Room 505A
Hubert H. Humphrey Building
200
Independence Avenue, S.W.
Washington, D.C. 20201
Call To Order/Welcome and Introductions, Dr. Detmer
Review of Agenda
UPDATE FROM THE DEPARTMENT
Committee Organization, Dr. Detmer
HHS Implementation of PL 104-191 Health Insurance Portabiliy and Accountability Act of 1996, Dr. Hamburg, Co-chair, HHS Data Council
Auditing Quality of HEDIS Data, Paul Elstein, Ph.D., HCFA
Comments on Quality, Dr. Starfield
Commission Final Report, Ms. Coltin
Presentation of ANSI HISB Inventory of Clinical Information Stansdards, Mr. Blair
Comments on NPRMs and Claim Attachment Recommendations, Dr. Lumpkin
DR. DETMER: I am Don Detmer. I am a university professor of health policy and Senior Vice President at the University of Virginia and Chair of the NCVHS, and I would like to call this meeting to order.
We typically begin by going around the room and introducing ourselves, starting with the Committee. I do want to make comment about the new space. This is the third time I have had a meeting in the new space, and the meetings have always been productive. So, I think environment does affect, actually influence things although we were productive before this, in any event.
So, with that, Jim, do you want to start?
MR. SCANLON: I am Jim Scanlon, from HHS. I am Executive Staff Director for the National Committee.
DR. STARFIELD: Barbara Starfield, Distinguished University Professor at Johns Hopkins.
MS. FRAWLEY: Kathleen Frawley, the American Health Information Management Association.
MR. STREIMER: Stewart Streimer, Health Care Financing Administration.
DR. FRIEDMAN: Dan Friedman, Massachusetts Department of Public Health.
MR. GELLMAN: Bob Gellman, Privacy and Information Policy Consultant.
DR. IEZZONI: Lisa Iezzoni, Beth Israel Deaconess Hospital in Boston.
MR. FANNING: John Fanning, Office of the Assistant Secretary for Planning and Evaluation, HHS.
MS. FYFFE: Kathleen Fyffe, member of the Committee. I work at the Health Insurance Association of America.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Health Care Policy and Research.
MS. COLTIN: Kathy Coltin, Harvard Pilgrim Health Care, member of the Committee.
DR. COHN: Simon Cohn, Kaiser Permanente Medical Care Program, member of the Committee.
MR. BLAIR: Jeff Blair, Medical Records Institute, member of the Committee.
MS. WARD: Elizabeth Ward from the Washington State Department of Health.
DR. LUMPKIN: John Lumpkin, Illinois Department of Public Health.
MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics and Executive Secretary to the Committee.
DR. DETMER: It is great to be here, and I think that I want to first make some additional introductions because there has actually been quite a change in some staffing, as well as some new reappointments and so forth.
So, I want to go through those. Dr. Peggy Hamburg will be joining us in a bit. She is the new Assistant Secretary for Planning and Evaluation and co-chairs with John Eisenberg the Data Council, and she has been wonderful to work with, and she will be with us shortly. John Eisenberg I think you all know.
New appointments, David Takauchi is a PhD in sociology and particularly in the mental health area. He is a professor at UCLA. His appointment to this Committee was made so recently he was unable to be with us for this meeting, but he will be with us, and we will do a little longer introduction then, but I wanted to announce that.
Stewart Streimer who introduced himself a little bit ago is at HCFA and replaces Bob Moore as our Committee rep from HCFA. He is the Director of Standards and Systems Group in the Office of Information Systems, if I am correct.
MR. STREIMER: Information Services.
DR. DETMER: Information Services. Thank you, and Michael Fitzmaurice is here, and he is the senior adviser to John Eisenberg for informatics at AHCPR. Is that correct?
DR. FITZMAURICE: Senior Science Adviser for Information Technology.
DR. DETMER: All right. Mike is well known to many of us, probably all of us at this point. We are delighted to have him on board.
Harvey Schwartz, as you know, had been the rep, and we, in fact, benefitted from his input over the years and in fact have already sent a letter to him.
George Van Amburg actually will be leaving the Committee, has been on the Committee since 1989, I believe which is really quite a legacy. A letter will be going to him, as well as a certificate and in fact, we decided to have a dinner in his honor even though it is in his absence tonight to pass along to him how much fun we had.
Bob Moore, again, had been the representative with Harvey and Stewart is replacing him, and what I would like to do if I could have a motion for the Committee to send letters of appreciation to George and Bob, I would appreciate that.
MS. FYFFE: So moved.
DR. DETMER: Okay, second?
MS. FRAWLEY: Second.
DR. DETMER: All in favor, say, "Aye."
(There was a chorus of ayes.)
DR. DETMER: Thank you very much. Reappointments are important, as well, and Dr. Iezzoni and Dr. McDonald have been reappointed, and we are delighted about that.
I think those are the key appointments. There are more as we get into the organization and some of the new staffing folks from the agencies and such, and we will be getting into that in a little bit or at that point in the agenda.
The agenda will start with updates. We do have a couple of important action items. Committee organization is probably as key as any, as well as comments for the Quality Commission final report, as well as the NPRMs and claims attachment recommendations.
Those are our key action items as well as if we can get there to review and approve the vision document and the plan for the 1997-98 annual report and then finally plans on the hearings for the unique individual identifiers.
In addition to that, we will have a variety of reports, as well as a couple of subcommittee meetings.
Subcommittees, working groups have been meeting since our last meeting, and I think a lot of progress is actually being made.
So, with that, unless there is a question about the agenda, I think I will go ahead and turn the floor over to John, and we will hear from him and then Dr. Hamburg.
Welcome, John.
MR. FANNING: Thank you. It is a pleasure to appear in this gracious and well-appointed place. I am here to give a report on confidentiality issues generally of interest to the Committee.
On the Hill we still have pending several confidentiality bills. There is no great forward movement on them. Senator Jeffords has his bill as S1921, and comments are being received on that by the Committee.
Congressman Shays in the House introduced HR3900, and Mr. Horne, the Chair of the Information Subcommittee of the Government Reform and Oversight Committee has held hearings, but there is no indication in any of those situations that a mark-up is forthcoming.
We, in the Department are beginning to consider our options should the Congress not act under the law which directed us to present recommendations to the Congress. If the Congress does not act by August of next year with health record confidentiality legislation covering the administrative and claims electronic transaction system, the Department is required to make regulations along those lines, and we are considering how we are going to approach that should the Congress not act.
A few other items, you perhaps saw the account of Mr. Gore's speech to the New York University commencement where he made favorable remarks about privacy including about the necessity to have a health record confidentiality law passed by the Congress. In connection with the same set of activities the President issued a --
DR. DETMER: Just a moment? Did everybody get a copy of the Vice President's speech? Okay, we will make sure that people get a copy of that. It is clearly important to this Committee.
Thank you.
MR. FANNING: Okay, the President, also, issued a directive to the heads of executive agencies calling for some actions to enhance privacy. He asked that every agency appoint a high level official to take responsibility for privacy policy, and we are in the process of working up that for this department, and he, also, asked that every agency conduct a review of its Privacy Act systems of records to ensure that they all complied with the requirements of the Privacy Act and that the policies in them corresponded with the principles for use of personal information, a document produced by the President's Information Infrastructure Task Force 2 years ago.
In particular the President asked that every agency should evaluate legislative proposals involving the collection, use and disclosure of personal information for consistency with these principles.
So, it is a push for something that we have been, I think somewhat attentive to to ensure that privacy considerations were taken into account in the developmental stage for any type of program.
Other government-wide activities related to this are a privacy summit to be held on June 23 and 24, which will probably focus on the Internet and the collection of personal information particularly with respect to children.
However, it can be of broader import. The Federal Trade Commission has recently come out with its study of web sites, and their practices in collecting information about people, and among the things they found was that 88 percent of the health web sites that they surveyed did collect personal information, and only a small proportion, 14 of them, 14 percent had good practices with respect to telling people what was going to be done with the information.
Web sites are important because now with prescription drug advertising direct to the public, the pharmaceutical manufacturers are obliged to provide information, either over a web site or by response to a 1-800 number, and that does involve a transaction with the person which can collect information. So, it will be continuing attention to that.
Just one last item that hopefully will please the Committee, you will be delighted to know that the Italian Data Protection Commissioner's web site includes a link to the web site of this Committee.
That is what I have, Mr. Chairman.
Mr. Scanlon, do you have anything else that we need to cover here?
DR. DETMER: I want to ask you because I was just asking her if we had that web site. What did you say that that web site is already linked to ours for that report?
Is there a web site for that report?
MR. FANNING: No, the Federal Trade Commission has a web site on which this appears.
DR. DETMER: Could you get that for us?
MR. FANNING: Sure.
DR. DETMER: Questions or comments for John?
Yes?
MS. FYFFE: Hi, John. You mentioned that the Department is gearing up for the possibility of Congress not enacting federal legislation on confidentiality of health information. If the Department needs to promulgate regulations can you clarify for everyone here that those regulations would apply to the electronic transactions and not be any broader than that, unless I am mistaken? Could you clarify all that?
MR. FANNING: We are still looking at all of the possibilities, and we are not ready to make a statement on the scope.
MS. FYFFE: Okay.
DR. DETMER: Other questions for John?
Could you summarize, I know it is on the spot here, but Bill Lawrence's comments at Data Council on what is happening in the EU side of this, if you could maybe just make a couple of comments about that? I think that was an interesting report.
MR. FANNING: Have we given out to the Committee the outline?
DR. DETMER: The subcommittee will, in fact, get that, but we will as a whole Committee. I don't think so.
MR. FANNING: The European Union has a data protection directive which requires all of the member states of the European Union to have data protection laws in effect by this October.
Now, many of those nations had data protection laws long before the EU directive. However, the ones that didn't have now enacted laws, and the others are working on them to conform them to the requirements of the EU directive.
It is of interest to us because one of the requirements that must appear in those laws is that the member nations may not permit the export of personal data to countries which do not have adequate privacy protection.
So, that has implications for the transfer of data from European nations to the United States, and it is the subject of ongoing debate and discussion within the Administration and in talks with the European Union and in dealings between particularly the Commerce Department which has the lead for this and private industry.
It is not clear that the European Union will shut down everything on the twenty-fifth of October.
On the other hand, they do expect some efforts on the part of the United States to ensure that the rights of Europeans whose information winds up in the United States are protected, and the exact mechanisms for that can differ.
They do recognize that we are not likely to have an omnibus data protection law the way European countries do. They recognize that we have sectoral legislation covering particular areas and the EU staff is particularly pleased that we have moved ahead with a proposal for health confidentiality legislation.
Now, we are going to have to work out what will happen by next year. If there are questions raised by European countries and among the solutions that can be talked of are contractual arrangements whereby the recipient in the United States would promise to treat information in a certain way, and a contract could be enforceable by the person involved.
Likewise the Federal Trade Commission is asking industry to give clear statements of how it will use information about people, and then they would be able to treat a violation of a company's own statement as a deceptive practice.
So, there are various possibilities. It should be noted that consent, unambiguous consent, I think is the phrase in the directive, of course, would allow the preservation of data.
So, if you are in a clinical trial and have signed papers that make clear to you where the data are going, that presents not such a great issue.
On the other hand, other types of information that might cross from Europe to the United States where there is not that kind of unambiguous consent could present a problem.
DR. DETMER: One of the things, if I heard him right was that he wasn't aware of actually high-level communications going on between Brussels and the US on some of these issues.
MR. FANNING: I think there are high-level communications going on, but they have not gotten down to working on particular data exchanges, and that is what he urged us to work on, and we are now surveying the Department in more detail to see what data exchanges go on within the purview of our Department.
DR. DETMER: Also, if I heard him right, the way their law is set up is actually if it is data that has once been subject to the European Union's standard, then that, in a way that legal force follows them wherever the data go; is that to other countries?
MR. FANNING: Yes, I think that is within the definition of the thing. If the information is assembled and generated in an EU nation it cannot come here unless --
DR. DETMER: No, but I understood that if it came from here to their and then went back actually some of those protections follow it.
MR. FANNING: Okay, I don't remember that specifically.
DR. DETMER: As a cynic one would think if our country cannot pass something maybe we could just send all of our information to Europe.
(Laughter.)
DR. DETMER: All right. Thank you very much. Bill?
DR. BRAITHWAITE: I have a very short update for you since our last meeting. As you know according to the directions in Public Law 104-191 the Department is publishing regulations to implement national standards for health care EDI and in six parts.
The first two proposed rules that for the national provider identifier and for the standards for transactions, administrative transactions was published in the Federal Register on May 7, and we are now in the 60-day comment period which closes on July 6, after which we will analyze the comments and prepare a final rule for each of those and publish that when it gets cleared.
I am, also, pleased to announce that the third NPRM, the one for the employer identifier, the standard national employer identifier for health care was published today in the Federal Register, and the comment period on that closes on August 17.
It is a very short report but I want to make sure that everyone understands the incredible amount of work that has gone on behind the scenes and behind getting these documents out, particularly by HCFA staff and, also, by the staff of all of the health care federal agencies who have contributed people to this process and who have worked diligently not only to produce and get modified and cleared these document but, also, they have been out on the road speaking at various conferences around the country, letting industry know what it is we are thinking, what we are doing, getting feedback and modifying things accordingly.
It has been one incredible effort to watch.
Thank you.
DR. DETMER: Do you have any report on the information that is already coming back at all?
DR. BRAITHWAITE: No, we haven't had all that many comments back yet, and I am told by those who have gone through this process before that they typically get a 10,000 flood of comments back 2 days before the close of the comment period.
So, we cannot really tell from what we have got so far what is going to happen.
DR. DETMER: : Questions or comments from the Committee?
All right, thank you.
Peggy is not here yet. Jim went to get her. Why don't we just get into our next item, and when she arrives we will stop and hear from her?
The next item is Committee organization. This item is Tab C. This proposal came out of the better part of a day's meeting that the Executive Committee had May 29. It was brought to you from the Executive Committee for discussion and amendment and/or approval.
Basically what had happened, just to summarize particularly for people in the audience who may have not tracked it, about half of this Committee came on new in August a year and one-half or a year and three-quarters ago, and as a result of that the prior structure was sort of reworked to some degree to get us rolling, and I think in light of the HIPAA mandates which gave this Committee a much larger specific task than it had had historically we really got under way with a set of subcommittees and work groups.
Essentially what we come to you today with is a reorganization proposal that would have four subcommittees, a subcommittee on privacy and confidentiality, and that essentially remains as it has been with no real change in charge unless that subcommittee wishes to make that; a subcommittee on standards and security.
This was previously the subcommittee on health data needs, standards and security, a subcommittee on populations which was formerly the subcommittee on population specific issues and a work group on population based data and an executive subcommittee.
The discussion that we had suggested that there should be a chair for the subcommittees and work groups and then vice chairs. Essentially their only role, but it is an important role would be a person who would chair the committee in the absence of the chair.
The Chair of the NCVHS would continue to chair the Executive Subcommittee and in the absence of that chair another member of the Executive Subcommittee would be asked to chair the meeting.
What is proposed in this scenario if you go on down through that would be a subcommittee on standards and security which would essentially assume the current charge of the K2 work group on data standards. John Lumpkin will chair that subcommittee, and a work group on computer based patient records will be cochaired by Jeff Blair and Simon Cohn.
As I mentioned, the subcommittee on privacy and confidentiality keeps its current charge. Dr. Iezzoni will chair the subcommittee on populations. The Vice Chair has yet to be named; Dan Friedman the work group on population based data. Dan has been actively involved with that.
The work group on quality of care will be chaired by Kathy Coltin. I think that at least as a set of comments will get us into the discussion. I think before we quit this item I do want to speak to the last page of that which, also, talks to NCVHS staffing complement needs.
I have had a couple of very productive meetings and conversations with the Data Council where they essentially asked us to come back to them laying out what we needed in terms of support and the response as you can see from that page is quite gratifying, but there are even some additional names that I want to mention today before we leave this item.
What we had done is send out as you know an e-mail to you folks saying that we meet so infrequently we thought it would be smart to move forward with this meeting in this new format unless you heard otherwise, and I think generally the folks that we have heard from have been quite complimentary about it. It seems like it sorts things out and moves us forward, but with that is a set of introductions.
I, also, made it very clear that we would not, in fact, act on this until we really were in the presence of one another and had a chance to really share thoughts on it. So, essentially the floor is open for discussion on this obviously very important item.
John?
DR. LUMPKIN: I like it.
DR. DETMER: You are on the Executive Subcommittee, no wonder, but do you want to comment?
DR. LUMPKIN: I think what this does, and it speaks to a number of concerns that I had. While I spent most of my time on the K2 activities of this Committee, my bread and my butter and my home is in population-based efforts, and I think that our previous structure by trying to put those two issues together really slighted population-based activities. So, I am very pleased to see that brought out so we can really focus in on that because that has been the history of this Committee, and I think it is a history we need to really ground ourselves on and move forward.
I do have just one slight suggested change, and this is only because my focus has been on administrative simplification. I would propose that these things be called committees because subcommittees uses up three more letters of the alphabet that we could use to assign to ANSI X12N committees or something else.
DR. DETMER: All right. Good morning, Dr. Hamburg. It is nice to have you here. Why don't we stop our discussion of this for the moment, and we will come back actually to talk about subs and committees and other comments?
We are delighted to have you here. I introduced you actually in your absence a little earlier. Dr. Hamburg is the Assistant Secretary for Planning and Evaluation, and we are pleased to have you here today.
DR. HAMBURG: Thank you. I was getting my marching orders actually. They have me here so scheduled. I knew I was supposed to be here, but I didn't know what I was supposed to do, but I was hoping I was just going to listen to all of you and have the opportunity to thank you for the hard work that you have been doing at the Data Council meetings.
I hear every month Don Detmer give a report about your activities, and I said to him, "I am amazed that anyone has other jobs. It seems like being on this Committee is a full-time job," but I do want to really thank you for your efforts and stress how really valuable it is to the Department and it adds a very important dimension that we simply could not have without your unique participation, input and role.
