming right here in their little slide.
DR. MOR: The real issue is that the items are structured in such a way as they ask the assessor to measure the patient's capacity.
DR. IEZZONI: Capacity --
DR. MOR: And that makes it very easy -- it makes it virtually unauditable, and it makes it much more amenable to interpretive bias.
DR. IEZZONI: Subjectivity.
DR. MOR: Interpret bias. So, for instance, you look at this report. Improvement in management of oral meds. That is 97 out of 121 had improvement of oral meds over presumably an average of the 60-day period. I guess that is about right. Now, what that means is that when they were first admitted home, they could not take their oral drugs independently, but 60 days later, they can. That is oral medications. There is another set of items about other kinds of administration of medications and those are, for example, it is the capacity to give yourself your own insulin shot, not your willingness to do it, not your fear of needles, just your physical capacity to do it. So, this interpretive issue about what capacity means, which is true for transferring, for ambulation, et cetera.
MS. WARD: Those are much better words. I think it is really unfortunate that they ever used the label gaming because that sounds like someone is being fraudulent.
PARTICIPANT: Fraud, right.
MS. WARD: And the people I have worked with have talked about --
DR. MOR: This is not fraud. I mean, it is just --
MS. WARD: Personal differences in interpretation.
DR. IEZZONI: That is why when Steve said, "Well, it is fraud," I shook my head. Okay, we do need to move on, but is this --
DR. MOR: I can draft --
DR. IEZZONI: What I wanted to know is do you have a laptop?
DR. MOR: What I would have to do, since I do not have a disc drive, I would have to e-mail it to you entirely.
DR. IEZZONI: Can we e-mail it --
DR. MOR: No.
[Simultaneous comments.]
I could e-mail it to somebody.
DR. IEZZONI: Because ideally, what would be great is if we could find a minute on the agenda tomorrow to address this to the full committee to be able to approve this, and then we could get the letter out to Dawn Detmer (?). So, Lynette, do you think you and Vince could talk about the mechanics of seeing whether it is
DR. AMARO: You can fax it --
DR. MOR: I will e-mail you tomorrow.
MS. RIMES: Yes, tomorrow I will find out what number it is.
DR. IEZZONI: Okay, so, Vince, you will work on this tonight. You and I can talk afterwards if you want some help. Are we all staying at this hotel? Yes, we can talk afterwards how to not burden Vince too much with this.
Lynette, could you talk to Marjorie, so she is the exec sec, and just tell her that we would like to find a minute on the agenda to see if we could get the full committee to approve us moving forward with this letter, that there is a time issue because the official rule making notice is past due, and so we need to get this out immediately.
MS. ARAKI: I can see there is some time.
DR. IEZZONI: There should be because we have a bunch of time set up for future meeting dates, and that never takes place. So, would you ask Marjorie about that.
MS. WARD: There should be a letter that everybody could read it and make comments.
MS. ARAKI: If you fax it to us by 9:00. You see the future meeting dates and all that topic there. In between there and before you have the recommendations of health data standards, there is from 10:15 to 12:00, so we can fit this in.
DR. IEZZONI: Let us plan to do that because I think it would be really a great statement on our part also if we move this particularly because it shows that this is an issue that is really important to us.
MS. ARAKI: Also, it would be difficult for the agency to ignore it since they already made the point that the official comment period is closed.
DR. IEZZONI: Okay. We will try to move on this.
MS. WARD: This is kind of like one technical point and then we will move onto something else. Does this kind of thing come to the data council?
MS. RIMES: We had this as part of -- when the Long-Term Care Committee was going on, we had like a whole day that was just like the rehab, the nursing home, the OASIS. It was a little over a year ago, maybe a year and a month ago. So, it is not an abnormal situation at all. Actually, I learn more here usually about what is going on or had gone in in the unit I was in than I ever learned in the office. So, this is a lot of standard HCFA stuff too.
DR. IEZZONI: George, let us look at your revision, and let us pass on that --
MR. VAN AMBURG: On the revision of the revision. My writing is very difficult to read.
