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Call to Order - Dr. Detmer 1
Report from Executive Subcommittee:
- Planning and Implementation - Ms. Coltin 2
- Public Education - Ms. Ward 25
Recommendations on Health Data Standards - Dr. Cohn 80
Status Report on OMB Directive 15 Revision - Ms. Wallman 132
Recommendations on Privacy and Confidentiality - Mr.Gellman 144
DR. DETMER: According to my calendar it is Wednesday, July 25, and from that it looks like we have some work to do today.
One addition to the agenda book, we do have as we mentioned from yesterday, we want to call on George to look at the recommendations that we discussed yesterday. That wasn't on our agenda initially. Then the data specific population group also had another item, a short, brief item they want to bring to us as well. So we'll either handle their two items either right after the break this morning, or right after the OMB Directive 15 comments this afternoon, if that's okay.
So I would like to call us to order, and I think we will at least have some faces in the audience that I didn't recognize from yesterday. So why don't we just go ahead again and quickly go around the room and introduce ourselves.
[Introductions were made.]
DR. DETMER: The first thing we want to do is talk about some Executive Subcommittee issues. We're going to be meeting, the Executive Subcommittee, following our session today as well, to then integrate some of this discussion. The two items that we really want to get some of your thoughts on and help with are planning and implementation and public education.
I'll call on Kathy first, please.
MS. COLTIN: The first thing that we talked about in the June meeting was the organization of the planning and implementation work group, and also trying to clarify the transition from the old committee structure to the new committee structure, as well as the carry over of responsibilities, unfinished business from some of the other committees, as well as where new business would reside in terms of the new structure.
I did put together a hand out. Do you have copies? Okay, they are going to come forward, to try to clarify a little bit what the structure is.
In terms of the planning and implementation work group, that work group will be a subcommittee of the Executive Subcommittee, and will include Don and myself and the chairpersons of each of the other subcommittees. So that would be Lisa and Bob and Barbara besides Don and myself.
So that's the first item.
DR. DETMER: That represents a shift of where we have been earlier, so let's discuss that if there is any concern about this, because I think I talked to one or two of you about also being on that group.
MS. COLTIN: Our rationale was really to make sure that we stayed in close touch with what was going on in each of the subcommittees, and were able to identify cross-cutting issues, as well as make certain that each of the subcommittees was on tract in terms of its particular areas of responsibility.
DR. DETMER: Any discussion on that? I think there are two kind of implementation issues. One is just implementing what we do as a committee. The other is implementing and tracking the things that come out of our reports. It seems to me the subcommittee ought to kind of track their own things, and that we really ought to use the planning and implementation to sort of track where the group as a whole is going, but let's talk about that.
Where are you on that?
DR. MOR: If I understand correctly, you are suggesting that each subcommittee somehow or another monitor developments out there in the world that are relevant or pertinent to its own domain of responsibility, as opposed to having that monitoring be a centralized staff function?
DR. DETMER: Well, yes, I think to some extent the planning and implementation group is responsible for tracking everything; sort of keeping an eye on it. I guess as a formal issue it seems to me it would be more appropriate for the subcommittees to worry about tracking, at least for the near future after they come out with something, whether there is reaction in the field and such.
That is what we are talking about. We are going to structure these past assignments so that they are clear in everybody's mind.
DR. MOR: I'm just thinking about the take. What is the most efficient mechanism? That might require for instance the same kind of hearing, or the same kind of testimony before a number of subcommittees, or some way to synthesize the different perspectives or takes that different subgroups might have on the issue of monitoring implementation or the consequences. I'm thinking of specific population groups, provider groups, et cetera.
DR. DETMER: Okay. Lisa, a comment?
DR. IEZZONI: Don, is there a formal requirement for us to report back under the HIPA(?) provisions on a yearly basis about implementation issues?
DR. DETMER: Yes.
DR. IEZZONI: I think that as part of that, implementation issues might be different for some of our subpopulations. As Hortensia has talked about very eloquently, we are concerned especially about settings of care that are not financially well endowed. For example, the implementation issues for them might be very different than for the rest of the health care sector.
So I think that it would be up to us to kind of continually remind us that we need to think about that, but there might be instances when there would have to be combined monitoring activities.
DR. DETMER: Others want to comment on that? What I'm hearing is that we probably ought to both be tracking it to some extent, but not in isolation.
DR. IEZZONI: Exactly.
DR. MOR: I think that's correct. I think there should somehow or other be a mechanism to make that tracking process somewhat more efficient than just sort of each of adopting our own strategy.
DR. DETMER: Kathy, do you have any other questions on that one or not?
MS. COLTIN: No, I don't think so. The first thing I wanted to do is just make sure people were comfortable with the composition of the work group. If that's okay -- and I have heard anything to the contrary -- then I thought we should also take a look at the transition from the old structure to the new structure, and see whether people are comfortable with where the particular responsibilities are moving.
I don't know about yours, but mine is a little bit out of order. The first one was just the former subcommittee structure. The second page should have been what I have as the last page, which is the current subcommittee structure. This shows the decision to sort of hang the planning and implementation work group off the executive committee as a subcommittee of that, or a work group under that subcommittee.
Then we have three subcommittees and then two work groups under the subcommittee on health data needs, standards and security; the K2 work group, which has been actively working all along. We had also decided at one of our more recent meetings to add a work group on population-based data as well, particularly to deal with some of the survey data issues.
That particular work group I think is going to be cross-cutting, because when you look at the chart on migration of subcommittee responsibilities, I think it is going to be particularly important that there be a feed into that work group from for instance the population-specific issues work group, but I think also perhaps from some of the other work groups as well, just to make sure that we can make certain that the range of responsibilities that were covered under the former subcommittees are in fact all covered.
A lot of the responsibilities that fell under the minority and special populations, disability and mental health did have to do with survey-related issues. So I think there is a lot of cooperation and collaboration that will need to occur between the population-specific issues subcommittee and the population-based data work group. That may be something that we have to tinker with and work out.
That's a new work group. It hasn't formulated a charge yet.
DR. IEZZONI: Who is on it?
MS. COLTIN: I think in the book there are a couple of people listed under that.
DR. DETMER: The charge on that, as you will recall, was going to wait until Ed Sondick's(?) workshop later this year that lays out essentially where they would like to see us help them go. So I think for the moment I think it's going to stay fairly gelatinous, but on the other hand I think we ought to discuss where we are today as it relates to those issues.
MS. COLTIN: I think that's a good idea. Right now, Lisa, I think you are the only continuing member listed on it.
DR. IEZZONI: Actually, I thought I said that I wanted to be absolved from membership in that committee. That's why I asked the pointed question.
DR. STARFIELD: I actually think we really didn't specify all the members of that work group, because we were expecting new members to the committee as well.
DR. IEZZONI: I agree. I think that one of the things I'm a little bit concerned about, Kathy, is what we talked about before when we were trying to figure out what the subcommittee structure should be before the new committee was appointed, and that is something that happened yesterday where we had break out sessions for the three subcommittees, and people are members of more than one subcommittee.
Because of that, we didn't have complete representation on any of the subcommittees. That actually was an issue. Richard, we need to talk about scheduling our future meeting dates and so on. I just would hate to see a structure set up that really was not operationally manageable given the time that we all have to commit and the break out sessions and so on.
MR. SCANLON: That's a good point.
MS. COLTIN: That's a very good point. I think that we have to figure out a way or a home base for that set of responsibilities in terms of keeping an eye on what is going on with survey development, and being able to respond.
DR. IEZZONI: We are going to be having a meeting in July that we scheduled yesterday, where Ed Sondick is going to be coming for an hour and a half and talking to us about NHANES-IV I think, Hortensia. So we have been doing some of that. I think that we do need a formal place for it, especially since Dr. Sondick has indicated a desire for that specific liaison.
I just am concerned about being too cumbersome, and having members diverted in different places simultaneously.
MS. COLTIN: I think it's a valid concern, and I think we all saw that yesterday. Your point is well taken. Does anyone have a suggestion for how this might be structured differently? One possibility would be to somewhat broaden the charge of your subcommittee to include this responsibility in addition to making certain that the issues pertinent to special populations are addressed, but I don't know how that would work either.
DR. STARFIELD: I think if we do that -- I'm not opposed to that, but we will then go back to diluting the focus of that committee; the way that we decided that we needed some special representation for special populations. We didn't call it that, but that's what the intent was.
I really want to go back to what I said before. We thought that we would have a couple of new members to be appointed. So I think that that work group really will have individual people who will be targeted for that work group, hopefully.
I guess everybody should be affiliated primarily with one group, but I wanted to respond to your specific comment that Ed Sondick was going to be at your meeting. Both Hortensia and I were at that planning group. It seems to me duplication of effort to have Ed come and talk about NHANES when in fact we have got complete notes about that. It's not making good use of the committee members.
DR. AMARO: If you want, I can fill you in on the history of that. As a result of our attendance at that meeting, I wrote a letter and a set of comments about feedback on the plans, and some of my concerns about that meeting. Ed called and thought that we should we meet to discuss some of my concerns.
He seems to be moving forward in thinking about some solutions to some of the issues that I brought up, and wanted a discussion with our committee about what those solutions might be. I think that hour and a half presentation is really going to be his laying out some of the options that he is thinking of putting into action, and also figuring out a mechanism for us to work more closely with him on this issues.
I don't think it will be repetition, because the issues he is going to discuss with us weren't discussed at that meeting.
DR. IEZZONI: Barbara, we are hoping to schedule -- we haven't actually asked him whether his calendar is free that day -- is that we are having a meeting that day for another purpose. Hortensia has indicated that Dr. Sondick has some urgency to move forward. There are some decisions that have to be made immediately, and so we just thought that for economy of effort frankly to avoid duplication, that we would see if he would be available to meet that afternoon specifically to address some of the issues that Hortensia has raised in her letter.
DR. MOR: Our subcommittee, the Population Subcommittee, yesterday or the day before decided that one of the issues on our work agenda this year is going to be looking at Medicaid managed care, the implications for data issues, et cetera. It will, I think, be difficult to accommodate a big other charge on top of that given the difficulty we had in coming up with just times for reviewing those.
On the other hand, this particular obvious overlap is an indicator that these are highly synergistic sets of concerns. So maybe it does make sense, Barbara, to sort of figure out who is going to come in to the committee, and then re-look at the allocation of responsibilities.
DR. DETMER: That's part of why we are doing what we're doing on our agenda today too, so I'm not uncomfortable about that. That's why we are doing this, but I think it will require continuing coordination, that's for sure.
MS. GREENBERG: I was just going to say there are really at least two issues on the table. One is the structure of the subcommittee or the committee; the other is the structure of your meetings, and how we can avoid what we were never able to avoid when we had six subcommittee, and are having difficulty with three as well.
On the former -- and I would agree, I think it would be better to wait until we get the full membership back up before we change this. This was part of the discussion before K2 passed, and before the new members were on the committee, that we didn't want to separate too cleanly, the whole standards issue from needs issues, and from population-based issues, and everything from having two separate committees, to having those divided between two subcommittees, so that they weren't really talking together as synergistic.
I think the feeling was that standards need to be informed by some of the broader needs for data. So at least at this point I would hope that you would keep that open. It sounds like that is where you are going.
On the other, I think yesterday clearly there was some real work that needed to get done by specific subcommittees as to recommendations that were going to go forward; I guess actually in each of the subcommittees. So I don't think anyone probably felt that there was too much time. The two and a half hours was needed by each of the subcommittees.
I do think there probably needs to be some guidance in setting up future agendas as to whether you want more of the meeting to be subcommittee meeting, and less of it to be plenary. There is always the possibility of extending to two and a half days in order to use people's time well.
So I think ideally we would have the meeting structured so that there wasn't the overlap. I think that needs to be considered.
MR. SCANLON: Just in terms of future planning in terms of new members, there are four vacancies that will be occurring, and hopefully they will be filled by the September meeting. Recall that we thought inside the department as well, what are the areas that the committee needs either because it has lost areas, or because it has new responsibilities?
I think there were four areas that came up, that expertise is being looked at. One is the area of surveys, so chances are very high that we'll have a survey person. A second area would be state data, because we're going to be losing George. George has had two terms now, and he's asking to be let go. But at any rate, that whole area of expertise, state public health data, we would need that as well.
A third area is really the payer/insurer side of life. We really are doing things that affect them very much, and yet we don't have a direct representation there. In a fourth area I think we have a little more leeway, and there are different areas, and this could be anything from consumer interests, consumer research to public education kinds of issues, to others as well.
So there will some help on all of the subcommittees. There really is a sort of overlap between population-based data and population-specific data. In fact, there is a focus on surveys in much of this. I don't want to see us get to the point where we are actually having dueling subcommittees and charges. I hope we can coordinate that a little better.
MS. FRAWLEY: I have just a couple of observations in terms of yesterday. I think that I certainly wouldn't want to see us have less time together as a full committee, because having sat as an observer for four years, and seeing how the process worked, then what you have is you're fragmented and only certain people know some things. So I would never want to see us have less time together as a full committee.
I think the challenge is going to be for the subcommittee chairs and the work group chairs to coordinate agendas, because I wanted to be in three places yesterday. I wanted to go to the OASIS discussion, because I sent a letter to HCFA saying this is troublesome. I was in the privacy and confidentiality group, but then I realized I was presenting stuff back here at the security hearings, which probably other people could have benefitted hearing from. So I was like almost schizophrenic yesterday afternoon, because I was never in the right spot in terms of that.
I think that that's the challenge. I think that this is an important discussion. I think the challenge will always be for the subcommittee chairs, the work group chairs to coordinate agenda so that we have a lot of time together as a group. I would just hate to see the fragmentation occur where people would roll in for a meeting, and then go into subcommittees and never kind of come back together.
I have seen that happen, and I think that's not helpful in terms of the full committee deliberations. So if we could just figure out a way to coordinate agendas so that we're not in direct clash.
DR. DETMER: Part of our conversation at one point was actually seeing the special populations as an executive subcommittee. That had been in the discussion at one point as well, because obviously the purpose of the population-specific issues was in fact to play an overview if you will, across all those things, so certain ideas clearly just don't get lost in the shuffle; so some really legitimate issues don't get lost.
So I think we are always going to have some tension there; however we do it in the boxology of this thing I think we are going to have some. The question is, how do we try and manage to it.
Other issues, or do you have other further questions?
MS. COLTIN: One of the things that we did a lot in past years was have joint meetings of some of the subcommittees. It seems that this work group on population-based issues, to the extent that you are going to have somebody like Ed Sondick in to talk about an entire survey, you may have specific population-based issues around that survey, but you are going to get also a broad view of the entire survey.
That inviting the members, once they are identified of the population-based data work group to join in that session, might be a way to also make sure that the coordination and collaboration occurs, and that others who have an interest in the survey side of things, have an opportunity to participate in those discussions.
MR. VAN AMBERG: I'm kind of curious about why you call this a work group, because to me a work group has a task in front of it to accomplish, and then it disbands. So you must have something in mind for this.
MS. COLTIN: I think we were trying to avoid creating another subcommittee for one thing, for some of the reasons we have just discussed in terms of dividing the members up and creating scheduling conflicts. Also the thought was that the Subcommittee on Health Data Needs, Standards and Security was an umbrella subcommittee, and that within that subcommittee there were members who had specific interest and expertise around standards, but there were also members who had broader interests in the whole area of health data needs, including survey-type information.
Now one of the possibilities is to just say okay, this should occur at the subcommittee level, and just get rid of that work group entirely, and make that part of the --
DR. DETMER: Unless there a specific survey issue came up.
MR. VAN AMBERG: Then you've got a work group on it.
MS. COLTIN: Make it more of an ad hoc type of thing.
MR. VAN AMBERG: It seems to me that is a better solution than trying to permanently assign people to work groups and subcommittees, and you are back in the trap of too many groups and not enough people, and not enough staff.
MS. GREENBERG: If I could weigh in, I think that's an excellent suggestion, because usually when you are addressing broader issues, the whole subcommittee is going to want to meet in any event. There are people who have both of those interests, and I think you are right about a work group needing to have more of a task.
DR. STARFIELD: I think it is a good suggestion, but I don't think it solves any of the problems. It doesn't solve the overlap between that subcommittee and this subcommittee. It doesn't solve the meeting problem conflict. It doesn't really solve the problem that we don't have people on that committee. So I don't know that it solves any of the problems, although it's not a bad suggestion.
DR. DETMER: I think you raised a relevant point though. Until you have a really specific agenda -- I kind of like the idea that work groups really are working on an identified task, which I think is your central point, isn't it?
MR. VAN AMBERG: Yes.
MS. COLTIN: I think part of our rationale when we talked about doing this was that Ed had made a specific request to get some advice from the committee, and we saw this as a potential vehicle for addressing his needs as well.
MS. GREENBERG: Actually, I think this was decided at the first meeting, before that request came from NCHS.
MS. COLTIN: Really?
MS. GREENBERG: Yes, it was. So that predated this.
DR. STARFIELD: Why don't we do what you suggested, Don, and wait until we see what develops with that?
DR. DETMER: It sounds to me like when we plan this meeting -- when Ed plans his meeting, it sounds to me like obviously both you, Barbara, and Lisa need to be at least in that loop for sure. There may be others as well. Obviously the Executive Committee will be tracking that too. When we get our new membership and a better sense of what Ed is really wanting, then who knows, we may need a work group. We may need two work groups, I don't know.
MR. SCANLON: I think in terms of what Ed is thinking, I think his thinking is still evolving as well, but he clearly wants some sort of broad-based advice for NCHS across the whole range of programs there. There are several possibilities. One could be as simple as a one or two day retreat, where members of this committee, plus other survey experts and others from the outside could simply meet and look over the Center's portfolio, and discuss issues like that.
To something more structured, like something like a one or two workshop at the National Academy of Sciences or anything in between. Then possibly see what arises in terms of the continuing advisory mechanism there as well. So he is quite open still.
DR. DETMER: I think the kinds of things you folks were talking about in your meeting before this group met, some of that strikes me as really the sort of things he is really interested in as well. It's not just looking back at what happened, but looking forward and what is coming, and trying to make sure that the National Center is tracking on things it ought to track on.
Okay, what else, Kathy?
MS. COLTIN: Well, let me just be clear then, we decided that for the time being we are going to table this work group, and fold it into the subcommittee, and see whether a particular charge comes up?
DR. DETMER: You can make it a dotted line or you can erase it, I don't care. Right now it's in limbo though.
MS. COLTIN: I think we are saying that the concept of a work group is one that we want to use when we have a particular assignment, and that for now those broader issues would be addressed by the full subcommittee. Should a particular assignment come up that deals with population-based data, that work group might be formed and given a particular charge, but for the time being it will disappear.
Then state and community health statistics, which had been channeled into that work group -- shall I assume that would be channeled into the full subcommittee, the Health Data Needs, Standards and Security Subcommittee? Okay.
The other thing we talked about are the major activities that need to be planned by the Planning and Implementation Work Group. There were three that were identified. One was really to formulate a strategy for education, and we heard quite a bit yesterday from the states in terms of the need for education.
That includes identifying the customers for education; identifying particular educational strategies for different customer groups; and identifying who among the committee members would be interested in taking the lead with particular customer groups.
Now Elizabeth, I understand, has volunteered to help with organizing this particular portion of the planning and implementation activities, but that is one set of activities that we need to talk about. I think we will need some time at the September meeting to really move ahead on that.
Whether there needs to be any conference calling or other types of meeting between now and then, I don't know, but it seems like this is a very important need. It may require enough lead that time that September may be pushing it, given that the regulations are going to already be out there. Part of the educational strategy may just be alerting people to the fact that there is something out there that they ought to be aware of and reacting to, and September is already kind of far along.
So that's an issue in terms of how we get that moving between now and then. I know that the K2 work group is meeting in August, but I don't think there is really any time in that particular time frame even to have much of our effort expended on this. I may be wrong, but I think it is pretty well scheduled.
MS. GREENBERG: I was just going to mention that the Executive Subcommittee is meeting after this meeting today, and that is going to be a major topic, public education.
MS. COLTIN: So we should try to get something done today.
DR. DETMER: I think do we need to, but we also really need to have some conversation now.
MS. GREENBERG: What I'm thinking also is that input from people who won't be at the Executive Subcommittee meeting at this point would be helpful.
MS. COLTIN: Do we want to do that now, or should I go through and list the two other areas?
DR. DETMER: I don't care; you may want to put them all on the table.
MS. COLTIN: I'll put them on the table. How about that? Then we can go back and talk about each one.
A second set of responsibilities is updating the work plans of the various subcommittees, and the work groups as well as the subcommittees. When we put work plans together for privacy and confidentiality or for K2, we had time lines. Many of those time lines are very far along now, and we have to start thinking about well, what are the next sets of activities, and how do we plan those out?
So I think that is a subcommittee responsibility, but it's something that planning and implementation needs to assign formally to the subcommittees, and make certain that each subcommittee chair, in their meetings, with their subcommittees, takes a look at the work plans, and in September comes back to the full committee with an updated work plan for us to review.
The third is a set of implementation issues following the adoption of the standards. There are certain responsibilities that have been assigned to the committee in terms of making an annual report to Congress for instance, on how implementation is going.
In order to do that, we need to think about what it is we want to update Congress about. We will need some mechanisms for gathering information in order to be able to report back, whether it is information on the rate of adoption of the standards by different sectors; problems that get identified; the kinds of things that might come up in the Special Populations Subcommittee around issues that are being observed, and that need to be formally addressed before the implementation time frame is out; let's identify those issues early on.
So we will need to plan for some mechanisms to enable us to monitor implementation to identify issues as they come up, to be able to report to Congress on how things are going, or what actions might be recommended to correct any shortcomings in the process.
So those are the three major activities that we had identified.
DR. DETMER: Why don't we come back, and then we'll just go down through all of those, because I think there are a couple of items that probably need to be surfaced on each of them.
Let's come back to the public education. Do you want to make some comments first on that?
MS. WARD: Yes, I don't think that timing is a problem. I think that timing is working out fine. We have some target dates about subject matter, and this summer should be a good time to put the communication plan together. The communication plan doesn't have to indicate whether it is going to be regulation A or B. It is when you know, what are you going to do about it?
That's what I am imagining putting together, and it could easily be done through e-mail and chatting with people electronically or by phone about is there a particular concern here. I can send out drafts of what the communication might be.
DR. DETMER: So that sounds fine for process. I think the issue is who do you want us to -- who are our stakeholders? Who do we wish to inform? That's one of the things that we need to discuss today. Who do we talk to?
MS. WARD: Who are the targeted audiences? What is the behavior we want to affect? If you can get that clear, then we can put a plan together.
MS. FRAWLEY: We talked about this a little bit yesterday afternoon. I guess the concern that we have is that even in San Francisco we heard during the hearings there were still huge segments of the provider community that were unaware of the impact of HIPA(?).
I guess the other piece that we talked about in the Privacy and Confidentiality Subcommittee is the continuing need for consumer education. I'm not sure that this is necessarily just in this committee's purview.
What we worry about is we have legislation that is going to mandate all these standards and all these things that have to happen, and yet we have got people that are responsible for implementing, and people who are directly going to be affected.
MR. MAYES: I would like to just sort of expand on that, Kathleen, and perhaps give a suggestion to the committee. I think that in terms of the actual implementations of the 10 transactions, that given the fact that we will have the regulation and the implementation guides, and we have actually started talking with groups like the ECRC from DOE even before the meetings yesterday, or the presentations by the states.