So, we are very, very grateful. Let me just say a couple of words about the Data Council and where we are and where we are going? As you are probably aware I recently joined the Department coming from a role as a colleague of John's as a health officer.
I was New York City's Health Commissioner where I must say I was very struck by the important role of data collection, data analysis in all of our ongoing activities and the remarkable under appreciation of the importance of data by the policy makers and the public in terms of what aspects of our activities they wanted to support, but I was very pleased when I arrived at the Department of Health and Human Services to find a Secretary who was deeply interested in data, in supporting the role of data in each and every agency of the Department and as a sort of theme throughout the work of the Department, and I think one important reflection of that commitment was the creation of the Data Council which was intended to be a forum to bring together data related activities both scholarly activities and programmatic activities and policy activities across all of the Department to try to integrate where there were overlapping issues and activities and to try to identify important gaps to fill and, also, to bring the best minds in the Department together to think about some of the important policy issues and future directions for the Department, and of course, in that work the Data Council is enormously enhanced by all of you.
But the Data Council has been going on for about 3 years now. The Assistant Secretary for Planning and Evaluation is one of the permanent co-chairs and on an annual basis the other co-chair is put in place.
I feel very fortunate that John Eisenberg, Director of ACFER(?) is the first co-chair that I am serving with, and he is a very, very well-informed, enthusiastic and energetic partner in this mission and I think that we really will be very productive this year and have a very full agenda.
Clearly among the issues that we will be working on are some of those issues that are very much on your agenda, as well. The privacy issues are something that we are addressing in a very serious way, and we expect to be ratcheting up those efforts soon as it looks as though there will not be legislation passed by Congress, at least not in the near future, and the requirements of HIPAA mean that need now to go forward as a Department to put forward regs or to figure out how to utilize existing authorities in order to enforce the requirements of HIPAA and, also, to address a set of broader privacy-related issues.
Obviously we are very concerned about formulating programs and policies that will reflect the complexity of needs raised by this issue, the need to both be able to support ongoing research efforts in an unhindered but responsible way to support quality efforts and to ensure that data are used to improve the lives of the individuals from whom data is collected and to protect their privacy and confidentiality.
So, we have a lot of activities going on in that arena and expect, as I said, that our efforts are going to be increasing in both scope and intensity as we move forward.
We, also, at the last meeting of the Data Council had a presentation from a colleague of ours in Europe, Bill Laurantz who has done some consulting for the Department in the past, and he raised an important set of issues with respect to relationships with the European Community.
They have a new law that will be going into effect in October that a higher standard and new expectations on arenas where we in the United States either receive or provide data to Europe mainly in the direction of data that we receive but they have some deep concerns about the adequacy of our standards to meet their current and anticipated laws.
So, we will be working on this issue from an international perspective as well.
The Data Council was as I understand it originally created in large part to address the concern about all the different data collection and survey activities going on in the Department and how could we most effectively utilize those.
Many of those surveys are enormously expensive, highly staff intensive and were there ways that we could collect the same information more efficiently, perhaps more effectively through integration of surveys and a very, very thoughtful process was developed, and some real strides were made in terms of integration, also creation of a new database and we are looking to continue that effort over the next years and, also, bring on board a new survey in response to the tobacco legislation that you have all probably been following but trying to now build in the capacity to collect through a household survey more information about youth tobacco use to the level of detail of brands and frequency of use.
So, that is a very important activity and one that was in large part the stimulus for the creation of the Data Council and, also, a reflection of the Vice President's reinventing government effort as well, and I think has really been an important focus for the Data Council and an important way of familiarizing across departmental agencies the staff working on these efforts and the content of the efforts so that we have more integration of thinking as well as activity.
You probably have, also, heard about the President's race initiative which was begun over a year ago, and different agencies have taken the President's broad initiative on race and developed initiatives within their own agencies, and we back, I guess in February announced a new initiative to eliminate racial and ethnic disparities in health, targeting six critical health status areas. I always have to count them on my fingers, cancer, cardiovascular disease, diabetes, immunization, infant mortality and HIV-AIDS, and the goal is to really truly drive to eliminate these disparities that exist in health among racial and ethnic subpopulations in these six health status areas by the year 2010 as an outgrowth of the Healthy People effort.
Currently we are working on the Year 2000 and developing the Year 2010, and this is kind of an effort that emerged from that.
We chose those six health status areas because they were the areas where first of all there was obviously an enormous burden of preventable disease and very marked disparities in health status when you looked at different racial and ethnic populations, but, also, because in those six areas we had the best data.
I won't say, "Very good." That might be too excessive, but we had the best baseline data from which to measure progress towards our goals, and in putting this initiative together I think it highlighted for the leadership of the Department the real problems that exist with data collection in this area and our ability to really look at data in terms of different racial and ethnic groups and, also, of course, underscored our need to learn a great deal more about the relationship not just between health status and racial and ethnic populations, but, also, the big issue of socioeconomic status and health status, but we are moving forward very seriously with this initiative.
An important component of it has to do with looking at data collection, data systems and opportunities to improve in that arena, and we have as part of this initiative a working group that is focusing specifically on data issues. We work very closely with a work group of the Data Council focused on those same issues, and of course, we would welcome your thinking on that important issue.
We, actually have an agenda of issues we would like to take up over the next year, plus that I think would have us in meetings practically every day of the week. So, we are going to be honing that agenda. I won't take the time right now to go through all of the issues, but there is a great deal of interest in using the Data Council as an important forum to develop agency-wide strategies and a coordinated focus.
One important activity we are involved in right now using the Data Council in that way is in the budget development process we are starting to put together the budget for the Year 2000, and I think it strengthens our ability to argue for resources in this arena when we can come together and really reflect true cross-departmental priorities so that it is not the Office of Management and Budget within the Department and outside that is sort of deciding that this set of activities is more important than this set of activities.
We are trying to be able to present a coordinated analysis of really what the needs are and the priorities so that we can utilize in the world of a balanced budget available resources in the most effective and meaningful way possible.
Why I don't stop and take a little time to answer some questions?
DR. DETMER: Great. We actually have a Healthy People 2010 data issues agenda as you may know on for tomorrow. It is great to have you here.
Questions or comments for Dr. Hamburg?
Okay, well, we will be doing plenty of work.
DR. HAMBURG: I know that.
DR. DETMER: And I am sure getting back to you. I think David Garrison and Bruce Flagg got the Data Council to really a great start, and I am, also, just really delighted to be working on your behalf with Dr. Hamburg and Dr. Eisenberg.
I think particularly what I have really felt is a lot of enthusiasm, and I think maturation sort of of this new initiative within the Department and I think particularly the focus on more strategic thinking which you mentioned and trying to in fact, improve the integration and such is something that I sense that I think we, also, want to try to help the Data Council actually do.
So, it is really great to have you here, and I appreciate your coming this morning.
DR. HAMBURG: I really appreciate as I said all of your efforts. It is an extraordinary commitment that you have all made to an important set of issues, and I think really with the leadership that you are providing we can make some great strides forward.
DR. LUMPKIN: I have a question, and one of the things that we have been doing under HIPAA is by default developing, I think quite a large data dictionary of standard definitions.
To what extent do you see that this will be now utilized throughout HHS and all the various programs that states and local health departments have to use to deal with population-based issues, registries and so forth? Do you think this will progress under the aegis of the Data Council a little bit more rapidly than it has in the past?
DR. HAMBURG: I guess it depends on a lot of factors. No. 1, it depends on the quality of the initial work, and if it has real, you know, I think that if we have moved forward and really created a dictionary that is of real value and addresses some of the needs and confusions out in the field that would be willingly adopted and would be a very positive thing.
As you know, state and local authorities have considerable independence, increasing independence with respect to data collection, and I don't think that there would be an expectation of sort of a uniform adoption of new approaches necessarily, but I think that it is very clear that we have a system that is fragmented and some of what is going on is worsening our ability to look at data across states in a meaningful way.
Unfortunately, with welfare reform there aren't real data collection standards, and some of the data collection mechanisms that we used to rely on no longer exist so that it is a very patchwork kind of a system now, and as we struggle to really assess what has happened with welfare reform and its impact on families and what its, you know, enduring sort of role will be in terms of a changing economy and all, it is really hard to do the analyses we need to do because we simply don't have the data.
We are starting to have the same concerns in the children's health insurance arena where states are very much developing their own unique programs and there aren't uniform data collection requirements, and we need as much as possible to get people to understand the importance of data, No. 1, and, also, data that can be used in a way that cuts across jurisdictions, and so, I think that that is what we are striving for, and I think that HIPAA gives us a context to try to do something that will then have ripple effects and broader benefits, but I think it does depend a little bit on the quality of the initial efforts.
DR. FITZMAURICE: I wonder if I could expand on that a little bit? Are you saying that under HIPAA there has been already a collection of data, and there are definitions, and that these definitions might be of use to the states, and so, if the Department were to look at it and find it of sufficient quality, you might want to put out this collection, this registry of data elements that have been collected as a guide for the states, kind of a leadership role?
DR. LUMPKIN: Actually different than that.
DR. HAMBURG: That is sort of the way I interpreted the question.
DR. LUMPKIN: The State of Illinois, for instance, our department has eight separate information systems related to HIV-AIDS. We have got one mandated by HRSA, a couple mandated by HRSA, a couple mandated by CDC. They don't speak to each other. They don't have the same data definitions.
To the extent that we can now begin to use some of the HIPAA data standards and data dictionary, it is possible to conceptualize now an integrated system where each piece plays a role, but that requires different pieces of HHS to agree to play in the game.
So, that is really the standardization that I was mentioning, and it would naturally flow down, but if we could see some standardization across non-financial systems, utilizing some of the standards that were developed under HIPAA, I think there is a lot of room to make progress in interchangeability of data between programs.
MS. GREENBERG: I might just contribute that I have always said about health data standards you need to be a very patient person to be in this field, but CDC is trying to develop standards for its multiple systems, surveillance systems, etc., which frequently do not speak to each other as you know so well at the state level and is using as a guide the HIPAA standards, the X12 and HL7 to the extent that they work, also, looking with what the needs are for public health, etc., and has gotten an agreement with HRSA at least to work together on integrated systems at the state level. So, I think we are making a little progress, but we can use all the encouragement we can get.
DR. DETMER: Other comments or questions?
I want to make sure that the Committee hears me thank you, personally, for the efforts that you have made to help bring us budget and staffing. As you know, we have had a few areas where we have needed more support, and I think the response actually that we are getting from the agency, really from your support has been very much appreciated, and I just want to make sure you hear that.
DR. HAMBURG: I will convey that to the operating division heads because I think that they have been quite responsive, and I think talking to the staff that have been working on various subcommittees, it is a very interesting activity and a good group of people to be working with.
I think this is one of those very nice situations where the work you are doing and the work we need to do within the Department dovetails so well that it really is a true partnership, and I just apologize for being late.
DR. DETMER: You are welcome to stay as long as you wish. I know you are a busy person. Your beeper is already chirping away, but in any event we look forward to seeing you when you can and as you can.
DR. HAMBURG: Thank you.
DR. DETMER: Okay, why don't we go back to our comments and such. I flagged your comment, John, about the issue of subcommittees.
Why don't we just get other things up on the table, and then we will come back to those. I don't know if other members of the Executive Committee want to weigh in at this point, but I really think it would be worth hearing from literally all of us because I think this is a fairly important issue.
Lisa?
DR. IEZZONI: I, similarly to John, support the change. I think the issue about vice chairs though we are going to have to work on in my subcommittee because it may not be something that needs to apply uniformly across all subcommittees.
DR. DETMER: Okay, Dan? We will catch Bob when he comes back.
DR. FRIEDMAN: I think it will work out well, and only specific comment I would make is that clearly as John just pointed out HIPAA has major implications for population-based data long term, both in terms of surveillance data as well as in terms of research, and clearly it is just going to be essential that both of the committees or subcommittees, whatever we end up calling them work closely together on the implications of HIPAA for population-based data, and certainly what we will hear about, and I don't know if it is this afternoon or tomorrow in terms of the NCHS workshop in November is a major step in that direction.
DR. DETMER: All right. Stewart, do you have a comment?
MR. STREIMER: I would just say, again, that is certainly a much more efficient approach. It seems that certainly with our contribution of staff to the activity I think it makes better use of the staff we are able to allocate to the various committees. So, I am very much in support of it.
DR. DETMER: Kathy?
MS. FRAWLEY: After all the comments so far I think it makes a lot of sense for us in terms of utilization of the Committee members and the staff support.
DR. DETMER: Barbara?
DR. STARFIELD: I agree, too. I just want to make one comment pursuant to what Dan said and that is do we want to work on the core data elements? It is not clear which committee, subcommittee, whatever it is, these fit into to. It may be that we need to divide the core data elements between the committees where the encounter data type fit more in one subcommittee and is person focused than the other one.
DR. DETMER: Okay. So, yours is really just how do you deal with this one issue, and where it should go more than the structure itself?
DR. STARFIELD: That is right, but along with that I agree that both committees really deal with population.
DR. DETMER: Right, good point.
Jim?
MR. SCANLON: I think the structure sort of fits our priorities, and it kind of streamlines our work. Hopefully we will be able to work more efficiently, but I think the major organization now reflects the priorities and future directions very well.
MS. GREENBERG: I would agree. I think that we are going to have to work really hard logistically to try to make sure that people who need to be involved in various types of discussions can do that and not overlapping too much, particularly in the full Committee meetings, and as we add to the structure with work groups I think we want to take advantage of the fact that everyone is here and so have work group and subcommittee working sessions as we have in the past, but there is going to be even more, I think, of a potential for conflict from the point of view of scheduling. So, I welcome your help in thinking that through.
It might require somewhat restructuring of the meetings, making them 2-1/2 days or I don't know. In this case we had a full subcommittee meeting yesterday which was, I think very productive, and we really needed the full day. A working session wouldn't have done it, and I guess one issue that came up a bit yesterday, and we might just do some thinking about or hear people's views on is although we have work groups within subcommittees, I think there may be people who want to participate in a particular work group, but not in that subcommittee and see how that works as well or whether that should be an option or how that is going to work.
So, my concerns, if they are concerns, are just the scheduling, the logistics, but I think the structure itself makes a lot of sense.
DR. DETMER: All right, more comments, John?
DR. LUMPKIN: Just following up on the comment about the work groups, I think we should encourage members to participate in work groups without necessarily participating in the committee.
MS. WARD: I think the one thing that we all keep saying is that it makes sense. I think that is the part that everyone keeps underlining. It just seems so much more logical now that that is the major comment. It now makes more sense.
DR. DETMER: Jeff?
MR. BLAIR: I am groping here. I feel very comfortable with the organization and the design, and I would only echo the comments that have already been made.
DR. DETMER: Okay, Simon?
DR. COHN: I think I would, also, echo the comments. The structure certainly makes a lot of sense. The other good piece of this is the new work groups being formed. They go into areas that we need now to go into. So, that is very helpful.
MS. COLTIN: I am, also, very supportive of it conceptually, and I think that the reorganization makes a lot of sense. I still have a few concerns about the fact that there are eight entities still, and 18 committee members and doing the math even though we talked about the fact that the work groups would be smaller and the subcommittees, we have put staff names in the boxes.
We haven't put committee member names in the boxes yet, and I am a little bit nervous about how that is going to work out.
So, I think we need to think about that.
MR. BLAIR: We need a subcommittee on cloning.
(Laughter.)
DR. DETMER: I will come back and comment on some of the discussion the Executive Committee had on all these items once we have made it around the room.
DR. FITZMAURICE: I think that Barbara, Marjorie and Kathy have put their finger on the basic problem that I saw with the reorganization, and that is that they have limited resources, maybe an infinite number of interests of the Committee and an infinite number of priority issues that need to be addressed, and so in some cases the structure was based on the fact that we had strong leadership that, also, wanted to participate in the work groups, and so, we have put them together like that.
It is probably in my view the most workable solution that we can come up with at this point, but we do need to address the issue of the scope of these components.
MS. FYFFE: The structure is good. Tell me what you want me to do.
(Laughter.)
DR. DETMER: I think this issue, the tension that we have got with the size of the Committee, the beast in front of us is daunting, and I think we did talk at the Executive Committee about having smaller groups and then essentially let people come to other meetings as they could and as the agenda move them, but what that suggests to me is that the Executive Committee function really becomes really important in tracking not only what does the work list look like of those and then making sure that the membership knows what is on the agenda as specifically as possible ahead of time so that in fact, if they do want to weigh in they have an opportunity to do that.
So, I think it is going to be a challenge, but it sounds like a good response to essentially the Executive Committee's recommendation.
Let us come back before we move to approve this in total and weigh in on the subcommittee to committee comment. As far as I know we don't have anything in the Department that keeps us from taking such an action, do we?.
MS. GREENBERG: I think that the charter actually requires subcommittees. I don't actually think that --
DR. DETMER: We could call them probably committees, even though clearly they are subcommittees to the committee.
DR. LUMPKIN: I think subcommittee is grammatically correct because we have the National Committee on Vital and Health Statistics, and then you have subcommittees under that. I just think the nomenclature is a little bit cumbersome because we talk about committees of the NCVHS.
DR. DETMER: Okay, let us open that up to discussion.
MS. GREENBERG: The charter says under structure, "Standing and ad hoc subcommittees composed solely of members of the parent Committee may be established to address specific issues and to provide the Committee with background study and proposals for consideration of an action." I actually think there is -- "And the Chair shall appoint members." I think, "And the subcommittees shall make their recommendations to the parent Committee." I think in that sense it is important to keep them as subcommittees. I think it is required by the charter but, also, it will eliminate and reduce any potential confusion.
DR. DETMER: I agree that they are subcommittees of the Committee, but I don't use that nomenclature myself, but at any rate let us put a motion on the table and decide what we want to do about this.
DR. LUMPKIN: I move that we name the subcommittees of the Committee the committee on blank, blank.