DR. IEZZONI: Has anyone gone through it to see if there are any typos?
MR. VAN AMBURG: Oh, there are. I had that all taken care of. It is not typos necessarily, it is their interpretation of my writing. There were three areas that were suggested for changes. The first one is imbedded in the middle of the first paragraph in the introduction, the issue on the privacy. It starts with the sentence, "Information shared for the community assessment process must comply with statutory or regulatory measures in place to protect the privacy of individuals." That is the sentence that I put in there.
PARTICIPANT: [Comment off microphone.]
MR. VAN AMBURG: The first page, right in the middle of the first paragraph. I could not think of anything else to say because there is nothing in place federally right now, but states do have things in place.
DR. IEZZONI: Should we make that a separate paragraph just to emphasize it because I am just worried that people will not see that. A one sentence paragraph.
MR. VAN AMBURG: You cannot have a one sentence paragraph.
DR. IEZZONI: No, but the rest of it could be -- maybe we could just have a paragraph break there.
MS. WARD: You could maybe just start the next paragraph with that.
DR. IEZZONI: It is just -- I have noticed --
MR. VAN AMBURG: That is fine. That would work.
DR. IEZZONI: There are often comments because people do not see the sentence imbedded in a lengthy paragraph.
MS. WARD: Just so we do not separate that as a separate paragraph.
DR. IEZZONI: No. Exactly..
MR. VAN AMBURG: That would be fine. I would go with that. All right, the second comment was John Lumpkin's comment about the performance measures. I have tried to do something in the last bit before our recommendations concerning -- it starts with, "An ongoing effort with feedback," in there. The last sentence should read, it should say, "The ongoing" -- rather than the own going -- "effort to measure progress should utilize, whenever possible, nationally recommended or accepted measures of outcomes and/or performance." Do you think that captures his comment?
DR. IEZZONI: I was not there for his comments.
DR. MOR: Actually, it is interesting because that -- his comments earlier, that discussion stimulated issues on thoughts I had on the state health [commenting off microphone] because it related in terms of what is the public versus the private ownership of the format in which you have feedback on performance measures. So, I think that is fine. What we are basically saying is that we are recommending that there be a common format for the production of outcome measures and common definitions. It is in the proprietary sense.
MR. VAN AMBURG: Okay, the last one is on the third page. It starts with the word "enhance." I really had it read, "Enhance and augment state databases." It then should read, "States and communities should take advantage of opportunities to participate in national data collection efforts that would provide state and/or community level data needed for community assessment." I did not want to use the word "buy-in".
PARTICIPANT: Yes.
PARTICIPANT: I agree.
MR. VAN AMBURG: I did not want to use the word, so just opportunities to participate was the only way I could think of phrasing that. If someone else has something better, that would be fine. Those are the three areas that I thought Kathy Golden and John's issues.
DR. IEZZONI: Hortensia, any comments?
DR. AMARO: The one thing that I thought of when I read this this morning was that I know this was done, what did you say, a year ago?
MR. VAN AMBURG: It was written a year ago. The terms were two years ago.
DR. AMARO: In discussing with different folks and especially with Mrs. Sondek and different folks in federal agencies that one of -- it is thought that one of the approaches to improving the sampling of different racial and ethnic groups is going to be this community within the state level and regional level data. So, this is really --
MS. ARAKI: Are you talking about the slates?
DR. AMARO: Yes, the slates and just the whole -- but the idea is the whole move towards state and more regional level data is going to help us to get -- it will be easier to order samples from populations because we can do it with populations that are relevant for that area as opposed to the national samplings. So, there is an additional sort of dimension to this that we have not -- maybe had not been considered back then. I wondered, I know you have been working on this for a year, so I do not want to add to the burden, but I just wondered whether we could somehow put something in there that helps state to use this as a mechanism for gathering, you know, where we support or encourage them to pay attention to race and ethnic data.