That specific area, I feel fairly comfortable that we are going to address pretty directly; however, one of the things that I do, given that I'm coming in this from a clinical background, as many of you are as well, when I go out to talk to groups, it is the groups that first look at the bill and say, that's the billing office. I don't have anything to worry about.
We are finding that we really need to get out and try and touch base and say, look, there is a lot in this legislation, that it's not just the billing office. We're all well aware, because we have heard all the testimony, this has some very far reaching impact, both directly in what is going to be mandated in February; but also give the further charge that you have to move to much broader issues of the computer-based health records.
I would suggest that would be a very appropriate sort of tact for a public education campaign for this group, is to try and expand people's consciousness that this is not just the claim or an activity that just insurance companies are involved in, but that it is going to lead to bigger things. In fact, it is very important that segments that have heretofore of the industry not been really involved in EDI in a coordinated fashion, need to start getting their act together and making their particular needs known.
MS. FRAWLEY: We saw that CPRI last week. I was shocked by the number of people sitting in the audience who were acting like this was the first time they had ever heard it, and then in break realizing it was the first time they had ever heard of it. I think that you bring up is a very good point; people saw that as a billing transaction, and not realizing the breadth of the language.
MR. MAYES: I just was in Charleston at a meeting which were basically pharmaceutical companies and supply manufacturers, doing this presentation. I just yesterday got some feedback saying that everybody ran back to their companies saying, does anybody know this is happening to us?
So I think there is a lot of that type of activity, and many of the members of the committee represent sectors which I think will be impacted, but may not be very aware of the facts.
DR. COHN: I actually think that this is an excellent time to be talking about communication planning. I have always noticed it is hard to communicate when you don't have really anything there. All you have is process to talk about. I think we are right at a time now where we begin to have conclusions that we can present.
I think we have all been out communicating. I think part of communicating planning needs to include all of the individual communications that we're doing around HIPA. I personally would look to a communication plan among other things, to assist us with the messages and the information that we need to get out, so maybe there is some clarity of that.
I think we are all being asked; we are all giving talks about HIPA locally, nationally, wherever, and to have some consistency I think would be very valuable.
DR. DETMER: Clearly, we have to have consistency when anyone speaks, so that we make sure that people speak what the committee has decided, and people separate their own additional comments.
DR. COHN: It's beyond that. It's the issue of clarity about key messages.
DR. MOR: A couple of points. First, it's a time when many medical software vendors are re-engineering their products. The point about certain sectors being totally unaware; that this is just something done in the back office for billing. This is no longer something being done in the back office in billing. This is actually a function of the integrated medical record system, not for medical records, but for the same information being entered once.
I don't have a clue of what the right channel is to get that information out. There is a lot of -- that's a big area that is now costing folks in the health care world lots and lots of money as they buy the wrong system time after time after time. I'm just very concerned for the small vendors who are at a substantial disadvantage anyway -- I'm sorry, the small providers, buying from the wrong vendor. So somehow or another a message has to get through to them.
Secondly, I for one -- if I'm going to start talking to folks about this, I need to have a presentation. I need a set of slides, or what have you in order to be able to do this kind of package. I understand it, but I don't want to have to sit down and --
DR. DETMER: We had talked about that as a piece of the process.
DR. MOR: Third, as we mentioned before, I think dissemination to the health services research community has also not happened at all, and we need to figure out a channel to do this. Perhaps some way of taking a basic message, and then form-fitting that message to the various audiences would be helpful; just identifying each of those channels.
MS. WARD: I was going to say the reason I agreed to do this is that I was promised access to a media specialist, because that is exactly what a communication plan is. That's what I'm assuming is going to be the product.
MR. BLAIR: While I was listening, a few professional organizations and trade associations came to mind as maybe being very productive for us to address early on. One is the Center for Health Care Information Management, which has both a vendor association of health care information system vendors, and that is for institutions and let's call the practice management systems, and clinical information systems that will be available in the ambulatory center. In any event, those are vendors that are part of CHCIM.
The other group that is also part of CHCIM are consultants. The consultants in the health care information systems would be very important for us as we begin to look at confidentiality, privacy and security. Kathleen was just prompting me of course that electronic signatures would be something that most payers and providers would turn to consultants for advise on. So anyway, that's one.
Then there are several other related groups, the American College of Health Care Executives, and there are a number of different associations, like HIMSS and AMIA(?). Anyway, we certainly could identify a nucleus of four, five or six associations that we could address, and I think a lot of the message would be taken from there.
MR. MAYES: Two points; one, Dr. Moore and the HHS implementation teams have in fact put together a sort of standard package of slides that we would be more than happy to expand and incorporate NCVHS-specific slides. We have a few on the expanded responsibilities and the upcoming activities, and we have put in the dates of your meetings, and that sort of thing.
Along those same lines, we have had a couple of sort of dual presentations. In fact, Don and I just did one at CPRI, where we had both a member of NCVHS and someone from the HHS side, the government side do a presentation. I think that that's quite effective. I know I have gotten a lot of positive feedback.
We would be again, more than happy to coordinate. We do have an outreach plan, and we have actually presented at many of the organizations that Jeff Blair just mentioned. We are always eager to hear about more, but we get a lot of requests from different organizations, and would be happy to try to coordinate presentations that way, so that we don't show up unbeknownst to each other.
DR. DETMER: We will need obviously both the package to people from the committee that would be willing to do some of that too, because it is obviously quite a burden if we don't spread the fun around.
DR. IEZZONI: I have a question, Don, going back to your comment about separating out what our personal opinions from what is the official position of the committee. Last week at the Association of Health Services Research meeting I did talk about HIPA as part of a broader presentation. I did not introduce myself as a member of the committee, and I do not say that I only represented myself.
I have talked to the editors of The Journal of Medical Care, and they have said, yes, I should write an editorial and they will try to publish it as soon as possible.
My question is, should there be an internal review mechanism of what I write? Should this come under my own signature as just coming from Lisa? How should we think about that as we go out and try to talk? I think putting something on paper is a lot more specific than speaking in public, and therefore I feel a lot more concerned about being absolutely accurate, if it is going to be represented as a committee position.
DR. DETMER: This is hardly the first time the committee has faced this question. There is already policy, and what advice do we usually have as standard?
MR. SCANLON: Well, again, like any advisory committee, if you want to speak as an individual, you simply say that, and you say these are not the views of the committee, these are Lisa Iezzoni's views. If you do want to speak for the committee, if you are there representing the committee, then you do more or less have to not stray beyond what the committee has already recommended.
You can either discuss the process and the status. Now at the point where we are getting to actually recommendations and conclusions, you could again present those. It is purely up to you.
MS. GREENBERG: I was just going to add to that, I certainly agree with what Jim is saying, but in the past the committee has attempted to actually get editorials or an article in one of the journals. They haven't really been very successful, and I think until the HIPA legislation there was -- if you think there's a lack of recognition now that these issues are really important to the entire health industry, that was particularly true in the past.
In that case, generally something was -- what was happened was at least the document ended up in the annual report of the committee. The document was prepared with input by someone on the committee, working with staff, or different arrangements, maybe working with a consultant. It was then actually reviewed by the entire committee, or the Executive Subcommittee, or a subset of the committee as decided upon.
I think there would have to be some type of review process. That can be agreed to by the members.
DR. IEZZONI: I think to be honest with you, Marjorie, I would need to turn this around pretty quickly. Turning around things quickly when they come from the whole committee is almost like an oxymoron. So I think that probably in this instance I want it come under my own signature, but I feel that I would like somebody who I can turn to, to look at it to make sure that it is technically accurate. Who should that be? Don?
DR. DETMER: I think Jim or I or Marjorie.
DR. IEZZONI: Jim and Don.
MS. FRAWLEY: A good model that we followed recently with the NRC was that Paul Clayton, who has had a number of editorials throughout the country and there have been articles. Basically, that was kind of the PR staff and the project staff in conjunction with the chair putting some things together. There are also individual members of the committee who also did some writing. Again, it was brought forward through the chair and the project staff.
As Lisa points out, when these opportunities present themselves, we are talking very tiny windows. We are not talking more than 48 hours, 72 hours. This is not like a week, two weeks.
DR. DETMER: On the other hand, I do think, as you said, the times are changing a little bit. I think this committee is really doing a couple of things, not only specific responses to legislation, but starting to really shape national health information policy, and speak to that more broadly. I think we have an opportunity to probably get on journals' agendas in a way in which might have been a little tougher in the past.
So probably a two approach strategy; one, a little longer range in prospective, and one in trying to respond as well might work.
MS. FRAWLEY: I think one of the things that would be helpful, and this is what the NRC staff did, is they came up with a template kind of that we all had, that could be the editorial or the article. It had already been blessed by the PR staff.
Before the report was released on March 5, we had talking points. We had a sample editorial. We had sample letters to the editor. We had a little package, so in case we had media opportunities, I didn't have to try and find somebody to say, oh, by the way, Newsweek just called. So it's like in the anticipation what I think we should do is put something together that we all have, that we don't have to then worry about if I add this sentence. We have like a little template.
There still needs to be a process where it has to be run back through people, but I think that it would at least be helpful to have some talking points, and a sample editorial.
DR. DETMER: At the end of this meeting we will start having some puffs of white smoke. So we probably ought to try to put those packets together.
DR. STARFIELD: That was the bottom line of what I wanted to recommend, but I don't think we can assume that we can ever talk as individuals, because we are invited to talk and to write because we are members of the committee. So we have to really think carefully of that, and I think having a sort of standardized package is good.
DR. MOR: I was going to second that comment, but I guess I will third the comment. We need some kind of compendium of the various different messages that have gone out, even the various editorials, I think would be extraordinarily useful, because that way one can cut and paste specific for the audience.
DR. IEZZONI: I don't have anything to add.
DR. HARDING: Just the idea that it would be nice if we could have those rules, so that we could follow them. All the reporters who have called me so far, I have referred to John Cain(?). I just said call John, and talk to him. So I haven't talked to any reporters, but am I allowed to? I assumed I wasn't, and so I didn't, but again, they are calling me because I'm on the committee, not because I'm an individual. So it's kind of implied that --
MS. FRAWLEY: As far as press, I have just referred everybody back to Jim Scanlon or Don Detmer.
DR. DETMER: That was our conversation out in California to the point that we discussed this at the Executive Committee, but I think this is a good question.
DR. HARDING: Couldn't we have five things like don't do this?
DR. DETMER: All right, we will create that and circulate it. If any of them cause you dyspepsia, let us know.
To summarize a little bit on this, I hear a fairly lengthy list of potential communities: providers, the public at large, the research community, consultants, vendors. That's just a partial list. So I think that if you have others to add to that, as we start trying to pull this together.
MS. COLTIN: One of the things that I have seen as a problem is when we put people into these broad buckets, we sometimes lose the ability to get the right message to the right subset of people within a bucket. So for instance if we think about payers or providers, health plans can fall in either of those two buckets.
When I think about my own organization, I would like to be able to say to the people in our IT department, this is what it means for you; to the people in our billing department, this is what it means for you; to the people in our quality assurance function, this is what it means for you; and to clinical people, this is what it means for you.
That is a different message for each of those subsets of people. That is part of the problem that we see that everybody looks and says, oh, this is a billing issue. They don't realize that gee, I'm a user of billing data; this has implications for me as well.
DR. DETMER: A matrix kind of approach.
MS. COLTIN: Some of the slides need to be perhaps more targeted to what it means for particular --
DR. DETMER: Actually, we don't have a lot of time, but if there are people in the audience -- we're talking about our communications strategies. Do you have a comment that any of you would like to make on this?
DR. SHERRILL: Dr. Sherrill from Alabama.
I'm just interested also in the fact that the PROs ought to be notified. We work with every organization in each state. We work with the universities, et cetera. It would certainly be a good source to get this information out. I was planning on talking with the committee, because we have an annual conference where all hospitals in the state are represented. That would be an excellent time to put on a presentation.
DR. DETMER: All right, thank you. I appreciate that. I didn't mention the state health groups as well, when we mentioned some of these others.
Any others?
DR. MOR: I'm assuming that at the end of July, the NCHS meeting on data, this is on the agenda.
MR. SCANLON: Don's on the agenda, and there are some others.
DR. AMARO: You mentioned the state health departments. I think that it varies by state how good the communication is between the state health department and the local health departments, so I would also try and include some effort to educate local health departments.
MS. WARD: They have their own organization, and we will have to target them. Then you have the subgroups, and the whole community-based organizations.
DR. DETMER: I think if each of the committee members, much like Jeff had the list, and you know a group and so forth, it might be good to send those to us so we at least can start finding out what those are.
DR. AMARO: I was also going to suggest that as we think of different journals that we sit on editorial boards, in order to make sure we are not overlapping efforts, that we try to create some strategic approach to who is going to try to connect with which journal, and maybe a list of the journals that we sit on or something like that might be useful that we could approach.
PARTICIPANT: I think one other thing that might be useful is a comprehensive, up-to-date calendar on the Web site. There are a number of people who actually are fairly knowledgeable. I think that's one of the segments that you need to recognize as well.
It is difficult for us to keep all of the different meetings, and all of the different deadlines, and when something is to be implemented. That would be a very helpful resource.
DR. DETMER: So the work plans and the meeting things, once we formalize those, we'll get those up there. That's a good suggestion.
The other question, we have talked with an entity that does teleconferencing about having a problem in early September. There has been discussion about whether we might wish to co-sponsor a terminology conference. If there is a group that is sponsoring something that we know exactly corresponds to things that we relate to, and this is an organization that clearly has been in the legitimate work of this area, we talked about trying to do some of that.
Obviously, there is a finite amount of things that we can take on, but what are your reactions also to that sort of thing, co-sponsorship and such? Is that troubling to people, or does that seem like something that could be in the public's interest and appropriate?
I see some heads nodding that it's okay.
MR. SCANLON: As long as we're careful what the other organization is or isn't. You're a public advisory body now.
MS. FRAWLEY: That was the only concern I would have, just kind of throwing in three cents worth, is that we always be careful who it is. I think obviously you and Marjorie and other staff can always investigate to make sure it's an appropriate group. It's not a for-profit organization or something that might really be driven by other motives.
DR. DETMER: There are fairly strict rules in the ways we can and cannot do that, but it sounds like as long as we follow our rules, that this is another way to get our message out, and also get feedback to us that could be useful to our task. Is that what I'm hearing?
MR. SCANLON: Virtually all of these associations and communities we're talking about this morning have newsletters. You can argue that newsletters are or are not read, but it would seem to me that a sort of standard article or letter even might help. I know we have already done this in a few journals and a few newsletters.
The other thing is there are clearly some audiences that for better or for worse are much more key than others, and those might be the first wave, if there is to be some triage. They might be the ones that we concentrate on first. Some communities, without their support, nothing will happen; others are more ancillary.
MS. FRAWLEY: I'll be happy to share with staff, but there are certain reporters who cover IT issues. So our association, when there is something happening, knows to call five or six key reporters, so there is like Modern Health Care, Health Care Informatics, Hospital and Health Networks, The Wall Street Journal. The message is right out. They know something is breaking.
So I think that all you need to do is cultivate a relationship with the key media that people in the industry read. People read Modern Health Care, Health Care Informatics, different newspapers. I think that obviously the AMA, the American Hospital Association, the Health Care Financial Managers' Association, ACHE, like Jeff mentioned, AMIA. These people all have newsletters and journals.
It's not like you have to write a different article. It could be an article that you provide them to insert into their copy.
DR. DETMER: Do you have any other questions, Elizabeth?
MS. WARD: I would just say that the suggestion was made that you all provide some stuff. I think it ought to be within two weeks. If we could reiterate what that stuff is. I think if you wait longer than two weeks, then you are all going to get involved in something else. I think that is the target audience, and of the other specific entities you relate to, reporters and subsets of those groups, any of your advice about things that ought to be in this communication plan in terms of the target audiences, then get that in.
DR. DETMER: We will be meeting, as I say, after this meeting, to start really trying to gel some of this. So that's helpful.
The second item was updating the work plans for subcommittees and work groups. Is there discussion on that item?
MS. COLTIN: I just wanted to clarify what it is that we talked about in California regarding the scope of that assignment. There were at least three things that we were going to ask each subcommittee to consider. One was unfinished business, and that broke down into two categories: unfinished business of the current subcommittee, looking at your existing work plans; as well as unfinished business of prior subcommittees that have now been channeled into your subcommittee.
So using that schematic that we were talking about before that showed the old committee structure, and which of those old committees is now under the umbrella of each of the new ones. If there are unfinished items of business from the old subcommittees, those now below to those respective new subcommittees, and they need to incorporate in their work plans, how they are going to proceed with those activities as well.
Then the third that we talked about were gaps. This went back to the document that Lisa and I had put together over a year ago of the camera, that kind of took a broad view of health data needs, and what the flow of activities might be once one had identified needs.
To sort of go back to that frame work and say okay, within our subcommittee are there areas that our current work plans or that carry over assignments haven't addressed, and that we really want to get on the agenda for our subcommittee? Things that we want to talk about, that we haven't had an opportunity to talk about either because of the press of K2 responsibilities and deadlines, or other activities that have taken our time up to now.
So it is those three things, the two categories of unfinished business, and then looking at gaps that we would like to address.
DR. DETMER: Let's discuss that a little bit. Is everybody clear on that and comfortable with it?
DR. IEZZONI: Yes, we did that on Monday. Can I just ask a somewhat related question? It's obvious from some of the comments we got in talking about what our subcommittee is doing, and did yesterday and on Monday that we need a better mode of communicating with other members of the committee when we are going to be holding meetings, what our topics are going to be.
So for example, Kathleen can know that we are talking about OASIS. I didn't know you were interested in that.
How had you thought about just communicating with other members, so if people are not specifically on a subcommittee, they might want to attend one or more meetings. Are there financial implications for the budget of NCVHS if that happens? Is it an open policy that anybody can get travel money to come to any of the subcommittee meetings, even if they are not on.
MS. GREENBERG: I think you are talking about extremes. Nobody can, everybody can. It's somewhere really in the middle. We don't really have a budget that would allow every committee member to go to every subcommittee meeting, but it generally has not been a problem, I can assure you.
DR. IEZZONI: I just wanted to know if there was a specific policy about that.
MS. GREENBERG: Particularly when the subcommittee feels that another member or a chair, or other members could be helpful, then it's not a problem.
DR. IEZZONI: Then how do we communicate what our agenda is going to be? For example, we know that we're going to be having two meetings within the next few months. Do people want to know about that? How will they want to know about?
MS. GREENBERG: Well, e-mail certainly. This gets back to the something we had talked about doing, but I don't think we have established it, and that would be more of an intranet; something before there is an agenda that is ready to go on the Home Page, but while it's being developed, like we have for the K2 in the department.
DR. DETMER: It seems to me like what we need to do is find out -- I know it's a pain -- but find out what everyone's home configurations are, so that in fact you really can connect. I get these messages, but I can't right now -- I spend a half an hour trying to unlock some of them, and usually then decide, well, I spent the time I would have spent reading it.
We've got to have a way. It's extra effort to get it sorted out, but that's the only way it communicates, and that's the only way it works. I think if it works that way, and you went through that on the front end, then I think it would be really quite a good a way of trying to do it.
DR. COHN: Isn't this sort of an e-mail issue? Some of us have staff back where we work that should be responsible for solving this problem.
DR. DETMER: But some don't; that's my point.
DR. COHN: I'm saying that there probably needs to be another strategy. I have gotten tired of the attachment issue. I have referred it over to my staff; they have actually fixed it for me now after some angst. I think the question is do some of you have staff that if you bring it to their attention, they could fix it? For some that don't have the staff, then the department needs to assist those individuals.
DR. DETMER: I have found it uneven. Sometimes people are very willing to work very hard to do that, but I think we haven't really developed a clean approach to this, is what I'm guessing.
MS. GREENBERG: We have a mixed media approach. With some people we fax to; some people can pick up the attachments; other people we put the attachments in. You're right, we're trying to customize it to needs.
DR. DETMER: Let's work on that.
DR. IEZZONI: Back to my question. I don't really want to put everybody's e-mail address into my system to be able to e-mail everybody what the meeting agendas are. So is there a key staff person who we could designate for the National Committee, not the key staff person for our subcommittee, but a key staff person for the National Committee that if I wrote them an e-mail message and I said, these are when our meetings are going to be, that that person could then disseminate it?
DR. DETMER: It would be you or Lynnette.
DR. IEZZONI: Well, can we designate who it should be?
MS. GREENBERG: I'd say probably that is appropriate or the executive secretary, so if you send it to me --
DR. IEZZONI: Even though your e-mail isn't working, Marjorie for a few days.
MS. GREENBERG: That was a very limited period of time.
DR. DETMER: So Marjorie is the designated person.
DR. AMARO: I just want to say that I'm glad to hear that I'm not the only one who has been having problems. I can never read just about anything.
DR. DETMER: Okay, we'll worry that one too.
MS. COLTIN: I think we should make the assumption that that sort of information would go out to everybody, because we can't guess about who is going to be interested; all the committee members. You don't know who is interested in OASIS. You need to send that out to all the committee members, and then we identify ourselves.
MS. GREENBERG: Your communication is among the subcommittee members about should we invite this one, should we invite that one, et cetera, I don't think that needs to go to the whole membership, because that can be a problem with a list server. I think when you really want everyone to know this is what you are thinking of doing, the announcements; not all of the chatting.
DR. DETMER: Then we'll see. We'll have to keep revisiting this, but at least we'll see how it goes on another iteration.
Implementation, that's another item.
DR. MOR: Actually, about implementation, in terms of the gaps, I noticed that this falls someplace between the disability and long-term care statistics versus ambulatory and hospital care statistics. There are now some statistics out there that are sort of generic, broad and not population-specific, but that are no longer just hospitals and ambulatory.
I would like consideration of those being sort of made more mainstream as it were. There are data sources that are out about which this committee tends not to have any information, tends not to be cognizant, that are as useful as the hospital and ambulatory care statistics were 10 years ago. I think they should be made a permanent part of the radar screen, as opposed to just sort of a separate segmented component.
I think that should be part of the Health Data Needs, Standards and Security agenda, so that it does not get dropped off. Those are standard data files, just like hospital discharge abstracts or hospital provider service files that are now available, that need to be considered as part of a data system that can be looked at for analytic and other purposes by this committee in the same way it addresses other kinds of broad population-based data issues about providers and populations served.
MR. SCANLON: Yesterday I mentioned that HHS had begun rethinking all of the provider surveys, capacity and supply kind of data as well, including what associations collect, what HHS collects and what others collect. I think we have a group within HHS, but I think we would like to at least get the committee involved at some point in terms of helping to think through some of those areas.
It is really a big step back. It's what, given the restructuring, given the tendency towards multiple settings, what kind of information does the nation even need anymore about providers? What is a provider? What is across the spectrum of providers? Then how do our current data systems and others stack up?
So we would like to get the committee involved perhaps in an agenda item or a break out in a future meeting in terms of a gap.
DR. MOR: As an example, NCHS does a survey every three or four years now of hospital and home care agencies. It's sort of a general survey that is done. It picks up a little information from sample records or so on and so forth as part of the survey to the providers. They have a response rate and so on and so forth.
It so happens that the Health Care Financing Administration has the population of all Medicaid/Medicaid certified providers on their provider service files. There is, to my knowledge, no interdigitation between those two on an ongoing basis.
MS. FRAWLEY: This is a little bit different spin on what Vince is bringing up on implementation, and I throw this out, because when Jim was making his report yesterday about Data Council, one of the things I think we have to try and track and kind of just keep in terms of the whole, broad picture is we're spending a lot of our time talking about K2 and the impact on the industry.