DR. DETMER: Okay, and I guess with the understanding clearly that they are subcommittees of the whole Committee.
Is there a second to that?
I don't hear a second.
DR. LUMPKIN: Never mind.
(Laughter.)
DR. DETMER: We won't even have an opportunity to address whether it is legal or not.
MS. GREENBERG: I will just point out that Betsy Humphreys when I said that something was a semantic difference told me that semantic differences were the only ones that mattered.
(Laughter.)
MR. SCANLON: Within the Data Council we named one of our subcommittees a committee on data standards, and it took about 3 weeks to explain to everyone that we weren't creating another committee.
DR. DETMER: All right. That takes care of that for lack of a second.
I think the issue of vice chair just to comment, at one point we discussed at the Executive Committee whether we should have a vice chair for the full Committee and after a fair amount of discussion that sort of went nowhere.
I think that as far as that goes I, personally, am comfortable as the Chair to let the chairs and the subcommittees, kind of talk that over and decide what particularly they want to do.
I think the key thing is, again, the organization and making sure that we do have somebody to chair a committee in the event that the chair cannot and that in fact that individual be fully informed and quite comfortable in assuming that kind of role.
Are people comfortable with that or what do you want to do? Okay, it looks like there is consensus on that.
We need to flag for the Executive Committee I think this issue of core data elements, and in fact some of that can come up in the discussions of the groups even at this meeting.
If something comes forward as a proposal, that would be fine, but at any rate we need to see where that goes, and we will need to obviously put names through this, and we did that as an Executive Committee because we wanted to make sure that obviously the Committee members principally did that.
So, is there a motion to approve this new structure?
DR. STARFIELD: So moved.
DR. DETMER: Okay, and a second?
MS. FYFFE: Second.
DR. DETMER: Any further discussion?
All in favor say, "Aye."
(There was a chorus of ayes.)
DR. DETMER: Opposed?
(No response.)
DR. DETMER: Abstentions?
(No response.)
DR. DETMER: Okay, thank you very much. I do, as I said, want to talk a bit as well before we leave this item about the staffing complement and needs. From my understanding the K2 work group on data standards actually subsumes right on into the subcommittee on standards and security.
The work group on computer-based patient records, Ross Wadner(?) is here, and he has agreed to sign on on the current staff agency list which is fairly hefty.
Going back up to the top there, Bill Braithwaite and Karen Trudell(?) are affected. If people are here and want to raise their hands in case some of the members of the Committee may not know you. You heard it as they introduced themselves coming around, but they are going to be co-leads on the standards and security. Michael Fitzmaurice and Bob Mayes are going to be co-leads on the computer-based patient records with Jeff and Simon.
Subcommittee on privacy and confidentiality, Winnie Leferts will be the lead staff, also, working with John, but she is the lead, and there is Bob Mayes who just came in. I just mentioned your name in your absence.
Chairing that committee will be Kathleen Frawley and Richard Harding will be the vice chair. Subcommittee on populations is Carolyn. You are here. Sorry, I didn't see you in the back, Carolyn. Also, Jim Sumi from AHCPR has agreed to participate on that subcommittee staff.
Jerry Handershot will take the lead on the work group on population-based data. We still expect to hear from other agencies as well on that, if I am not mistaken.
The work group on quality care, the lead is still in question. Stan Eddinger from AHCPR. Great, it is good to see you. Stan and we don't know yet who will be the lead although I am sure if Stan is the man that would be fine. No, that needs to be discussed as I understand it.
The work group on national health information infrastructure, Mary Jo Dearing is not here. Dina Pushkin will, also, be joining us from HRSA and some of the other agencies have not weighed in yet. I think I mentioned on the work group earlier on quality care that Kathy Coltin will be chairing that, and I will be chairing the health information infrastructure work group for the moment because it is sort of integrated across I think all of our efforts.
So, those are essentially other announcements, but I may have missed something or misspoke on something.
DR. STARFIELD: We really don't have a work group on population specific issues as this is laid out.
DR. DETMER: Yes.
MS. GREENBERG: I think that was inadvertently left off this matrix because if you look at the memo document --
DR. DETMER: It is integrated into the population is what has happened.
MS. GREENBERG: There can be a separate work group for that.
DR. DETMER: Yes, and I think it is integrated in the full subcommittee, but the Committee is going to be meeting.
MS. GREENBERG: Yes, we will decide that. I mean I am a little concerned with what Kathy said about the proliferation of work groups, and to be honest how you define population-specific issues apart from population-based data, the semantic differences may be important but they somewhat elude me.
DR. DETMER: The subcommittees need to sort that out, and then come back to us.
Other questions or comments? I think what we will want you to do because we named obviously some members of all these, but we did not mention all members of all these, and so I would urge you to look down this list because it would be great I think before we end tomorrow to know which members plan to be on which of these so that in fact, we will have that, and part of the trade-off we recognize is that we will just have smaller subcommittees.
I mean that is just the way it will be, and then I think we will have people, also, as we said, act as free agents to come to those meetings where they can.
That is uncomfortable, but on the other hand we do have lives beyond the Committee, and I think it is, also, a reality. So questions or comments?
John?
DR. LUMPKIN: I am surprised we have lives beyond the Committee.
MS. GREENBERG: We do our best to try to circumscribe those, but I think that some type of agreement or sense -- I don't know that the subcommittees will really be smaller, though I think at least from what I have seen so far, but work groups obviously won't be the size of the subcommittees although in some cases they might be. I don't know.
I think probably you need, what the memo says or proposed by the Executive Subcommittee was that everybody would need to be on, every member should be on at least, and it may be maximum for some and it may not be, one subcommittee and one work group.
That work group could, also, be within the subcommittee that the member is, also, a member of, and I think the idea was, but we need feedback on this, would be that that would be a commitment to one work group and one subcommittee so that you would be expected to go to the meetings that that work group or that subcommittee held, review documents, review minutes, participate in planning of agenda and whatever is involved.
Beyond that I think people could, you know, to the extent that the interests are there and the budget permits participate in another work group if they wanted to, but I would think that each of the work groups needs to have in addition to a lead, at least one or two additional members who are really committed to it, and maybe that is something in the sense of what Kathy was suggesting because we will have staff dedicated to particular work groups, and I think they need to have a core of at least three members probably.
I am just throwing this out.
DR. DETMER: Let us see how it shakes out. We will have to see how it plays out.
Kathleen?
MS. FYFFE: Yes, can we assume that the work groups will not meet concurrently?
MS. GREENBERG: That was the issue I was raising. I think we are going to have to be very creative here in allowing, maximizing our time but not tearing people apart which is really what happened with the previous structure two times ago and why we went to the structure that we had gone to about 2 years ago, and so, I think this is going to take some creative management, but with everyone's forbearance I think we will work it out.
DR. DETMER: Obviously I think there is going to be a tension period, and the numbers are really too small to not have some difficulties. I think the goal is to see if the structure better serves us, and it sounds like we are convinced it is worth a shot.
Good morning, Dr. Harding.
Jeff?
MR. BLAIR: You folks are usually ahead of me anyway, but just in case, Marjorie, if you have a list of names of the individuals that are interested in working on the different subcommittees and work groups you may be able to simply map that out and it may be clear that for example you may find a lot of cross population between the privacy and confidentiality and the standards and data security, and it may be clear that you don't want those to overlap. That is just an example, but in any event in terms of managing it once you get the names we may be able to minimize some of the overlap.
MS. GREENBERG: One would hope so, but I sort of doubt it actually from what I have seen, but I think we will have to work with that.
Do you want people to let you know by the end of --
DR. DETMER: Let one of us know, either Marjorie or myself what you want, and then before we leave tomorrow we will circulate a list and make sure that no stone is left unturned.
MS. GREENBERG: Is there any objection to sort of at least taking that as first a commitment to one work group and one subcommittee and then beyond that you can certainly indicate interest, but so that --
DR. DETMER: Yes, I think we will see where that shakes out, and then if we have to discuss it more we will. I think that is fair.
Are there more items on that discussion for today?
DR. STARFIELD: Can we just agree that the breakout sessions this afternoon is, in fact, for the subcommittee as reconstituted rather than as the original?
DR. DETMER: Okay, I think that is fair in light of our having passed this, I think we will be moving forward the rest of this meeting in light of the new organization.
Thanks.
DR. IEZZONI: I found an agenda that nobody else seems to have that has the subcommittee on population-specific issues having a breakout separate from the work group, and so, who knows where this agenda came from, but the problem has now been solved.
DR. DETMER: Okay, well, if they are all in one room, I guess --
DR. IEZZONI: Could I request, also, that I gather that Hortensia and Vince will be in tomorrow morning for the breakout that starts at 8 o'clock of the subcommittees as well because tomorrow morning is when hopefully at least our subcommittee, and, Kathy, I don't think you can be there tomorrow morning? Right.
That is when our subcommittee was going to try to hash out some of our organizational issues. You and I should probably talk, but we need to make sure that everybody knows the room number, especially since Vince and Hortensia --
MS. GREENBERG: Let me go with that now before we break. This afternoon in deference to the Committee, whether the Committee would actually approve this, some of the agendas, etc., used the former subcommittee names because they had not been officially approved by the full Committee.
So, that is why there might be a little confusion semantically, but in any event the subcommittee on populations will meet this afternoon in this room, the full afternoon from the time the sessions start, I think at two-thirty.
The subcommittee on standards and security is planning to meet in the, may be having some type of a meeting at lunchtime as I understand it, from yesterday's discussion but will be meeting this afternoon in the conference room, and the number on that is -- it is right next to Jim Scanlon's office. It is in his area. So, it is 440D.
So that is what is happening this afternoon, and the population-based data work group will be meeting with the subcommittee on populations. They will be meeting together. I mean there won't be two separate meetings.
Tomorrow morning at 8 a.m., the subcommittee on privacy and confidentiality will be meeting in this room, and then the subcommittee on populations will be meeting in 440D.
Now, I don't know that the subcommittee on standards and securities needs to meet tomorrow morning as well, but if you do we will try to find a place for you. There is always the cafeteria, but it seemed that since you had a full day meeting yesterday in this room we didn't provide for that.
Is that clear?
DR. DETMER: Okay, I think what we will do is take a break and why don't we make it 15 minutes, and then we will promptly resume.
(Brief recess.)
DR. DETMER: Now, that we are adequately reprovisioned, Glen, welcome. Hortensia I saw. There she is. It is good to have you with us, and, also, to have Paul Elstein with us who is going to talk about the quality of the HEDIS data, and he is here from HCFA.
Good morning.
DR. ELSTEIN: Good morning. Thank you. I guess I spoke a little bit about HEDIS data several months ago before your Committee, and I guess my charge is really to say what was found in the HEDIS audit, and what we can learn from it.
I was hoping that the people from the Alan Preavy(?) organization who did the bulk of the activities could be here today, but they are off on a site visit. However, I talked to Marjorie recently and suggested that maybe in the fall you would invite them to speak about what they have learned from this year's audit, and they can give you a much better discussion of some of the details from the data.
Going back briefly to what I mentioned last time, last year HCFA performed working with the Alan Preavy organization and some other subcontractors the first, quote, audit or validation of the HEDIS data.
What you have seen in the media was that, and my former manager, Bruce Fried was quoted prominently in one of the handouts, was that there were major problems with the HEDIS data as found in the audit.
However, the audit itself had some limitations, and I think it is important to look at those. First of all, while every Medicare contract received a baseline assessment, only 78 contracts were actually visited. That makes up about one-quarter of the contracts, but it makes up about 60 percent of the beneficiaries.
So, A, not every contract was audited. B, there was no real medical record review at that point. So, while the auditors looked at the systems, they did not look at medical records.
To me the plan had no, was not given the ability to correct the rates. So, once the rates were sent to NCQA with or without the audit, those were the final rates.
As I will say in a few minutes, we learned a lot from last year's audit, and I will talk about what we are doing this year.
I did give out a three-or-four-page handout which went out to the plans several months ago which you can read at your leisure. It goes into some of the details of the audit.
However, I think it is fair to say that there were a number of problems that were found by IPRO and the subcontractors. It could be broken down in different ways, and I will give you those areas that had the most problems, and then we can talk about how this could be corrected for the future.
One major area that caused problems was use of proprietary coding or proprietary forms. About 40 percent of the contracts use proprietary forms, and there were a number of problems with that. For example, several of the forms did not have enough spaces for all the diagnosis codes or procedural codes.
Many plans did not differentiate between primary and secondary diagnosis codes and often what they did was just look at where the code was placed on the form. So, the first code that was checked was considered a primary, and sometimes because the codes were arranged alphabetically on the encounter data forms diagnoses and diseases beginning with A or B were incorrectly coded as primary.
About 60 percent of the contracts used internally developed codes in their systems, and we found that a number of times the mappings, the standards codes were performed manually and were poorly documented.
Sometimes they would bundle services into one all inclusive code or use more detailed codes that had no standard coding equivalent.
Going back a step, the audit looked only at four HEDIS measures, breast cancer screening, beta blockers, the medical examination for patients with diabetes and the follow-up for hospitalization for mental illness along with frequency of procedures.
I think it might be worth our while to recognize those limitations to see what the problems were with each of those four or five conditions.
The breast cancer screening which was women from 55 through 69 having a mammogram at least once every 2 years was probably the best HEDIS measure that the auditors looked at. Even then there were some problems either with tracking 2 years of continuous enrollment or programming for the appropriate denominator population.
As I said, they were 55 to 69, but sometimes patients who were women who were 70 or older were included. There were some contraindications to the breast cancer screening, and those were often improperly applied, but in general the breast cancer screening measure was the best or at least the least worst.
Beta blockers which was, also, probably almost as good as the breast cancer except for the fact that the denominators were much smaller had a few problems of its own. For one thing the specifications called for use of a discharge date, but many plans used the admission date instead.
The specifications told them to exclude subsequent AMI episodes. Sometimes they were included, and often they included members who had discharged outside of the reporting years. Those two are the better ones.
Diabetic retinal examination had problems with denominator, numerator and with sampling. Again, the continuous enrollment criteria frequently was not met and this is one of the areas where many plans use proprietary codes that cannot be mapped back to the standard codes.
Sampling errors were sometimes plans incorrectly substituted medical records inappropriately and the major numerator problem was that to be credited for a retinal examination the procedure had to be done by an ophthalmologist or an optometrist, and in many cases the plan just noticed that a physician performed the procedure but did not check to make sure that it was appropriately done by an ophthalmologist or optometrist.
The measure looking at follow-up of hospitalization for mental illness had by far probably the most problems. Some of the problems we are seeing is others use discharge dates rather than admission dates. They used codes that were not in the HEDIS text of the manual and in the numerator failed to check that the required service was performed by a mental health specialist.
They often did not follow HEDIS medical record documentation standards and finally, with finished procedures we looked at about 12 procedures. There was incomplete database. They often understated the true performance of the plans.
I can proceed several ways. I can go on to some of the more common data problems. I want to spend some time on where we are going this year or I can answer questions, and I am not sure what the best --
DR. DETMER: Are there questions right now? If not, we can proceed.
Michael?
DR. FITZMAURICE: You mentioned the problem of low cohorts. That seem to be something that a pronouncement from the National Committee on Vital and Health Statistics could address. Is that something that will be helpful to HCFA and maybe to NCQH to recognize that as a problem nationally?
DR. ELSTEIN: I think it would be helpful for us to hear that that is a problem nationally. I am not sure given the current state of data systems whether HCFA, and I will speak for just myself, wants to abolish all local coding, whether even if we did want it, whether it would be feasible at this time, but it was clearly a major concern of trying to track it back.
DR. STARFIELD: You are saying that it may be a benefit for payment but a detriment for quality.
DR. ELSTEIN: No, I am saying that it may take a lot of time before that can get fully implemented.
DR. STARFIELD: That is fair.
DR. DETMER: Barbara?
DR. STARFIELD: Could you just say a couple more sentences about the frequency of procedures?
DR. ELSTEIN: Yes, we looked at 12, I believe it was 12 procedures, prostatectomy and a bunch of others to see how often they were performed and unlike the effectiveness of care measures which where there was any problem and let me be blunt about this, IPRO did not find any fraud, did not find any intentional miscoding but where there were problems it was often over reporting in the effectiveness areas.
In the frequency of procedures it was the opposite, that because of the incompleteness issue which I want to talk about a little bit later on, that they often did not produce, their data systems were such that they did not have enough information. So, they frequently understated their true performance.
Now, we could argue or the clinicians here could argue whether it is good to have a lot of procedures or bad to have a lot of procedures, but the point is that whether it is good or bad, the numbers were inaccurate, on the low side.
DR. STARFIELD: The thought was to get sort of population rates of these procedures, population being the enrollees.
DR. ELSTEIN: In looking at the HEDIS measures we thought that the frequency was the best utilization measure that we could find, and they were easier to audit than some other measures.
MS. COLTIN: Did you happen to look at in your data whether or not the plans that had the most problems were plans that had never produced HEDIS measures before? I mean some plans had been voluntarily producing them for the commercial population, but when HCFA required them for Medicare it really became the first time that they had to do them, and there was a learning curve.
DR. ELSTEIN: The answer to the question is it has not quite been done yet. We do have the data both from last year and certainly from this year on which plans had previously reported HEDIS data. We could do a crosswalk. The problem with doing it last year was because with 79 markets that were reporting it might or might not have been interesting.
However, I think since we are going to have all the markets reporting this year we could very much do that kind of analysis, and I believe our feeling, and I think IPRO would say if they were here that in general those that had previous either HEDIS reporting for commercial or Medicaid or others had a better data system than those that did not.
Perhaps the other side of the picture was the larger contracts would be the ones more likely to have had previous HEDIS reporting and more likely than not they would have the better data systems as well, but I think it is something we will be looking at this year because we are asking for it and how many years they reported it, also.
MS. COLTIN: So, we don't know what is causing what? We don't know if it is that the plans that had the better data systems were the ones that chose to report and therefore, also, did better or whether in fact the fact that they had reported in the past led them to improve their data systems.