MR. VAN AMBURG: I was talking about that in the hearings, and none of the items in here specify any data elements essentially. It is whatever the community feels is needed for their community assessment. If we are doing something in the Arabic community in Dearborn, Michigan, clearly we are going to get data on the Arabic group compared with whatever else is there. You would not want to do that somewhere else. So, it is going to be the community deciding how they want to partition their data and how they want that handled. I mean, the issue is getting data that fits the community and how you assess it, no matter what the ethnic composition of the community is.
MS. WARD: I was wondering about something like that. We have found one thing in Washington. We do have some local areas who have proceeded with their community assessment, ignoring many of those subcommittee areas because it was just sort of the power structure is in place, and it keeps perpetuating itself.
PARTICIPANT: Right.
MS. WARD: We had to go back and try to point out to people and encourage that community decision level, that they be inclusive.
DR. AMARO: I have been surprised that some of the southwestern states with large Hispanic populations and how badly they -- what a bad job they do in gathering --
MS. WARD: That is one of the risks that you take when you go farther and farther down, as the decisionmaking does get made at the local level, and they may, either because they want to ignore or they just --
MR. MOR: It becomes a very technically complicated problem to have stratified sampling, to oversample within small areas. Actually, it creates a whole other complicated problem because the standard errors for all of the estimates become very problematic because the sampling rates become so big, the sample that they design is very, very large.
DR. AMARO: So that the state approach to emphasis is not based on what we have been told it is going to be based?
MR. MOR: No, it is, but once you begin going down to smaller units, it becomes even bigger. Even the state -- I assume some great sample statistician can do this, to say all right, let's take, so that we can get a good estimate with the proper level of oversampling so we can get minority/non-minority sampling for Kansas plus get -- somehow out of Kansas formulated into the overarching oversampling from the U.S. populations. It is a very complicated sampling structure.
DR. AMARO: Right, yes, but this includes a lot of --
DR. MOR: More community sampling.
DR. AMARO: Right, local or state specific.
MS. WARD: The technical difficulties lead into them sort of putting it off because it does become burdensome.
DR. IEZZONI: Well, Hortensia, is there a place where a sentence or a couple of sentences could be added to just raise the sensitivity to making sure that if there are specific populations that have important health needs that --
MR. VAN AMBURG: I was thinking -- you would not have to restructure it, but where we say, "Enhance state-based data systems to provide information at appropriate levels of geographic detail," "and demographic characteristics" would be the way to do that.
PARTICIPANT: Right.
MR. VAN AMBURG: But then I would have to put something in that paragraph. If you want to craft a sentence on the demographic characteristics. The committee actually focused on the geographic issues, not the demographic issues, because the geography is what is driving the community health process, having data available at the right geographic level.
PARTICIPANT: Right.
DR. IEZZONI: Hortensia, would you feel okay sending it in as it is? I guess I would like to resolve this right now. We either need a sentence or two or we just send it in like this and assume that since it is talking about community data, meeting the community's needs, that hopefully communities will become sensitive.
MS. WARD: Certainly from where I sit, providing leadership and training, that is one of the areas that we try to provide is getting at that level of state level epidemiological entities to the local ones.
DR. MOR: Also, the first to second page, the bottom paragraph, "Community health assessment is a process."
MS. WARD: If we could say something that says encouragement of inclusiveness, I would --
DR. MOR: In the process. I think you could go into that in this paragraph, that community health assessment is a process--it involves the community in identifying problems, setting priorities," or maybe it involves all components, all aspects, all populations, all features or aspects of the community.
DR. AMARO: You have something here already. You talk about subpopulations which is broader, but could it be understood in part to be racial and ethnic. It is on the second page, 1-2-3-4 under "Make use of data." It says, "Make use of data from...Examine data for sub-areas all sub-populations," so maybe something brief there that could say all racial, ethnic and other sub-populations or something like that.
MR. VAN AMBURG: You do not want to say all racial and ethnic populations. You will never get data for all of them. That would be impossible. You could have -- there are communities that have significant sub-populations. I would prefer to leave it just the way it is.
DR. IEZZONI: Why don't we leave it as it is because I think it is a nice document.
DR. AMARO: I realize you were working on this.
DR. IEZZONI: I think the spirit of it actually does address your concerns.