At the same time, within HHS we have tons of regulations kicking out that I don't think people are integrating well. So just for an example, because every day I read the Federal Register, and have to respond to this stuff, we had the revisions, the proposed revisions, the conditions for participation for home health, and comments were due June 9th.
The same notice also contained requirements regarding OASIS, which is very troublesome in terms of the inability to look across the continuum of care. You have revisions, conditions of participation coming out for hospitals which will be very, very significant. They are apparently in the secretary's office right now.
You've got a proposal on the street right now, people from HCFA talking about the implementation of an APG-like system for ambulatory/surgical procedures. The tentative date is sometime in 1998.
We now know from the reconciliation bill that we've got proposals for prospective payment systems, skilled nursing facilities, home health, and there are a couple of other groups on that laundry list.
The problem that you've got is we are sitting here talking about this hitting in the year 2000, and meanwhile we've got all this stuff kicking out that somebody has to manage. The problem you have is that when you read all these notices, it is almost like everybody is in a little box, not thinking about how this all gets integrated. We are asking the industry to go ahead and run and do all this stuff.
So it's kind of a flip on the implementation, but I think we have got to kind of keep this broader view that we're dealing with the year 2000. We're dealing with new coding systems. We're dealing with new reimbursement methodologies. We're changing the standards that organizations are held accountable to, to participate in the Medicare or Medicaid program, and it is a lot for people to keep track of.
DR. DETMER: How much can we stand?
It does seem occasionally I hear something coming from a committee member that they read in the Federal Register that hasn't really even come to us. It seems like there ought to be some way for this group to at least make sure that this committee knows a heads up on all of these things, because if we are late getting the comment in, that's very frustrating, frankly. It is hardly really consistent with our serving really what we want to do.
So I don't know if there is a way to do that, but it certainly seems like it would be useful.
MR. SCANLON: Now this is way beyond data. Now this is health policy and reimbursement policy and other things that you are referring to.
DR. IEZZONI: The OASIS is a case in point that we'll talking about in a few minutes, but we didn't have a clue about this. Kathleen, I'm glad that you did, and that you wrote a letter, but we are going to be coming up with our letter late, and that is data.
DR. MOR: The same is true for the FMDRG. Every one of these new reimbursement structures, prospective reimbursement have data collection requirements in order to make them work. They are absolutely mandatory data collection requirements. They are intertwined. You can't do policy without data.
MS. GREENBERG: I actually think this is an issue that you probably need to discuss with perhaps the co-chairs of the Data Council, because many of these things are coming out from an individual agency, and are not even going before the Data Council.
DR. DETMER: I'll put it on the Data Council report, that this came out as a very strong concern of the committee at really two levels; one, the data level, but also as it relates to the data feeding policy. Both of issues are of concern to us.
MS. FRAWLEY: As an interim solution, since I track all of this stuff, I would be happy to send you a little e-mail message once a week, laying out what was in the Federal Register for the week, or what I read in trade publications. It should be handled internally, but until you solve the problem, I would be happy to give the flag saying, oh, by the way, here are the three Federal Register notices that are out this week.
My concern is there is all this stuff happening, and every time you go to a meeting people are just keeling over, because it's almost like the insanity of are people talking to each other, because you are expecting all these things to happen.
DR. DETMER: I doubt we will want to comment on everything, but we at least ought to know what is coming down the stream.
MS. WARD: I was just going to add that at the point any of us begin taking larger roles speaking out with groups, if this is going on, we are putting ourselves at risk, because we will eventually present to a group to say, this is the issue about standardization. Someone in that audience will point out, why is therefore then in the Register something that is coming out that has none of the year 2000 requirements.
That's exactly what we are facing with OASIS, is it is saying this is a new data collection system, and it is totally disconnected from where we are going with the proposals for how to start collecting data differently.
DR. DETMER: Well, it sounds like two things I'm hearing too. One of the things we can do is not only use our link to the Data Council to raise issues like this, but I think also as a way of feeding specific input that may be easier than our meeting formally going through a letter to the secretary too.
It seems to me we can use this as a way to short cut some of this feedback into the department as well, but we will have to think through that a little bit. It seems like that might facilitate, because I just don't think our process is such that we'll be able to respond in a timely fashion on all of these when we need it, at the rate that we need.
MS. COLTIN: I was going to say, there are decisions that are clearly within our purview, or recommendations at least that are clearly within our purview that are impacted by these other activities that are going on. We were discussing yesterday in the K2 work group, the implementation time frame. The two versus three year implementation time frame.
The considerations that were coming up around all of the systems changes that need to take place in organizations to accommodate the year 2000, and what implications that has for the implementation time frame for K2. What about all the systems changes that these other requirements are going to impose on those very same organizations in that same time frame? How does that impact on our recommendation for whether this should be two years or three years?
So if we don't know about other requests that are being made, we don't have the information to make a sound recommendation around where our particularly responsibilities should focus.
DR. DETMER: I have heard you loud and clear.
DR. AMARO: With respect to implementation, are there any current plans for us to try to track how the field is responding, and problems and glitches that come up, and the impact on the people in the systems that have to implement all of this? It would seem that we would need to develop or design something like that. Has the group discussed that at all?
MS. COLTIN: That is the third bullet that I had brought up at the very beginning, which is the implementation issues following adoption of the standards, and the fact that we need to report to Congress once a year on what is going on out there, and what is happening. That really requires us to have some sort of a surveillance function in place, to say look, this is not moving at all in this sector because, or that the rate of adoption appears to be ahead of schedule, or that sort of thing.
We talked a little bit in the Executive Committee about whether this was something we could subcontract out to a vendor to help work with us on developing some sort of a monitoring function that would enable us to gather the information that we would need to put into a report. The first thing we have to do is decide what information do we need? What are the kinds of things that we want to monitor, and that we want to put into that report? Then figure out a mechanism for how we are going to get that information.
So I think you are raising exactly the kind of issue that we need to hear about. If they are coming out of the subcommittee on special populations, our concerns about not just wanting to monitor problems or barriers to adoption, but wanting to look in particular segments of the various constituent groups about problems; small providers versus large provider groups. We need to know that.
That is the other item that we need to plan for.
DR. AMARO: I know that through the different testimonies we have gotten input from different sectors about concerns or problems that might arise, but I was wondering if there was any way for us to do a more formal assessment of the problems that different sectors and types of providers might face.
So that as we recommend ideas for implementation -- we have talked about technical assistance, maybe incentives; you asked yesterday about that, or financial support to different agencies that might need that in order to implement this -- so that we could develop some recommendations that respond to that assessment before it is implemented.
MR. SCANLON: The other way to do this is through hearings. Literally call in various representatives from various settings.
DR. AMARO: Right, but I think that the limitation with that is that you get the people who have the money to travel. You certainly get a large number of people who we need to hear from, but I think that there is a bias in who can come there, and it probably leads to an underrepresentation of probably the people that have the most problems implementing systems.
So I just wonder whether there are other ways for us to get a handle on what some of the implementation issues might be, and how that might differ across different groups before, so that we can develop implementation strategies that respond ahead of time to those problems.
DR. DETMER: It sounds like this is something that staff could maybe help us look at, worry a bit more what are the best ways of getting some of that, and perhaps come back with some suggestions that the committee could respond to.
MR. MAYES: Just along those lines, as part of the regulatory process, the rulemaking process, when we go out with the regulations, we will have to define some of the implementation strategies that we're proposing. I would suggest that certainly the public comment period might give us a good outline for those that may be problematic, or that we want to monitor, or that you would want to monitor on a continuing basis as well.
DR. MOR: Is there any provision in the law for a study of the impact? Or is there any specification as to what the content of our annual report to Congress should be?
MR. SCANLON: There is some guidance, Vince. There are some specific questions in terms of the extent to which the provisions of the law are actually being implemented, like proportion of EDI that is being done. That part doesn't really kick in until they are adopted, and the implementation schedule actually is reached.
There is some preliminary work. I think for the first annual report, for example, Don, I think we would want to report everything that the committee has done, and the department has done, and where we are. We will have recommendations by then already. We may have some baseline information from existing sources on the extent of EDI. For these specific provisions, I think it is going to require some more of an assessment. We probably will get in a report after that.
DR. DETMER: So it is additional task that has some detail deliverables.
MR. SCANLON: There are some specific ones.
DR. DETMER: Okay, well this has been a very useful discussion, and I think really is going to help us respond to what you feel need in order to both get our work done, and then have people know what our work was that we did.
We need to talk about future meeting dates and some agenda topics.
I, for one -- and I don't know when we ought to do it; maybe following the approval of the work plans as an agenda issue. If we approve those at the September meeting, the question I guess is that this camera metaphor has really captured a couple of our members' minds, and I'm not in that camera shot as much as I feel I should be. I am probably not the only committee member that feels that way.
What I think would be useful maybe, if I have heard the thrust or gist of that, is that perhaps either the meeting after the September meeting, after we have had a chance to then look at all the work plans in the Executive Committee, and maybe at that next meeting we could get a camera shot of what some of all this is, because it sounds like it is a useful metaphor.
It seems like we need to get a full sense of our inputs before we then kind of could lay out what that terrain map or picture ought to look like or something.
DR. IEZZONI: We're kind of going to be doing that in our July on July 21st.
DR. DETMER: So you would be ready by the September meeting?
DR. IEZZONI: Well, Medicare managed care, which is what we have decided as a subcommittee is going to be our major agenda item. What we are going to be doing in July is looking at the first level of the camera, which is what are the health care questions that are raised by Medicare managed care, and then proceeding down into more detail.
As you begin to think, okay, here are the questions, what are the data elements that we need to know to be able to answer those questions. Then the next layer being how should you get those data elements?
So I think we'll have a model for how this should be done after our July 21st meeting that we could use as an example.
DR. DETMER: Okay. All right, meeting dates. What do we need to do on that, Marjorie?
MS. GREENBERG: We have for the rest of this calendar year we have September 8-9, and November 5-6. We have no meeting dates selected for 1998, and perhaps the best thing to do for that -- Lynnette, why don't you come forward? -- is that we will query everyone on dates. Generally, you probably think in terms of March, June and actually in the past the committee was having three meetings a year. Now this year we are having four meetings, and I don't think it is excessive.
DR. DETMER: It's excessive, but it is essential.
MS. GREENBERG: I said I don't think it is excessive. We obviously have work to do at these meeting, but we need some feedback from you, particularly because we're now having to put in our plans for the fiscal year 1998 budget, how many meetings you want to have in calendar year 1998.
MS. ARAKI: Also I think whether you want an off-site meeting and where, because we do have to at least anticipate something like this in the fiscal year.
MS. GREENBERG: Well, there can be some flexibility as to where. We can estimate. In fact, I believe that we are being asked for some budgetary figures in the next few weeks, so that would be helpful.
MS. ARAKI: Also, if you have identified subcommittee meeting dates, we need to get that on the calendar now, and you need to plan for 1998 as well.
MS. GREENBERG: Some sense of how frequently you would want to meet in 1998.
DR. IEZZONI: We have a couple of subcommittee meeting dates that let me just list for you -- July 21st will be a full day meeting from 9:30 a.m. until 5:00 p.m. Then September 29-30 will be a day and a half meeting, with a full meeting on the 29th and then half a day on the 30th. I'll be getting back to Marjorie's office about what the topics will be for those two different meetings in case any other members of the committee want to attend.
MS. GREENBERG: Right.
DR. IEZZONI: Don, can I also say that our subcommittee has some agenda items that we would like partner with another subcommittee on. Are we going to be talking about that now too?
DR. DETMER: Talk about it.
DR. IEZZONI: Okay. Barbara, our subcommittee would like to partner with you.
DR. STARFIELD: We have already accepted.
DR. IEZZONI: Well, on two specific items. The two specific items are in fact kind of in some ways catching up on old work that is undone, but also moving on to new work.
The first has to do with mental health. That is that SAMHSA right now -- Ron Manderschid(?) being our subcommittee staff person from SAMHSA, articulated that they are right now developing encounter and enrollment standards for mental health services under those auspices. They will be ready I think sometime in the fall. What we would like to do is to be able -- and I think it's a great idea -- to present those encounter and enrollment standards to us, to be able to get our input.
So that is a mental health issue, but it is also a standard setting issue, so we would like to try to have that done in conjunction with the standards and data needs subcommittee.
DR. STARFIELD: Are you talking about the September 29th meeting or not?
DR. IEZZONI: We are going to have to wait and see what SAMHSA has completed, and we should perhaps ask the staff if they can keep track of what is going on there. As soon as we know that they are ready to be able to come to us with those standards for mental health enrollment encounter, I think we ought to try to plan a date for that.
The second issue had to do with coding. I think that our subcommittee would like to see a new presentation of ICD-10-CM, because we are hearing a lot about it, and hearing that it includes more than we might have thought in just looking at ICD-9-CM. The question obviously will be for our subcommittee, is this diagnostic nomenclature going to be appropriate and adequate for some of the people with disabilities and other populations that we might be interested in?
Again, maybe appending to that a really honest discussion about the role of ICIDH, the International Classification of Impairments, Disabilities and Handicaps, so we can really get a read on whether that is a standard that we might want to recommend as a coding standard. So again, those are two items that overlap the coding subcommittee and the special populations.
DR. STARFIELD: I thought that there was a third one that you were going to mention, and that was the new HCFA work on the data release policies.
DR. IEZZONI: We kind of view that actually as more a committee level issue, rather than a population- specific subcommittee issue, but that is one item that we would like to have on the broad committee agenda.
DR. DETMER: How about other of the subcommittees and items that may cross the lines.
MS. FRAWLEY: One that occurred to me is that we are going to be having a day and a half hearings in August on security, but it is very difficult to talk about security without talking about some confidentiality issues. That is why yesterday when I was presenting to the subcommittee up here what the proposed panels look like, and the questions that we are going to be raising to industry on this very important issue is something that obviously the subcommittee on privacy and confidentiality would want to be aware.
I just don't think we can always operate in these little boxes. I raise that because we have got those hearings on August 5, 6 and 7; a day and a half of hearings and a day and a half of subcommittee discussion, and some recommendations that we hope to bring forward in September to the full committee.
MS. GREENBERG: I think it's important too that the full committee knows that at that meeting in the day and a half -- and it may be a real marathon meeting -- but the subcommittee is going to be looking at the whole issue of data content for these transactions, so clearly that is of interest to the subcommittee on population-specific issues as well.
DR. STARFIELD: Well, also the whole issue of the surveys. It clearly surfaced this morning that there is already tremendous overlap between that committee and the data committee. So maybe for those survey issues we ought to try to figure out some kind of Internet e-mail mechanism for just keeping each other aware. For example, Hortensia, your correspondence with Ed and that sort of thing.
MS. GREENBERG: On the security hearings, this is very soon. So I think we need to probably e-mail to everyone the proposed list and questions that was given to the subcommittee on health data needs yesterday. I think we should probably do that as soon as we get back to the office. If you can e-mail what you have to us, then we will get that out to everyone, with a very quick turnaround, because then we have to get out letters of invitation, et cetera, and get it in the Federal Register obviously. So we welcome everybody's input to that.
DR. IEZZONI: So for these joint subcommittee activities such as the ones that I have just articulated, would we hold those at a separate time, separate free standing dates, or would we try to have them be part of the part of the break out at the November meeting? I'm a little confused.
DR. DETMER: I guess my own feeling on that, Lisa, is that where we have these issues that we're trying to reach closure on, literally put out statements, if we have some of those that are on our agenda, I think this pattern that we have used for this meeting has been good. Have a full discussion. Let the group then try to integrate that, and come back for last round discussion and approval.
If there are no action items, then it seems to me that that sounds reasonable to use some of our break out time for that. If there is an action item, it seems like we should not clutter if you will, our agenda. That is my own sense of it.
DR. IEZZONI: Who is the super scheduler? Who knows this?
MS. GREENBERG: Excuse me, what?
DR. IEZZONI: Who is the super scheduler? The scheduler in the sky.
MS. GREENBERG: We work with Jim, obviously, Lynnette and I, under the executive secretary function. I think if you really want presentations and getting background information, et cetera, it is best to do that in a separate meeting, which could be a combined subcommittee meeting.
As some of you know, the mental health and disability and long-term care statistics subcommittees had several meetings together. Sometimes what they did was they had a day together, and each one had a half day, or a day separate. So I think that works well with combining travel also.
I think when we try to use break out sessions for presentations and hearing type of environment, it is difficult. I would agree with Don that really you need those to have really subcommittee discussion and maybe working towards action items, planning future agendas, et cetera.
DR. COHN: I was going to comment, Lisa, on one topic which has to do with coding. I think we should creatively try to plan some time that isn't at a break out session potentially around one of the other activities we have going on later on this year to look at those issues further.
DR. IEZZONI: The reason that I asked this is that we spent how long yesterday subcommittee, trying to come up with dates just for the -- it was unbelievably difficult. I think that we should maybe move on to the agenda item that Don really wants, which are the dates for 1998, because I think that we should really be putting some of this on our calendars.
MS. GREENBERG: Absolutely. I would think we would need probably to do that, to survey people. It would be very helpful at least if you could agree today if you want three or four meetings in 1998.
DR. DETMER: Clearly we had an extraordinary work agenda with the K2 issue. I think over this eight, almost nine months we have delivered some babies here it looks like today. I guess the question is do we see exactly the same kind of heavy agenda for the coming year, and if so, fine. What is your pleasure?
DR. COHN: I think we have all been commenting that this is certainly not a 10 percent commitment this past year. Most of us feel it's a little bit more, but it's an important commitment that we are all willing to make. I guess as I look at what the agenda is coming up, which is sort of very thorny issues of claims attachments, unique health identifier, which I know we are not going to get settled today, and all the other things that haven't been easy is really what is coming up, including data standards for electronic health records.
Now whether it will be four full meetings, I think the reality is the budget is going to be the same, if we have just three full meetings of the committee, and then more subcommittee meetings versus the other way, it is all going to turn out to be the same. I think you need to be planning for four meetings, and probably a significant number of subcommittee meetings.
MS. GREENBERG: I think particularly for the full committee the calendar issue becomes very significant, and if we have dates for the entire year, it is helpful. So we will plan on four full committees, and probably a subcommittee meeting per quarter at a minimum; I mean each subcommittee.
DR. DETMER: Do you have other questions or comments, Lynnette?
MS. ARAKI: Let me think.
DR. DETMER: Do you have other questions or comments while Lynnette is thinking?
MS. GREENBERG: I think those are the main things, the full committee meetings.
DR. IEZZONI: I do have one comment. I think we need to hold a meeting outside of Washington. That was one of the questions. I think the San Francisco meetings were much appreciated in the field, and were extremely revealing in a way that the Washington-based meetings weren't.
MS. GREENBERG: I couldn't agree more.
MS. ARAKI: Are you thinking in terms of a full committee outside?
DR. IEZZONI: I don't know. I think we would have to decide what the agenda would be for this outside meeting, and try to take advantage of the fact that we are in a place where we could be hearing from people. I think that we need to at some point have --
MS. GREENBERG: Would it be your preference to have more than one meeting outside of Washington during the year? You were talking about possible hearings on the impact of --
DR. DETMER: You mean maybe a subcommittee as well as a full committee?
MS. GREENBERG: As part of the way of gathering information about the impact of the standards.
MR. GELLMAN: Could I make a suggestion? Just something to think about. We're having full committee meetings. We might think about hanging hearings before or after the full committee meeting. You get people together. You have a day of hearings. It might be a subcommittee meeting, but for the data standards subcommittee, that's most of the committee. In any event, it's just a way of organizing to make things easier for everybody.
DR. DETMER: Well, it certainly makes it less expensive. Some people have a harder time getting away for three or four days.
MS. GREENBERG: Gee, this sounds familiar, doesn't it, George? It's always the issue. People who have a long way to travel -- we have to try to balance people's needs.
DR. COHN: I obviously have the farthest to come. It isn't for me just a day to wander in and come to the meeting and be gone. So I probably am most impacted by any of these decisions, but I do have to say as someone who has to come this far, I think two, two and a half days -- we probably ought not to push much beyond that. It gets to be sort of hard, being away from work and everything else.
DR. AMARO: My only suggestion with respect to meetings outside of D.C. -- and I think that it is important for us to do that, because I think we hear from different people and different people hear from us, and are able to experience the meetings -- is that we try and distribute our meetings through different regions in the U.S., so that we give people in different regions a chance to know the committee's work and to have input.
MR. SCANLON: In planning for the work plans, we are almost approaching the next fiscal year actually, we typically try to reserve a certain amount of money for contract work. We had a fair amount this year for consultants, for contract work or something like that. We'll be doing the same for fiscal year 1998. I think I have already set aside some.
So that will take care of sort of the relatively smaller size consultants or contracts. If there are much bigger things or projects, please think about them before September.
DR. DETMER: I think the only that really has hit our screen is implementation. I think that that is something we are really saying that is kind of a new task in a sense, and we better tool up for it.
MS. ARAKI: I think it is also the public education initiative. Those are the two major ones that we have to work on.
DR. DETMER: Yes, I agree 100 percent. Underline that.
DR. MOR: I think in terms of the implementation, I agree with Hortensia. This is not a strategy where merely holding hearings is adequate. I think we owe it to ourselves and the secretary to understand something about what is going on out there. Now whether it happens now, or we wait for two years before the effort occurs, but there is a planning process that needs to begin unfolding if in the year 2000, one wants to know what is going on.
DR. DETMER: Then that needs to be integrated well with the department, because some of that is already going on, so we don't duplicate things.
DR. AMARO: Along those lines, it might be useful to really hear from the different sectors that you were talking about, Kathleen. You are saying that you would like to, in your agency, tell the different employees -- functional areas how they are going to be impacted, and kind of translating that for them.
I think it would be important to hear from those different function areas in terms of what this implementation has meant. So some way of thinking about that; that we are not hearing just from one type of individual, but from all the different functional areas that are affected.
MS. GREENBERG: I can almost see some kind of a video in which you have some kind of interview with each group. I thought what you described was very good, so it's a good model to think in terms of, because you get one representative from an organization, and yet there is really a multifaceted type of approach.
DR. AMARO: Also what I like about you suggestion is that it really helps to translate for leaders within agencies, what it is going to mean for them and for their different employees. You sort of give it to them already ready, so they don't have to figure it out. I think it is going to facilitate translation.
DR. DETMER: Dr. Braithwaite, we have been talking about a number of issues. Before we go on our coffee break, this whole issue of some of these planning issues and meetings and hearing and such, you track these things also very intensively for us. Do you have any questions or things to offer that could be useful? I'm sure you do; what are we missing?
DR. BRAITHWAITE: It's clear that when we go out into the field to talk to various organizations, many of them have never heard of the committee, and it is a surprise to them that there is in fact a public sector advisory group into this process, and that the process is not just being done by HCFA for example, which is a common misconception out there.
I don't know whether that is because the various trade press and newsletters tend to focus on a narrow vision of that is going on, and they tend to put out the word quickly about what is going on, but they do it in terms of well there are news rules for HCFA or something like that. I have seen a few articles like that.
I'm not sure how to get to all of those people, but I'm sure that with a sort of cooperative input from the members of this committee, who have incredibly broad representation across the industry, that we might be able to come up with a coordinated strategy of not press releases in the usual sense, but documents which could be shared by each of you with the various organizations and press representatives that you run into, that would get a consistent message out that there is a very broad and open process going on in this realm.