DR. ELSTEIN: Yes, I would think at least the second one has face validity, that going to HEDIS last year, especially for the small contractors, but even for some of the larger ones who did it the first time for Medicare, the first time they saw HEDIS was a massive effort, data collection effort and a difficult one which was compounded by software and other problems that were outside of the control of the plans.
DR. DETMER: Lisa?
DR. IEZZONI: Yes, I was going to follow up on Kathy's question. Kathy, didn't MCQA audit some HEDIS data a number of years ago?
MS. COLTIN: When they did the report card pilot project in 1993, there were 25 plans that participated in that, and all of them were audited, and having been one of the plans that got audited I can say that we learned a lot from that process.
DR. IEZZONI: I was going to ask whether the same kind of problems, you know, from what you are hearing from HCFA, are those the kind of problems that you had back in 1993?
MS. COLTIN: Yes.
DR. IEZZONI: Are they the same kind of learning curve problems?
MS. COLTIN: Yes, I mean I think that a lot depends on where you are starting from and how good your data systems are to start out because if you have problems with your base data systems fixing those takes longer. It is not likely that your next year's measures are going to look far superior because by the time you are getting these measures you already are halfway into the next year. So, you discover a problem.
You cannot really fix it in time to affect your measurement for that year, but, also, some of these things require changes that need to go all the way through the delivery system in terms of changing source documents that may be getting used in individual physician practices, you know, in order to supply the data.
So, a lot depends on whether the problems have to do with the underlying data or whether they have to do with the plan's ability to implement the specifications for the measures.
DR. IEZZONI: Could I follow up on that? I guess what I was wondering was what the remedy is going to be, you know and whether the same kind of problems that NCQA found a number of years ago were the kind of problems that you were finding; what kind of remedies were implemented a number of years ago when NCQA found the problems with their 25-plan audit and whether these are sheer educational issues or whether they are real systems issues that are going to require resources on the part of the health plans to be able to fix, and that is expensive, and they might have priorities in other areas like 2K problems or whatever, you know, that they need to address and so how you are thinking about remedying what you found?
DR. ELSTEIN: It is certainly a major concern. We cannot live year after year with plans reporting data that might not be, based on systems that might not be able to report accurate data.
Sometime within the next, I was going to say the next couple of weeks but certainly within the next month, I pray, all the HEDIS data are going to be out on the Internet, along with the Executive Summary of the IPRO, along with ways of consumers using the data. It probably won't be out for several more weeks.
If consumers want to use the data to compare plans which is certainly one of our goals, no matter how many times we tell them that these data may not be totally accurate, they are still going to use it. What we have to do, and this year we are doing an audit of any contract market, not just a sample, we have to work with the plans to make sure that these data are accurate.
We have three purposes for using the data. One is quality improvement, working through the PAVU organizations or other organizations and through our own monitoring. A second is for the plans to use it for their own quality improvement purposes, but in using it for plan-to-plan comparison you don't want to penalize a plan that has a good data system and reported data accurately, even if it is a little low compared to one that may have a poor system that inaccurately reports higher rates, not because of fraud, not because of bad reasons but because the data system is not working.
So, we recognize it is expensive to fix these. We recognize that Y2K is around the corner, and that is going to cost presumably many of the plans much money but on the same hand as we require encounter data now as we report HEDIS data the next few years we have to work with the plans and get across the methods that these data systems have major problems.
The IPRO and its subcontractors are sharing their results with the plans, and I don't know, Kathy or the plan people, if you have gone through your audit this year yet, but I am not going to ask you. I will wait, but realistically the plans are hearing from the auditors what their problems are. How they are going to be fixed requires much more discussion than I can give and certainly we would welcome the Committee's recommendations on this.
DR. DETMER: Kathy?
MS. COLTIN: I actually think you hit on one of the most important things you are doing that is going to fix it, and that is requiring the encounter data and basing payment on it because yes, it is going to cost money to fix the systems, but not fixing them could cost more money.
So, I think your problem of inadequate reporting or not capturing all the secondary diagnosis codes is going to be a costly problem in the long run given the way you are heading, and I think that the same thing may be true on the procedure side as well.
So, some of those kinds of occurrences, and those are happening in the states with regard to Medicaid reporting as well are going to do a lot to improve the quality and completeness of the data that the plans submit, and you don't fix a problem like that for one population. You fix a system and it becomes better data for the commercial population as well as the Medicare and Medicaid populations.
So, I think that is a big factor that you are going to see. I know that back in 1993, when we went through this we were one of the plans that had the problem with not differentiating a primary and a secondary diagnosis in the outpatient setting in our staff model health centers because we didn't generate claims and in a computer-based patient record we didn't need to designate primary and secondary diagnoses for these visits. So, it wasn't being done, and we had those problems.
That problem was fixed, but it wasn't fixed because of producing HEDIS measures. It was fixed because those staff models eventually had to be able to generate bills and in order to generate bills they had to be able to differentiate primary and secondary diagnoses.
So, I think financing really is a big factor in driving the data.
DR. DETMER: Richard?
MR. HARDING: You may have mentioned it, and I apologize, this is Richard Harding for the recording. You mentioned that the HEDIS data were going to come out on the Internet within a month.
DR. ELSTEIN: I was hoping by June 15, but it is not out.
MR. HARDING: And that the data aren't exactly apples to apples. It is apples to oranges sometimes. What kind of a disclaimer or how is that explained over the Internet because I can see the consumers getting mixed up and also this being used by health plans to brag or to duck? What is the process of disclaimer?
DR. ELSTEIN: Actually let me tell you first why it is going to be on the Internet with all the problems, and this is summary data. It not patient specific or anything like that. It is the rates.
The Freedom of Information Act requires us to make this data available. We can give it out without any kind of caveat, and we feel that would be a major error. So, rather than give it out at random, we will be writing in the materials that will be on Internet many of the caveats, some of which we talked about today, others that we didn't mention.
Some plans will not have rates for some of the measures because their denominators were too small or for other reasons. Obviously we hope people will read them. More importantly we hope the media will read them. We cannot guarantee that will happen, but we will have a caveat there.
We, also, will have a few measures which will be part of the general -- and I said that the Executive Summary IPRO report will be part of that package. Another part of it will be a few areas, a few measures which we think are more useful to consumers than the other 27 or 26, and we will have those in more of a market area basis, perhaps MSA or county. It hasn't been worked out yet.
Not all those measures will have been audited measures, and IPRO did raise the point which is worth thinking about that you cannot draw from audited measures information about non-audited measures, but we are in a box because of the Freedom of Information requirements that we had to figure out a way to list the problems while at the same time making the data available to the public, and as I said, our main concern isn't so much the consumer, and we recognize many beneficiaries are on the Internet but most are not.
It is what the media does with these reports, and if they say that Harvard Pilgrim is let us say better or worse than other plans in New England we want them to recognize what some of the limitations are of those data.
DR. DETMER: Lisa?
DR. IEZZONI: I am a little bit confused about the Freedom of Information Act justification.
As you know, in 1986, HCFA started releasing hospital mortality rates. Bruce Vladick rescinded that back I think in 1993, specifically because he felt that the data quality was so poor that the mortality rates weren't telling people anything meaningful about quality of care, and so if Vladick rescinded the mortality rates at that time, and it was no longer done under Freedom of Information Act I am just a little bit concerned about the use of this rationale now for releasing what sound like highly kind of suspect data.
DR. ELSTEIN: Vladick, I mean I was involved with some of the discussions that are worse than that. It wasn't on freedom of information grounds. It was that the data weren't collected. Therefore we didn't have to report. HEDIS, we have gotten the data. We have got to use it.
DR. IEZZONI: I won't spend time, but the data were collected on mortality.
DR. ELSTEIN: They weren't analyzed.
DR. STARFIELD: Why do you have to publish them by plan, I mean since it was a sampling anyway? Can't you just A, B, C, D, E, that kind of thing?
DR. ELSTEIN: We could do that, but now that we have the data by plan, I mean realistically we want to use the data. We want to use it for quality improvement purposes. We want to have the plans use it, and the plans have gone to a lot of expense and time as have we, as have the auditors to look at this. We are not saying that these data are no good. We are saying that there are problems with the data, and we are expecting that next year's data will be better for several reasons.
One issue I did not mention before, as far as the medical records we found that or IPRO found that many of the plans, the people who did the medical record abstraction or review had little or no training in HEDIS, and there were some major problems with the medical records.
We did not do a sample of medical records review in last year's audit. This year we are. IPRO will be doing a random review of charts for each plan, for each measure they audit. That will give us a better understanding of the accuracy of the medical record review that plans have done. Those plans use the Harvard method this year.
This year we are looking at the data and auditing the data prior to their submission. So, the data that are submitted to NCQA this year will have been audited data and the plans will have adopted planning to correct the findings. That means that for next year's release which I am sure will be on Internet or something like that and don't forget that those data are more accurate because of the reviewers going over the data with the plans prior to submission and because of the medical record review.
What I started to say is we have Balanced Budget Act requirements to report the data in hard copy next year. So, as bad as our obligation has been on the Internet what we report in the Medicare Handbook I think is a lot more serious, and HCFA has a much bigger burden to ensure that these data are as accurate as possible.
MS. COLTIN: In my experience there were three types of major categories of problems. One is problems with the underlying data. One is problems with the experience of the staff in the plans with applying the specifications which for many of these measures are very complex, and if they haven't done this sort of thing before going through the audit process will be a real learning experience for them, and that will get better, and my sense is those improve a lot more quickly, those kinds of mistake go away.
The third is new measures that get introduced in a given year. It is very difficult to specify a measure perfectly, and so measures get introduced, and they have some ambiguities in them that are not identified at the time they are being released, but when programmers who need to get down to the very, very specific level start to do it, they say, "Did you mean this or did you mean that?"
Different plans start interpreting those specifications differently because of the ambiguity in the measure itself, and as a result of that my understanding is that NCQA is adopting a policy that they will not put a measure into quality compass, in other make it public the first year it is produced until they have learned what some of the problems are with the measure itself and been able to fix the measure.
The beta blocker measure is a very good example of not having done that and having had a problem. There is a list of exclusions of patients who are supposed to be excluded from the denominator because they have conditions that would be contraindications for using beta blockers, and it makes a big difference to the measure whether those contraindications are applied at the time you identify the AMI discharges and then apply those exclusions and then look for beta blocker or whether you look for beta blockers for all of the patients and then for the ones where you don't find it you say, "Was there a reason for them not getting it?" and then apply the exclusion.
We found that there were lots of patients who got beta blockers who had a diagnosis on the exclusion list and when we looked into it further we found that a lot of that was patients who were inappropriately included in the diagnosis.
So, this is a case of a patient having a diagnosis in administrative data who that is really a false positive. So, for instance, someone got a blood glucose test and got the label of diabetes, but they are really not a diabetic. So, they would get excluded from the measure, but in fact, they really didn't need to be excluded. So, you have those kinds of underlying data problems, too, but I think that one can be fixed as well by having this kind of one-year learning period and tightening the measures and saying, "Okay, everyone is going to apply the exclusions at this point in the process."
DR. ELSTEIN: On that last point, the measures for this past year were identical as far as the measures were concerned to the previous years. Now, specifications have been refined both because of the HEDIS users' group and I guess the HEDIS coalition and others. The specifications problem is a major concern.
Quality compass refined the point. It really wasn't audited data. So, maybe now it may be audited.
I think one of HCFA's burdens which will be coming out tomorrow at the CPM meeting is do we automatically adopt measures that the Committee on Performance Measurement recommends or do what Kathy suggested or I guess what Quality Compass is doing is wait a year. They will have the specifications more clearly defined.
I mean the measures have gone for public comment, and most of these have been testing measures. I am not clear how much comment is being given on specifications.
DR. DETMER: What else do you have to offer and then we will continue to take more questions?
DR. ELSTEIN: I want to spend a couple of minutes on this issue of data completeness. This was something that we found last year. It ties in with a little bit of the discussion we had before on the procedures, but it was something that last year we noticed, and we are trying to figure out how to deal with this year, that when IPRO looked at the data they did find that there was a large percentage, and I will make up a number but it was around 20 percent of the data were not really complete.
In other words these were services that were performed that were documented in the claims database or the ENCAVASON(?) database. This incompleteness may have been due to lag factors or the fact that whether providers under capitation are required to submit these data and document the services.
So, this year we are going to be looking at the completeness issue, look at medical data, especially provider data, membership data. The audit documenting the assessments, now we are not going to use completeness scores for plan-to-plan comparison this year.
In other words, if a plan has a very incomplete database we are not going to say or list it as NR, a not report. We felt it was inappropriate because of the very short time frame given to the plans on this.
We will make note of it, however, but I think for next year, for 1999 when we do the, however the audits are next year we will be looking at completeness. We will be saying on any kind of comparison chart that this plan may have reported this measure but the measure was not complete and therefore they get an NR which means not report which I think will give the plans a real incentive to have more complete data, if not this year then next year.
The only other issue I would like to raise, and then I will go back to questions is for the past 3 years HCFA has financed the cost of the audit using IPRO and two subcontractors last year, IPRO and several more this year.
Our intent for next year, and this obviously is still in the final stages is that the plans will be required to fund the audit using a pool of certified auditors either NCQA certified or maybe certified some other ways like they are doing with some other areas, the HEDIS help with seniors measure being one.
As I said, I expect the HEDIS data this year will be actually what we talked about including the experience the plans have had in reporting the data, but until the plans really have strong incentives to have good data systems, whether it is because of payment areas, because of the fact that the media picks up on these measures and tries to look behind the measures or whatever reasons, until that happens the managed care data will not be 100 percent complete or accurate.
DR. DETMER: Richard and Dan?
MR. HARDING: I just came back to my disclaimer thought on the Internet. It would make me more comfortable if when I logged on and so forth it said something like,"This is self-reported data that varies with expertise in abilities and so forth, some of it audited, some of it not, that it is probably most valuable for internal evaluation within a system as opposed to comparing non-profits versus profits" which I have seen that kind of thing all of a sudden sprout up, that it is not really accurate for comparisons because of the data the way it is collected and the expertise at this point, you see, this data that is coming on line and that the data completeness varies with the plan.
Those kinds of disclaimers would make me feel better about people then using that data for all kinds of good and complicated reasons.
DR. ELSTEIN: If you want to e-mail to me, and I am serious, I would like that.
MR. HARDING: Those are just a couple of thoughts.
DR. ELSTEIN: When you get back, it is P. Elstein at HCFA.gov. I think there are a couple of areas in there which might not be quite the way you said it, but I would like to get that or anyone else on the Committee's thoughts as well before this does go on the Internet, but there are clearly are going to be a number of disclaimers along the lines of what you are saying.
Now, having done the hospital mortality for 5 years we have made disclaimers on there as well, and even the informed press often chose to ignore it. So, I will leave it at that.
DR. DETMER: Dan?
DR. FRIEDMAN: You had mentioned that some of the data were going to be available by market area?
DR. ELSTEIN: Perhaps.
DR. FRIEDMAN: Within plan by market area or across plans?
DR. ELSTEIN: Certainly when we go into the published version, in other words, when it goes to beneficiaries as part of the information I will be getting in the Balanced Budget Act, we don't want to send beneficiaries 500 pages of text.
So, in that case we would certainly go by market area, maybe state, and some states have very few plans, maybe being an MSA in those states which have a lot. It is, also, quite possible that this year on the Internet when we look at the measures that we consider the better or more useful measures we would, also, have that by a comparison done by market areas, quote, market areas, and as I said, there again it could be a state. It could be an MSA. It could be a couple of counties.
DR. DETMER: Jim?
MR. SCANLON: Paul, are there consumer satisfaction measures as part of the array of indicators, and what is the source of that information?
DR. ELSTEIN: In HEDIS there were a consumer satisfaction survey which we are not using. We are using a CAPS satisfaction survey developed at AHCPR by R. T. Eye and Rand and Harvard. The CAPS survey was administered separately by a contractor this spring.
Our expectations are that I will say November, and I think that is probably a pretty good guess, those of you who have looked at Medicare Compare which is on the HCFA web page right not it is basically plan-to-plan listing of benefits, copayments and some other information.
Our expectations are the CAPS satisfaction survey measures or summary measures or compilations of those will be included on the Medicare Compare this fall.
So, for example, there is a huge number of measures in CAPS. Our people will be doing a compilation of putting together measures in one area or two areas of satisfaction with the providers, for example, satisfaction with the way the plan harmonizes the responses.
I mean I cannot go into what they are now because I don't know, to be honest, but those would be on Medicare Compare. Because they are not part of HEDIS they are not going to be part of this selection.
Now, there is a major effort under way to merge the CAPS and the HEDIS satisfaction surveys. So, in the future it may well be included with HEDIS Medicare. The commercials have been often using the HEDIS satisfaction survey themselves.
DR. DETMER: Paul, I think what I am hearing from the group is that I think we would like to hear back actually from you explicitly either through Stewart or whatever what this Committee could do to obviously help this process because it is fraught with both a lot of upside potential but, also, downside potential, and I think among other questions that I have got, do you have that you could include with that report sort of an information about the information systems themselves and how much does in fact some of the robustness of those systems really does correlate as a proxy of better data and so forth.
I mean one question obviously that is sort of an implicit assumption is that if people have better data systems then in fact you typically get more accurate information. I don't know if you have really tested that hypothesis, but I think it is very useful because there is a lot of sense that these are expensive systems.
They involve a lot of behavior changes. Well, do they really lead us to greater fame and glory, and I think a number of us want to believe that and do, but it would be good to have some data.
In March I testified to the Health Subcommittee, Ways and Means and one of the questions that I got from Congressman Thomas is do we need to be doing something to help actually put incentives to try to help underwrite some of these information system costs that move us toward computer-based records, and so, I think there is a set of questions about information systems.
There is a set of questions about terminology and how does that play in and I think a set of questions about what could this Committee explicitly do to help obviously quality be improved in the country which is what we want to do.