DR. AMARO: I am hoping that in practice it will because I think it is a good opportunity to do it.
MR. VAN AMBURG: I think the kind of things the states are doing with community assessment process are getting data for their various groups in the communities when they are a significant factor in the community.
PARTICIPANT: Right.
DR. IEZZONI: Lynette, is there a process to correct the typos?
MS. ARAKI: Yes.
DR. IEZZONI: So, we will correct the typos, and this will be given to the full committee tomorrow. It will be at people's places. So, hopefully we will be able to pass on it tomorrow, and that will be nice to get that out.
Okay, we have two more agenda items. One is hearing from Hortensia about her conversation with Ed Sondek from this morning. The second is coming up with some dates.
Why don't we all -- while Lynette is running to get her calendar, let me just talk through again what our goals are so Vince can understand.
PARTICIPANT: [Comment off microphone.]
DR. IEZZONI: Basically, what we want to do is have as our major kind of agenda item for the next year, looking at the impact of Medicaid managed care. That immediately kind of --
[Simultaneous comments by other speakers.]
I think the national committee really -- it cuts across a lot of issues, children's health, mental health, substance abuse, underinsured, poor people. So, I think that it really was an area that people felt immediate -- there was absolute, immediate consensus that this is what we should look at.
DR. MOR: You include the eligibility there?
DR. IEZZONI: Sure, yes.
DR. MOR: What do you mean "eligible," Medicare and Medicaid? A very large proportion of people --
DR. IEZZONI: All right. Now, we are hoping to hold a meeting in July, specifically to maybe have a couple of presentations from -- I guess who was it, Caroline, who we heard about? There has been some Presidential Commission looking at children? There were a couple of people who were talked about yesterday.
MS. RIMES: There is the Child Health Board.
DR. IEZZONI: The Child Health Board.
MS. RIMES: And --
DR. IEZZONI: And there was a work group on managed care and Medicaid, is there not?
MS. RIMES: Oh, yes, there are several work groups. Are we going to do the Medicare Managed Care in July? I had it in September.
DR. IEZZONI: No, we were. What we are going to do in July is have the Medicaid managed care meeting to talk about what our questions are going to be, and come up with our work plan, and then in the morning, we would have a few presentations to just kind of get us off on the right foot, hear what the feds are thinking, what other people are thinking. So, that would be what the July meeting is. It would be a one-day meeting.
DR. MOR: Are the feds the people who are pushing Medicaid managed care? Most of that is coming from the states.
DR. IEZZONI: I guess that is really the Medicaid working group.
MS. RIMES: We talked about pulling some people in from HCFA from the contractors to just summarize some of the things dealing with the states.
DR. IEZZONI: Get us some information. So, Caroline and we were going to work on coming up with like morning presentations, and then in the afternoon, we could spend time talking about what are the questions that we want to ask, what is the work plan, because Jim Scanlon told me that we do have some contractor money that we can spend on this, but we have to come up with our budget for the next year and the scope of the work, and so that will be the purpose of the one day in July is to really flush out what we want to do, how we want to spend our resources, how much it is going to cost, and be very specific.
MS. ARAKI: [Commenting off microphone.] Several public hearings that we are trying to target.
DR. IEZZONI: So, we need to find some day in the first two weeks of July because the NCHS has their biennial meeting at the end of July, so they will be very busy with that at the end of July.
PARTICIPANT: [Comment off microphone.]
MS. ARAKI: July 28th through the 31st. The issue is --
DR. AMARO: How about the 21st.
MS. ARAKI: That is staff time. I am talking about the people who are going to help get the meeting together, and the same people are involved in this.
DR. IEZZONI: Right. We cannot burden the staff that way.
MS. ARAKI: But there is that list right there. Hortensia, didn't you give your dates?
DR. AMARO: I did. I am really booked in July, and I think that the 3rd. I am talking earlier. I was available the 21st and 29th, and I do not even know what I put down there. The 3rd is a possibility.
MR. VAN AMBURG: The third is not going to be a good day for anybody.
PARTICIPANT: What?