MR. BLAIR: I was asked by Health Care Informatics magazine to prepare an article for them, which I prepared in October, to be in the January issue, which is like going to be a health care information standards issue. That might be an opportunity for us to include that message in there, and maybe I could be working with a number of folks to make sure that we get the proper message included in there.
I believe the Health Care Informatics is a fairly widespread, influential magazine within the health care information systems vendors and users. So that is one possibility.
DR. DETMER: That sounds good.
Other comments as well?
DR. BRAITHWAITE: I think we are getting a large number of hits on our Web site. I have to inform you, we have done some looking at how many people are actually accessing the Web site. It is in the hundreds per week. This is not one individual who is looking at it every day, because we track it by the IP address of where these hits are coming from.
So there is a large number of people looking there. So that we ought to perhaps try out some of the committee's attempts at putting something together for the outside world to look at on the Web, and get feedback that way. We ought not to lose sight of the fact that we can reach a fairly large audience that way, and get immediate feedback about it if people say don't understand it, or want more information of a certain type in that kind of publication.
MS. FRAWLEY: Since I'm out at meetings most of the time and never in my office, I just want to commend the department, particularly the staff who have been out. I mean for the committee members that are not out as much as I seem to be, if I don't go to a meeting and see Bill or Bob or Jim or Don or somebody else, then I'm like, what's the matter? It's like, why am I the only person here?
I really do have to commend the department, because I think the effort that has been ongoing within HHS, and the openness of the dialogue, and certainly publishing the URLs has been really very helpful, because people are happy that they can go in and see what's going on with the Data Council, go in and see what is going on with NCVHS.
So the more that we can get out on those Web pages. I just think the commitment by the department to get people out talking to people, so that it's not perceived as a HCFA thing, has been very helpful.
DR. DETMER: I think before we break I also would just say I think we really did get a heavy work load. I think the staff and the department have really responded to help us get the job done. I thank you very much for that, because that has not been simple, and yet a lot has happened on time sort of, and I appreciate it.
I have 10:05 a.m. Why we don't take a 15 minute break.
[Brief recess.]
DR. DETMER: I actually I was going to call on Dr. Starfield -- are you ready? -- to come back for the action item discussion. I don't know who is up.
DR. STARFIELD: I think I will defer to Simon.
DR. DETMER: Simon, you're up.
DR. COHN: I have two documents that we need to address. One which I tend to think is going to be likely an easy discussion; the other one is going to be a little more difficult.
The first document, as you will remember, is the national provider identifier, the NPI letter that we reviewed yesterday. Now the subcommittee has evaluated --
DR. STARFIELD: Why don't you tell everybody where that is? Tell me anyway.
DR. DETMER: It was Tab G.
DR. COHN: The K2 work group and subcommittee on health data standards reviewed this document. Our recommendation was that we strike the one sentence that seemed to be so problematic for everyone. That sentence that was being struck is the sentence in the third paragraph that reads, "In the interest of operational efficiency and simplification, we suggest that the department also evaluate a slightly longer ten digit numeric identifier."
We felt with just striking that, leaving everything else the same, that the paragraph reads well, continues to read well. It has the same intent, and I think resolves most of the issues previously brought up.
DR. DETMER: So that's your recommendation?
DR. COHN: That's the recommendation.
DR. DETMER: I'll take that as a motion.
MS. WARD: Second.
DR. DETMER: Is there discussion of this? Hearing none, all in favor say aye. Opposed? Abstentions?
[Whereupon the motion was unanimously adopted.]
It's unanimous.
DR. COHN: Now the second document everybody needs to read, because it has gone from a two to three page document. I will try to describe a couple of the changes. I think I will give my apologies to everyone that when you are doing work on various drafts, it's always nice to be able to see the changes that occur from draft to draft.
Let me just very briefly describe the areas where changes occurred, and then let everybody read it for a minute or two, and then we will proceed on with the discussion.
The subcommittee reviewed this document; decided to explicitly list the standards that we were recommending rather than just referring to nine or ten transaction standards, and which standard we were recommending. The committee also recommended that rather than specifying a specific version, that we recommend to the secretary that she recommend current versions and implementation guides, rather than trying to specify what version will be in existence in the year 2000.
There are the same exceptions to the X12 standards. There is actually work ongoing, literally as we speak, to a modification to the transaction data content, which I'm hoping that Bill Braithwaite will be able to bring up to us in a couple of minutes, that I think is a wordsmith that indicates the committee's interest in providing leadership in the area of data content.
Finally, the committee spent a lot of time working on the supporting standards issues. Once again, we are continuing to wordsmith piece even as we speak. The first parts I think are generally without problem. There was an issue around how we were characterizing the procedure coding system, the new unified system, and I think we have agreed on the word "framework" rather than system.
DR. DETMER: Where are you?
DR. COHN: This is on page 3, under "Supporting Standards." I'll identify the changes, and then everybody can read through the whole thing, and then we can discuss it.
Where we say at the end of the -- where we are talking about a major change to a unified coding system for procedures, we changed that word "system" to be framework for procedures.
Then once again I'm speaking for Bill on this one. I think we're striking the over to mid to long-term, but just recommend that you identify and implement an approach, with that next sentence referencing this change will occur in the year 2002 or 2003. These are relatively substantive, significant changes.
DR. STARFIELD: I missed what you said. Are we changing the word "system?"
DR. COHN: Yes, to framework. I believe what we are doing is getting rid of the over the mid to long term of the next sentence, whereas -- which is the words that we recommend -- and then the rest of that.
DR. MOR: Simon, is that the same recommendation as you would be proposing in the prior paragraph above, where you say, "The committee's recommendations on data content also will include specific recommendations for a process for changing, maintaining and updating standards." Is that the same thing? I just want to make sure. Are there two separate recommendations there or not?
DR. COHN: A distinction between the transaction data content recommendations and procedure coding system recommendations?
DR. MOR: Yes.
DR. COHN: I actually think that those are very separate recommendations.
DR. MOR: Okay.
DR. COHN: Data content includes things like new elements to be recommended. This is actually an approach to moving forward on procedure coding systems that I think we have all talked about in various ways.
With those changes -- and I think everybody just needs to review the entire three page document -- and we'll start talking about them after everyone is done.
[Recording stops while the committee reviews the document.]
DR. DETMER: Are you ready?
DR. STARFIELD: Can I just give a little background to that? This is what I think it is. It is responsive to the discussion that we had yesterday, the comments of several people about the future and new data, and therefore the need for new standards after we have done with this process. Also responsive to the discussion we had this morning on the same topic. So that's the background for that. It is an amalgamation of four or five people's separate sentences.
DR. COHN: It's an excellent thought. We were just trying to integrate it into a succinct fashion. This is actually going to replace the transaction data content at the bottom of the second page. Bill is now going to read it slowly.
DR. BRAITWAITE: "The committee has a long history of national leadership on health data content issues." That replaces the first sentence. The next sentence is the same, "We will review the information now being collected by HHS in the master data dictionary of transaction data elements, and once that is available, will formulate its recommendations."
The next sentence is also the same. "The committee's recommendations on data content also will include specific recommendations for a process for changing, maintaining and updating the standard data content specifications for the above administrative transactions."
An additional sentence, "As part of our ongoing responsibilities, we will continue to advise you on the need for new data elements, as well as deletions and modifications to current data elements for health care transactions."
DR. COHN: Why don't you actually read it slowly enough that everybody can actually write it down and see how it looks on the page.
DR. BRAITWAITE: I wanted you to get a flavor of it first. So the first sentence and the last sentence are the only changes. The first sentence is, "The committee has a long history of national leadership on health data content issues." The last sentence, "As part of our ongoing responsibilities we will continue to advise you on the need for new data elements, as well as deletions and modifications to current data elements for health care transactions."
DR. STARFIELD: That actually boiled down about ten sentences into one; a masterful job of doing it at that. It may not represent all the things that people contributed to it.
DR. DETMER: Okay, so do you want to put this whole letter up on the table for discussion with these amendments?
DR. MC DONALD: Sure. I have about four suggestions. The header called, "Transaction Architecture" I think would be more correctly titled, "Administrative Transaction Messages." There is nothing architectural in this particular set of sections.
DR. DETMER: Are people comfortable with that or not?
DR. MC DONALD: The second thing is on pharmacy we say later we will advise about versions, but we have a version in here. I think we should take it out, unless someone knows otherwise.
DR. STARFIELD: Where is that?
DR. COHN: In the Table 3.2 as specified in the table.
DR. MC DONALD: The sentence above says we will recommend. Now in that sentence, instead of saying "current," we should say the acceptable versions and implementation guides, because we had agreed there would be more than one version probably allowed. It is below the heading, "Administrative Transaction Messages."
DR. BRAITWAITE: In other words, "In addition, we recommend that you specify the acceptable versions and implementation guides for these standards at the time the final rules are issued."
DR. MC DONALD: That's correct.
Then on the second page, I think the thing saying "exception to X12N standards," and the two one-line paragraphs, and about a four line paragraph should just go out. We have said what we said. If you look at the middle the page in bold, it says, "Exceptions to X12N standards." Then there is a line that says, "Note that all these are X12N with two exceptions." Then we say, "As the first exception."
I don't see any reason for any of that. We have said what we have said. We haven't explained why the ADA had got a slight variant. It's unambiguous. This is just a remanent of what we used to say when we didn't have the table.
DR. COHN: You're saying the first sentence and that next paragraph need to be gone?
DR. BRAITWAITE: The rationale for including that, Clem, was because it stands out as an exception, it seemed to need a justification. If you don't think a justification, that could be reworded.
DR. MC DONALD: When you put all 20 standards on here, it ends up being finished. This isn't the rule necessarily, and this says it. It's very unambiguous, what we are doing.
Now the second to the last paragraph is saying something additional.
MS. GREENBERG: Just kind of in support of that, this is a note that all recommendations are with two exceptions. One of them is actually mentioned here, the pharmacy, but the exception related to the 837 isn't noted in the table before. So probably it's just better to call attention to that exception. It actually isn't accurate to note the two exceptions, one of which isn't there. Striking the first two paragraphs.
DR. BRAITWAITE: What about the title, Clem? The title doesn't need to be there either, right?
DR. COHN: I guess the question, Clem, is would it be an adequate footnote to the NCPDP, to the pharmacy transaction piece?
DR. MC DONALD: I don't understand -- industry agrees, everyone agrees, there are letters of support. This is what we decided. We're not explaining why we decided the other ones. What you are suggesting is that everyone assumes the other, and I haven't seen that in any of the notes, messages, letters, testimony that anyone seems to find this surprising.
DR. COHN: Other comments about that specifically?
MS. COLTIN: I agree with Clem.
DR. DETMER: So what I'm hearing is strike the title, "Exceptions to X12N Standards," and down to, "Although we recommend that all."
DR. MC DONALD: I need one other little change. In the next paragraph we have to say, "Although we recommend that all."
DR. STARFIELD: Why don't we just start that sentence with, as an exception?
DR. MC DONALD: Well, it isn't really an exception. It's a variant.
MS. COLTIN: I have a suggestion on that. I would suggest that it be worded, although we recommend that institutional and professional claims should move to the ANSI X12N 837 standard, then strike the next four words, "we recommend a strategy," and then go on.
DR. BRAITWAITE: It now reads, "Although we recommend that institutional and professional claims should move to the ANSI X12N 837 standard, we recommend a strategy," et cetera.
DR. DETMER: Is that it? Others?
DR. COHN: Just to focus everyone, let's stay above the transaction data content issue for the moment. As we move down into those things, we need to be a little bit careful, and we'll just focus the discussion.
MS. COLTIN: I have one issue. We discussed yesterday whether we should put in a recommendation on the time line. We put to a vote at the work group, the idea of moving all of the parties to a three year time line. Right now the law allows small plans three years, large plans two years for implementation. I'm not talking about the decisions or the timing for making the recommendation as to what the standard should be. We're still on the same time line. It is the compliance deadline that we're talking about.
It's a no later than, which never precludes anyone from implementing earlier, but it's this no later than deadline where there was testimony from a number of organizations regarding the difficulties of adhering to the February 2000 time line because of the year 2000 computer software changes that need to be made.
From what I have heard this morning, there are other arguments that may also make it difficult for organizations to comply with that deadline, given other systems modifications that may be required by other recommendations that are coming down the pike. So that was one set of issues, the ability to comply with that time line.
The other was the complications of having two different time lines; a three year for one segment of the industry, and a two year for another. Whether in fact having a single time line wouldn't simplify everything for everyone? We put it to a vote yesterday, and we were split right down the middle. There were only six of us and the vote was three and three, and so my recollection is that we had agreed to bring it to the full committee for reconsideration. I'm just laying out what I think the issues were for your consideration.
DR. MC DONALD: One of the voters is gone that voted against it. Now the language that is in there, the number there, did I see as 2002, which is four years, not two years or three years?
MS. COLTIN: The proposal we voted on yesterday was January 2001, which is actually 11 months. It would actually move it up a month for the small plans, who would have had until February 2001. We were talking about using January. That is probably not an issue. We could use February if that were going to create a problem.
DR. DETMER: That did come to a tie vote. It would strike me as being relevant enough that you maybe ought to -- I don't know. It came to a tie vote.
MS. FRAWLEY: I'm a member of that subcommittee, and I was not there for the vote, but I can tell you if I was, I would have voted against it. I just think that when we start tweaking off the deadlines, we are starting to send mixed messages to the industry, who is not taking this seriously to some extent, because it's not just going to happen, so if they ignore it, it will go away.
I understand the problem, because every time I get up, people ask me to define what a small health plan is, and why do they get 12 months more. I guess as soon as you start tweaking with time lines, it is then sending mixed messages. So if I had been at the subcommittee meeting, I would have voted against that particular change.
I think the others are very appropriate. The coding thing we heard very clearly on. I heard mixed messages on the ability of organizations to comply. So we all have different recollections of what we heard.
MR. SCANLON: I think we also heard witnesses who said both.
DR. MC DONALD: I was one of the supporters of the motion, and I will try again. I guess we lost one and gained one today.
When the bill was written the time lines would not have collided anywhere near the year 2000. So things have shifted up and changed. If the year 2000 may be all a big fraud of the consulting firms, but people are spending a lot of money on it, and you can't find programmers anymore anywhere on earth, because people that use PC programs are doing COBOL now to make extra bucks.
So I just think that we are subject to criticism by a segment of the industry, whether it is true or not, for not paying attention to such possible collisions. I frankly don't think for someone who has worked on standards for 14 years, if they get done, that's all right. You've got to be patient.
DR. DETMER: Jeff, did you want to comment?
MR. BLAIR: Yes, a little comment. I haven't taken a survey of all of the information systems departments to know how severe this is. The view that I take I will just express here; I do not have supporting information to back it up.
The perception that I have is that the migration from flat files to X12N for the most part is going to be the replacement of a particular application, not recoding, and they are going to get that from a vendor. I don't see that that conflicts with the problems that they are having with examining their legacy software.
So the feeling that I had -- and I didn't want to wind up just saying, well, there is no conflict at all, because there is probably going to be some shops where most of their software is homegrown, and in fact they will actually be recoding, so I know that there is going to be some of those. I also don't want to be insensitive to the fact that some folks have told us that they have a concern.
So far from what I have heard, I felt that there would only be a few shops that had homegrown systems that really would find it difficult, but I would like to hear from anyone else that either has a different view, or knows that my thinking is faulty.
DR. MOR: If I could just put a different perspective on this. I can't comment on the computer coding, but what all of us do know that big plans are gobbling up little plans as fast as we can see straight. The question is, is any of this going to make any difference to a big plan's acquisition targets, and to a little plan's not saying well I can do this more slowly. I think this will have nothing to do with business decisions. It only matters in small markets.
DR. MC DONALD: The issue of programs, if you think about buying say a new financial system. You get a whole new one, install it, and it takes two years. Now that is not because they are writing code in the shop. It's because they are matching this impedance match between the variables in the code and the procedures and processes.
I'm not intimate with the differences, but I have understood that there are substantial differences in the fields and the data elements and the ones that are required and not required. That is going to cascade into the whole system up to the registration screens. So I can't see that as being a trivial install for anybody, whether they buy it or they build it.
DR. BRAITWAITE: I can only tell you what I have heard from the industry, and that is mixed. There are those people that say that it is not a big deal. For $5,000 you can buy a translator to stick on the front end of your legacy system, and forget about it. There are others who say, now wait a minute, that is simplistic. There are as Clem says, some data elements that need to be tweaked to make the more compatible, but they don't seem to make that big a deal out of that.
I have heard others that say this disparity between the two year group and the three year group is more of an issue than the issue of actually buying the translator and installing it. If you get half, let's say two-thirds of the claims, maybe even more, capable of doing 837s, and the small plans all opt to wait the extra year, then you have taken away the advantage that providers have of buying a consistent software package that can send an electronic transaction in a standard form to any payer. If the small payers don't have to respond for an extra year, that's a problem.
DR. DETMER: How do you see it really to this point of the more broad question of letting some dates slip, as being a read of somehow a signal broader than just this point?
DR. BRAITWAITE: I think Kathleen is right that the industry really is going to say, you tell me the date and we'll do it -- that's what they have been telling us -- but if you slip the date, we're going slip doing it.
MS. GREENBERG: I would tend to agree with that. I know although there have been differing views, I think the ANSI HBS at the previous meeting made it quite clear that please do not slip the date. I think it might be a little premature also in the sense that it is my understanding that the department is going forward with the plan, as required in the law.
Now I think that obviously that's going to be out for public comment. If there is tremendous volume of public comment that this will not be possible to implement, I think the committee could come back and revisit this. I think the committee is going to need to obviously be informed of what the public comment is.
To at this point suggest a delay, when the law requires a certain date and the department is planning to go ahead with that in its proposed regulations, I think might be a problematic message.
DR. BRAITWAITE: Well, the committee also has the responsibility to monitor how things are going with the implementation, and there is a two year window for the committee to make a recommendation to the secretary that hey, our feedback is that people are going to have real problems with this, and you better let it slip a year.
MS. GREENBERG: Right.
DR. DETMER: There are dimensions of this that aren't on the table. It sounds like to me we've gotten a fairly good --
DR. MC DONALD: One last look at it. Which is the worst error to make? It seems to me that what do we lose with a year? It's making it more uniform for the two kinds of plans. We avoid having some mud in our face. We are the ones that are supposed to adjust and give the view of the industry and the public and the private sector.
DR. DETMER: But I hear a potential of mud on both sides of our faces.
DR. MC DONALD: I don't buy it. We're not slipping a date, we are unifying a date.
DR. DETMER: Would you like to comment?
MR. JONES: Yes, I would. My name is Wayne Jones, and I have a practice management company. I'm a practice management vendor. I can tell you that from reading all the data, your own estimates are that the insurance industry would save about $9 billion a year. I'd like to go ahead and get started with that.
DR. COHN: I think on that I would actually chime in. I had talked to my technical staff prior to coming here about the dates, and they were actually very comfortable with them. On the basis of our discussions last night, I went back and requeried them, and they still are very comfortable with the current dates that we are talking about. So there are pros and cons.
DR. DETMER: Is there a motion on this?
DR. MC DONALD: I don't know if it is worth a vote. Actually, I think I can read the panel.
DR. DETMER: It sounds like we have a sense that we have discussed, but the sense was no change.
DR. COHN: Other comments, concerns regarding the first sections having to do with administrative transaction messages, the everything up to transaction data content?
DR. IEZZONI: Simon, I have a comment on the introduction. It's trivial. On the second paragraph, the last sentence makes it seem as if the only people that used to generate your recommendations was the private sector. I know that is not what you meant, but the way that it's phrased, it makes it look that way.
DR. COHN: Okay, thank you. Other comments, changes, or otherwise to those first sections?
Let's talk about transaction data content. Obviously, what we have done is tried to represent I think a lot of concerns, a lot of issues that everyone had yesterday. I think I need first of all to hear from Barbara and others who worked on one of the edits to that, and Kathleen and Lisa, to make sure that we have fairly represented your concerns in that section.
Are you all satisfied?
MS. FRAWLEY: I'm comfortable.
DR. COHN: Lisa, are you satisfied with the way we represented wordsmith things in the transaction data content?
DR. IEZZONI: I am impressed by the skill of people in -- gosh, how can I phrase this? -- distilling down a lot of information to almost say nothing. To make a reasonable point, I guess the sentence that Bill read I think is accurate. I think that it doesn't full represent what my concerns are, but that is fine.
DR. MC DONALD: Could you say them though? I would like to hear them.
DR. IEZZONI: It was yesterday morning when we were talking -- Vince and I were talking about just the need to make clear that this document may be less appropriate for some settings and types of patients than others in terms of the coding sets.
DR. COHN: We're talking about the transaction data content area.
DR. IEZZONI: Oh, I'm sorry, I got lost where we are. Well, then remember that comment.
DR. COHN: Okay, we'll save that one.
DR. MOR: If I think I understand this correctly, the difference between the transaction data content and the supporting standards, because you have a clause saying that we'll talking about attachments later, is that right? I would like to at least put on the table there is a linkage between the supporting standards and this transaction content that is not apparent here.
The recommendations that you are making here -- that's why I asked the question before, is this the same recommendation -- is that the recommendation for a continued look at the process for changing, maintaining and updating standard data content, and then the next paragraph down, the supporting standards that you identified, implementing an approach for procedure coding that addresses deficiencies, where you also have a process in place for that, I would like those linked, because right now we are looking at sort of boxes that are distinct.
I'm not quite sure I'm adequately expressing this, but there is a linkage between the standards and the content, and the best way that I would like that somehow or another to be expressed, because at some point it is possible to think of the standards allowing for content that is more flexible than simply coded standards.
MS. FRAWLEY: I agree with your point, but I think on the coding issue you have to recognize that these systems form the base of our reimbursement for this country. There are already longstanding traditions where the cooperating parties, which is the American Hospital Association, the National Center for Health Statistics, HCFA and AHIMA work on coding guidelines.
We also have the process in terms of how NCHS and HCFA update the procedure and diagnostic classification system, and have a forum through the ICD-9-CM Coordination and Maintenance Committee. The American Medical Association has a process in terms of their editorial advisory panels. There are things set up that happen in this country. We can't disrupt everything.
So I understand your linkage point, but the coding thing is a very unique situation that does merit a reflection. I don't disagree with you, but I just want to make sure that not everyone understands the process as well.
DR. STARFIELD: I actually think we meant that sentence to go after the supporting standards.
DR. MOR: The sentence above on the recommendations?
DR. STARFIELD: The one we just put in, the one that Bill read, to include health data transactions and supporting standards. The way it's written now, the last word says, "for health data transactions." I actually think it meant for health data transactions and supporting standards, so it comes after both paragraphs.
DR. MOR: I just want to somehow or other have that linked together, because that creates more of a dynamic.
DR. MC DONALD: I think in support of Vince, I don't think he is really saying that we shouldn't have these billing codes, but rather that there is a misrepresentation in the sense that content includes the codes, and the code thing does include all the codes that are or could be. It doesn't include NDC, which is part of the NDCPDP standard for example. I don't know how to do this as a committee though, to do the further wordsmithing.
MS. BALL: One way to make this linkage with doing the least amount of damage is to take the header that says "Transaction Data Content," and make it say, transaction data content and supporting standards, so that these two sections will flow together.
MS. COLTIN: I think there is one problem with that, which is that the first paragraph under supporting standards deals with the NPI. I would just propose a modification to what you are suggesting, which is to call it transaction data content and code sets, and then just take the second paragraph under supporting standards, and move it up under that heading.