DR. ELSTEIN: I will work with Stewart and with Bob Mayes, also, on that.
DR. DETMER: That would be terrific.
DR. ELSTEIN: I, also, suggest that maybe in 6 months or so when IPRO has finished the second audit, I think if you get much more technical information it may show improvements but, also, I think it will lead to questions that you might think about further.
DR. DETMER: Kathy?
MS. COLTIN: I was going to say that another area where this Committee might want to make a recommendation is it has come up again and again in discussions among the plans around developing these measures that a really scarce resource is trained analysts, people who come out with a master's in public health who know how to work with data systems, who have a background in measurement design and know how to construct these kinds of measures and plans are out there competing for these types of individuals to hire them to work on producing quality measures, and there aren't enough people like that.
We are competing with academia. We are competing with consulting firms, and the funding of traineeships, I think for people to develop these kinds of skills is an area where we might want to make a recommendation.
DR. DETMER: Yes, I think our next agenda item in fact is another letter of response to the Quality Commission for example, and I think what we will in all likelihood want to respond to this as an issue because it is very visible; it is very important, and I think it would be frankly much more helpful for us to try to respond to you about some of those issues rather than maybe your inheriting a response from us that may or may not be really useful, you know, as useful to you as it might be, but I think that could be good.
I mean we ought to look at this pretty comprehensively, and we may want to track it because it sounds like clearly HCFA is going to be in the business of doing these sorts of things.
I mean they have sort of said that over the last number of meetings, and they are moving that way. So, I think it is going to be very important for this group to help try to serve that function between government and the greater sector out there so that the thing actually at least does some good without creating both confusion and other kinds of emotional responses.
DR. ELSTEIN: We would like to work with you very closely on that.
DR. DETMER: Okay, great.
Thank you very much.
Okay, our next item is as I mentioned, comments on the Quality Commission final report, and you have actually at your seat a draft, and this is something that Dr. Starfield and Ms. Coltin have put together, and I don't know which of you wants to lead us through this.
I think it would probably be useful to do it that way, and then we can discuss it and see if we want to, in fact, have this as an action item that comes out of the Committee for signature.
MS. COLTIN: Let me say that the first thing we did was start off by referring to the previous letter from the Committee on the consumer bill of rights and responsibilities because a lot of the same issues that are raised in the final report were raised in that previous report, and we had previously commented on those.
So, we have referred back to that letter of March 10, and I believe it is in our meeting material packet as well for anyone who wants to reference that, and in that letter we had talked about things like standardization of quality measures, comprehensiveness of measurement sets, cost effectiveness of data collection strategies, the importance of cultural competence of providers to a consumer empowerment strategy and the need for a comprehensive confidentiality law, and therefore we did not go into those issues again in any depth in this letter.
We felt that the points were actually well made in the previous letter. We then proceeded to identify those areas that we felt we wanted to lend our endorsement to those particular recommendations. Those begin at the bottom of the first page and continue on to the second page.
I don't know if you want me to read through them. I know you haven't had this long or if you just want to glance at them, but I think it will be important to determine whether we have a consensus on whether we want to endorse each of those points as a Committee.
DR. DETMER: I think if you don't mind, just go through them, and if we have questions, I mean I guess it is up to the group, but it seems to me it would be worth doing this, and then if we find that we want to study it overnight or something and act on it tomorrow, fine. I think we ought to go ahead and just go on through it.
MS. COLTIN: Okay, the first point that we wanted to endorse was strengthening the evidence basis for health practices while noting the previous communication in our March 10, letter about the need for flexibility in defining what constitutes an acceptable evidence base for particular populations or services.
Did you want to stop and have discussion on each one?
MR. HARVARD: That sounds a little like a hedge on that issue. I wouldn't know what to think about it, if I was reading it.
MS. COLTIN: I think the previous letter had more to do with requiring an evidence basis. Here we are talking about strengthening the evidence basis, and our reservations in the earlier letter had to do with requiring it before it existed.
Here they are talking about building it, and I think that is the difference in terms of endorsing the strengthening of it because really our reservations did, I think revolve more around the --
DR. IEZZONI: Yes, and Richard, if you go back to the March 10, letter, we talk about how different services, for example, defining effectiveness in mental health services is going to have a very different standard than defining whether a beta blocker is appropriate after an AMI, and so what this is doing is kind of just re-emphasizing what we said in the March letter. You might have to have different types of evidence for different types of services.
DR. DETMER: Arguing for evidence, just trying to make sure that it is the right evidence related to the issue at hand.
DR. IEZZONI: It is not totally acute medical paradigm base.
MS. COLTIN: If it reads as a hedge we may want to consider the wording. It is not a hedge. It is saying that we endorse it but when you do it, be aware of the need to --
DR. DETMER: All right. We may want to word smith that.
MS. COLTIN: Okay, second point was the recommendation to strengthen and coordinate quality measurement reporting and oversight functions within and across the various sectors of the health are industry. There were a number of recommendations that dealt with that.
Third is stimulating quality improvement within health care organizations and professions. A lot of this is motherhood and apple pie. So, I don't know.
Next is promoting accountability for performance throughout the health care industry and at the community level, and the final one was empowering consumers to make informed choices about their health plans, providers and treatments.
Okay, then we singled out the area of investing in information systems because that was a chapter of the report that related very directly to a lot of the work of this Committee, and we wanted to make some particular comments around that area. We are actually trying to, also, make the point that there is a real connection between what was being recommended and what we are doing here, and how what we are doing actually does relate to some of the objectives.
So, the major bullets that are listed, the three of them have to do more with what we are doing here and the sub-bullets under them have to do with how what we are doing contributes to areas that the Commission has identified as objectives.
DR. DETMER: Part of the reason I think this is really pretty critical is that among their recommendations they recommended creating some new fora and new mechanisms by which some of these things can be related to.
This is very much our charter and our area and although we testified certainly to the Commission the report doesn't necessarily as sharply perhaps and as clearly identify what I think we are doing as this letter I think could do. Is that --
MS. COLTIN: Right, and I think that was part of the underlying intent here was to make it clear that we have and can continue to play a very important role in helping to further some of the recommendations that came from the Commission.
In fact, I skipped over the introductory sentence in the second paragraph where we acknowledge that a number of us were in fact, asked to provide expert testimony to the Commission as well.
DR. STARFIELD: One more thing about that towards the end of the letter, as you will see, we identified areas that we have begun working on that may not be visible yet.
DR. DETMER: Good.
MS. COLTIN: So, I am going to move on then to the next page. We made one point around the investing in information systems that you may want to discuss further.
The statement reads that while we applaud the Commission's focus on investment in information systems we would like to encourage a broadening of this concept to information technologies, thus including telemedicine as a tool for improving access to needed care.
I didn't really see anything much in the report around that. Okay, one of the points that we, also, wanted to make, the next paragraph really begins to lead into how we can further the work of the Commission.
The second sentence talks about the fact that the Commission did an excellent job of articulating what needs to be done to further their stated purpose and now we as a Committee have the opportunity to articulate how some of the more data dependent objectives might best be supported.
So, for example, we strongly agree that measuring and reporting on care for vulnerable populations is an important objective, but the ability to achieve that objective rests in great part on the ability to identify relevant population subgroups through existing data channels, an area where this Committee has and continues to play an important role.
So, it is those kinds of connections that we are trying to make around how are they going to further that objective when that objective rests in large part upon the availability of data that may or may not be up to the test.
So, there are a number of areas identified. I don't know if you want me to go through all of them. I talk about addressing gaps in existing data that would include evaluating and recommending sources of information for tracking errors in health care delivery and sources of consumer satisfaction information that might complement standardized member or patient surveys, so just information on complaints or grievances or on reasons for disenrollment from a health plan as examples.
I then say, "Indeed, we were struck by the number of opportunities we now have to contribute toward realizing the many objectives of the Commission for enhancing quality measurement and improvement capabilities that depend upon a strong health data and information infrastructure, and that many of our activities, and I list some of the nature of some of those activities will actually go a long way toward supporting those recommendations.
I then move more to our work plans for the coming year, and say that in formulating our work plans there are a number of key areas in which we are proposing to further those ends within the scope of our own charter, and Barbara and I mention a few of them that we thought were particularly worth noting.
So, evaluating the adequacy of existing data on which to base quality measurement priorities, one of the starting points that the Commission identified for the council, the advisory council is setting priorities for measurement. On what basis will those priorities be set? What types of data will be necessary in order to do that, and do we have the information that we need to support those kinds of activities? I think the data are a lot stronger in terms of things like prevalence of morbidities, causes of death and so forth than they are causes of errors, for instance and problems in the system.
So, I think that is an area where we can look at the data that would be necessary to inform those decisions and make some recommendations.
A second is improving data quality through facilitating the adoption of the computerized patient record and monitoring adoption of administrative transaction standards, facilitating data linkage through the adoption of the uniform health identifier and other health identifiers.
This really just ties into the work that is going on in our standards security subcommittees and the CPR work group. Identifying important data context gaps with respect to quality measurement and offering recommendations for resolving them in future releases of claims enrollment, pharmacy and administrative transaction standards or in the CPR.
I would expect that work to be done in the quality work group. Recommending data content formats and functionality of CPRs to support quality measurement and improvement, that is something that could be part of the work plan in the CPR work group, and assessing the risks and benefits of alternative definitions of individually identifiable data, I think that is something that has been addressed somewhat in the subcommittee on privacy and confidentiality and may warrant further exploration, and then we go on to identify some longer term areas where we may make contributions toward particular objectives, such as ensuring the appropriate use of health services and what kinds of data are necessary to do that, expanding research on new treatments and evidence of effectiveness and what types of data are important to that and reducing the underlying causes of illness and injury and the types of data important to that.
We, also mention that we are currently planning the National Conference on Data Needs for the Twenty-First Century as another activity that we feel will be important in contributing toward understanding the underlying data issues and data needs that are important to accomplishing many of the objectives that the Commission identifies.
So, that is really I think a summary of the main points.
DR. DETMER: I think that is very useful and gets this fully out on the table.
Do you want to make some other comments?
DR. STARFIELD: I was just going to make a clarification. This is really a question for the Committee. You may recall that early on in the report the Commission identified six areas, and I will just remind you what they are.
First is addressing over supply and under supply of health care resources. The second one was ensuring the appropriate use of health care services. The third was expanding research on new treatments and evidence of effectiveness. The fourth was reducing health care errors. Fifth was increasing patient participation in their care, and sixth was reducing the underlying causes of illness, injury and disability.
Now, I thought they actually could be collapsed into three and the recommendations here relate to three of them, but one is omitted and I didn't know whether we wanted to relate the work of this Committee to that one and that was addressing the over supply and under supply of health care resources which I guess we really haven't been that involved in.
DR. DETMER: What is your pleasure, folks?
You stupefied us.
DR. STARFIELD: And I don't know whether we should be into that or not.
DR. DETMER: Elizabeth?
MS. WARD: It seems to me that it is not an area we have addressed. So, I don't know why we would bring it up unless we want to say that we have not done such and such.
DR. DETMER: I guess there is a sense that you made the right decision on the front end.
DR. STARFIELD: So we just leave it?
DR. DETMER: That sounds good.
Other questions or comments about what we do have in here or areas that we don't have that we think should be added?
John?
DR. LUMPKIN: One of the areas that is not addressed here, but I think is added reason for our involvement is the issue of the impact on quality assessment on administrative burden, and there are two components to that.
One is the fact of the uniformity of these quality measurement systems, providers who deal with more than one managed care plan, who have to deal with two or three or four different surveys all trying to collect the same, quote, HEDIS data or whatever quality data that may occur, and that adds an additional burden, and certainly we have been charged and tasked with administrative simplification.
The second piece is some disturbing reports I am getting back of patients who if you have the right disease your chances of being surveyed and quality assessment goes up dramatically as we begin to focus on certain areas in the quality measurement arena, and that begins to present a burden upon patients, and so, some standardization of data collection methodology I think is really being demanded or will be demanded, and of course, that is consistent with our charge.
DR. DETMER: Would you want to draft a couple of sentences to summarize some of that for this?
DR. LUMPKIN: Sure.
DR. DETMER: Okay.
Richard?
MR. HARDING: Just an editorial thing on Page 3. Would it be possible, would it be considered a friendly amendment so to speak to put the third bullet either second or first? It always seems to be the last one, nothing personal on this one, but it always seems --
DR. DETMER: I certainly don't see why we cannot do that.
MR. HARDING: Juts make it second or first and that would make me feel a little better.
DR. DETMER: All right.
MR. HARDING: And the second bullet at the top, empowering consumers to make informed choices about their health plans, providers and treatments, it would seem to me that the issue there would be empowering consumers to make non-coerced choices, informed choices or is that too strong for what you had in mind?
MS. FYFFE: It puts too much of a value on it. Informed sounds a little more neutral.
MR. HARDING: Okay, that is why I was asking the question.
DR. DETMER: Do you have others?
MR. HARDING: That is all.
DR. DETMER: Stewart and then Barbara?
MR. STREIMER: I have a couple of minor edits. May I just e-mail those to you?
DR. DETMER: Sure.
MR. STREIMER: Rather than take the Committee's time.
DR. DETMER: They don't change content?
MR. STREIMER: No.
DR. DETMER: Okay, Barbara?
DR. STARFIELD: I intend to ask Kathy if we can change the term post-acute to something else? You look puzzled.
DR. DETMER: That just is a continuing dialogue. I don't know how quickly we can resolve that. I don't want to hold the letter up for it.
DR. STARFIELD: Will anybody be upset if we find a substitute?
DR. DETMER: If you can find the right one I am sure they won't be upset. I am, personally, not troubled, but I know that this is a word that has some value around it.
DR. STARFIELD: Can someone fill me in on what is wrong with --
DR. DETMER: It may be fine. She doesn't like it. What would you substitute.
DR. STARFIELD: It really isn't post-acute. What we are really after is data in all those that are not so conventional places. We have always used encounter data in terms of the traditional physician patient office and the traditional hospital, but there are still lots of other settings which aren't well described by post-acute. What we really mean is care over time, that kind of thing, and it is not always post-acute.
MS. COLTIN: Except that in the context in which it was used in this sentence I think we were trying to refer to the initiative that had been undertaken by the population specific issues work group which was called post-acute and I believe which focused primarily on skilled nursing facilities and home care.
DR. IEZZONI: I understand Barbara's reservations about the term. The problem is that the term has a meaning to a lot of people right now and coming up with something that is succinct and terse and would have similar meaning to a lot of people would take time, and so, I suggest we continue to use post-acute care in this letter, and we hash out in our subcommittee how we might try to move the ocean liner slowly to point in a direction that Barbara feels more comfortable with to appropriately reflect the caveats around the term "post-acute."
DR. STARFIELD: Like Betsy Humphrey says, "Semantics is everything," right?
DR. DETMER: Right, exactly.
Mike?
DR. FITZMAURICE: Would it be inappropriate to suggest that maybe NCVHS has been a proponent for the development of appropriate data and tools for measuring the quality of care provided in all settings, not just restricted to post-acute but say, "We are interested in all settings"?
DR. IEZZONI: I think that the Balanced Budget Act makes very clear that there have to be certain prospective reimbursement systems for home health for nursing homes, for rehab settings. This is a policy, a top policy issue right now that frankly has gotten a lot of short shrift in a lot of our Committee's discussions and other places, and I do think that it would be appropriate to pull them out and just underscore them, using the imperfect term "post-acute."
DR. DETMER: Maybe what I am hearing is either a footnote that may explain some of this to folks who aren't aware of the balance in this particular word, but that might help because we are interested in, obviously, a variety of areas.
MS. COLTIN: It is not speaking to what our broad interests are and where we are going in the future. This is trying to look at what we have done and our focus recently has been more limited.
DR. DETMER: Kathleen, did you have something?
MS. FYFFE: No.
DR. DETMER: All right. I think this is very helpful.
Other questions or comments?
Yes, Marjorie?
MS. GREENBERG: Maybe I missed your explanation, but the second to last paragraph here about we are currently planning a national conference on data needs for the 21st century, is this a workshop that NCHS would be doing with CNSTAT?
MS. COLTIN: I don't know. You will have to ask Barbara that one.
DR. DETMER: I think they are talking about Dan. It needs to be word smithed because this is misleading a bit, but I think it is that effort.
DR. STARFIELD: How should we describe it, Dan?
DR. FRIEDMAN: I was wondering what it was. So, thank you for the clarification.
DR. STARFIELD: If you can give us the right terms, we will substitute them.
DR. FRIEDMAN: It needs to be worded slightly differently.
DR. DETMER: All right. I guess the question before us is do we wish to see the final document with its corrections or are we comfortable passing this in substance with going ahead and doing the final drafting and moving forward?
Is there a motion?
DR. COHN: I move that we move forward.
DR. DETMER: Okay, Simon has suggested that we move forward with the corrections.
Is there a second?
DR. IEZZONI: Second.
DR. DETMER: Any further discussion?
Hearing none, all in favor say, "Aye."
(There was a chorus of ayes.)
DR. DETMER: Opposed?
(No response.)
DR. DETMER: Abstentions?
MS. FYFFE: I abstain.
DR. DETMER: One abstention by Kathleen Fyffe for the record.
Okay, I think we have got, actually we were planning on breaking for lunch at twelve-thirty.
I think what we will do is just go ahead and break now and then what we will do, we were going to be taking a 45-minute lunch. Why don't we go ahead and just resume at one, and we will start promptly at one.
Thank you.
DR. LUMPKIN: The subcommittee on standards and security as we talked about, we do have a revised draft of our comments. So, if we could sort of just get together, it is right here. So, for those of you who are involved in that, congregate in this corner during the lunch break before lunch, now.
MS. GREENBERG: Also, I have sign-up sheets for the members for all of the subcommittees and work groups.
(Thereupon at 12 noon, a recess was taken until 1 p.m., the same day.)