MR. VAN AMBURG: The 3rd of July is not going to be --
DR. IEZZONI: I think some of us are going to have to see whether there are any meetings that we can push to other times. I am looking at my calendar, too, and it is pretty full, too. So, I think just by looking at our calendars, we have to think legitimately what meetings can we maybe rearrange to try to accommodate this.
Lynette, would you help me just look at this really quickly? We should probably start with Hortensia. Hortensia, the 9th.
MS. ARAKI: That is also the date that is an all-day data --
DR. IEZZONI: That's right, that is the NIH Data Council meeting, so we cannot do that.
MS. ARAKI: What about the 10th, though?
DR. IEZZONI: The 10th I could do. Can you do the 10th?
DR. MOR: I am in Nova Scotia.
DR. IEZZONI: When are you in Nova Scotia?
DR. MOR: The 9th, 10th and 11th.
DR. IEZZONI: Okay.
MS. ARAKI: The level of staff that you need, once we pick the date, what I asked Barbara Hetzler to do, because she is going to staff this, she may have to have somebody to back her up because she is basically responsible for the public health conference. I asked her to start looking for a room. If it could be in the federal Humphrey Building. The room that we had the meeting in yesterday, was that satisfactory?
PARTICIPANT: That was fine.
PARTICIPANT: That was fine, yes.
MS. ARAKI: Yes, so that is one thing. Now, the agenda, you are not going to be -- it is not going to be as complex as a public hearing, because you are not --
DR. IEZZONI: No, we just want to have some presentations.
MS. ARAKI: And then Caroline is going to take care of that, so it is a matter of just developing the agenda, so it might not be that bad. So, let us --
DR. IEZZONI: The whole week of the 14th is off for Hortensia, and it looks like the week of July 1st is the July 4th weekend, and I agree with George that travel would be a disaster. The week of July 7th, Vince is out the 9th, 10th and 11th, and George is out the 9th, 10th and 11th.
PARTICIPANT: What about the 8th?
DR. IEZZONI: The 8th I could do.
PARTICIPANT: The 8th, I can't. I could do the 7th.
DR. IEZZONI: It is either the 7th or the 8th. Hortensia, is there anything that you could rearrange?
DR. AMARO: I cannot miss the 8th. The Public Health Commission meeting. I have two meetings that I can't change. I have a meeting on the 7th that I can change, but the 8th.
MS. ARAKI: Now, the week of the 14th, you said you are completely booked? You cannot change any of it?
DR. AMARO: That week, I cannot. I am not available.
DR. IEZZONI: The 7th, I have a meeting that I booked like three months ago, but I could -- I could probably change it. I have another meeting that I have also booked, but I could probably change that, too. So, the 7th. Other people can do the 7th? Can everybody do the 7th?
Now, can I just say, if we commit to the 7th today, will people come on the 7th? Okay. Let us all agree, not in blood but kind of near.
MS. ARAKI: You say you can make it on the 7th?
DR. AMARO: I can make it on the 7th.
DR. IEZZONI: To commit to the 7th.
[Simultaneous comments by participants.]
DR. IEZZONI: Plus the hours are different for you.
MS. ARAKI: You are better by vision because -- you know, when you can see people, it is better than when you only hear them. Well, George knows because he has participated that way.
MS. WARD: Part of the concern is there is a three-hour time difference anyway.
MS. ARAKI: Let is work it on the 7th. We will work and see if I can get [Moving away from microphone].
DR. IEZZONI: Okay, but we need your input for the work plan. You might be willing to not hear the presentations in the morning or just get written materials about that, but we really need your input for the work plan.
PARTICIPANT: [Comment off microphone.]
MS. ARAKI: So you absolutely can fly in. That is what I am asking.
MS. WARD: I may decide that I am willing to fly in for a one-day meeting.
DR. IEZZONI: It is the 4th of July weekend, though.
MR. VAN AMBURG: That is the 4th of July weekend.
PARTICIPANT: I have to fly all day on Sunday to get here to go to a meeting, and unless I fly and get home at two the next morning, I have to leave at 3:30 in the afternoon on a Monday. It just does not -- the best flight for me is 5:00.