MS. GREENBERG: It's my understanding that the unique identifiers are in the law as supporting standards. Is that the case?
MS. COLTIN: Yes.
MS. GREENBERG: I was going to recommend something simpler. To leave these two separate, but when you have the heading supporting standards, to recognize that some aspects of data content are actually defined or treated as supporting standards in the law, and we can make some specific recommendations on that.
To add to this other sentence, and supporting standards, really doesn't make sense, because you are talking about data elements, data definitions, and that is a different animal than talking about coding and classification systems.
So it really doesn't make sense to say deletions or modifications of current data elements for health care transactions and supporting standards. I don't think that makes sense, but I think you could note just after the section on data content, in the beginning of the section on supporting standards, that some of the data content are actually treated as supporting standards, and you can make recommendations on those.
DR. MC DONALD: How do we do this thing?
DR. MOR: As a single sentence paragraph, the supporting standards would be fine, because that would provide a linkage to the prior sentence.
DR. COHN: I know Bill is looking confused. I'm looking a little confused too. What I'm hearing is that you are going to take that first paragraph, which has to do with the identifier; move it down to the end of that area?
MS. GREENBERG: No. Leave it the same way, but have an introductory sentence that ties it.
DR. MOR: Insert a new introductory sentence right under supporting standards.
DR. STARFIELD: But Marjorie, you also suggested taking that big paragraph under supporting standards, and moving that up, did you not?
DR. MOR: That was Kathy.
MS. FRAWLEY: I'll back off that.
DR. DETMER: So a variant of repeating a more precise version of the last sentence that would have been added into the first sentence as well of supporting standards?
MS. GREENBERG: Right, an introductory sentence noting that part of data content includes specific supporting standards for unique identifiers, and for codes and classifications.
MS. BALL: So something like, the committee wishes to make recommendations on two specific data content issues in this package?
MS. GREENBERG: Which are classified as supporting standards in the legislation.
DR. BRAITWAITE: The word support standards was made up to kind of chunk off everything that wasn't a transaction standard, so that's not in the law.
MS. GREENBERG: Okay, well then forget the last part of it.
DR. COHN: Are we talking about transaction data content and code sets, and then other heading is identifiers?
MS. FRAWLEY: I have a suggestion. Maybe you add a sentence at the end of the paragraph on diagnosis and procedure coding, which the sentence says, after you get to we recommend you identify an approach, blah, blah, then you would say that of course this has to be developed in the broader context of the transaction data content stuff. You pull it in that way.
DR. MOR: Right, and in the technology and the mechanisms for transmitting this kind of information.
MS. FRAWLEY: That's how you bridge the gap between the two.
DR. MOR: That would be fine.
DR. MC DONALD: But we don't have words on paper. I think we have to find another mechanism to make words on paper.
DR. COHN: Bill is our mechanism for making words on paper.
DR. DETMER: I think the question is are there other discussion items, while somebody could kind of work this? I think we understand what we want to say.
DR. COHN: Let's see if we can recapitulate what it is that we want to say, because I've heard about five things that we want to say. Maybe, since you feel that you understand it, why don't you put up a straw man.
DR. DETMER: I guess we need more discussion. You have been closest to it of all. If you are confused, I ought to be confused.
DR. COHN: I guess what I'm hearing is a comment about the relationship between the data model or the data content standards, and the codes. Now that is something that we all know. I guess I personally am not sure that needs to be reflected in the document, but I am very well aware that there is a relationship between work that needs to go on in terminology, in code sets, that obviously is driven by content issues. I guess I'm confused about why that needs to be represented here.
DR. MC DONALD: This is a process issue. I think that some people around here have a better sense of the words, and I would like to suggest that we get them to write it down, rather than discuss it at large.
DR. DETMER: If there are other ideas that need to get on the table though, we better get them on there.
MS. FRAWLEY: I guess the problem is that I don't see that there needs to be anything more added to the letter, but I'm trying to respond to Vince's concern, and also concerns that we had this morning, is that we are not putting things in boxes, and not always going back and making sure that we have the bridge between the two boxes.
So the point is if we are talking about data content and we are talking about code sets, that we always make sure that there is a parallel process. I guess that was kind of the discussion. I personally don't think you need to put anything in the letter, but I'm trying to accommodate other people's concerns.
DR. BRAITWAITE: I would make a suggestion perhaps to take out the two titles that say supporting standards and security standard, or whatever it was, so that it all appears under the subtitle of content. Then add a sort of introductory sentence to the place where it talks about the NPI to say, at this time we would like to make recommendations about several specific data elements.
DR. MC DONALD: If you just leave the security still a header, I think it would be cleaner. It's not a content.
DR. BRAITWAITE: All right.
DR. MOR: Can I ask for clarification of the sentence in the second to last paragraph.
DR. MC DONALD: Are we done with this?
DR. MOR: This could actually help. Initially we recommend that you advise industry to build and modify their information systems to accommodate a change to ICD-10 diagnostic coding in the year 2001, and a major change to a unified coding system for procedures.
DR. COHN: It's unified coding framework.
So other issues?
DR. DETMER: So I'm hearing some agreement with Bill's recommendation?
DR. STARFIELD: Could I clarify what you would call that? We had data content and code sets.
MS. COLTIN: It's just data content.
DR. MC DONALD: I hate to kind of tweak these things, but I don't think anyone knows what a framework is. I know we all kind of know what it is, but I don't think it's going to tell anybody anything when they read the letter.
DR. STARFIELD: What was the reason for changing it from system to framework?
DR. COHN: I think the question was, was one system multiple systems together? I think the conceptualization really is I think indicated in the next sentence, which is really meant to describe what we are talking about, which is something that handles both specificity and aggregation, avoids unnecessary redundancy, and allows for coverage of the various domains that I think Lisa and others have commented on many times, that includes more than medical procedures, that includes home health, long term care, ancillary procedures and others.
DR. SCHWARTZ: Perhaps using the word "approach" instead of framework would cover it, and also be consistent with the following sentence. It's just a suggestion.
MS. COLTIN: I was going to suggest the same thing, except to reorder the words a little bit to say, a unified approach for coding procedures, as opposed to a unified coding approach.
DR. DETMER: Others?
DR. COHN: I actually think the only question, and one that I think was left unstated by the committee in relationship to this paragraph which has to do about code sets is that -- and I think I had brought up about the concept of an RFP yesterday, and those sorts of questions, is do we want to recommend that we participate at all in that process, or is this something that we just recommend that she do this and off we go?
That was really the only question I have in relationship to that entire paragraph. Do we add a final paragraph saying we, of course, are happy to assist you in this process?
DR. DETMER: Jeff?
MR. BLAIR: Simon, could you just clarify for me, because I always thought of an RFP as a request for purchase. So I thought that you were really talking about a request for information.
DR. COHN: Maybe it's an RFI. I was thinking of request for proposal on how to do this.
MR. BLAIR: Oh, proposal instead of purchase. Okay. Then maybe just spell it out, instead of abbreviating it.
DR. COHN: There is a question I would just bring up to the committee. I don't think we need to include that level of specificity in this letter. The question is, is this just a recommendation and we're handing this off now to the secretary? We obviously have this terminology conference coming up for example, so we are continuing to be involved in this.
DR. DETMER: Of course, we're mandated.
DR. IEZZONI: Simon, I think we need to come up to the fence on this one. This is where the people have been harping on this issue for years and years, and so we ought to take the heat and try to participate in this.
MS. COLTIN: I would like to see a sentence that says the committee would like to continue to participate with you in this endeavor, or something like that. I think we might even want to be a little bit broader than that, and say as well as the development of appropriate code sets for other data elements that may be added. I'm thinking of data elements like living arrangements.
MR. SCANLON: The idea is that you want a process on an accountable basis.
DR. COHN: Kathy, I actually like your sentence, but I was going to make sure that Bill -- were you capturing any of that?
DR. BRAITWAITE: I'll get the exact wording from Kathleen, but I added, the committee will continue to participate in this effort at the end of the paragraph. Is that close to what you recommended?
MS. COLTIN: I said something like, in addition, the committee would like to continue to participate.
DR. COHN: It's funny; I sort of like the word "leadership" in a lot of these things. When I change words, I add leadership; maybe will continue its leadership in this area or something?
DR. BRAITWAITE: The committee will continue its leadership and participation in this effort.
MS. COLTIN: I think I said in this endeavor or something like that.
DR. COHN: In this endeavor, okay.
Other comments?
MS. COLTIN: Just one word change. In the paragraph that begins -- the one that deals with the diagnosis and procedure coding, on the fourth line down where it says, "in the year 2000." I think we want to say through the year 2000, because those who implement prior -- 2000 is the deadline, right?
You can actually implement earlier. So we're talking about up to and including the year 2000, that those code sets would be maintained, right? So the word "in" to me is a little misleading. I would rather say through the year 2000. Some will implement in 1999.
DR. STARFIELD: By is better.
MS. COLTIN: By is fine, as long as it encompasses the time before as well.
DR. DETMER: Any other adjectives, adverbs, nouns?
DR. COHN: Do we need to vote on this one?
MS. FRAWLEY: I'm just wondering if people will feel comfortable voting without seeing another copy.
DR. MC DONALD: I think the problem is if you took the same document and showed it to them once, and we showed it ourselves again, we'll get another set of comments on it.
DR. DETMER: We can put it to a vote and decide I guess. If it doesn't pass, then we'll reconsider.
DR. MC DONALD: I move that accept the document with the corrections we have made so far.
MS. COLTIN: Second.
DR. DETMER: Discussion.
DR. HARDING: So just a point of information, the vote is to accept it, or a no vote would be to say that we are going to wait until after lunch and look at the document.
DR. DETMER: A no vote would just mean we did not accept it. Then we could take a motion that we look at it after lunch.
All in favor say aye. Opposed? Abstentions?
[Whereupon the document was accepted as presented.]
DR. STARFIELD: Are we going to look at it after lunch?
DR. DETMER: I think that we will see it after lunch. I also think that Clem is probably right too.
DR. COHN: I just want to make a comment about the process that we just went through, and obviously I'm happy to lead these processes. I'm actually amazed that we got done with this document. I want to thank everyone for their help on all this.
I do think that the overall process that you have been working on with this committee of discussing it, talking about it, showing early versions, and then working through drafts works very well, however, there is some technology that could come to our aid. I mean I think we are all familiar with use of LCD panels, with computers, so literally we're seeing the changes up on the screen as we talk.
I would personally suggest if we do this again, which I think we will, because the process is a good one, that we have got to have that sort of capability, because otherwise we're all in our minds sort of adding things up.
MR. SCANLON: In fact, Bill and I talked about this yesterday.
DR. DETMER: Unfortunately, we will be grappling with this the rest of the day, but I think your point for the next round is very well taken.
MS. GREENBERG: The previous thing we said this was accepted unanimously.
DR. DETMER: Because it was.
MS. GREENBERG: We're now in a situation where this was not unanimous.
DR. DETMER: Exactly.
DR. HARDING(?): I will change my vote.
DR. DETMER: To abstention or approval?
DR. HARDING: To approval. It's just the issue that I would like to see it on paper.
DR. DETMER: We will get a copy of this thing after lunch.
DR. MC DONALD: We should remember that this letter doesn't have force of law, and an adjective change will not have probably any effect on the secretary, unless she just reads it real fast and gets it wrong.
DR. DETMER: Well, speaking of how quickly the secretary can read, I want to first of all say she is a quick reader, a very quick reader, but beyond that, we need to keep I think all of our deliberations embargoed until July 1.
We want to make sure I can sign these letters and get them to her before she gets calls from various quarters wondering what we have sent her; it seems only fair and appropriate. Just so everyone knows that, please don't go forth.
DR. MC DONALD: This is a public meeting.
DR. DETMER: I understand. I'm just making the point that it is really not our position until the secretary gets the mail.
MS. GREENBERG: I think it might just be better to put it that way, that as soon as the letter is sent, because the July 1 date may be --
DR. DETMER: Fine. We will clearly try to make that. It goes from the fourth floor to the eighth floor. We can probably do that. I am mostly just wanting to make sure that the secretary has a chance to read our deliberations before there are deliberations out there.
MS. GREENBERG: We should note too -- Bill, before you leave, you might want to correct me -- any recommendations of the committee are not on the HIPA or to be published in the Federal Register. So although it doesn't have the force of legislation, they will be out and carefully read by a lot of people.
MR. SCANLON: We will have to publish in the Federal Register, both of these recommendations. We'll probably try and get them up on the Web site later next week as well.
DR. DETMER: I think what we'll do is go to your comment, George. I know the second one is not ready.
DR. IEZZONI: No, it is ready. We've got it.
DR. DETMER: Which of the two do you want to do first?
DR. IEZZONI: Why don't we do George?
DR. DETMER: Take it away, George.
MR. VAN AMBERG: This is the draft recommendations of the Subcommittee on State and Community Health Statistics. I think you were all handed a redraft this morning. There were three areas that the committee suggested that we consider, and we have handled them by inserting some language in various parts of the document. I will read the additions in the subjects they cover.
In the introduction we added a sentence concerning the issue of protecting patients' privacy. It reads, "Information shared for community assessment process must comply with statutory and regulatory measures in place to protect the privacy of individuals." I think that covers that issue.
The second issue was John Lumpkin's issue about the ongoing measurement process. We added a sentence, the last sentence on the subparagraph on the ongoing effort with feed to read, "The ongoing effort to measure progress should utilize, whenever possible, nationally recommended or accepted measures of outcomes and/or performance."
MS. GREENBERG: Could you read that one again?
MR. VAN AMBERG: "The ongoing effort to measure progress should utilize, whenever possible, nationally recommended or accepted measures of outcomes and/or performance."
Then the last area that was considered, it was recommend that the states take advantage of opportunities to buy into national survey efforts to get state or community level data. I added a separate little recommendation. It is on page 2 at the bottom that reads, "Enhance and augment state databases. 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 specifically did not want to use the word "buy in" in this document; participation worked out fairly well.
Those are the three areas. This was retyped yesterday, and there are a few typos in there that need to be corrected as well, which we would do.
DR. DETMER: But the rest of it is essentially as it was.
MR. VAN AMBERG: Right.
DR. DETMER: Okay, this is on the table for discussion and action.
MR. VAN AMBERG: I recommend that the committee accept this document, and authorize the staff and the committee chairperson to develop a letter of transmittal to the secretary, to NACCHO, to NASTO and to state health statistics.
DR. AMARO: Second.
DR. DETMER: It has been moved and seconded. Any discussion? Hearing none, all in favor say aye. Opposed? Abstentions?
[Whereupon the document was unanimously approved as presented.]
Okay then we will take the one page hand out and we'll let everybody read that. We'll describe it, and then we'll discuss it.
DR. IEZZONI: Don, should I perhaps indicate the context as people are reading it?
DR. DETMER: Yes, sure.
DR. IEZZONI: Yesterday afternoon we heard presentations from people at HCFA talking about a new data collection initiative that was first presented in the Federal Register March 10th, with a 60 day comment period. It basically will require home health agencies participating with Medicare to collect data using a system called OASIS. Kathleen has talked about that a little bit this morning.
We have some issues that we feel we would like to communicate to the people at HCFA who are doing this. The comment period has officially passed, but we were assured by the HCFA presenters that they would value and welcome our comments. So this is the context.
DR. DETMER: Okay. Everybody can read the letter, and we'll discuss it.
DR. MOR: Since I'm the author of the letter, I apologize for the long sentences. I tend to write long sentences and then break them up afterwards.
DR. MC DONALD: The bottom line is you are not happy with it right now?
DR. MOR: Yes.
There were distributed copies of the Federal Register which includes a copy of it yesterday to the subcommittee members who met. Are there any more of those around?
DR. DETMER: I think that's very relevant. Before we act on something, we ought to have that as a committee, to tune that we may act on this after lunch as far as that goes.
MS. FRAWLEY: I can give you some background just in terms of some of the things. We actually started talking about this in San Francisco. Vince was sitting next to me, and I didn't realize that he was also tracking this issue.
The OASIS data set was originally developed 12 years ago, and currently is only being tested in 50 home health agencies. The problem is that it does not link any of the data sets that we use to capture information about patients. So if you discharge a patient from acute care to home health, or acute to long term to home health, there is no linkage. There is no linkage between the UHDDS. It's just like this little box of data.
The second problem we have is that it doesn't recognize the coding specificity that one needs. So the tool only reflects a three digit ICD-9 code, when we use four or five digits to describe a condition, and does not recognize the use of V codes, which is typically in a home health after care scenario. If they administer chemo, there is a code V blah, blah, blah.
So just in terms of data, the quality of the data that this tool would capture -- you are not even going to get a complete picture of what the home health attendant or the nurse was doing there, because it is not following official coding guidelines, which have been promulgated by HCFA and other parties.
So there are some problems just about the tool in terms of the fact that it doesn't integrate to other systems that we're using. So if you are trying to track a patient across the continuum of care, you can't do it. Unfortunately, with integrated delivery systems, the same people are filling out all these little tools. So you are asking people to come up with new little ways to capture information, and not following already previously adopted guidelines.
DR. IEZZONI: The other point is that the HCFA presenters yesterday made quite explicit that the 50 home health agencies where it's being tested are among the leaders in the field. So it hasn't been tested broadly across the entire home health agencies.
MS. FRAWLEY: It presumes that you have nurses who are going in with lap tops or very sophisticated capture tools, and that is not the reality in most home health agencies in this country.
DR. MC DONALD: Has HCFA done the same activity to compare the fields and a cost list with this set, as with say between the NSF and the 837?
DR. IEZZONI: We actually were at a bit of a disadvantage yesterday, because the two HCFA presenters were from the Office of Research. They were not people who are really involved with the implementation. For example, Hortensia asked the question about whether it had been translated into Spanish, and they were unable to answer that question.
DR. DETMER: Bob, can you enlighten us on this, please? If you know.
MR. MAYES: I would have to say that I can't necessarily tell you the specific about your question about that, but this is an ongoing issue within HCFA, and one that a number of us have been struggling with, and one of the reasons why I'm here with all the standards work, is that traditionally HCFA has not been very good about cross-referencing, even within itself, much less to broader sets.
It is a recognized problem, and perhaps under the new reorganization which is taking place as we sit here actually, it will be better addressed. Traditionally, there has not been a lot of cross-referencing between systems. So I would not be at all surprised if the answer is no, it has not been looked at data element by data element.
DR. MOR: One of the questions that I tried to get at yesterday, but again there were research people who were responding, so they weren't necessarily in a position to give us a position, as to why the rush? There is no legislative mandate as there was with the minimum data set, which came directly from Congress. You had to have one for assessments.
This came from the research arm, and moved into the policy implementation side of HCFA in a process that I'm just not sure I really fully understand, and I'm reasonably cognizant of what goes on there.
This is relatively unusual. The only other process that would be like this would be actually something like the adoption of DRGs, which actually went from the research testing field to an implementation stage in 1982, with the passage of whatever that particular law was then, all those years ago, but that was the process, whereas it was quite different for other systems.
MR. MAYES: One other point. There is an initiative within HCFA to begin to try and link all of these various data sets, particularly those that have to do with post-acute care.
DR. MC DONALD: There are two different issues though. There is the linking of the records; this is the same patient. Then there is the coherence and consistency of the fields and their code sets. I understand that the gender codes in 837 are different from DB92. I imagine they are different again in this one.
DR. MOR: The race and ethnic codes do not conform to minimum standards.
DR. IEZZONI: Do people feel that the letter is acceptable for us to send out? Any modifications?
DR. MC DONALD: I just had one suggestion. I thought that the middle of the second to last paragraph, about the bias of those people writing down -- that may be a little hard to overcome unless you are going to also suggest not just a different form, but different manpower and labor. That may be a bigger bite.
You're basically saying that the nurses who go out there and write the forms -- I can't think of an easy, economic alternative.
DR. IEZZONI: We talked about that, Clem. The problem is that you are absolutely right, that there really is no kind of other way to propose other than the nurses writing down this information, but this OASIS tool is explicitly for quality assurance. They haven't really tested it in that environment to see what the impact is of the nurses evaluating themselves, because that is basically what this ends up being, is that the nurse who is writing down the information, is evaluating herself.
MR. GELLMAN: I don't pretend to understand all of this, but I do have just a question about the letter. On the first page you say the committee doesn't understand the reasons to rush to issue final rules in this area. You get to the second page in the end, and there is no recommendation to stop the process, hold it off, another round of comments, something.
DR. IEZZONI: Yes, that's a good point.
DR. MOR: There wasn't any specific recommendation that came from our discussions yesterday. It was just sort of these are comments. It made sense to have a discussion about recommendations should be made.
DR. DETMER: I think our options are to make a comment and recommendation.
DR. IEZZONI: I think, Bob, that we felt some urgency, because the comment period has ended. So we felt like we wanted this letter to come out of the full committee.
MR. GELLMAN: Well, that's fine, but what do you want them to do?
DR. MOR: Really the recommendation is to not go forward until some of these issues are addressed.
DR. IEZZONI: I wondered about the word -- Bob, is the word "testimony" a very specific word, but we just heard presentations yesterday; in the second line.
MR. GELLMAN: I don't think anyone will read the letter and assume you were at court. I don't think it makes any difference.
DR. IEZZONI: I didn't know. I wanted to ask a lawyer.
DR. MC DONALD: In terms of operationalizing, we're saying you do this until you fix this, are we saying -- I'm still worried about telling them how to fix the problem. One could say one should plan to evaluate it, but to say don't do it until you have --
DR. IEZZONI: Let me say something that we haven't mentioned yet. They started a demonstration project in 1996, to look at its utility for quality assessment. It's a three year demonstration project. It's not going to be done until 1999, but they are rushing now to implement it.
DR. MOR: That was really the most confusing part of the discussion, was that they are in the midst of very substantial changes, recognizing that there is a lot of form fitting that is actually being quite loosely done on an agency-by-agency basis as to try to integrate these data elements, which are essentially designed for one purpose, into agencies' ongoing assessment process, without specifying how that should be done.
Then still the demonstration process of trying to understand how are people using this, and then going to make final rules.
DR. MC DONALD: You've got all these things. You're working on them.
DR. MOR: Don't do this until all the results of the demonstrations and programs are in place.
MS. FRAWLEY: I think the important thing is you want to support the concept of improving documentation in the home health arena, because we know that's been very weak. You discharge patients and then they go off to home health, and then they get referred back in for whatever, and there is poor documentation. So I think we want to support that notion.
You want to support the migration in terms of computer-based patient records, to help that care arena. But I think what you said -- you would just be jumping a whole industry. There are like 9,200 home health agencies in this country, and telling them to go jump with not a whole lot of good data on what the experience would be.
DR. MOR: The complicating factor of this is that they were telling us yesterday that the industry is apparently all in favor of this. That's what we heard yesterday from them. I don't have a clue whether that is true or not, but I know the national association certainly is supportive of this.
DR. IEZZONI: My statement was of course they would be supportive, because they are evaluating themselves. I guess can we move forward on this? Can we perhaps make the recommendation that HCFA reconsider the time table, and postpone implementation of this until they have completed their studies?
MR. GELLMAN: Do you want to ask that they have another round of public comments before they adopt final regulations?
DR. DETMER: The committee would be delighted to work with them or relate to them on this.
DR. MOR: What I would recommend is that they actually wait until the results of the demonstration projects underway, and then have an additional public comment period, in which the committee would be happy to -- does that make sense?