DR. DETMER: Okay, I think we will resume. Mr. Blair is going to give a presentation on ANSI HISB Inventory of Clinical Information Standards.
MR. BLAIR: Thank you.
Does everyone have a copy of the inventory because if the binder is on your desk, and I was assuming it would be, then that saves me from getting up and going through an hour and one-half of flip charts.
There are just a few things that I want to mention. First of all, this was a work effort from literally hundreds of people, and it was done on a voluntary basis, and acknowledgements are in order.
First of all, the idea for us to do a follow-up inventory of clinical information standards, that idea was Michael Fitzmaurice's. Is Michael here?
Okay, I want to acknowledge Michael.
Both Michael and Jim Scanlon not only had their personal commitment and support, and Jim is here, throughout this as well as garnering the support of their departments and agencies to help in this effort.
Since you have the binder in front of you, may I ask you to turn to the second page in the binder where the acknowledgements are? Standards development in the United States is essentially a voluntary process as opposed to Europe where Federal Governments and academic medical institutions will pay for that.
So, the names that you see there basically have contributed their time. Of course, behind their time is the fact that the government agencies, professional associations, vendors and sometimes even on their own funding were behind their ability to be able to spend the time to be able to pull together the information that you see in this binder.
As many names as you see there, it is a page and one-half, those are the names of the individuals that authored each profile, as well as those in many of these entities and organizations that coordinated and facilitated the help, and I know that I am sure that I failed to include everybody that has been part of this.
I want to thank my employer, the Medical Records Institute and Peter Regan for making it possible for me to spend the time trying to coordinate and pull this together.
This is an ANSI Health Care Informatics Standards Board document. You notice it is copyrighted by ANSI HISB. The support of ANSI HISB, of course, is very clear, and last but not least my wife who spent evenings and weekend doing the editing and format to pull this document together.
If you could turn now to the introduction section, the document, I think you could probably just sort of glance. What I did was I sort of listed the major sections of each profile, and it is similar to the one we delivered a year ago.
I am not going to read down them except that you should be aware that ANSI HISB went through a 90-day process to come up with templates, three different types of templates. There was one template that is used for the message format standards, another for patient clinical information, a third for code sets.
You don't see that in the section differences but each section has three to 12 questions to try to ferret out the status of each of these data sets and code sets and standards. So, that is why the templates had to be different for each of these different sections, and there are 79, quote standards.
Let me see if I remember the numbers correctly. I guess it is 16 message format standards, 30 patient clinical information profiles and 33 code set ones. We know that is not the entire universe, but hopefully that will be a good start for the beginning of the work that we want to do.
Please keep in mind that this inventory is only a compilation of information, and as Paul was saying, it is unaudited data. We did the very best we could through several iterations to try to encourage completeness and relevance and I believe that each of the profiles is much more informative than we were able to get the first time around a year ago, but you know there was no one that was going over and critically saying that things had to be changed.
So, in short this is a compilation. The Committee may choose to go through a process of evaluating and analyzing the information that is here, and we will leave that for a separate heading, and if that does happen, then I am sure as we go through this we will find that there may be gaps in information or clarifications that are needed, but nevertheless, I believe that this is at least much more of a foundation for us to build on than we had up until now.
Are there any questions that anyone has about the document?
DR. DETMER: I don't think there is any question it is going to move things forward. I commend you.
Let us open this for discussion.
Simon, do you want to comment? I know that you have been tracking these sorts of things for a long time.
DR. COHN: I guess my general comment would be that it is certainly somewhat overwhelming just in its size. I suspect that this will be a key document that we will use in the work group on computer-based patient records as part of the work plan to get the work done for August 2000. So, I really want to thank Jeff, as well as HISB for showing the leadership in doing this.
DR. DETMER: Questions or comments?
At this point I am sure we will be obviously hearing more from you on this as we move forward on the HIPAA piece really. You don't have it on a CD-ROM yet do you?
MR. BLAIR: If there are other folks who are not on the Committee who didn't receive a hard copy or even those on the Committee that would like to have this information in a diskette form ANSI HISB will be distributed in 2 weeks to all ANSI HISB members a diskette version. It is, also being put up on the web site for ANSI HISB, and if anyone either wants to e-mail me or Allison Turner at ANSIS HISB and request a diskette, beyond the ANSI HISB members there probably will have to be a modest charge of some type, but you know just for the work effort involved here, but you know, feel free to communicate that you have an interest in getting a copy.
DR. DETMER: I am glad I asked the question.
All right, let us move on to Dr. Lumpkin's Comments on NPRMs and Claims Attachment Recommendations.
DR. LUMPKIN: You should have in front of you four documents that were handed out over lunch. They are all dated June 16. The first one has in bold Attention HCFA 0149P. The first one I am going to cover. The second one is Attention HCFA 0045P.
They are being handed out now to the whole Committee. The subcommittee members already have them.
There should be four documents, two responses and there is an 045 and an 049 that are letters to Mr. Burke and Ms. Eyte. There should be two of those. They both say roughly the same thing.
Okay, if you start off with HCFA, the one that says, "Attention HCFA 0149P, To Whom It May Concern," this is the response to the transaction standards, and I would like to sort of walk through the issues that we raised. I won't go into detail obviously through NPRM because we don't have enough time this afternoon to do that until tomorrow morning.
The first item has to do with the issue mentioned in NPRM about long-term care facilities, and it was raised that perhaps these proposed rules should not apply to these types of facilities and basically our recommendation is that they should.
That is based on a couple of --
DR. IEZZONI: We don't have it yet. Could we do 0045?
DR. LUMPKIN: Do you have 0045?
DR. IEZZONI: Yes.
DR. LUMPKIN: Okay, let us do 0045. Let us do that one first.
DR. DETMER: This is the two-page letter?
DR. LUMPKIN: No, this is the multipage To Whom It May Concern. Does everybody have that one?
The key issues there are the two principles that we are recommending. The provider ID as described in the NPRM deals well with the issue of individuals, and it deals well with bricks and mortar. It is a little bit fuzzy on organizations of individuals, and what we are suggesting is that there are only two classes of provider IDs, one for an individual and one, well, it would be the same number but, also, for bricks and mortar places, and for the purpose of enumerating and identifying providers organizations to which providers belong don't give care.
So, that is Principle A. If they don't give care, they don't get a number.
Principle 2 is that the processes of enumeration and enrollment have been intertwined, and we are proposing that they be decoupled, dissected apart.
If we do that, the ideal system would not be a system where the information in the registry changes frequently, so that if you have enrollment information tied into enumeration, you are going to have to change that registry on a regular basis as people change their affiliations and so forth.
Second is that there is no funding for this particular initiative, and so, HCFA because their budget is so big, especially compared to like my budget, but has found in their good graces a way to fund this because they have no choice, but obviously they do have other obligations like paying for care and things like that.
Therefore we think that we ought to propose a system that is affordable and meaningful. We recognize that there are uses for the data on providers other than for enumeration, and we urge that HHS do a cost/benefit analysis for each data item rather than adopt the full set that is in the NPRM.
So, we are recommending that fewer things be enumerated, just people and places and that in the enumeration process less data be collected on each provider, just the data that need to be collected for legitimate purposes of enumeration and those other things that HHS feels has a positive cost/benefit return, research and so forth.
The next principle is on Page 4, and that really goes to how enumeration should occur. In the NPRM they discuss two options, Option 1 being the total federal system, and Option 3 being a hybrid system with some federal keeping of the registry and some state agencies, Medicaid agencies and so forth as a process of enrollment would, also, do enumeration.
Our recommendation is that since we have decreased the number of things that people and organizations that would be included and we are shrinking the size of the registry that we believe the cost savings should allow the implementation of the more efficient system which is to have a single enumerator, that being the Federal Government.
I think those really are the key points unless others on the Committee may want to raise some.
DR. DETMER: Does anybody else on the Committee want to comment on this first document?
DR. LUMPKIN: Oh, I am sorry, there is one other thing. We recognize, also, and that is the last part of A on Page 1 and 2 of the principles that there are certain entities that don't get identified as a provider yet may have some electronic data interchange utility and that we propose that a consideration should be made of an EDI identifier for routing purposes but that the provider identifier should not be used for that.
So, if someone has a multispecialty group, that group may get a routing identifier because that is where the bill gets sent, but that really isn't the provider. The individual clinicians and caregivers would be the providers.
DR. DETMER: I assume you are bringing this to us from the group for approval?
DR. LUMPKIN: That is correct, for transmission, for approval and then subsequently comments.
DR. DETMER: We can either take them one at a time or take them all as a group.
What do you recommend?
DR. LUMPKIN: I think that we will take this one with the one that is similarly labeled, HCFA 0045 because we have a few other items.
DR. DETMER: The two-page --
DR. LUMPKIN: Right, the two-page letter, and this has to do with the Paperwork Reduction Act. In the NPRM they request comments on the applicability of the Paperwork Reduction Act. It has to do with the issue of data collection, information collection, and I think we heard an analogy, and I am trying to remember the analogy from yesterday.
If we look upon the standard as not saying what information needs to be collected but if it is collected it is in this format, then we believe that the Paperwork Reduction Act should not apply because to add that additional process to it would make it unnecessarily burdensome, and so, this letter speaks to that issue.
DR. DETMER: Questions or comments about it, the two-page letter?
Personally I think this is an excellent idea.
DR. LUMPKIN: I want to point out by trying to reduce paperwork we have an additional two pages.
DR. DETMER: Right. Well, there you have it, but maybe it will reduce future pages.
Okay, does someone care to make a motion that we accept these two documents?
MS. FYFFE: So moved.
DR. DETMER: Second?
MS. COLTIN: Second.
DR. DETMER: Okay, it has been moved and seconded.
Is there discussion?
Hearing none, all in favor -- oh, Lisa?
DR. IEZZONI: May I just ask a question since this is all new to me since I am not on your Committee? On the issue about the long-term care industry, Barbara, we won't even get into how we are going to define long-term care, but is the long-term care industry not being enumerated or not being given IDs because this first letter the OO45-P seems to be about kind of giving IDs, and so that is why I am a little bit confused about why they are talked about in this way here.
DR. LUMPKIN: The concern is that because the long-term care industry does not have a high level of automation that they should be perhaps excluded from this in the other regulations we are talking about. We note that long-term care facilities should be enumerated, obviously, and in addition the standards for transactions only apply to those who decide to send electronic transactions.
DR. IEZZONI: Then should we say on Page 3 that the long-term care industry should be enumerated because this is the letter 0045-P because the paragraph about long-term care industry seems to be talking about transaction standards, and it doesn't really talk to the fact that they should be enumerated or at least that is the way that I am reading it.
So, do you think that you should amend that paragraph and say that they should be enumerated?
DR. LUMPKIN: Yes, I think that we can probably streamline that and just basically say what you just said.
DR. IEZZONI: Okay, and does the proposed rule making really just single out long-term care? How about home health and substance abuse clinics and various other health care providers that, also, don't have, quote, a lot of automation, rehab hospitals, chronic disease hospitals?
MS. FRAWLEY: The NPRM simply asks for comments on the issue regarding the long-term care industry.
DR. IEZZONI: But can't we make a comment that that seems kinds of strange?
DR. LUMPKIN: I think what we have here, the last one says that it would be an unfortunate precedent to exempt segments of the health care industry from these rules.
DR. IEZZONI: Okay, I don't think that is as clear that it seems strange that they are just singling out long-term care.
DR. DETMER: You identify these other areas.
Bill?
DR. BRAITHWAITE: The reason it was singled out in the NPRM is because that industry came forward and said, "We don't do computers."
The law says, "All health care providers and payers will participate according to those following rules," and so the question was put out in the NPRM should there be an exception made for an industry that as an industry claims they don't do that, and this Committee is recommending that they not be excepted nor should any other subsegment. There are no exceptions.
DR. DETMER: I think you are correct. It is strange, but I am not sure that we need to point it out. Obviously the issue really relates more to the political process of why they got special consideration. If home health or the substance abuse, it may very well be that that industry hasn't even realized it is on the radar screen, but even if they did I don't think we would want to make a recommendation for exclusion of any.
DR. IEZZONI: I am not suggesting that we make a recommendation. I am just suggesting that we say instead of all health care providers, we should just say, "Including such as" or maybe enumerating so that it is clear that we recognize that long-term care is being singled out and that there are other places that --
MS. BALL: Lisa, this identical language is in the other NPRM as well. This doesn't have just to do with enumerating providers. This is the background or boiler plate.
DR. DETMER: Maybe if you just put the word "any" segments of the health care industry at least it would make it look a little more comprehensive. Would that help?
DR. LUMPKIN: Okay.
DR. DETMER: Other questions or comments?
Hearing none, all in favor say, "Aye."
(There was a chorus of ayes.)
DR. DETMER: Opposed?
(No response.)
DR. DETMER: Abstentions?
(No response.)
DR. LUMPKIN: That brings us to 0149P. I will do the easy one first, the letter to Burke and Eyte. It is essentially the same one on Paperwork Reduction Act as we voted on before for the identifier.
The other document I will tell you that there is one item that the Committee is still working on. So, what we would like to do is pass the rest of this. I will identify that item and rather than trying to do the whole thing tomorrow, we, in our Committee report, will come back with the recommended language for that one section, and I will point that out when we get to it.
The first item is the long-term care issue that we just discussed. The second one is the implementation time frame. Under the HIPAA law it just says that they have to be in place by 2 years after the rule has been published.
There is no transition discussed. WIDI(?) has recommended that for the first year it not be required even though technically a trading partner, a payer could mandate this tomorrow. We are suggesting that it not be required and that there be a 6-month grace period or time period between when a trading partner requires compliance with these transaction standards and when the compliance would be in effect.
So, if this is adopted, then after the rule becomes finalized in the first 6 months there would be no message or requirements. After that there could be a notice to the providers that these transactions will be required by a payer and then subsequently in that following year they will come into compliance.
MR. BLAIR: This is as a guidance or recommendation or suggestion as opposed to a matter of law?
DR. LUMPKIN: There is some question whether or not this could be imposed by HHS under HIPAA, but we are recommending that they evaluate the legality of this, and if they cannot then they would strongly urge payers to comply with the WIDI recommendation.
On the code sets we congratulate HHS for eliminating or planning to the HICPIC's(?) J codes. We, also, recommend that they begin to take the steps to go to the UPN, universal product number, and that they look at what the Department of Defense is doing in California to begin to work towards spiffing up this code and adopting it.
The next issue has to do with local codes, HICPIC's codes. It was identified that for a procedure and a diagnosis that these are used -- okay for HICPIC's level 3 codes many of these are used by state Medicaid agencies. They tend to be codes that are only applicable in local areas, and we are recommending or encouraging that these be eliminated.
We, also, recognize that the reason why these codes come into existence is sometimes new drugs hit the scene, new treatments and so, we believe that the system has to be responsive to allow codes to be developed if we are going to justify eliminating local codes.
Page 3 on enrollment, 834 transaction, we encourage that this be used to raise ethnicity and other demographic information that we think is important to collect, not only for obviously many of our interests in the public health arena about being able to apply it to what is going on with health care for populations, but we, also, identify that as plans try to meet the standards for being culturally sensitive and competent you won't know what you need to do if you don't know the demographic make-up of the population that you are serving.
We believe that this ought to be in the enrollment and not in the transactions. That allows it to be self-reported once rather than as frequently as is done, reported by the care provider every time a person comes to health care resulting in multiple designations which may be discrepant with each other.
The next item is all the way on Page 4 that I wanted to call your attention to. This is the last item, and this has to do with updating the changes.
There are two options that were identified in the NPRM on how organizations should be identified that would then make the changes. For the SDOs that are ANSI accredited, that is an easy one, because both options would identify those as being acceptable organizations, but the NUBC, the NUCC and a number of the coding development organizations would not necessarily meet ANSI accreditation, and so there are two options that are being proposed.
One option is a list of criteria that they would need to meet. The second option is that they would have to meet the ANSI standard although not be ANSI accredited.
The Committee is still wrestling with that. We are wrestling with it because we feel that this is an issue that we wanted to hold hearings on. We are not quite sure what the right decision is and so what we will do is come back tomorrow with a list of principles that we believe ought to be here and our response will be to that list of principles and a suggestion that we will be holding hearings soon to give more detailed input to HHS.
MR. BLAIR: There was a word that you said, "To meet the ANSI standard." I am reading into that to meet the ANSI standards for consensus for arriving at consensus and for openness is that what you are referring to?
DR. LUMPKIN: It is actually ANSI standard for due process and criteria for approval and withdrawal of American National Standards.
DR. DETMER: Other comments?
MR. MC DONALD: Just to elaborate on that issue, the message standards which are only ANSI provestios(?) there is no real issue. The challenge really is when we are talking about a code sets and the like which have a different kind of response cycle and regulatory cycles. Historically they haven't been quite as formal, and so we are worried that we don't want to break the processes that now work while still making sure everything is fair.
DR. DETMER: So, it sounds like maybe if I hear you, you are perhaps moving approval of these two documents with the understanding that more refined language will be coming tomorrow for one piece of this?
DR. LUMPKIN: That is correct.
DR. DETMER: Does someone want to move that?
DR. LUMPKIN: I will move it.
MS. COLTIN: Second.
DR. DETMER: I would like to have in these letters somewhere before each set of initials, if the future civilization looks back at our deliberations it would be just nice to have, so, somewhere for example, as an added-in issue but like the NDC and so forth let me just throw the first one.
Okay, any further discussion?
Hearing none, all in favor say, "Aye."
(There was a chorus of ayes.)
DR. DETMER: Opposed?
(No response.)
DR. DETMER: Abstentions?
(No response.)
DR. DETMER: Okay, great.
DR. LUMPKIN: We then proceeded to have a discussion about claims attachments. In that discussion we noted that there was one issue which the Committee has a recommendation on, and noted the progress that was occurring. The issue, and then I will talk about that because there were two recommendations that were voted on by the Committee.
The first one has to do with the issue of including medical information in the claims attachment, the 275 and 277, and that has to do with whether or not we embed ASKI(?) tax or HL7 format.