PARTICIPANT: A.M.?
MS. WARD: No, 5:00 p.m. leaving. So, even if I --
MR. VAN AMBURG: Just out of curiosity, could it be staffed on the 21st? Hortensia is available on the 21st. Could it be staffed on the 21st? I think --
DR. IEZZONI: Right. Is everybody available -- everybody else available on the 21st?
DR. MOR: I actually would much prefer the 21st.
DR. IEZZONI: I much prefer the 21st.
MS. RIMES: Also, it might give me a little time.
DR. IEZZONI: Okay, let's change it to the 21st then. Okay, and we still have the issue about Elizabeth deciding whether or not to come in. You will work on that in terms of the connection. So, now we have sworn in blood that we will do it on the 21st. Okay? Hortensia, I am looking at you.
MS. ARAKI: We will have to get -- like neither Olivia nor Pat Golden. They did not identify that as available. Those are not their available dates, but I do not know what that means because they are not here.
DR. IEZZONI: We will have to deal with the committee on this one, especially since what we are really concerned about is the committee talking to each other, to come up with our work plan. We are just going to want to make sure that we have a transcript of this.
PARTICIPANT: We will.
DR. AMARO: At this meeting, we were going to do the managed care thing, and we are also going to get some kind of discussion on the directive, the revisions of Directive 15, which hopefully by then we will have. Also, that is good because that may not come out until sometime in the middle of July, so if we met in the beginning, we would not have that.
DR. IEZZONI: That is right. That is a very good point. So, at the end of the day or the beginning of the day, we will look at the response that has been drafted by Hortensia.
DR. MOR: It is the 21st.
DR. IEZZONI: Vince, I am going to look you in the eye. It is the 21st of July 1997. It is in ink, okay.
All right, and we will get travel orders and everything cut.
MS. ARAKI: It will be a good start, and then Hortensia can fly in at 9:30.
DR. IEZZONI: 9:30. 9:30. Okay.
PARTICIPANT: 9:30 to 4:00.
MS. ARAKI: Elizabeth, you should be glad you are in this meeting instead of the one downstairs.
MS. WARD: Are they still having to --
MS. ARAKI: They are actually typing. So, you are -- I mean, the discussion is around that document. The room is packed with people. I do not know if they are still there.
DR. IEZZONI: We do not have anybody in our area. I think that is nice, actually.
Now, Lynette, we had an issue about Puerto Rico and the territories and islands. We wanted to have a full-day session in either September or October about that. What we needed to know is whether there is a compelling financial reason to have it in September because of the fiscal year or whether we could do it in October.
MS. RIMES: -- left me a note from whoever said what on whether there is money by the end of the fiscal year.
MS. ARAKI: We can handle the committee members.
DR. IEZZONI: But can we do it in October, I guess is the question?
MS. ARAKI: That would be another fiscal year, but --
DR. AMARO: Can I ask a question. In September, I have two dates in my book for --
MS. ARAKI: The national committee is the 8th and 9th. There was one that was the 16th and 17th and we changed that.
PARTICIPANT: The 8th and 9th is what I have in my calendar.
DR. IEZZONI: Good. Okay, so, Lynette, why do we not try to find a meeting date for that right now because -- could you find out whether we should try to have it in September before the fiscal year is over or whether it is okay to have it in October?
MS. ARAKI: It is fine what you decide because what we are doing now is our funds -- well, it is a long story.
DR. AMARO: But if we have to bring in people, then that might be a problem?
MS. ARAKI: The meetings can only -- you can only obligate for the meetings in the fiscal year. You cannot cross fiscal years. The other issue about bringing people in, we cannot -- just so people know, the national committee travel funds are very limited. So, we have to be frugal. It is not a carte blanche, you know, whoever you want, we can bring in. That really has to be justified.
DR. IEZZONI: I am thinking that it might give us a little bit of extra time to plan who we want to bring in, too. Because we are going to be busy this summer.
DR. AMARO: I just want you to know that I am going to be gone to Venezuela from the 11th of October on, so instead of October, could we do it late September, maybe the 29th?