DR. MC DONALD: But if the industry is ready to go, what's the conflict you are going to create with the reader of the letter? Are they going to just do nothing? There are two steps. One is you're going to wait two years. That's what you are saying. The other is you've got to fix the linkages and make the code sets consistent, and we would like to see you understand the results of the study.
There is sort of like at step one or a step two. Do you want to only go for step two? Is it viable? Will they still go ahead, and then we won't even fix the easier problems?
DR. MOR: I can't speak to whether or not they are going to go ahead.
MS. COLTIN: As I understand it, the evaluation is an evaluation of this system. Some of your concerns have to do with whether this is the right system, given that you can't look across the continuum of post-acute settings, if you use the MDS in one setting and you use OASIS in another; that they are not compatible in terms of measuring outcomes along the same continuum of outcome, never mind continuum of setting. That's an issue that won't be addressed by the evaluation.
MS. FRAWLEY: See, the problem is if you take the data elements from both.
DR. MC DONALD: We've got two problems. You've got a problem with the mechanics of it, which probably could be fixed if they could move fast, in some reasonable time period. You've got the problem that we don't know if the whole idea is any good. I would like to just distinguish those two. It is good, because we want to measure.
So really I just suggest if we could decouple those a little bit, to be very strong about trying to this thing so it makes sense. If they could do it in a year, not as strongly as saying wait two years. I'm just afraid if you say that, they will do nothing.
DR. IEZZONI: How about if Vince and I and Kathleen maybe work over lunch on a couple of sentences, and we'll come back after lunch.
DR. DETMER: That would be great. That would be very useful, because I think there is concerned interest in this, but some disquietude about really what are we trying to say.
DR. MC DONALD: I think we can support a letter like this.
DR. DETMER: It's ten until noon. I think what we will do is break for lunch at this point. Why don't we try to definitely be back at 1:00 p.m., because we still have a lot of work to do in addition to this.
[Whereupon the meeting was recessed for lunch at 11:50 a.m., to reconvene at 1:00 p.m.]
A F T E R N O O N S E S S I O N (1:00 p.m.)
DR. DETMER: I'd like to call us back to order. We're fortunate to have Katherine Wallman here, who has the Statistical Policy Office at OMB. She will be giving us a status report on the OMB Directive 15 Revision. We appreciate you braving the hot weather outside to run the gamut here between the two buildings. The floor is yours.
MS. WALLMAN: Thank you.
As I mentioned to you just a few minutes ago, this is a very awkward time for me to come to you in the sense that we are just issuing recommendations from our interagency committee that has been dealing with the issue of the standards for data on race and ethnicity, but we are not out yet. Within weeks we will be out, early in July. At that time we will have a 60 day comment period.
So what I would like to do is spend a few minutes reminding you about the process that we have been going through. Some of you are very familiar with this, and some of you are middle familiar, and some of you are unfamiliar perhaps with what we have been going through on this, so let me level the field a little bit, just so everybody is up to speed, and tell you what you can look forward to over the next couple of months as we bring this process to a close.
As you may know or recall, we have had standards for the collection of data on race and ethnicity now in place for 20 years, since 1977, when we first issued a standard that was used across the federal government. Those standards have been used by a wide array of agencies that have responsibility not only for the statistical activities, most visibly for the decennial census, and you are seeing a lot of press coverage in that context, but also agencies such as the National Center for Health Statistics and other statistical agencies.
Unlike other standards we have, these standards were developed also explicitly to be used for administrative reporting and for regulatory reporting, so that we have the same kinds of categories being used across all those different areas.
The agencies have been using the standards over this 20 year period, and particularly after the taking of the last census in 1990, we began to hear increasingly about concerns about whether the standards were in tune with changes in the demographic composition of the population, with changes brought mostly by increasing immigration from particular areas, and by increases in the number of interracial marriages, and the children resulting from those marriages.
There were a number of other smaller issues, if you will. I hate to sound like I'm making value judgments, because to individuals these issues are not big or small, if it is your particular issue. So let me make clear that I'm not judging it that way.
Anyway, there were a number of other issues that people had brought to our attention, and so four years ago next month actually, we agreed in a congressional hearing that we would undertake a comprehensive review of these standards, in cooperation with the agencies that use and produce the data, and that we would conclude any review and any recommendations that might stem from that in a time period that would allow any modifications that might be made, to be incorporated beginning with the next decennial census.
Which for those who are familiar with the census schedule, recognize that that means we have to make any decisions by the fall of 1997, in order to go forward with the field testing, the dress rehearsal and so on for the next census. So that gives you the general outline of the four year time frame that started in July of 1993, and will conclude in October of 1997.
During this process, as you know, we have been attempting to be extraordinarily open in terms of going out to various groups -- interest groups, professional groups, associations, statisticians, public health people, education folks, almost any group you can think of -- to try to gather both through formal and informal means, comments from the public, from various using community about their concerns about the standards, and what kinds of things they think that we should be looking at.
We have also had a strong component of our work that has involved research. Research to learn how certain changes, if they were to be implemented, might affect the quality and the usefulness of the information that would be collected in the future, looking at a variety of issues including what would happen to historical comparability of the information that would result.
I keep saying as you know, or as you may know, depending upon how much you have been following this process, we had in the summer of 1994, we had some public hearings in four locations. We had an extensive Federal Register notice that summer, and invited public comment. You may recall that we got about 100 people testifying in public hearings, and we had another 800 or so letters of various kinds presenting interests, concerns, suggestions to us.
Then about a year later we published another major Federal Register notice telling people what we had heard, giving a synopses of the various issues that people had discussed, the pros and cons of some of the kinds of changes, and essentially laying out what we would be undertaking as the research component over the next couple of years to test out some of the proposals that have been made to us.
There have been a variety of research activities that have been undertaken. The three most highly visible probably in terms of the way they have been covered in the national press have been the supplement that was done to the current population survey, followed by the national content survey, which essentially is looking at all of the items for the 2000 census, and some of the testing with respect to the race and ethnicity options was done in that context.
Third, we did most recently something that was called the race and ethnic targeted test, which allowed us to look at a number of smaller population groups that would be most affected by some of the proposals that were being made. The results of that last national -- I use the word loosely -- test, the race and ethnic targeted test were released in May of this year.
There have also been a number of studies that have been relevant to particular areas. There have been some done in the health arena. There have been some done in education, some done in conjunction with some of the civil rights monitoring offices in HHS and the Department of Education, and so on.
The results of that research, together with the public opinions have been studied very thoroughly by our interagency committee, and in particular by a research working group that was constituted under the broader interagency committee.
That committee has brought to the Office of Management and Budget a set of recommendations for possible changes to Directive 15. That is what will be the subject of the Federal Register announcement that will be going out in early July for a 60 day public period.
Let me be clear that what is coming in the Federal Register is recommendations from the interagency committee to the Office of Management and Budget. It is those recommendations on which we will be seeking comment from anyone who is interested.
Then that period will extend roughly to Labor Day, depending on the precise day that it gets in the Federal Register. For those of you familiar with that process, or not familiar with it, we give it to them and then there is a little period of a few days, and we'll exactly then when it will be coming out.
We will have approximately a month from the time that the public comment finishes to take under advisement any additional public comments, and then come out with what will then be the Office of Management and Budget's recommendation for any possible revisions to the standards. That is the process that needs to be tied up by the middle of October. So that's where we are at.
The Federal Register notice will be quite extensive. There has been, as I indicated, a great deal of research done on the specific proposals that have been put forward. There is a very rich and valuable report as a result of that, that will look at some of the most important, most significant issues that we have been examining.
That full report will be published. So you will see something that indicates that here is a little history of what this is all about. Here are the principles that have guided this review. Here are some of the cross-cutting concerns that we have with any recommendations that might be made. Here are some of the particular areas, and I'll tell you what those are.
The particular areas that the announcement will treat are those that you have heard us say are the ones we have done the most testing on. One of those areas is the ability to report multiple races, or to have a multi-racial response; two different things. I will go back on this if you want. So that is one major area that is treated in the report.
A second major area that is treated is the question of whether Hispanic origin should be treated as a separate ethnicity item or whether it should be merged in some way with the categories for race. I'm being fairly cryptic in what I'm saying here, but details on that.
Then there is a third set of issues if you will, that combines issues of terminology. Some people expressed an interest in having the names of some of the categories changed. For example, the black category, whether it should be changed to African American; the Hispanic category, should it be changed to Latino.
There were requests for additions to the minimum set of categories. So some had argued that we should add a Caberdian(?) category to the minimum set of standards. Some had argued that we should add a Middle Eastern or Arab category to the minimum standards. That third sort of major chapter in this report treats this set of issues, ranging from terminology to the addition of additional categories to the minimum set of standards.
When I say that, it always reminds me that it is important for people to recall that the standard that we put out does represent a minimum set of categories that are to be used across government, and that the standard historically -- and it's not that I'm giving you any secrets -- and in the future we would anticipate that we would still have that same general principle, that this is a minimum set of standards.
Agencies that have a reason to collect more detail, as the health agencies sometimes do, or studies that have a reason to collect more detail in a particular area of the country or whatever, would still be free to do that. It's just that when we think about adding to the minimum, we need to think carefully about what kind of sense that makes to impose that requirement on every single data collection that goes on in the country and so on. So that context should be kept in mind a bit.
So those three major areas will be treated in the report. There will be a series of recommendations in what I believe will be chapter six on the report that will be published.
I'm not exactly what else to tell you at this point. I would be happy to entertain any questions, try to fill in gaps. I tend to be a little cryptic about this now. Part of that is a result of doing this for four years. I may not be filling in the blanks on things that may be occurring to you when I do this.
DR. DETMER: Thank you. Let's open it up for discussion. We had some time on this obviously a couple of days ago.
DR. IEZZONI: We did, on Monday. We had presentations from the studies that you have described. It was remarkable, the depth in which people kind of had gone through the statistics and really tried to analyze what they had found. It was a very impressive effort I think that had been undertaken.
DR. DETMER: Other comments or questions?
DR. MC DONALD: Will we get a copy of the report when it comes out as a matter of course?
DR. IEZZONI: The plan, Clem, is for us to respond. So when the Federal Register notice comes out, the Subcommittee on Population-Specific Issues will be drafting a response. Hortensia Amaro specifically will be leading our drafting. We'll be reviewing our draft response probably at the July 21st meeting.
Then we'll be circulating that I suspect by e-mail, fax or other vehicle, depending on local capabilities, to try to get the full committee's sign off on that for Dr. Detmer to be able to submit it under our name.
DR. DETMER: Other questions or comments at this time?
MS. WALLMAN: Let me encourage you that if you have comments, questions, whatever that you would like to share with us even before you get to the formal submission or something, we would welcome that kind of continuing dialogue. We have been doing that all along. During this last period here, it would be real important to hear from people as early and in as much detail as possible. So we extend our offer on that.
I can't tell who is here from HHS. I guess you all will figure this out logistically, how you are going to be sure the Register announcement gets to everybody who needs it in a timely fashion.
DR. STARFIELD: When is it expected?
DR. DETMER: Is there a specific date set or not?
MS. WALLMAN: Well, as I tried to do my lateral best on that, I anticipate that it will be out within the next couple of weeks. We have said all along early July, and it will still be early July. I cannot pin the Register down to precisely what day; I'm trying real hard. I think you can look forward to seeing it soon.
It is probably going to be about 50 Federal Register pages. That's why I'm concerned about the mechanism for getting to you. Federal Registers do not fax well. We're getting a certain number of off prints. I hate to say these things with people behind me.
DR. DETMER: Please comment if you would like.
PARTICIPANT: I was just going to add that we can make sure that NCHS gets a hard copy, and so the National Committee members can get a hard copy, but in addition, the Office of Minority Health plans to hot link to OMB's home page, which will have the Federal Register notice once it gets out.
We are sending out between 10,000-11,000 postcards to people on our Office of Minority Health Resource Center mailing list. All those advocacy groups are going to find out that it is out there. The Indian Health Service is sending out copies to all of their federally recognized tribes and several state recognized tribes, and American Indian advocacy groups.
Census is going to be sending out hard copies to approximately 2,000 individuals and organizations. So you may actually, in addition to your National Committee role, you may also get a copy through one of these other avenues.
MS. WALLMAN: I knew about the 2,000 the Census was sending out, because I have the envelopes in my office. Thank you. I guess you're well covered. I just wanted to make sure, and I forgot about the hot link. So you'll have that.
DR. DETMER: If there are no other questions or comments, thank you very much. I appreciate it. We will be looking forward to the information.
MS. WALLMAN: You are meeting again in July, right?
DR. IEZZONI: Our subcommittee will be meeting in July.
MS. GREENBERG: We'll make sure that everyone on the committee gets the Federal Register notice. So if you are not on the Subcommittee on Population-Specific Issues, just e-mail ideas or suggestions to Lisa and Hortensia.
DR. DETMER: Okay, before we move to the privacy and confidentiality, it actually seems like as hot as it is out, we ought to be talking about OASIS and so forth. In any event, why don't we revisit that issue before we do, because I think you are ready at this point?
DR. MOR: I believe I have e-mailed out the document, and it will be coming back by fax. Next time I will remember to bring my little disk drive with me.
DR. IEZZONI: Lynnette, do we know when this will be ready?
MS. ARAKI: I just called Carolyn to check her e-mail.
DR. IEZZONI: You need to move forward.
DR. DETMER: Why don't we move to the privacy and confidentiality draft. I'll call on Mr. Gellman to lead us through that, please.
MR. GELLMAN: The subcommittee spend a couple of hours yesterday afternoon making revisions to the draft, and you have got a copy of it. It took us the whole time to get through the document and to consider all the comments.
The one thing we just didn't have the capability or time to do was to sort of produce a list of all the changes. There probably are 15 or 20 changes. None of them is wildly major. The document in most respects is exactly as it was before. It continues to say that we are in the midst of a health privacy crisis, and that protection of privacy has eroded in the last 20 years, and that this is an issue that urgently needs attention. It calls for legislation by the end of this Congress.
So all of that, the basic findings and recommendations are intact and largely unchanged. There may have been some wordsmithing here and there, but there really wasn't any change in the main thrust in general. I'll describe some of the changes that were made.
Here and there discussion was made sharper or clearer, or particularly on some of the controversial areas where the report doesn't take a position, the arguments were made a little more balanced, so that both positions -- this is slightly oversimplistic -- but arguments on different sides were more clearly presented.
There was some concern here about the amendment section, patients' right to amend, and the we included the word "append" in that discussion.
There was concern expressed here that the provision that said that records that are obtained by third party users should not be used against the patient. One of the concerns expressed was that may not be directly applicable in the public health area, because sometimes it is used, and so we have clarified that.
There were comments about the discrimination issue, and we have strengthened the discussion here, and made a specific recommendation that there be some more consideration given to this.
We discussed the paragraph about employers. That was again strengthened to be more direct in saying that we think something needs to be done there.
The safety valve provision which is at the end, has been relabeled as unforeseen consequences. I don't know if that is better or worse. The discussion was changed a little bit essentially to keep the basic idea that was presented that maybe there is a need for some kind of administrative safety valve, but to more narrowly constrain the authority that might go with it to override the statute even if temporarily, to suggest that we need exceptional circumstances, and to make it clear that this would be very unusual authority.
We intend to add an appendix, for which there is a place holder now, that will identify all the of witnesses that testified before the subcommittee.
Again, on the controversial areas, particularly those for preemption and the uniformity section, have been amended to be a little bit more clear. We also made it clear in the uniformity section that there is disagreement among committee members about what the right answer is. It just didn't say that before, and there was sort of the implication of it, so we just made that expressed.
Things that are unchanged in the report that were not controversial were the support for researcher access to records, subject to the usual set of procedures or slightly enhanced ones, and the ability of public health authorities to get access to records for their purposes. Those were all substantially unchanged or totally unchanged, or fiddled with at the margins, but the basic strong support for that kind of access remains the same.
I sort of tried to go through this after the fact about what we changed, and it is actually hard to off the top of my head, to remember it all. Kathleen and others may have more yet.
MS. FRAWLEY: I went through and checked off every single sentence that has been changed. We don't have red line versions, so I just went back and checked off. So I can walk people through the document page-by-page if they want.
DR. DETMER: That's fine. I think it's a matter of what you wish.
MS. FRAWLEY: On page 4, under principle findings and recommendations we added a little paragraph that talks about the importance -- and we have to still do some spell checking, so we realize we are not consistent in our language. Basically what we say is they appoint a trust in the position. We are going to change that to the provider/patient relationship must be preserved.
Patients must feel comfortable in communicating sensitive personal information. We that thought that was really an important tenet. We needed to make sure that nothing that we do erodes the basic trust that is really critical.
Then we added -- down at the bottom of the page you will see, because again, we have to edit -- on the other hand, again to kind of balance discussion, "The confidentiality of the doctor/patient relationship and the confidentiality of health records has been the foundation by which the health care system helps insure the best possible health care. It is not easy to strike a fair balance between these sometimes competing concerns." So those were the substantive changes on page 4.
On page 6, if you look at the third sentence in that first paragraph, "Health records are primarily used for the treatment of patients." That was implied, and we realized we never said it. Then we said, "And to improve the quality of health care, reduce the cost of health care, extend the availability, protect the public health and assure public accountability of the health care system." So the phrase that was inserted there was about the fact that we reference to provide for treatment.
On page 7 during the discrimination discussion, paragraph 4, last sentence, we thought that we had to make a recommendation to the secretary in the changes. "The committee urges the secretary to propose legislation expanding the anti-discrimination provisions of HIPA to cover all aspect of discrimination based on health status and condition." So we thought that kind of brought together your discussion yesterday.
At the bottom of the page, again, discussion on unique identifiers. We added a sentence to reflect yesterday's discussion of properly chosen patient identification systems have the potential to enhance privacy. That's the addition there.
On page 9, under (A) Technology and Identifiable Information, the is just some wordsmithing. We just changed some of the words in the second paragraph where it says, "One response would be increased criminal and civil penalties for misuse of computerized health records." There were just some word changes there from the prior draft.
Then the next paragraph -- this is again, about consumer education -- we thought that there needed to be a more balanced discussion about the value of risk of computers is essential. Then we had changed the last sentence to just say, "Better consumer education may help." There was a whole bunch of other verbiage that followed, that we took out, because we thought it deluded what we were trying to make a point on.
Page 11, we mentioned this, but we did make some wordsmithing changes. If you look at the document, we talk about the fact that there be the need for some exceptions, and for us it was information about others. We moved clinical drug trial information. We did not change it up to number 2. Information whose disclosure would result in harm to the treatment or well being of the patient became item 3. So we flipped that positioning.
DR. DETMER: Richard and I scratched our heads for about ten minutes trying to think of a specific example we might be able to give to respond to one of your questions, but we had trouble.
MS. FRAWLEY: Then in the next paragraph we just did some language changing here. The right to seek an amendment often concerns health professionals. There were some things about making them nervous, and we changed the language.
Then to reflect Jeff's concern, we changed the next sentence to, "It is the usual procedure that questions or incorrect information is clearly, and amended information is appended to a health record." So it was reflecting our discussion yesterday morning.
On page 12, second paragraph, again under the authorization section we added a sentence. "Under this approach patients are asked to sign authorizations for non-routine purposes, would be alerted to the unusual nature of the request." So they should expect to sign authorization for treatment or payment, but that in other situations they may have to be aware that this may not be a routine type of request.
DR. MC DONALD: Where is that?
MS. FRAWLEY: It's on the second paragraph, page 12, last sentence, "Under this approach . . ." is how the sentence starts, "patients are asked to sign authorizations for non-routine purposes would be alerted the unusual nature of the request." The point is that patients are signed in blindly, because they don't know. So the point is we have to make sure they understand.
Next paragraph, last sentence, we did some wordsmithing. "Others have recognized that most patients routinely sign any authorization form . . . " There is probably a word in there. We have to look at grammar again. "And seem unaware of the potential problem of doing so," to reach a different conclusion against the balanced discussion approach. We were trying to make sure that the arguments were always reflected accurately.
Page 13, under general limitations on use and disclosure, second paragraph, last sentence, "Though computer-based health records have the potential to enhance the capacity, to limit the scope of data that is properly disclosed." Again, there was some wordsmithing. If you go back and look at your prior document you will see that we changed some verbs and cleaned up the language.
Next paragraph, again this is responding to the public health concern. We eliminated some language. We just said, "Another important aspect of patient protection would protect third party users who had access to health information from using information against the patient in matters unrelated to health." This is an issue especially with research. We deleted public health, law enforcement and oversight functions. So again, that was in response to John Lumpkin's concerns yesterday.
On the next paragraph we added a sentence at the end. "When identifiable health information is made available for non-treatment uses, patients deserve a strong assurance that the data will not be used to harm them." That's a new sentence. Again, to make sure people understand that there are limitations on use of disclosure, and that patients will not be harmed. That was to reflect the discussion yesterday.
DR. MC DONALD: Will that work with public health disclosures?
MS. FRAWLEY: I'm just walking you through the discussion on what was changed, and then we are going to open it for discussion. I'm just walking you through changes.
Page 14, third party disclosures, last paragraph, it is the third sentence, management functions. Then we inserted, "Including cost containment and quality measurement." Quality measurement was identified previously. We inserted the words "cost containment," to reflect some of the committee's discussion yesterday.
There are no changes on page 15. There may have been some wordsmithing, I'm not sure, under public health. I'm not sure about that, Bob. There are no changes on 16, 17 or 18.
Page 19, preemption, it's the second paragraph where we made some changes. The first sentence, again this is some wordsmithing, so if you walk to back to prior document, it says "On the other hand, it would be difficult for many patient groups, privacy advocates and perhaps some provider groups to accept any proposal that does not allow states to adopt stronger privacy provisions as specified in HIPA."
Then we moved some sentences around. This is the discussion on the floor versus the ceiling. We changed the sentence. It says, "There is strong support in some communities for a minimum federal confidentiality standard that allows states to address and erect stronger privacy barriers." Then we added the sentence that was already there. "HIPA reflects the policy that stronger state laws should be allowed to prevail." So if you go back and look, you can see we did some cutting and pasting on that paragraph under preemption.
On page 20, under uniformity, the top of the page. In the discussion about record keepers and different rules we added some sentences in that paragraph. It says, "It may well be impossible to draw clear lines between these categories of special records, however, providing additional protection for particularly sensitive health records is also regarded by many as essential to protecting the public health." The citation there is Jackie v. Resin(?) which was the Supreme Court decision that came down last year.
Next paragraph, we added a sentence, again to reflect the concerns about discrimination. There is a sentence, "Concerns about use of the categories of health records needs to be addressed through anti-discrimination laws, not privacy laws." That's a new sentence there.
We changed on page 21, the header from state valve to unforeseen consequences. That's as much as I remember, typing all the changes. So there might be one or two others that are in there.
MR. GELLMAN: In the text of the unforeseen consequences thing we added a kind of second paragraph there. We added the words, "exceptional circumstances." We also added in both paragraphs in the list of justifications for possibly making regulatory changes we added, "major breaches to confidentiality."
So in other words, basically if the law overshoots one way or the other, perhaps this procedure can be used to try and either allow records to be used in some way that wasn't allowed, or to stop records from being used in some way that seems to be unnecessary, with the same limited authority to do this, with high barriers to being able to do this on a limited term.
DR. DETMER: The last item, what page is it on? That had been a matter of conversation between a couple of committee members. It got in the draft. It wasn't brought before the whole group. On page 14, at the bottom, I think we need to discuss that one as well before we move.