The concern is that small providers as was raised by some of the commenters that if we mandated HL7 small providers would not be able to meet that standard. As we kind of dissected that issue out with our panel yesterday, in the end it became clear that we weren't talking about small providers. We are really talking about providers who have small vendors.
If you have a small office, one or two or five or 15 physicians and your vendor is a large national organization then as they implement the transaction standards they are all capable of handling embedded HL7 tax, but where you may have five or 10 physicians who get together, hire somebody to write their program, to manage their office, these are the kinds of individuals or groups that would not be able to handle embedded tax.
DR. DETMER: Or may have more difficulty.
DR. LUMPKIN: I mean HL7 or may have more difficulty. But the point was made, also, that these individuals are going to have to redo their whole program anyway in order to be compliant with the other transaction standards, and so, the incremental requirement to differentiate ASKI tax and HL7 tax would not be that great. It was in that context.
In addition, since it was posed as an option we have not in any of our standards that we have presented given people an option to either do one thing or the other. It has been by and large here is the standard for the transaction and by presenting transactions in ASKI text you lose all contextual formatting and so the ability to extract meaningful data out of it would be limited.
The Committee based upon that discussion voted to make a recommendation that would then go through the implementation team, that the standard for the transaction would include only HL7 formatted text.
DR. DETMER: Additions from other members of the group?
MR. MC DONALD: There was actually a report which said more, and the one thing that was an issue was whether there would be this option or not, and I don't know whether some of the Committee folks who were related on the infrastructure team and other teams would want to speak on that or not.
I mean there was actually a very specific proposal about the details of how the patient information would be embedded within the X12 messages. It was a very detailed technical proposal.
MS. STAHLECKER: I am Chris Stahlecker with Empire Medicare Services. We did have an evaluation of this subject matter about presenting unformatted text, and felt that as Dr. Lumpkin just pointed out that it could be completely expressed within the structure of an HL7 message and by inserting the structure of the HL7 message around that text gave a better processing capability on the receiving side with minimal hardship on creating that information on the center side.
So, we would strongly advise that unformatted ASKI text not be included.
DR. DETMER: I am sure that is crystal clear to everyone. You did a wonderful job describing. I am saying that if you are not in the guts of this thing, I am not sure how clear it is, but at any rate is there a motion?
DR. LUMPKIN: There is a motion that our recommendations on claims attachment include the requirement only for HL7 formatted text.
MR. MC DONALD: Maybe to clarify it, the big proposal is to have an existing X12 message which is designed as sort of like a boxcar to carry miscellaneous things, and there is a segment called a BIN for binary segment and that is where the payload is, and that payload would only be HL7 and so it is in that context that that specification is what he said.
(Laughter.)
DR. DETMER: Okay, is there a second to the boxcar and payloads? No, actually I am not making light of this. I actually do understand.
MR. BLAIR: I will be happy to second it.
DR. DETMER: Okay, Jeff seconds it.
Is there discussion?
This sounds like it is really more just of a formatting burden and not per se really necessarily a cost burden. In fact, it gives you more portability. So, it ends up being a more desirable way of sending it. Is that basically --
MR. BARR: Steven Barr, from HCFA. That is true. It is basically a formatting. There is no change. HL7 is ASKI text in reality. We are just making it streamlined so that every message that comes in is sent in one way and one way only rather than having a variable.
So, you are just taking any optionality out of it and making it conform to all HIPAA standards.
DR. DETMER: Okay. Is there further discussion?
All in favor, say, "Aye."
(There was a chorus of ayes.)
DR. DETMER: Opposed?
(No response.)
DR. DETMER: Abstentions?
MS. FYFFE: Abstain.
DR. DETMER: One abstention.
DR. LUMPKIN: The second issue had to do with the implementation of these standards which under the requirements of HIPAA an NPRM would be required to be issued this summer.
We as a Committee supported the development of that NPRM, but I think some of the recent developments have led us to the point where we are going to have some discussion and perhaps another recommendation.
There is a funding issue about the process of field testing this particular transaction standard, and one of the things that we will need to look at very closely as a subcommittee and I think as a full Committee is whether or not we can recommend a transaction standard that has not been tested to make sure it works, and I think there is some hesitancy on the Committee. So, we will come back with recommendations as we delve further into that.
It became an issue of funding because of the fact that there was no funding in HCFA for testing this. The initial testing that was done was done through funds that were squirreled away from other sources. That was stopped until the new FY 1999 budget on October 1, is adopted.
We understand that there are funds in there, but in the interim under the time lines of HIPAA the standard would have to be adopted, and we just are a little bit hesitant about doing it before it is tested.
So, I am not sure that there is action that is required, but I just wanted to include that in the report.
DR. DETMER: Questions or comments about that? It sounds like we just wait until you come back to us.
Bill, do you have anything to add on any of these?
Okay, thank you. You have been busy people.
All right. I think we have got a couple of options here. One, we could actually go through a consideration of the vision document and annual report that is scheduled for ten in the morning now rather than starting our subcommittee work early and move up tomorrow's agenda a bit.
We still have your 8 o'clock meeting.
MR. GELLMAN: No, but I just prefer to see the vision document come up tomorrow. I am not prepared to discuss it.
DR. DETMER: Okay, that sounds fine.
It looks like, do you have the capacity or will you need to be talking about your hearings on unique identifiers on the basis of meetings you are going to be having yet?
DR. LUMPKIN: Yes, if we have a handout. Do we have copies of the handout for this yet?
Okay, let me utilize that draft, and then we can get them out to everyone.
We received a recommendation from the implementation team on the hearings for the unique identifier. The first hearing will be on July 20 and 21, in Chicago, and we are all pleased as punch that you are coming to the home of the Chicago Bulls, the only winning team we have and at this hearing again we originally planned to have the Chicago hearing as part of a series of hearings, and I think it is still our intent to do so although we have been delayed.
The notice of intent which is what HHS will publish will list a whole host of methodologies for uniquely identifying an individual for purposes of connecting an individual with his health information.
This process would then receive comments and then based upon those comments HHS would then come forward with a notice of proposed rule making.
So, this is different than all the other HIPAA items that are coming down the pike.
This notice of intent is still going through departmental clearance. We had a hearing scheduled in May which we canceled. It is our intent not to cancel this hearing if the notice of intent is not published. Rather, we hope to have a white paper produced by the Committee which will list all the options that will serve the function of being the document that will be discussed.
The first hearing we intend to bring in a varied group which would include the usual way that we approach it which are providers, payers, standard development organizations and plans and then spend a fair bit of time with consumers.
So, we will have more than one panel of consumers. Our hope is to invite a number of populations of individuals or representatives of those for whom this may become a key issue.
We don't know whether they are going to be pro or con, but I think it is important to hear from homeless population for instance, to what extent they believe that a unique identifier may help or hurt in providing services; individuals particularly who have been very concerned about medical confidentiality, for instance, HIV-AIDS community, in addition to many of the suggestions that were made by the Confidentiality and Privacy Committee.
It is our intent to then have subsequent hearings and including one here in Washington in which we would like to invite international spokespersons who will be able to give us their perspective from countries where they have instituted a unique identifier system. Also, at that hearing we would like to get presentations from -- we are not going to spend much time on the technology at the first hearing.
At the second hearing we would like to get some of the biometrics folks in to talk about their particular systems, retinal scans, iris scans and other kinds of systems where you are uniquely identifying individuals so we can understand the technology.
So, that is our plan.
MR. GELLMAN: Mr. Chairman, I would like to offer a motion.
DR. DETMER: Okay.
MR. GELLMAN: I move that all Committee and subcommittee hearings intended to focus on the subject of unique patient identifiers be postponed until 2 weeks after the Department of Health and Human Services has published in the Federal Register the planned notice of inquiry on that subject.
DR. DETMER: Is there a second to that motion?
MR. GELLMAN: Notice of intent, I am sorry, I used the wrong word, sorry.
MR. BLAIR: Some of us are not familiar with what you are referring to. Could you explain a little bit so we understand the implications of this?
MS. FYFFE: Did you move that?
MR. GELLMAN: Yes.
MS. FYFFE: I second it.
MR. GELLMAN: Thank you.
Let me explain why I have offered this motion. The issue with patient identifiers is not a patient identifier issue. This is a national identifier. That is what is being created.
It is not going to be something used for health. It is going to be used for every purpose, and depending on what is done, what is carried out this may lead to a requirement that basically every citizen go down to a government office and get an official card that they are basically going to be required to carry for all governmental purposes.
I think this is an issue of much broader scope and import than most of the issues that this Committee deals with, and I think that we have a particular obligation here to be as fair and as open and complete as we can.
I think that it is very easy to make a case that this Committee is really not the right Committee to deal with these issues, not the Committee to make a recommendation to the Secretary, not a Committee for the Secretary to rely on to conduct hearings.
I want to make a point that relates to this issue and this issue only. I am not raising this as a general question about what this Committee does or how it is composed, but on this issue this is a very unbalanced Committee.
Virtually all of the members of this Committee come directly out of the health care establishment. There are no consumer representatives. There are no immigration groups. There are no labor organizations. There are no patient advocates. There are no privacy advocacy organizations. There are no religious organizations and no civil liberties groups, no computer scientists. There are no Internet organizations.
One could argue that under FACA, the Federal Advisory Committee Act that this is a statutorily unbalanced Committee on this issue. A requirement of the law is that an advisory committee be fairly balanced in terms of the points of view represented and the functions to be performed by the advisory committee, and on this issue only it is not that everybody here isn't a perfectly reasonable person, but collectively all of us together are not necessarily the right Committee.
Furthermore, I think that one can make a case, whether anyone agrees with it or not. I think this can be put forward that this Committee is biased on this issue. First, we commissioned a background paper on this from a contractor who himself is clearly biased both in favor of an identifier and in favor of using the Social Security number.
Secondly, this Committee has already taken a position on this issue. September 9, the Committee approved a letter saying that we continue to support the concept of a unique health identifier for individuals. This was before the hearings were held, before costs were identified, before alternatives were scrutinized. Basically the Committee couldn't wait to take a position favoring a health identifier.
Thirdly, I will note that, and I just discovered this yesterday, the Committee's letter to the Secretary supporting a health identifier, with a dissent from myself and from Richard Harding that if you go to the Committee's web page and you find the letter to the Secretary there is no cross reference to the dissent.
The dissent is buried elsewhere on the web page, and if you don't know it is there you don't go looking for it. You only can find it there as an indication of a dissent.
So, I think that there are lots of reasons why this Committee needs to bend over backwards to be as procedurally fair as possible, and I think rushing to start hearings before the core Committee document is available is unfair.
It is an insult to the process. It provides an advantage to those people in the health care establishment who already support an identifier and have already done work on the issue, and it is a disadvantage to opponents, and I think that is why I am offering a motion that we postpone these hearings.
I will offer a second motion later on with respect to how we deal with some of these issues, but I think we should postpone these hearings until everyone has had a chance to see the paper from the Department.
DR. DETMER: We have a motion and a second on the floor.
Let us open this for discussion.
MR. MC DONALD: I support the motion, but what I wanted to really ask about though in terms of some of the, I think, strongly felt and expressed opinions that we were charged to do this by the law, weren't we, because the law says that there will be a national patient identifier, and I just want to clarify it?
MR. GELLMAN: Yes, I think that is right, and I did not offer a motion that we should not hold these hearings. I said that we have a special obligation on this issue to be as fair as possible.
MS. FYFFE: Bob, I am confused. You said that the number was going to be a national --
MR. GELLMAN: This is my interpretation of this that any patient identifier will become a national identifier.
MS. FYFFE: Let me quote from the law itself? The Secretary shall adopt standards providing for a standard unique health identifier for each individual, employer, health plan and health care provider for use in the health care system. Isn't it sort of a leap to go from this to what you are saying?
MR. GELLMAN: When the Congress passed the law for setting up a Social Security number it said that it was to be used for Social Security purposes only, and look what has happened. I am not saying that the law directly mandates that there be a national identifier. The effect of requiring every citizen to have a health identifier will be to create a national identifier, and those are the stakes in this battle.
DR. DETMER: But that is your personal opinion.
MR. GELLMAN: That is my opinion, yes.
DR. DETMER: I understand.
Jeff, and then we will just work our way around.
MR. BLAIR: Bob, I feel like the message that you have given the Committee is profound and we need to recognize it, and I am trying to balance that with the mandate that the Committee was given under HIPAA.
So, let me ask you if this idea might be a way to balance it? If we were to propose any recommendations from this Committee until after what, and I don't remember exactly what you said you know, was it another hearing or another report or something? What was that?
MR. GELLMAN: The idea was to not begin hearings until 2 weeks after the Department produces its document on this subject.
MR. BLAIR: My thought, and you tell me whether you think that this won't meet what you are saying, I don't understand why we shouldn't have hearings to inform us and educate us about feelings within the health care sector. I do understand from what you have said that we should defer making a final recommendation until we hear this other report.
MR. GELLMAN: It seems to me that we have witnesses who are going to come up before the Department's paper is available. They will comment. They will say what they please, and then when the paper comes out you will have to go back to those witnesses all over again and ask them to comment specifically on what the Secretary has put in the paper.
I mean the purpose of the paper is to attract comments, and if you are going to begin the hearing process before that paper is available, then you are going to be asking people to do twice as much work as they would anyway, and you are not going to be able to test those, whatever the Secretary proposes, whatever alternatives are laid out in that paper at a hearing with these people because they will not have seen the document.
DR. LUMPKIN: I disagree with the motion, and the reason that I disagree is first of all our Committee is given a charge under law, and the role of Congress is to weigh the good and the bad of implementing a policy, and then they choose. That is what our Legislative Branch of the government is responsible for.
The Executive Branch which we are an advisory board to is then charged with implementing the policy direction set by Congress, in this case to create a unique identifier, but we as an advisory committee constituted by Congress; the size of the Committee, in fact, was expanded under HIPAA, appointed by the Secretary are charged to give our best advice.
The notice of intent is for individuals to give, for HHS to request advice from the public. We, as a Committee as we just did on the NPRMs will be making our own best advice.
As we go through this process, the function of the hearings is really to provide us with an informational base on which to make our best opinion and best advice to the Secretary.
The document that we will have available will cover all the issues that are in the notice of intent which is very similar to the issues that were raised by the document that we had commissioned and never really conducted any significant hearings about.
So, because of our unique position I think it is in our best interests to be in a position when the period of time expires for the notice of intent to give some reasonable advice, and that is what I see the function of these hearings.
I don't see the utility of delaying. We are not the ones who are making the decision on the NOI. It is the Department, and in fact, we are not conducting the hearings for the Department. It is a public process which is what the NOI is set up to do.
DR. DETMER: Barbara?
DR. STARFIELD: I am having trouble reconciling the reasoning that accompanied your motion with the motion itself because it seems to me that even waiting 2 weeks or more after the NOI is published wouldn't change your reasoning for having the hearings.
MR. GELLMAN: I am not arguing that we shouldn't hold the hearings. I think essentially we are required to do all this, but we are operating on this issue it seems to me under a cloud, and that provides an additional reason why I think we have to be as fair as possible in the conduct of the hearings.
Yes, I could have offered this motion and said none of the other things and simply have said that we ought to wait until the document is out, but I wanted to emphasize the breadth of this issue and the large number of interest groups and individuals who are potentially affected by this and may be interested in it beyond the normal range of people that we hear from in this Committee, and I am not suggesting that on other issues that what we do is necessarily unfair.
We deal with a lot of technical issues, and we hear from appropriate people, but on this issue, and this is the broadest issue that the Committee has ever dealt with as far as I have seen, and I think that we have to be extremely careful.
DR. DETMER: Mike?
DR. FITZMAURICE: Bob has raised an important consideration, and that is that it would be much more useful for people when they testify to have in hand a paper describing what the Department sees as the options.
In fact, the Department has thought about this and agrees and has started the process to develop such a white paper that should be available 2 weeks before the hearings that will describe what is in the regulations or the NOI without being the NOI itself.
We have gotten informal approval from OGC that we can do that, that we can take it; we can repackage it and we will put out a white paper that describes what the options are.
MR. GELLMAN: Have you gotten approval from OMB to do that?
DR. FITZMAURICE: No, we have not sought or received approval from OMB to do that.
MS. FRAWLEY: I just wanted to reiterate for the Committee some of our decision making last fall so we don't lose sight of it. If you remember at our September meeting when some of the teams were coming forward with their recommendations we chose not to accept any recommendation on unique health identifier because of the fact that we thought it was an important issue, that we needed to get significant input from more than just industry, and we, also, were concerned in the absence of privacy legislation that it would be premature for this Committee to make a recommendation, and therefore last September this Committee chose not to accept any recommendation coming forward from any of the HHS staff and to defer any consideration until we started holding hearings.
We did not tie that into the publication of a notice of intent or a notice of proposed rule making. We thought that it was important that this Committee have sound deliberations.
I brought that recommendation forward to the Data Council since Don was not able to attend that particular meeting, and I know at the Data Council there was a fairly deliberate discussion about this and again, the members of the Data Council felt that this was an important issue because again it had implications much broader than some of the other recommendations this Committee has considered.
I think that to not go forward with hearings at this point would be a problem. We have held hearings in the past without any NPRM. I think the way the Department has laid out their plans in terms of developing the white paper and providing information, this will not be the only hearing. This is the first of several. If you remember we decided we would have three, and so we have talked about the fact that we did not want to tie it in, and we discussed that again at our meeting and, also, at the Executive Committee meeting.
So, I think we have been making very sound deliberations on this. This has been going on now for over a year. So, I disagree with your motion and just want to make sure that the Committee remembers some of the decision making and why we made certain decisions.
MR. GELLMAN: If I could respond, the Committee's decision in September, much of what you said is exactly correct. The Committee's decision was to support an identifier. It didn't pick one. It supported an identifier for health. That is an open question as far as I am concerned whether there should be an identifier.