DR. IEZZONI: How about the first week in October?
DR. MOR: The first week in October.
PARTICIPANT: The first week in October starts September 29th.
DR. MOR: The 2nd is Rosh Hashanha, so --
PARTICIPANT: That is out.
MS. ARAKI: Rosh Hashanha is -- begins at sunset.
DR. MOR: It begins on the 2nd at sunset.
DR. IEZZONI: Okay, so, September.
DR. AMARO: Is the 29th, is that any good for anybody?
DR. MOR: I am in England.
DR. IEZZONI: Okay, when do you get back from England then?
DR. MOR: I come back on the 30th, just in time for Rosh Hashanha, and then the next week, we have the Liaison Committee for Medical Education, and since I am the department chair, I have to be there.
DR. IEZZONI: How about October 6th.
DR. MOR: It is likely that I will be able to be there.
DR. IEZZONI: Okay, October 6th.
PARTICIPANTS: [Comments off microphone.]
DR. IEZZONI: I mean, one day sounds like awfully rushed.
PARTICIPANT: [Comment off microphone.]
DR. IEZZONI: I know, that is really quick. Now, Hortensia is gone the whole month of October, basically, except the last week, and Vince, you and I are in South Carolina. Shall we look back in September? The week of the 22nd? Any day the week of the 22nd. Vince, you are going to England.
DR. MOR: Before that, I have a conference in Cleveland.
[Pause in tape for discussion.]
DR. IEZZONI: September 22nd. How does that sound to people? Or, since Vince is not going to be able to come, it could also --
PARTICIPANT: [Comment off microphone.]
DR. IEZZONI: Right. Either the week of September 22nd or the week of September 29th, since we are no longer thinking about Vince. Sorry, Vince. What would be best for people? Hortensia? On the week of the 27th and the week of the 29th, what days can you do it?
DR. AMARO: The 24th and part of the 25th. I am teaching a class that night, so I would have to leave around 2:00 or 1:00 or something. The 24th and part of the 25th I could do or -- that week you said, right?
DR. IEZZONI: That week or the following week.
DR. AMARO: The following week, I could do the 29th or the 30th.
DR. IEZZONI: The 29th and 30th? We could also do -- how would the 30th and the 1st be for you, Hortensia?
DR. AMARO: I cannot do the 1st.
DR. IEZZONI: Okay, I was just thinking about Elizabeth and flying.
MS. WARD: If I am coming two days, it is not a problem.
DR. IEZZONI: Two days. Okay, the 29th and 30th will be the days. The 29th and 30th of September. If you are back from England.
DR. MOR: I will be thinking of you all as I am having dinner at Leeds Castle on the 29th.
DR. IEZZONI: Well, we will be in Puerto Rico. Isn't that where we are going to be holding these hearings?
PARTICIPANT: We will show you. Didn't we tell that that is where we were going to do this?
[Laughter.]
DR. IEZZONI: Now, okay, who is going to be staffing this one, Lynette and Caroline, do you know?
PARTICIPANT: Pat.
DR. IEZZONI: Pat Golden?
PARTICIPANT: Yes. She is committed to that.
DR. IEZZONI: That is right. I just had forgotten. Okay, can one of you tell her that those are the dates, and she should get in touch with -- Hortensia, do you have some ideas about who in Puerto Rico we might want to hear from?
DR. AMARO: Yes, I think it would be myself and Marjorie and Olivia [Commenting off microphone.]
PARTICIPANT: We need to talk about somebody presenting what you were saying, the legal relationships and the difference between all of the categories so that we can be clear about what we are talking about before we go on to looking at what health systems.
MS. ARAKI: Right. We probably need somebody from the Department of the Interior that actually has that.
PARTICIPANT: We will propose something, though.
DR. IEZZONI: Now, the calendar took a lot longer than I had hoped it was going to.
[Simultaneous comments by participants.]
Lynette, could you let him know about those dates.
MS. RIMES: I will.
DR. IEZZONI: Caroline? Okay. Hortensia wanted to talk for a few minutes about Ed Sondek.