So I don't know how you want to do this; start at the top and go on through?
MR. GELLMAN: Why don't we just do it randomly?
DR. MC DONALD: I would like to scratch one more time at the patient access modification. I'm not against it, but I had a discussion with one of the other members last night about there is a real cost that can be involved in it. That is the people that for the most time want to read the records, are sometimes the most public people.
Like if you've got to photocopy, have you got to charge for the photocopying? There is some way to put some minor -- I don't know what page it was anymore -- some minor trip level. You could either have certain kinds of patients just pushed away from the care system because they didn't want to have to spend hours explaining their records and/or you are going to have some guys break them. They are not going to be able to get home.
MS. FRAWLEY: Can I make a comment on that? Most state patient access statutes allow the provider to set conditions on the inspection, review and copying of the record. We're not writing legislation. A typical statute will allow the provider to say make your request Monday through Friday, during usual business hours. There may be a charge for the inspection.
In most of the state statutes it is all over the place in terms of what the charge per page may be. There have been documented abuses within the industry where providers have refused to provide that just because the bill is not paid. So certainly that was the subject of some federal hearings. Congress, in some of the proposals that are up on the Hill right now talk about that you can charge like a reasonable cost based fee. So the answer is not that you just hand over everything and that you burden providers.
DR. MC DONALD: There is no phrasing at all where you suggest according to usual procedures or something like that.
MR. GELLMAN: One of the problems here is that there is some diversity. For example at least one state, I believe Minnesota, allows you to have a free copy of the record. So this actually starts to fall back into one of these questions of preemption. All of the federal bills I believe say that you can charge a reasonable charge and that sort of thing.
There has always been a recognition that there is an expense to this, and the patient seeking to see a record may have to do it, but when you're presented with a state law that says, okay, in this state you get it for free, it gets complicated. This thing doesn't take a position on it one way. It simply says that there is a right of access and the procedure or detail is left to the legislators.
MS. FRAWLEY: In the 28 states that allow patient access the experience to date has not been that people have been running all over the place looking for their records. So I just throw that out, because our association monitors that very carefully to see what the barriers are.
DR. MC DONALD: The other one was where you changed the discussion of the permissions. I'm not quite sure I understood it. At our university and many universities one of the permission statements say your chart and your specimens may be used for research purposes. Are we really saying that that is not going to be legal?
MR. GELLMAN: No, there is nothing in here that says that.
DR. MC DONALD: Well, you are so fast I only picked up the tops of the mountain peaks in the discussion, but I thought you said that the only thing that they ought to do is get routine permissions for billing --
MR. GELLMAN: There is no substantive change. First of all, it doesn't take a position on this point. It says that essentially in other words there are proposals to allow disclosures for treatment and payment without expressed consent. It says these are worthy of review. It doesn't take a position either on that, and authorizations for other purposes aren't really discussed, but what you describe would not be affected by this.
MS. FRAWLEY: Under this approach patients are asked to sign off authorizations for non-routine purposes. It would largely the unusual nature of the request. In the next paragraph the last sentence is an additional sentence.
DR. MC DONALD: It does cast it as sort of an evil thing to watch out for, when it is sort of the standard in at least academic institutions now. I don't know of any abuses that have come from it, or damages or harms.
DR. DETMER: I guess it's a question of what you would define as non-routine in a way. I guess that's obviously open to interpretation.
DR. MC DONALD: In truth it's probably the billing that hurts patients more than any of this. They are going out to everybody.
MR. GELLMAN: That may be true, but the recommendations take a very strong position on making records available for research without consent. I think the procedure you described is fully consistent with this, and there is a separate procedure that will allow you to get records even if you can't get consent.
DR. MC DONALD: Never mind.
MR. VAN AMBERG: On page 16 and page 18, I'm a bit confused about the registry comment at the bottom of page 18, public health surveillance, and the fact that they need special rules in the procedures, where I really think they are talking more about the research-based registries maintained by researchers or companies for surveillance of their employees and health or special studies. Because in public health almost all the surveillance systems are registries.
MR. GELLMAN: I don't take issue with what you say. The problem here is that the registry issue generally -- there are no definitions. There is no proposal that I have seen that deals with it. This is an important issue. The document here is very supportive of registries. It simply says you need to have a clear way that people can disclose information to registries. It may be under state public health laws covers some of them, but there are international registries.
There are private registries that are okay. There are private registries that may not be okay, and you want to make sure that you do this in a way that you don't create loopholes for marketing registries to be created for other purposes. It's just something that needs attention. It's more of a technical thing than anything else, but it's an issue that no one has paid attention to.
Does that help?
MR. VAN AMBERG: I'm afraid that this can be interpreted as usurping some of the state registry laws, and the need for more regulation on them. All registries in public health are in state laws.
MR. GELLMAN: This provision doesn't really tie the concept of registries to public health or anything else. It simply says registries need to be addressed so people can make disclosures to registries that are worthwhile. Those details are for later on.
MS. FRAWLEY: I can give you an example. When some of the bills were released from the 104th Congress, the American Cancer Society, the National Cancer Registrars' Association were concerned that cancer registries that presently exist that are not state registries, that that process would continue, because of the importance of that function. So the problem that you have is that when people read legislative language and they don't see their issue addressed, they automatically assume that stops the data flow.
The registry, when we had hearings, that's when we began to realize that there are all kinds of registries that some of us didn't even know about before. So it's a complex issue, but we want to make sure that we support these functions, not that we stop them.
DR. DETMER: By the same token, any potential use could just throw the name registry on it, and then obviously do anything they kind of wanted.
MS. WARD: I hear your concern from the public health perspective, but also realize, having our own state variety of legislation through this last legislative session, registries are becoming a lightening rod. I think that's part of why I was supportive of this language, is that public health I think is at risk of losing the registries that have a fairly significant public health history, because of all these other kinds.
It's like registry looks like a good word, because it has been sort of sanctified under public health, and now everybody has got a registry, and it is really threatening what has been a fairly narrow, but hopefully reasonable way of using them. I think if we can some highlight to sort of get that dealt with, public health might be less at risk.
MR. VAN AMBERG: I would agree with that. I would like to see one change in the public health, and that is this whole public section is written as if public health is only communicable diseases, and that's not true. You have surveillance systems for chronic diseases and other conditions as well.
DR. DETMER: Page 16 on the top?
MR. VAN AMBERG: Page 16 on the top. I would like to see some language inserted there.
DR. DETMER: Do you have some suggested language.
MR. VAN AMBERG: I would suggest that we simply say surveillance system for communicable diseases, chronic disease and condition. It would be much broader.
DR. DETMER: Sure.
MR. VAN AMBERG: Injuries.
MS. WARD: It's broader than that. It's prevention and protection as well.
DR. DETMER: I think it adds something to define it a bit.
MR. GELLMAN: So what do we have, chronic diseases, injuries, and other conditions?
DR. MOR: It is simply the issue of personal health practices. That's what the annual behavioral risk survey is.
DR. STARFIELD: It's all public health efforts towards prevention and health promotion, which are not diseases. They are the things that they do to make sure people don't get diseases.
DR. MOR: What is the rate of smoking? What's the rate of a whole series of activities that the public is engaged in?
MR. GELLMAN: Another way to deal with this, the sentence that you picked on simply says, "Surveillance systems for communicable diseases attract public support more readily than abstract research." We could simply say public health functions attract public support more readily than abstract research, and leave it at that, without being specific. Does that help?
DR. MOR: Public health surveillance functions.
MR. VAN AMBERG: Yes, public health surveillance functions.
DR. STARFIELD: You didn't make any changes in the executive summary, which is good, except --
MR. GELLMAN: We didn't get to that.
DR. STARFIELD: I think the executive summary if fine except the bottom line. The bottom line is not the bottom line. I sort of think that a bottom line, the last sentence is a summary statement that sort of is punchy, and this ends on law enforcement, which is a really bad way to end.
DR. MC DONALD: I would just like some clarification from the public health colleagues about the exclusion for public health regarding reporting. Clearly, if someone needs to be held to be treated, that actually isn't harming anybody. That might be regarded as harm, then that is covered.
I don't know currently the practice in terms of infectious chains. There is a harm to the husband if the wife doesn't want to see him anymore. We actually had a guy come along the other night, and we asked her to be excused to discuss things further, and she left. She concluded things from the fact that she was asked to leave, which we really screwed up.
Anyway, you can imagine that the harm -- is that something public health still does?
MR. VAN AMBERG: Yes.
DR. MC DONALD: So is there a problem there? That's you guys, that's not me. It's when you are trying to treat the contact.
MR. VAN AMBERG: Which is almost all of local health.
MR. GELLMAN: I don't know of anything in here that undermines or criticizes that kind of activity.
DR. MC DONALD: The exception is treatment in public health is treatment. There was nothing about secondary case reporting and treating -- or maybe that's implying treating someone else. Maybe that's what covers it.
MS. WARD: That's the reason you do it, because there are more people who need treatment.
MR. GELLMAN: I don't know that there is a problem here. The goal here was to be as supportive.
DR. MC DONALD: No, I know the goal. It sounded to me like the only exception was for treatment. You are not covering contact tracing. It's not under public health, it is under the no harm.
MR. GELLMAN: That wasn't for treatment. That was for non-health conditions or non-health activities I believe was the language we added. So it was broader than treatment.
Where was that Kathleen?
MS. FRAWLEY: That was non-routine uses under the authorization section. That was on page 12, second paragraph, that sentence that we added.
MR. GELLMAN: No, that's not the one.
DR. MC DONALD: No, it's the use of data. The last paragraph on page 13. It says for non-treatment uses. The last sentence on page 13.
MS. FRAWLEY: You have to read it in terms of the context. We know that information is being obtained by law enforcement and other people, and the point is that you don't want them if they are going in on fraud and abuse against a provider, to turn around while they've got him and say, oh good, now I've got some information I can use on --
DR. MC DONALD: No, I'm in full support of that.
MR. FANNING: You may want to change the term "treatment" to health. I think we have concluded all along that locking someone up to prevent transmission of disease is a health activity. Disclosure under confidentiality statutes is permitted for that purpose.
MR. GELLMAN: I think that solves the problem.
DR. HARDING: So what was the change again?
DR. DETMER: The last sentence on page 13.
DR. HARDING: I think George brought up an interesting point that it may not be exactly what he was thinking, but something that concerned me, and that is the hooking up of public health with registries. Public health has registries. Other people have registries. Registries are databases.
If you start in mixing databases and public health, that has potential for good, and also some concern. If you get into the issue of non-traditional public health things, like in the future when they are working together with say a for-profit organization or something. That has been a concern of mine, and I talked about it yesterday I guess a little bit.
The issue of registries -- and Bob has really led out in this in the discussions -- is a troublesome one, and what to do with those when they are not for the public good so to speak, but instead are for a congregating of people, maybe with financial issues involved in that.
I just wondered if anybody has any thoughts about that issue.
DR. MC DONALD: What page?
DR. HARDING: That was just a statement responding to George's comment.
DR. DETMER: We struggled with words for a while, and finally thought that we had tried to cover it at least, but obviously didn't, I don't think cover it as precisely.
MR. GELLMAN: The point somebody made, we are not writing statutes. For some of these things we are just flagging issues. On the registry thing, I think there is lots of support, but there are some concerns there. Ultimately what we are saying is when somebody writes legislative language, this has to be carefully done to make sure that we cover the appropriate functions, and we don't cover the inappropriate functions, and we don't really try to define appropriate or inappropriate either. That's another tricky issue we leave for somebody else.
DR. DETMER: It was kind of fascinating when we were talking about using traditional, we knew what we were talking about. On the other hand, if you talk about for example some of the problem with corporatization of health care, is that access is worsening. So there may be some registries you may want to in fact relating to access to services and so forth, that could be very important.
So the idea if you just used a word that maybe was the way it used to be, but wouldn't deal with some again, legitimate new kinds of data that one would need to look for in the public interest, you could miss the boat. So it was how to find the right words to try to preserve what obviously is in the public and personal health interest, but at the same time worry about if you will, a lot of people masquerading under the wrong banner, or the right banner inappropriately.
DR. MC DONALD: Would profit or non-profit help at all?
MR. GELLMAN: Not necessarily.
DR. DETMER: I don't think so. I think it's just too coarse a flag. It really wouldn't deal with it.
DR. MC DONALD: I think the idea though of isolating the public health thing as a separate issue; I think it's all the more important.
MR. GELLMAN: I think every bill that has ever been proposed has a definition of public health and public health authorities, and tries to set up separate standards for public health, which I think in just about every bill proposed to date, has public health as the easiest category to deal with. I'm not saying it is easy, but compared to most of the rest of them, public health gets at least a semi-free ride, and I think it is appropriate.
DR. MOR: I was just going to say that the differentiation is whether the registry is a public health function, recognizing that there are a lot of registries that are actually research tools now -- Alzheimer's registries, et cetera. They may or may not be population-based. They are research tools, and are composed of lots of different things, but they are not public health functions per se. They are really there for research.
DR. HARDING: Research is public health. It's part of public health.
DR. MC DONALD: Mammals are dogs and dogs are mammals.
DR. HARDING: I'd delighted myself to have my record used by public health for research or for public health facilities. I have no problem. I'm not sure that there are some entities that I want to have my record for their research.
DR. MC DONALD: It is easy to take credit cards and make a registry by some disease.
DR. DETMER: Let me raise this point before I forget it, and I can't remember where you tagged it for me, but the concept was where do we go between if you will the standard IRB for a clear research issue, and essentially what is quality assurance. Maybe that cost reviews in a variety of issues.
One of the things that we were thinking about here, but hadn't discussed with the full group to see how you feel about that was that one way of at least I think assuring the public to some extent that data are not being used willy-nilly if you will, by essentially against the patient's interest in managed care kinds of structures or whatever, would be to have health professionals involved in those functions.
If you look at the poll data, over a ten year period it shows pretty consistently that there is really quite a bit of public confidence and assurance that physicians and nurses, and to some extent even hospital directors use data -- there is a lot of confidence, or a fair amount of confidence that those people will preserve confidentiality and use the data appropriately.
It then starts dropping quite significantly -- by the way, researchers lead the list for the most confidence in those polls. At any rate, one thought on this would be that you could suggest having health professionals involved where person-specific data are being used for some of these internal management functions, as a walking proxy if you will, of people who, through their training and through their performance behavior have been hard at work worrying about these things generally, and are quite sensitive to them, and the public generally feels that that is generally true too.
That was the question, because to drive everything through an IRB process or otherwise have nothing sort of there seems pretty extreme. So the question was how could we put some flexible, but nonetheless probably useful -- I think it would be useful frankly -- kind of walking control into that process, so that the data are being used by somebody at least by temperament and experience, nature is trained and lives that way.
That is the sentiment. Now whether the verbiage says that, or how you feel about that hasn't been talked about here. We have had sidebar conversations, and it got into the draft.
DR. STARFIELD: I think it's a good idea in principle, but I am just worried about the possibility of the professionals subject to recrimination by managers.
DR. DETMER: I hear you.
DR. AMARO: I have that concern too. So my suggestion was to offer an amendment to say something like non-affiliated health professionals. I think it is important to have health professionals who are not affiliated with the organization that they are going to --
DR. DETMER: I think the cost of trying to actually implement that and do it would just be unreal. I hear you, and I think it's not irrelevant, but I worry also about just trying to implement it.
DR. AMARO: I also think that while the survey that you quoted may be accurate for the general population, there are certainly major communities in which the confidence in health professionals is not high.
DR. DETMER: So I guess the question is does it add enough to be worth it, or do we just go with what we have historically done?
DR. AMARO: I don't know about the issue of cost, but there are professionals, as well as community members -- I would add representation by --
DR. DETMER: That came up also in our discussion. I think that also ought to be on the table.
DR. AMARO: People have more confidence in a group that had patient representation. People serve on advisory boards all the time without compensation. I think to have credibility they have to not be affiliated, and that I would add representation from community members or patients; something like that.
DR. MC DONALD: I don't know how you can do this if you are talking about an internal organization. I don't own an organization, but they pass out daily census figures. There is just activities around the organization. They are looking at cost figures now on a more daily, by DRG, by this, by that.
How can you do this when the economics of this thing is getting squeezed? Say you are going to have to have a monthly delay? The reason why they define it now for quality assurance sort of separately was because I think pragmatics.
External data I think you can make a whole other case if they are going to do something, send it out. Just thinking of the pragmatics, tell me how you are going to have a shop run where they can't just go and check on something when they think there's a problem somewhere?
DR. DETMER: I agree, there are both good and tough sides on this.
MR. VAN AMBERG: As you know, there are problems with IRB boards as well, because there is a lot of research that they statutorily do not have to review, which involves access to identifiable data, which is what we are concerned about.
We have stepped around that by having research proposals reviewed by what we call a scientific advisory panel of independent researchers. That seems to work very well, and is very acceptable to at least one state legislature group, so that we don't have to go through an IRB board, but we've got a professional review process.
DR. IEZZONI: I think we have to underscore that what we are concerned about here is identifiable data, because the functions that Clem was just talking about, you don't need identifiable data. Frankly, I'm sitting here trying to think through exactly what an example would be of the problem that you are talking about.
I'm involved with my institution right now in thinking about using our data to help management try to figure out how to allocate resources within a capitated payment system. We don't need identifiable data. We adjust by age and sex and diagnoses. We don't need to know who those people are.
There is one exception that I think is becoming increasingly prevalent in the payment community, and that is efforts to identify potentially high cost cases for improved case management. That is really something that a lot of places are now doing, trying to identify the type of 5 or 10 percent of people in terms of predicting next year costs.
Again, this process involves clinicians, because implicit in the effort to try to manage cases, to try to figure out how to help the patients. It is really both the cost control and health.
So I think until we can come up with a series of very specific examples of what would be egregious breaching of this process -- I have trouble crafting around language around it.
MS. FRAWLEY: My only concern in is response to Hortensia's recommendation, is that when you are talking about manager functions such as quality measurement, quality assurance risk management, if you had non-affiliated health professionals involved in that function, you would lose of your peer review protections under federal and state statutes.
I don't think anybody on this committee wants to recommend that. So you have to be very careful about making sure you understand what protections are afforded health professionals in terms of privilege. So you have to be very careful about those kinds of things, because when you bring external groups in, you have to be very careful about the process.
IRBs right now do have consumer representation, do have people from the community, but they are typically not talking identifiable patient-specific. You are talking about a much higher level in terms of a clinical trial, a treatment protocol. You are not sitting there talking about specific patients, or looking at specific medical records per se. I think it's an important point. You don't want to eliminate protections that people currently enjoy.
DR. MOR: I think I would like to weigh in on the side that wants to leave well enough alone, simply because it just gets so complicated trying to frame language around this.
Any more specification of what requirements have to be present in what is essentially becoming really a care plan for the organization. In quality assurance functions now, it is possible to delineate and identify patients with certain classes of problems, and those patients with those classes of problems can be grouped and looked at as a group in a bundle, where individual characteristics of those patients are relevant in terms of understanding should there be a care map structured around this, or should there be not a care map structured around this?
This is the process of doing the business of health care in a clinical and efficiency and management perspective. I think if we begin to interpose review processes over which there is -- this is not research; this is ongoing, every day it happens. It just becomes excessively cumbersome.
MR. GELLMAN: I can't bring any medical judgment to this, or actually to anything else for that matter, but if you look at the language here -- first of all, the discussion here is very interesting. We've got a problem that we have already recognized which is that we've got all these activities going on; some of them are regulated in some way, and some them aren't. We made reference to that already in this section, and that's a known problem. We don't have a solution to it, but we flagged it.
What the language here says is one approach deserving of more discussion -- it doesn't say we're for it; it says it's deserving more discussion. I think that this is sort of saying here is one idea, not necessarily that we are recommending it. I think there have been good points back and forth. It may expand, as you suggested, into non-affiliated people, or patients or whatever. You can make arguments about all of these things.
All we are saying is this is something worthy of discussion. So I don't think that you should carry this language beyond what it says.
DR. MC DONALD: Maybe we ought to make some words if they are not in there already.
DR. IEZZONI: Other studies require IRBs. I go through an IRB all the time.
MR. VAN AMBERG: There are some research protocols that need identifiable data are not required to be reviewed by an IRB.
DR. DETMER: Well our process, and in most academic centers you just do it. This way it is done.
DR. MOR: Our undergraduate students require that we have to go through a board review if they are going to talk to patients, talk to individuals, even their fellow students.
DR. DETMER: Well, what is your pleasure, should we scratch this piece or leave it in?
MR. GELLMAN: It's the last sentence on page 14 and on the top of page 15.
DR. DETMER: How many would scratch it?
MR. GELLMAN: Let me read the sentence. "One approach deserving of more discussion would be to require the involvement of health professionals in an oversight group within each provider organization, and to require the maintenance of a record of the group's deliberations and judgment."
DR. DETMER: Straw vote -- who would scratch it? Who would keep it? How did you count it? It looked to me like there was one more vote for scratching it. Let's try it one more time. Scratch -- six. Keep -- six. Swell. We'll keep it.
Other items?
MS. GREENBERG: Page 4, under principle findings and recommendations, I'm a little confused about what you tried to do here. The first paragraph is the same as it was, correct?
MR. GELLMAN: Yes.
MS. GREENBERG: Then you have added, "The importance of trust in the provider/patient relationship must be preserved. Patients must feel comfortable in communicating sensitive personal information." Then the next paragraph has stayed the same?
MR. GELLMAN: Yes.
MS. GREENBERG: Now you have come back and said, "On the other hand." On the other hand from what? You have already mentioned the importance here. I don't understand what you are talking about balancing.
MS. FRAWLEY: It's just the order. That sentence belongs in that paragraph.
DR. DETMER: That's shouldn't be a paragraph, where "On the other hand.?"
MS. FRAWLEY: Right.
DR. DETMER: That should actually be right there.
MS. FRAWLEY: It's just the other flip argument. It is all one paragraph.
DR. DETMER: It looks like a new pseudo-paragraph.
MS. FRAWLEY: Well, we didn't see it.
DR. MOR: I need some clarification on page 15 in the health research. The paragraph that begins, "The procedures that regulate." The next sentence is, "Institutional review boards are in widespread use, and the standards that IRBs should apply in weighing." Weighing what? Was there some part of the sentence dropped there?
MR. GELLMAN: There is probably a word missing -- risks and benefits.
DR. SCHWARTZ: Just on that page, I had a few what I think will be brief issues regarding health research. In that same paragraph, the sentence that begins, "Finally some have questioned." Perhaps we could be more specific, such as, if this is true, finally some privacy advocates and patient groups have questioned --
MR. GELLMAN: There have been questions about IRBs from many places. I don't know if you want to start putting a list in.
DR. SCHWARTZ: Well, I was thinking of doing it in a parallel manner perhaps as the way we did preemption, because based on yesterday's discussion with preemption, when we saw some, we decided to indicate which groups there were. Now if you feel it is better not to do that, we could take it out of preemption, particularly if it is okay with Richard as well, then I would feel more comfortable with it not being in research.
MR. GELLMAN: I don't feel obliged to be consistent. There is a reason for doing it in one place, and there is a reason for not doing it here, and I think each reason is just fine the way it is. I don't feel obliged that they have to be exactly the same.
MS. WARD: Agreed.
DR. DETMER: You agree with who?
MS. WARD: With Bob.
DR. SCHWARTZ: Let me ask you whether or not in the first paragraph where it says, "Other argue," after it is referenced that some privacy advocates argue that each patient should be able to prevent the use of his or her records for research, is it reasonable to just say others argue, as opposed to stipulate who?