Secondly, the Committee endorsed a set of criteria for selecting an identifier. That is another major point in this process. So, that is why I am suggesting that the Committee has gone a good part of the way toward making a final decision on this.
The only thing left is which one rather than whether we should have one or how we should decide it.
DR. DETMER: As a matter of record and correct me, but actually this Committee of course, has been around for almost 50 years, and indeed there are positions actually that the Committee has taken prior to us on this, and in fact actually is on record as favoring a unique identifier. So, actually it is not as though all of this started, also, here, but I just want to get that out as another point of information.
Kathleen?
MS. FYFFE: A clarification question to Kathleen Frawley. You said that there were going to be three hearings.
MS. FRAWLEY: Yes.
MS. FYFFE: Okay, what is the general schedule of those?
MS. FRAWLEY: Originally it was supposed to be May, July and then one in the fall, and we made the decision because of the fact that it would have been too soon in light of the Committee schedule not to go forward in May.
MS. FYFFE: Okay, so if we were to hold the hearings in July before the notice of intent comes out, there are still two more opportunities for hearings potentially after the NOI comes out?
MS. FRAWLEY: Yes.
MR. MC DONALD: Just further clarification, what would be the time effect if we vote for this motion on the deliberations? Would this effectively hang this up for the next 2 years or is this just a matter that we put it off for a month, because I heard these other issues about what, the tangles about maybe perhaps getting something out, and could we put something in the Federal Register saying that we are going to discuss it?
PARTICIPANT: We announce all our hearings.
DR. DETMER: John and then Stewart.
DR. LUMPKIN: I think that schedule-wise it is starting to get a little bit late to talk about a hearing in August. So, the next date would be to coincide with our meeting in September, and then we would probably -- this is the time we had talked about for a second hearing date.
Then fall being a kind of busy time of year to get one in, we could probably fit one in between now and Christmas and then if we were to move the schedule back we would probably have a hearing in February. That would be the next one.
So, we would probably lose 3 months, but in the big picture 3 months, I mean I guess the question really is is this going to -- you have sort of spoken your feelings I think very well about this particular direction, and is this really just something that, I mean it is not that you weren't aware or were you that we were going to have hearings in the future?
MR. GELLMAN: I knew there were going to be hearings, but I first found out that we weren't going to wait for the NOI at the Executive Committee meeting.
DR. LUMPKIN: I would suggest if it is a matter of just weeks and months that we would be a more harmonious Committee and would make better deliberations if we listen to the person who has been most worried about this zone of interest for the last 20 years, but if it really is indefinite delay --
DR. DETMER: What are the time lines actually listed in the legislation? Are there specific time lines on this?
DR. BRAITHWAITE: The legislation requires the Secretary to adopt a standard for a unique identifier for individuals for health care purposes by February 1998.
(Laughter.)
DR. DETMER: I guess that says something about a time line.
Okay, Stewart?
MR. STREIMER: One of my comments as we schedule or as we think about the fact that there is a comment period associated with the NOI that will facilitate the development of the notice of proposed rule making, and you might want to think about scheduling hearings around those time frames once the NOI is published so that the Committee has an opportunity to provide a comment on the NOI which is I think 60 days. Is that correct?
MS. GREENBERG: In the context of that and laying aside whether this is a different kind of standard the Committee held hearings well in advance of the NPRMs being published so that they were able to, the Committee was able to make recommendations that then were taken into account in the development of the NPRM and now also, is making comments on those NPRMs.
If you delay the hearings which is certainly an option that has been discussed at great length I think as well, so it is not, it is certainly a very legitimate concern which is why the suggestion that a white paper containing all the information that is really substantive in the NOI be prepared prior to the hearings.
If you delay the hearings and wait until the NOI is actually published it is very difficult to schedule hearings particularly out of town on sort of a dime. I mean you really need a lead. We have been working on the Chicago one actually for a number of months. We had some plans that we then deferred because none of the NPRMs had been published, but we were able to then transfer those plans to the July dates which we had already selected, but just logistically it does take quite a while particularly to schedule hearings out of town and to give the proper notice.
The Department thinks that the NOI actually could be published prior to the July 20, 21, meeting but probably definitely will be published this summer.
PARTICIPANT: Probably definitely?
MS. GREENBERG: I mean there is no reason to think that it won't be particularly now that some have already been published and it is an NOI not an NPRM. I think that is a pretty good guess although like Bill never would put his mortgage on these things and I certainly wouldn't either, but the idea is that after an NOI is published there is a 60-day comment period and then from that the Department decides if it can move to an NPRM.
The Committee by starting to have hearings in late July and carrying those out through the fall would probably be more in sync with being able to advice the Department on whether it can move to an NPRM based on both the hearings and the NOI comments and the whole package rather than waiting to have these hearings until the NOI is published, probably not even completing its hearings until after the comment period is over and I mean it can work the other way, too, but I am just trying to lay out what some of the advantages are of moving ahead with this but not obviously completing the process until the comment period is over for the NOI.
DR. DETMER: I have Stewart and then, Jeff, did you have your hand up?
MR. BLAIR: Yes.
DR. DETMER: Okay.
MR. STREIMER: I just want to clarify my remark because I want to make it clear that I do support having the hearings in July even before the NOI is published. I think that the white paper that the Department is preparing will very clearly lay out the substance of what the NOI will look like.
I think that is really what you are looking for is to be able to see that before the hearing, and I think we agree that that kind of information in the hands of the public is important to have meaningful hearings.
I was only suggesting that since we are scheduling three hearings that maybe the second hearing should occur sometime during the comment period so that the Committee has the benefit of not only hopefully the NOI if not the white paper but the debate that will take place during that first hearing to basically hold that second hearing during that comment period and then to formulate a response.
MR. GELLMAN: May I ask a question?
DR. DETMER: Sure.
MR. GELLMAN: I am a little confused about this white paper. If you can publish a white paper but you cannot publish the NOI there has got to be a reason which I suspect means that you cannot get the thing cleared through OMB, and it seems to me to be passing strange to be publishing the same document more or less in advance of OMB clearance and it doesn't seem to me that there is any assurance that you are going to be able to A, publish this paper or publish it in time even if you could.
Could somebody clarify that?
DR. FITZMAURICE: That probably takes a lawyer to clarify it which I am not, but among the considerations are that this is not a regulation. It is a notice of intent. So, the final action will be different for it that if we do not put it out as a notice of intent or a proposed regulation then we can paraphrase it and still put the same substance out because it has been done before.
MS. GREENBERG: Actually for the NPRMs we had a meeting, was it last July or a year ago July? I guess it was last July in which the substance of what the Department was planning to propose was announced. It was discussed during an open meeting and on the web site and then the entire implementation guides for the transactions have been on the Washington Publishing Company web site for months, long before the NPRMs were actually published.
Now, they were out there as what was likely to be required or adopted in the NPRMs. They obviously weren't clearly what was going to be proposed to be adopted until the NPRM was published. So, there was a lot of information out on the NPRMs before they were ever published.
DR. DETMER: Jeff?
DR. LUMPKIN: I just wanted to follow up on that issue. I think if you will look at it that by and large government doesn't release the content of rules because they don't want to generate discussion and argument before the rules are published.
There is really no requirement that the content of a proposed rule except for administrative considerations and political considerations internally and what has been our experience in this whole process is that I have seen a much more open process by HHS in relationship to what they are thinking about than in any other I have seen in a very long time.
So, I think that publishing a white paper is very consistent with that openness of this particular process.
MR. BLAIR: Michael, apparently you are involved with the development of the white paper, and if I understand correctly, Stewart, you are involved with the NOI. Is that correct?
MR. STREIMER: I think we are all involved with the development of the white paper and the NOI.
MR. BLAIR: Okay, I am not involved in either, but Bob Gellman seems to feel very, very strongly that at least when the NOI becomes available that that will alter the way people look at these issues significantly and make the value of the hearings we have in Chicago significantly less. So, Michael, and Stewart, could you tell me whether you share that same feeling since you are both knowledgeable about what is likely to come out in the white paper and the NOI? Do you feel like it is going to change the playing field significantly in terms of how we look at health care identifiers?
DR. FITZMAURICE: I guess my opinion is that many people are not aware of it, and this is going to strongly increase their awareness that these discussions are a reality but if they look at the white paper and then later on they look at the notice of intent I don't think they are going to be shocked by what is in the notice of intent. They will have most of the substance of what is in the notice of intent in the white paper.
It is a matter of openness. We are not hiding anything under it is predecisional material and you cannot have it. It may be predecisional material but you can have it.
MR. BLAIR: Do you feel like it is likely to -- do you agree with Bob that if the hearings are conducted in Chicago in July before the white paper and the NOI are out --
MR. GREENBERG: The white paper would be out. It would have to be out. In lieu of the NOI the white paper will be available.
DR. DETMER: Stewart, I guess you stated your position fairly clearly.
MR. STREIMER: The white paper is being prepared with the sole purpose of being ready for those hearings so that the public has an opportunity to review what has been done thus far pretty much.
DR. DETMER: Simon?
DR. COHN: I have been sitting here relatively quietly. Bob, I think you bring up some very good questions, and I have been mulling over really where I stood around this issue.
As I think about it I think for the Committee the real question is first of all developing light on this issue rather than heat, and certainly we think the NOI will develop a lot of heat. So, I think that is part of the value of getting the NOI out.
We need to sort of see what the feelings of the public are, but because of our schedule, we know that there are going to be hearings that we are going to have. They are going to be out of sync with the 60-day comment which I think is what Marjorie was commenting about, and I think for the Committee to be of major value in this process we need to develop our opinions as closely in sync with the NOI process as we can so that we can appropriately advise HHS afterwards about whether they should proceed on with an NPRM, and if we wait until they are beginning the 60-day process we are going to be holding hearings 3, 4 months after the NOI period is done, and I don't think that is going to benefit anybody.
So, I sort of come down after thinking about this that we really ought to proceed on in July, and I think I would recommend that to the Committee.
DR. DETMER: Jim?
MR. SCANLON: Procedurally I think the model to think of for this notice of intent is something like a request for information. It is a pre-rule making kind of an activity in which HHS and other federal agencies potentially will be regulating in an area, and you ask for information.
So the normal proposed rule-type activities about predecisional material necessarily don't apply to the same extent. So view this notice of intent in this discussion more as along the model of a request for information a systematic public request for information rather than a proposed rule, a step in a proposed rule.
MR. MC DONALD: I just have to get more clarification from Bob about would a white paper satisfy because 2 weeks would be then in the right state because this thing was in the law 3 years ago. So, it is not exactly -- it says that they shall, not should you or not. I mean I am still puzzled as to whom you think is going to be made aware of this, who is going to be activated who might not otherwise be?
MR. GELLMAN: First of all, I haven't heard any guarantees that there is going to be a white paper out in time. I wouldn't be surprised. I didn't know about this white paper. I didn't hear about it until yesterday, but I wouldn't be surprised if OMB says that you cannot do it.
Second of all, it seems to me that we have got a requirement here that is to do something that everyone is proceeding very slowly on. Bill pointed out it should have been done in February. It hasn't been done. The Department is not putting out a notice of proposed rule making. At best they are putting out an advanced notice of something that might ultimately lead to something else.
There is no hurry on this. Clearly this is not an urgent thing on the part of the Department and the convenience of the Committee in terms of scheduling hearings is not an excuse for unfairness.
MR. MEYER: As an outside observer --
DR. DETMER: Introduce yourself?
MR. MEYER: Chuck Meyer, HBO and company although frequent participant in these hearings. I have not heard anybody say that the hearings aren't appropriate.
Also, it is very evident that the first hearing is not going to result in a recommendation nor is the second hearing, and given the comment period on the NOI when it is published which is open and free to the public and all interested parties, such responses would also, be available to this Committee, and finally, this Committee does not represent the arbiter of opinion on this issue. It is only one voice to be heard by the Secretary.
So, I think your role, Mr. Gellman would serve better as an ombudsman for these particular groups and keep your championship role rather than trying to prohibit the process, a personal opinion, sir.
MR. GELLMAN: I haven't tried to prohibit the process. I have suggested delaying it 2 weeks.
DR. DETMER: Any other questions or comments?
I think we have had a very open, complete discussion of this. Do you want to add anything, Bob?
All right. Let us call the question then.
The motion is that we wait until an NOI was put out before we would hold hearings.
MR. MC DONALD: May I clarify, is the white paper NOI issue still as important here?
DR. DETMER: As his motion it was the NOI, but that was what was moved and seconded.
MR. MC DONALD: You wouldn't want to change your motion?
MR. GELLMAN: No.
DR. DETMER: So, that is the motion before us.
Let us do this in a show of hands.
All in favor of the motion raise your hand?
(There was a show of hands.)
DR. DETMER: All opposed?
(There was a show of hands.)
DR. DETMER: Abstentions?
(There was a show of hands.)
DR. DETMER: Three abstentions.
Let us go back again.
For, raise your hands.
(There was a show of hands.)
DR. DETMER: I am sorry. We are going back for the motion, and then we will do against the motion. Then we will do abstentions.
For the motion?
(There was a show of hands.)
PARTICIPANT: Two.
DR. DETMER: Against the motion?
(There was a show of hands.)
PARTICIPANT: Ten.
DR. DETMER: That is what I get.
Abstentions?
(There was a show of hands.)
PARTICIPANT: Two.
MR. GELLMAN: Another motion?
DR. DETMER: Okay.
MR. GELLMAN: I move that all NCVHS Committee and subcommittee documents that address this subject of the unique patient identifier whether they relate to any committee or subcommittee activities about the unique patient identifier be exempt from the secrecy rules for documents contained in the Committee's ground rules for dealing with the media and other external organizations, Paragraphs 1, 2 and 3 from the documents section and that these documents be made available to the public at the same time that they are circulated to members of the Committee or any of its subcommittees.
DR. DETMER: Okay, could you repeat it again and then we will see if there is a second?
MR. GELLMAN: I move that all NCVH Committee and subcommittee documents that address the subject of the unique patient identifier or that relate to any Committee or subcommittee activities about the unique patient identifier be exempt from the secrecy rules for documents in the Committee's ground rules for dealing with the media and other external organization, Paragraphs 1, 2 and 3 from the documents section and that these documents pertaining to the unique patient identifier be made available to the public at the same time that they are circulated to members of the Committee or any of its subcommittees.
DR. DETMER: Okay, is there a second to the motion?
MR. HARDING: Second.
DR. DETMER: Okay, there is a second.
Discussion.
DR. LUMPKIN: Point of information. Could that section be read?
MS. GREENBERG: I do want to point out, too, that I think it is important that this get full discussion, but we have reached two-thirty, and we have particularly once the Subcommittee on Populations has peopled schedule to give testimony --
DR. DETMER: Okay. We have got it on the floor. We can do it tomorrow.
MS. GREENBERG: I can read this though. Was it exempt from Paragraphs 1, 2 and 3 in the documents section of the media guidelines?
MR. GELLMAN: Right.
MS. GREENBERG: Okay, one is all predecisional documents -- these are the ground rules for dealing with the media and other external organizations. I believe they were either approved in September or November. I am not quite sure but last fall.
No. 1, all predecisional documents provided to NCVHS members by the Department should be kept in strict confidence and should not be shared or discussed with anyone who is not a member of the Committee or staff to the Committee.
Requests for predecisional departmental documents should be referred to the Executive Staff Director, Mr. Scanlon.
Okay, 2, all Committee or subcommittee documents that have not been approved by the full Committee and transmitted to the Department should not be shared or discussed with anyone who is not a member of the Committee or staff to the Committee. This includes documents being prepared by a contractor.
Requests for predecisional NCVHS documents should be referred to the Executive Secretary, myself.
Three, a good rule of thumb is that a departmental or Committee document can be freely shared and discussed as soon as it appears on the HHS Data Council or NCVHS home page. Requests for this should be referred to the extent possible to these web sites for documents.
DR. DETMER: Okay, why don't we pick this back up in the time slot we had originally, but we got into this issue, and we will come back to this, and then what we will do is adjourn, but we have one question.
MR. MC DONALD: I think we ought to worry about procedural. We have got a motion on the floor, and can we really and with a second. Can we really put it off?
MR. HARDING: I would move to table it until a time certain tomorrow at that specific time.
MS. FRAWLEY: Second.
DR. DETMER: Okay, that has priority over the motion that is on the floor.
All in favor say, "Aye."
(There was a chorus of ayes.)
DR. DETMER: Opposed?
(No response.)
DR. DETMER: Abstentions?
(No response.)
DR. DETMER: Okay.
MS. GREENBERG: We have two issues. I had developed, I had a sign-up sheet for each subcommittee and work group. Does anyone know where those are? Okay.
I will be the holder of them. We can do it later.
DR. DETMER: But I would like for you to do that today so we can circulate that tomorrow.
The other thing, we need a couple of minutes to decide where we are going to go celebrate George Van Amburg's service for dinner tonight.
Does anybody have a suggestion?
MS. GREENBERG: Kathleen Frawley I believe was --
MS. FRAWLEY: I didn't have a chance to do anything yet.
MS. GREENBERG: Lisa, when will your subcommittee meeting go until?
DR. IEZZONI: I would like to start now. The problem is that Kathy is not going to be here tomorrow and to the extent that we can talk about work plan and so on today that is a benefit for us because of Kathy's presence.
MS. GREENBERG: Would you say it will go to five-thirty?
DR. IEZZONI: We might, also, peter out. I would say let us not assume it will break before five.
DR. DETMER: But we would probably have dinner at six anyway.
MS. GREENBERG: We can meet here at five-thirty, people who want to go out to dinner as a group and by then Kathleen will have figured out where we are going, right, Kathleen?
MS. FRAWLEY: Yes.
DR. IEZZONI: May I just make a request? Why doesn't my subcommittee take a 5-minute break which we need before convening, and can the subcommittee all kind of convene over in that corner so we are not all kind of spread out around the room?
(Thereupon, at 2:30 p.m., a recess was taken until 8:00 a.m., Wednesday, June 17, 1998.)