DR. AMARO: I met with Ed Sondek because I attended the Hispanic People 2000 Review and also the NHANES next version planning meeting. As a result of each of those, I wrote letters back, comments regarding some suggestions and concerns that I have had. So, one of the issues had to do with -- I was actually pretty concerned at the NHANES meeting because it was a full day meeting really to talk about methodology and priority areas in content. The meeting ended at 5:00, and at 5 to 5:00, the issue of race and ethnicity was brought up.
DR. IEZZONI: That is not enough time.
DR. AMARO: So, I said, well, I do not think we should even start talking about this. I think this deserves a full discussion. So, I wrote a letter and talked about the need to really have a more thoughtful discussion about these issues. Not just, you know, not just missing identifiers but issues of methodology. You know, for years this issue has been coming up, that there are populations which -- where the national sampling strategy does not work because they are not distributed throughout and that we need to have specialized studies and different ways of thinking about how to get data that informs us on their health. We never seem to get to the next step of okay, well, what are those methods, which would be more appropriate for these populations and how does, for example, NCHS start to incorporate these into its overall plan.
So, actually, between those two meetings, Ed Sondek seemed to be pretty convinced about the need to start really dealing with this. It was refreshing because for at least 15 years, we have been talking to NCHS about it.
So, I met with him this morning, and he has already begun to think about how does his agency develop a comprehensive plan to help the national committee to deal with the need for state and local data specific to different ethnic and racial populations. For example, what he wants to do is really to interface with us more, to come and present some of the things, the options that he and the staff are thinking about to get our input and start airing their ideas and getting feedback and creating -- working with us as a mechanism to get some of those efforts moving.
So, he actually asked if he could be on our agenda at some point. We talked about sooner rather than later because they are having to make decisions about the next cycle, data gathering. He seemed to feel like July was really -- you know, they are sort of at a decisionmaking point. He mentioned to me several of the options that they are thinking about, and they are substantial changes from the way you have done business in the past. So, I wonder whether we could dedicate an hour to an initial meeting and then maybe developing a working group with him or something.
DR. MOR: I do not know if we have a choice if we have a time line.
DR. IEZZONI: Yes, I know. I think what we should do is to extend our meeting in July until 5:00. You know, rather than quitting at 4:00, we will go from 9:30 until 5:00 and take the later flight back.
PARTICIPANTS: [Simultaneous comments.]
DR. IEZZONI: Lynette, can you make sure that he knows about this date?
MS. ARAKI: The 21st date?
DR. IEZZONI: Yes.
MS. ARAKI: What I will do, Hortensia, is based on your conversation, this is fulfilling a request that he made to you?
DR. AMARO: Yes, that is right.
DR. IEZZONI: Lynette, why don't we plan to have him come in around 3:30 or so. That will give an hour and a half, and it would also force us to be very efficient in coming up with our work plan for the year. I like efficiency. Did you have a notice?
DR. MOR: So what we are talking about is 9:30 through noon or something like that would be --
DR. IEZZONI: The presentations.
DR. MOR: -- presentations, and then a 45 minute lunch.
DR. IEZZONI: Right. If we are meeting in the Humphrey Building, half an hour for lunch would suffice.
PARTICIPANT: [Comment off microphone.]
DR. IEZZONI: That really is really true. We might want to say that it will be a working lunch.
PARTICIPANTS: [Simultaneous comments.]
DR. MOR: It will take us 15 minutes to get food and then come back.
DR. IEZZONI: Then come back. Basically, it will just be us talking. So, we will do a working lunch that day.
MS. ARAKI: You are flying in, are you not?
MS. WARD: I have not decided yet. It is still a one-day meeting. I will let you know.
MS. ARAKI: The issue is which room. We have to --
MS. WARD: I will let you know by Monday.
PARTICIPANT: So, it will be 9:30 to 5:00, right?
DR. IEZZONI: Yes, 9:30 to 5:00. Okay, shall we adjourn our meeting? Very successful.
[Whereupon, at 5:37 p.m., the meeting was concluded.]