DR. DETMER: I see heads nodding.
DR. SCHWARTZ: First sentence, I perhaps am the only one here -- I don't really fully understand that sentence. "Testimony revealed that no consensus exists about the overlapping values of health research and personal privacy."
MR. GELLMAN: Where are you?
DR. SCHWARTZ: The first sentence under (G).
DR. MC DONALD: Isn't it conflicting?
DR. SCHWARTZ: That's what I was thinking. My suggestion would be what about testimony revealed that no consensus exists about how to weigh the conflicting values of health research and personal privacy.
DR. MOR: We're going to have a lot of weighing.
MR. GELLMAN: How to balance?
DR. SCHWARTZ: I understand that that's a problem, but just put them out there as overlapping values, I'm not sure what it means to say there is no consensus about the overlapping values.
MR. GELLMAN: How to balance values of privacy.
DR. DETMER: Others?
MS. FRAWLEY: To go back to Vince's point, the weighing word is not in the original document either. I don't what we were weighing.
DR. DETMER: John, do you want to make any comments?
MR. FANNING: No.
DR. MC DONALD: There is, in the last paragraph under health research, it is saying a patient consent as a condition of researcher access. Does access mean access to their records or is it access to them as a subject?
MR. GELLMAN: Well, we could add records. I think in a context where we are talking about -- the whole document really is about records and information. I think it is clear in context, but if you want to add the word, we can do it, if you think it would help.
DR. DETMER: You were saying you add access to data?
DR. MC DONALD: Yes, access to a patient's data. It gets picky when you start being specific, but there is this business about being able to go and grab any patient and put them into a study.
MR. GELLMAN: It is clearly not an issue raised at all in this document. This document is talking about records.
DR. DETMER: Is it clear to people?
DR. MC DONALD: Never mind.
DR. DETMER: Good reading, Clem.
DR. HARDING: If I could just say a word. It's kind of like deja vu all over again, and talking yesterday. It has been very interesting. I think this is a better document today than it was yesterday. I appreciate very much the energy and the time -- and it was a lot of time -- going into yesterday's time with that.
There are several good provisions in here that I completely agree with, that I support. Then there are others that I still have difficulty with on the basis of the kind of things that I was talking about yesterday. I just wanted to say a few more words.
I guess I have a concern that some of the background information, some of the subtleties of it is not adequately in my mind pro privacy. It's more that we were talking about the tilt and so forth, between uniformity maybe and privacy. I still feel that it still is a little bit that way. I think it is better now than it was, and I appreciate the ability to try to help that.
Yesterday I talked about several issues that I felt were very important; discrimination, and how it is connected to the question of privacy. I think Barbara had brought that up, and how important that was. I think that was helped a little bit in the writing, and I felt better about that.
It is critically important, however, to provide a higher level of protection for the most sensitive information. That wasn't addressed in here. The issue of segregation of medical records, the issue of mental health or alcohol and drug, AIDS, some of the STDs and so forth. I know that a lot of people are very concerned about that outside of this committee on the issue of databases and what is going to happen, and what are going to be the recommendations coming out of this committee.
Then what will happen to those databases? Will they be used, and so forth; genetics. A very nice geneticist yesterday came up after the meeting and asked me to keep trying to fight for the privacy and for the segregation of things from the genetics standpoint. It is addressed in here, but not clearly recommended to the secretary what to do about that.
Informed consent needs to be the backbone of patient privacy legislation, but we didn't take quite a stand on that. We discussed the issue. I would like to have that be a part of it.
There are no clear distinctions drawn between the clinical uses of health information and the secondary uses. That is, we have now a little better possibility of an informed consent document there, that still that is a troublesome spot to me.
If I felt that several quick amendments would solve all these things, I would offer them, as I did yesterday, and go through them for the next several hours, however, I think that the thread in it is, from my perspective, a little more on again the uniformity side, as opposed to the privacy side, which is so bred into me.
For the sake of smooth operations of the committee, I'm not going to run a bunch of amendment through to this. I don't think that would be helpful, and like Bob Dylan said, "You don't need to be a weatherman to know which way the wind blows." I think that would not be beneficial.
I hope that the issues of discrimination within privacy legislation, and then tougher regulations on the secondary use of health information, and then special protections for special populations will continue to be something that we all push for, and hope to have involved in legislation at some time.
Because of those concerns that I have, and because of the hard work that has gone into this document, I am not going to vote against the document, but I'm going to abstain. I talked with Don and Bob about that, and will be abstaining from the vote, because of those concerns that I have about kind of the threads of the document, as opposed to any one specific thing.
DR. DETMER: We haven't called the vote yet. So let's discuss these points and where we are.
MR. GELLMAN: I want to agree with a lot of what you said actually. I think that this is a better document for all the suggestions people have made yesterday and before yesterday, and today as well, and especially you. I think you added a lot to it.
I think all the issues that you touched on are very difficult issues. The draft didn't take positions on them expressly simply because it didn't seem that there was a value in having -- like we just had a vote on the one sentence, and seven to six it stays in. It seemed better just to make some comments about it.
In some of these issues, they are not black or white. They are not issues that necessarily can be put -- in the legislative context you always come down to an amendment or not an amendment. A lot of these things need more development and more work. If you start working on these things, I think as you recognize, you can get lost very quickly in detail.
I think that your concerns -- certainly I share a lot of your concerns. I have just sort of given up some of these fights a little earlier than you have in I think the overriding interest of seeing something. Something needs to be done. The legislation has been sitting around Capitol Hill for 20 years, and hasn't passed. In that whole time, the protections for privacy have deteriorated enormously. If there is no legislation in the near future, things are just going to continue to get worse.
So I am very much in the camp of I'll take half a loaf if that's all I can get, because I think we are better off for it. I respect the people that want to say, no, we have to hold out for something a little better. I think everybody has got really the same concerns and the same interest in protecting information, and protecting patients, and protecting the doctor/patient relationship.
We're really fighting over the details. They are very important details, but I'm glad that we agree on the basic principles that this is an important issue, and it needs action, and it needs it soon.
DR. DETMER: Some of the committee of course have not been as aware that you folks have been exchanging e-mail and an awfully lot of conversation that has been very useful up to this point, but some of you are hitting this topic pretty fresh. So let's still talk a bit about some of the points that were raised, if they deserve to get in the language before we do try to move to action on this.
DR. MC DONALD: I don't know what is practical, but reading some of the bills and all, one of the points that is really clearly distinguishing the care provision usage of data from the others -- I'm looking at it maybe from the opposite side of it though -- they shouldn't be lumped. You're not really lumping them here.
MR. GELLMAN: What do you mean lumping them?
DR. MC DONALD: Some of the bills say, this is a record. This is how it behaves. Boom, all the things apply to everybody, exactly the same. I think that that theme is not optimal. I don't know what the alternative theme is, because there are some pragmatics associated with quick care and all the rest.
DR. HARDING: That's what I'm referring to, is uniformity.
DR. MC DONALD: I don't have a repair paragraph or sentence in mind, but I do think there are some issues there.
I haven't memorized this. It's a beautiful document, but I haven't got it really in my head. I thought there was some distinction about internal/external when I read it once.
MR. GELLMAN: There is, yes.
DR. MC DONALD: I think that's another distinction that you've got to be much tighter on externals than internals, because of statistical threats and all the rest.
MR. GELLMAN: That is another issue that is very difficult to deal with in any context. We talked about this a little bit yesterday. You cannot be that specific. You can write general rules, especially for internal uses. At some point whatever you are doing, you have to rely on good faith of the people who are doing this.
Certainly on the internal side within health care providers, I think that there is a higher degree of confidence that you will find that good faith, and you will find physicians who are concerned about these issues, and will look out after their patients.
One of the problems is that records go further afield and to other camps and other people who have not relationships to the patient, and less concern about that. That is why you need legislation. To begin with, it was just a matter of learning about what the physicians did with records. I'm not sure we're even talking about legislation at all, but the world has grown more complicated than that.
DR. AMARO: I want to really support the really critical issues that Richard has brought up, and I am concerned about them as well. I think that there are special protections for specific groups and areas that are needed. I think that the inappropriate communication of information or loss of privacy also is not sort of equally distributed across population groups.
I think some studies have been done that indicate that health care providers tend to bridge confidentiality different by socio-economic status, patient population and so forth. So I think that --
DR. MC DONALD: Isn't that mostly just movie stars?
DR. DETMER: I wish it were just movie stars. I totally agree with that. In fact, the poorer you are, the less privacy our society thinks about giving you.
DR. AMARO: I think some of the issues -- mental health, substance abuse, HIV and STDs are -- some of those disproportionately impact certain socio-economic groups, which then places you at higher risk for those populations.
So I think that these are really central issues. I would prefer that we would be able to come up with some language that would address these, than to put this document out and then feel that we didn't address this appropriately.
DR. DETMER: I think there is a difference of opinion whether it was addressed appropriately or not. Obviously here you are feeling that it didn't. I think there is language in here that does speak to that. It's a question of does one agree that it speaks to it enough or not?
MR. GELLMAN: I make it clear that on these issues, the document doesn't say no. It doesn't say yes. It says this is an issue. There are concerns here. There are other concerns on the other side, and it leaves it alone, because the judgment was, and I think it is pretty well reflected in the conversations that we have had, that there isn't a consensus on these issues; that they are very hard, and we just left it.
It doesn't say Richard is wrong and somebody is right. It simply says this is a hard issue, and someone else is going to have to make a decision.
DR. AMARO: But is the issue that there is disagreement about whether these are important, or that there is disagreement about, or there is concern about how do we fix it, or appropriate response?
DR. DETMER: I really that it's absolutely the latter. I really think that's accurate. This stuff is very humbling to spend much work on, because it goes beyond Solomon to try to really sort out a lot of these.
I think there is a lot of sensitivity to the issue. The issue is how do you best as a democratic society, highly complex systems in the world, move that? I think is where I think that there is a lot of division in terms of how does one get to a cure. Again, I'm just trying to put a few words around it myself. As somebody who has struggled with trying to find the answer to things.
DR. AMARO: So if the issue isn't disagreement on the importance of these matters, but of sort of how do we resolve it, and what kind of suggestions do we give, are there any recommendations that we can put forth in the document that acknowledges that, and that tries to move the development of some solutions further?
MR. GELLMAN: The problem is that I don't think there is. Everybody recognizes that all of these issues are important. There are hundreds of issues that aren't raised in this document, because you can't deal with everything. They are important. They are sensitive. The problem is there is no agreement. I don't think there is any consensus on solutions.
If we sat here and started to talk about this, I don't think we would reach any agreement among ourselves, because the issues are very complicated. So what we have done in this document is said this is an important issue. We flagged it as one, and let it go at that, because I'm not sure that we can usefully make progress toward a recommendation that we are all going to be comfortable with.
MS. FRAWLEY: I just want to eliminate a point. This is not just something that the committee has been struggling with. The first hearing on privacy on health information was held on June 5th. Rep. Horn asked all of the witnesses who testified whether they prefer a floor or a ceiling. My association was the only one that said a ceiling. We've got to raise the threshold. We've got to get everybody up there. Every person in this country deserves protections of their information; and everybody else is aiming for a floor.
These are professional associations. People are very committed to privacy issues. So the problem that you've got is that we are not going to solve all the societal problems. I think that is the problem that we are struggling with, is that there is no easy answer. People who say it should be a floor or a ceiling, have very legitimate reasons why.
DR. DETMER: I think part of the answer that is real is that we have a Subcommittee on Privacy and Confidentiality. We have another that is worrying on the security. So I guess my only comfort that we can't get to really unanimous consensus on this, is that we are going to absolutely continue to worry this, and I think that is the best, and that's not trivial.
There is a lot of hard work and a lot of good intention and efforts that have already gone into this, and it's going to stay on. John is working hard on his document that is going to come forward as well. Congress I think is worrying about it.
So I think that you also raise very good points, but I really worry about if we try to give another -- first of all, we have to respond to the secretary on a mandate, and I am really not sure that we could get too much further, although if somebody's got language, that's why we're here. We've still got some time.
I guess my other feeling is that this is a long way from not saying anything, that's for sure. I think there is consensus on that. So I think the issue is what is our pleasure, and what can we still yet do with the time right at the moment?
DR. MC DONALD: I was just going to respond. When I sort of think through some of it, I can imagine very vaguely defining categories. There are categories that are set aside, but then when you really start to implement them, and can't recognize them, how do you really, really do it?
And for whom? That is, does that mean a physician can't see X, Y or Z? Does it mean a billing person can't see X, Y or Z? Actually the truth is once the billing people can see, it's all out. We have this huge gaping hole in some sense. We have these billing permissions. This stuff goes in charts, gets photocopied, and sent off everywhere.
What do we really do? What physical thing would we really do? I can guess at some things we might be able to say, but I don't know how you would bound them. I think maybe it's a regulatory issue.
DR. DETMER: Some of what you are talking about is non-discrimination policies. A lot of what you are talking about is not in one sense, tightly a privacy issue. It has to do with our society's collective decision about access to basic health care services for the whole culture. Some of it is clearly that.
DR. MC DONALD: Let's take alcohol abuse. So what counts and what gets in? That they had DTs? That is important, because they will have it again, when they are coming in and shaking a little bit, you will maybe admit them, or if the other guy never had them, you wouldn't.
Who gets to see what? So you've got to turn that to yes, we want to be special to this data, in what way? I think that is the struggle we have. How would you be able to implement -- say a rule in a short page that would inform, and who would get to see what, how, when and why? How could it be implemented? How could the controls be implemented?
DR. MOR: I've been sort of struggling with this, because this is something I don't know a great deal about, and certainly haven't spent a lot of time thinking about, but it seems to me that the issue that is most paramount is the extent to which disclosures can harm individuals, and the extent to which disclosures are done systematically to deny coverage, care and/or somehow or another shape the nature of the care that specific individuals receive.
It seems to me that as long as we have a "health insurance" system, those kinds of review processes are going to be happening all the time, and that the real question is, is that's the societal bind, is the one of resources that are restricted, and management controls are demanded for the implementation or direction of a health care system, whether it is universal access or not.
I think it's not really the issue of universal access. Universal access makes it more problematic, because there is obvious discrimination. Even in a universally accessible world, limits are going to be put on the care, and those limits are going to require some kind of monitoring system on those limits.
I think that is where a lot of the real crux comes down to. Anti-discrimination will certainly help whether there was universal or not universal coverage, because that would limit the likelihood that the people getting hurt would be the most powerless.
I don't think it is a research issue. It's not any of those kinds of things. It is really about denying care and hurting people with the information.
DR. MC DONALD: There are some other examples I have been thinking about. I don't mean to be picking on movie stars, it is amazing the value to somebody to find out information about VIPs. A corporate president who is getting sick might change the stock close or something like that.
So there are some real values for stuff that wouldn't ordinarily be as -- someone gets a heart attack in my neighborhood, it doesn't all get shut down. We talk about it. Not many get a heart attack in my neighborhood, because I take good care of them.
When you get into these other things, it really gets messy. There have got to be internal controls against these things, anyway, somehow. We haven't spoken to any of that.
MS. FRAWLEY: The thing is you have to make sure that you realize that the subcommittee that is dealing with security is going to be making a series of recommendations. The HHS security implementation team will be making a series of recommendations.
When we set up our committee work, this is privacy and confidentiality. We've got a whole other process for security. So every organization is going to have to have a suite of things they have to do. It is not like we are just passing this document on to the secretary and just saying, we finished our job.
We have hearings for a day and a half. The subcommittee will be deliberating. The HHS security implementation team is going to be working.
DR. DETMER: I think it does say quite a bit, I really do. I think it does say quite a bit. In fact, one of my biggest worries was that we really not say enough, and sort of pass along to the secretary, well, we disagree about this, so good luck. We are here because it isn't a simple thing. If it were simple, we wouldn't be sitting here grappling with it.
So I think it is our job to agonize over these, but still come down with something that is going to help our society try to get through next week. We are also going to be around. I think that is also there. If we did err on this, we will probably hear about it, and we'll have a chance to relook at it.
If we didn't then we will probably hear about it and we'll go from there. So at some point I think that's -- the society is struggling with this, so it's not a surprise that we are struggling with it. I think that probably means that we are a balanced enough committee to reflect that.
Are there other issues, or do you want to move to a vote on it? What do you want to do?
MR. GELLMAN: I move the adoption of the report with the changes we discussed.
DR. STARFIELD: Second.
DR. DETMER: Any further discussion? All in favor raise their hands. All opposed? Abstentions?
[Whereupon the document was accepted as revised.]
So ruled. So we will then move forward with preparing all three -- wait, we've got to do OASIS. Here it comes.
DR. MC DONALD: A comment on this. Some of us thought this was a very productive day, because we are talking a lot to each other. We're getting reports out. The folks who have been listening say it's really pretty boring to listen to people wordsmith. I just thought I'd get that on the record.
DR. IEZZONI: Vince, do you want to lead us through what the changes are?
DR. DETMER: Most of the changes are in the last paragraph?
DR. IEZZONI: No.
DR. MOR: There was a change in the second paragraph. The first change is I believe we changed testimony to briefing in the first paragraph. We were briefed by two HCFA staff.
In the second paragraph we broke things up a bit. We left the first sentence as it was, then emphasized that we were told about the major demonstration that is not scheduled for completion; that HCFA is currently having discussions about the viability of integrating data collection across the most acute. We just broke this up into smaller sentences. In the absence of a legislative mandate -- that's as we had before. We just broke up some wordsmithing there.
The next paragraph stayed as it was.
Then next paragraph has several detailed questions. What we did was we added one. The next page, there is an item, three lines up from the bottom. "It appears that some data elements do not correspond with established NCHS coding guidelines. The subcommittee suggests that HCFA fully review all data elements to insure that they follow established coding guidelines where they exist." That is in response to Kathleen's comments, as well as the fact that the race and ethnicity questions do not correspond at a minimum.
The next paragraph, the issue on OASIS -- Clem, you mentioned something about bias, and we're responsive. We have now made it subjectivity instead of bias, and dealt with it. We took out that other thing.
Then finally we came up with that last paragraph, which replaces the prior last paragraph, and specifically makes recommendations. Bob, wherever you are, thank you for pointing out the fact that we wrote this nice letter and didn't have any specific recommendations. Here they are.
We recommend the complete internal review of all their data collection, HCFA's data collection initiatives having to do with post-acute, to insure that new data collection mandates are consistent with what they have got in place and established procedures, or to have a compelling justification when there is something different.
Then we specifically recommend that, "You reconsider implementation of the OASIS until this review is complete, and the results of the major demonstration project underway are available." At that point they could issue another notice for proposed rulemaking and get public comment.
DR. DETMER: Okay, discussion.
DR. MC DONALD: A little bit of the same thing. This is very good, and I will just something good and concrete at the end. The only part is still worry if you couldn't give them an out to maybe say some results are available, because if there is a lot of industry pressure for it, and you say you've got to wait until 1999, you may get nothing out of it.
DR. STARFIELD: It only says that you reconsider implementation until the review is complete. It's not clear what you mean by the review.
DR. MOR: The internal review of data collection. Maybe then what Clem is saying, and the results are --
DR. MC DONALD: Well, if you could split those two out, because I think you can make an extremely strong statement that it makes no sense under --
DR. DETMER: It makes a shorter sentence too.
DR. MOR: Until this review is complete, bingo.
DR. MC DONALD: Yes. Then you can say another statement about you also ought to be looking the results to guide you.
DR. STARFIELD: Can't we just say not implement, instead of reconsider implementation?
DR. MC DONALD: If getting all these forms the same, it seems to me almost just a sine qua non. The other one is good too, but I was afraid that in two more years they are going to say, well, screw the whole thing. So if you could make two different statements, and we would also suggest that you take advantage of some of the results of the study you've got before you commit.
DR. MOR: So what Barbara is suggesting is that we specifically recommend that you not implement OASIS until this review is complete.
DR. IEZZONI: I think that we should use the word "reconsider." One of the reasons that I say that is because we had a briefing from two people from the research community. We have not had enough time to really know exactly what all the issues are. So asking them to reconsider seems to me to be better, given what we know about the situation right now.
DR. STARFIELD: But that suggests that we don't really believe what we say.
DR. IEZZONI: I think that the word "reconsider" is just more polite. I think in this context it feels more comfortable, at least to me.
DR. DETMER: We're going with the kinder, gentler version?
DR. MOR: Whatever the committee feels on this. I think they should not go ahead until it's done.
DR. IEZZONI: I think we have a lot of concerns that we raised in this letter. We're hammering them pretty hard in this letter.
DR. MC DONALD: Reconsider I think is okay.
MR. SCANLON: I think you have made the point, to be honest with you.
DR. IEZZONI: I do too.
MR. SCANLON: I don't think you tell them how to do it.
DR. DETMER: Other issues?
DR. STARFIELD: But we're going to take out the end of that sentence, right?
DR. MOR: That is going to turn into a separate sentence, additionally, the results of the major demonstration should be helpful to your process; should be considered.
MS. GREENBERG: You have added a sentence, it appears that some data elements do not correspond; I think you could just say with established coding guidelines. It's not necessarily NCHS coding guidelines.
MS. FRAWLEY: I was actually going to give them some language that was more official, but that's fine.
MS. COLTIN: The word "correspond," as opposed to "comply." I don't quite understand.
DR. MOR: Where?
MS. COLTIN: In that same sentence about the coding guidelines.
DR. AMARO: I think that the validity issues that we discussed were sort of two types. One is just general validity. They have done all the reliability studies, but there is no evidence these are valid items for anybody. Then on top of it there were some questions about cross-cultural appropriateness. So you might want to just add that.
DR. MOR: It would require a whole separate set of comments. That really is not an issue that came up in the context of our discussions yesterday. I tried to restrict myself in writing yesterday afternoon to those specific things that came, as opposed to writing my letter.
DR. MC DONALD: The second sentence does say cross-cultural validity. It does say that.
DR. MOR: No, Hortensia is saying there are issues of validity that are broader than cross-cultural validity.
DR. AMARO: When we discussed this after they left, I brought up the point that there was no evidence of validity of any of these measures.
DR. MOR: My problem is I don't know the answer to that, whether or not that has been done.
DR. AMARO: That's true. We didn't ask that question, so we don't know.
DR. MOR: I just don't know the answer.
DR. AMARO: They only talked about reliability. Didn't I ask a question on validity?
DR. IEZZONI: After they left.
DR. MOR: We didn't have that much time. I don't know the answer to the question.
DR. AMARO: You're right, we don't know.
DR. MOR: I do know that the cross-cultural is specifically there.
DR. IEZZONI: I think this letter again, has a lot of content in it. It is not exactly supportive. So I think it made the points. So I move that we adopt this letter and ask Don to send it on to whoever the appropriate authorities are.
DR. DETMER: This will go to the address that was responding in the comment period, plus the co-chairs of the Data Council.
Is there a second?
MR. VAN AMBERG: Second.
DR. DETMER: Any further discussion? All in favor say aye. Opposed? Abstentions?
[Whereupon the document was unanimously approved as revised.]
Thank you.
It looks like we have completed our work for today. We do on occasion offer the floor to anyone in the audience who would like to make a brief statement, because we have otherwise come to the end of our formal agenda. Before we adjourn, if anyone would care to say something for us, to us, with us, about us, whatever.
If not, I would take a motion that we adjourn.
[Whereupon the meeting was adjourned at 2:55 p.m.]