[This Transcript is Unedited]
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
Hubert H. Humphrey Building
200 Independence Avenue S.W.
Washington, D.C.
DR. LUMPKIN: We will do introductions. To remind everyone, when they speak, to speak into the microphones. We are going out through the Internet.
I was reminded by Marjorie today because, as you remember, she was in homeland security limbo yesterday, when we started off I failed to do something. As required, we need to identify any potential conflicts of interest with the items on the agenda that members may be voting on. If you have such a conflict, now is the time to declare that.
DR. GREENBERG: We thought one way to introduce it was when we were going to do introductions.
DR. LUMPKIN: So when you introduce yourself, you can tell us. Well, conflicts of interest with items on the agenda. If you are conflicted, we don't really need to go into that. You can talk to Richard later.
My name is John Lumpkin. I am Chairman of the committee and Director of the Illinois Department of Health. Why don't we start off with Marjorie?
DR. GREENBERG: I am Marjorie Greenberg, National Center for Health Statistics, CDC, and Executive Secretary to the committee.
MS. COLTIN: I am Kathryn Coltin, Harvard Public Healthcare, member.
DR. COHN: I am Simon Cohn. I am the National Director for Health Information Policy for Kaiser Permanente and a member of the committee.
DR. NEWACHECK: I am Paul Newacheck with the University of California-San Francisco and a member of the committee.
DR. FRIEDMAN: Dan Friedman, Massachusetts Department of Public Health, member of the committee.
MR. AUGUSTINE: Ray Augustine with Gambrio Healthcare, Corporate Director for Special Projects, senior files statistician and member of the committee.
DR. SONDIK: Ed Sondik, Director of the National Center for Health Statistics.
MR. BLAIR: Jeff Blair, Medical Records Institute and member of the committee.
DR. LENGERICH: Gene Lengerich, Penn State University and member of the committee.
DR. SHORTLIFFE: Ted Shortliffe, Columbia University, medical informatics and a member of the committee.
DR. HARDING: Richard Harding, University of South Carolina Department of Psychiatry and President of the American Psychiatric Association.
DR. LUMPKIN: And member of the committee.
DR. HARDING: And member of the committee.
DR. FITZMAURICE: Michael Fitzmaurice, Senior Science Advisor for Information Technology to the Agency for Health Care Research and Quality, lead staff to the Secretary for private sector initiatives, and liaison to the National Committee.
DR. ROTHSTEIN: Mark Rothstein, University of Louisville School of Medicine, member of the committee.
DR. MAYS: Vickie Mays, University of California-Los Angeles, member of the committee.
DR. STARFIELD: Barbara Starfield from Johns Hopkins University, medical institutions, member of the committee.
MR. STOSS: Eric Stoss, Center for Regulatory Effectiveness.
DR. JONES: Katherine Jones, National Center for Health Statistics and staff to the Executive Committee.
MS. KANON: Susan Kanon, writer for the committee.
MS. JACKSON: Debbie Jackson, NCHS staff, committee staff.
MR. WEINZIMMER: Rob Weinzimmer, National Center for Health Statistics.
MR. HUNTER: Ed Hunter, NCHS.
MR. GRUBERMAN: Mel Gruberman, Walter Reed Army Medical Center, former FDA representative to the group.
MR. HITCHCOCK: Dale Hitchcock, HHS data policy office, staff to the subcommittee on populations.
MS. AULT: Vivian Ault, National Library of Medicine.
DR. STANDELL: Steve Standell, Centers for Disease Control and Prevention.
MR. EDDINGER: Stan Eddinger, Agency for Health Care Research and Quality and staff to the quality work group.
MR. BUSSOWITZ: Roy Bussowitz, National Association of Chain Drugstores.
MS. TRENTI: Nancy Trenti, American Psychiatric Association.
MS. KAMINSKI: Stephanie Kaminski, Office for Civil Rights and staff to the privacy subcommittee.
MS. BICKFORD: Carol Bickford, American Nurses Association.
MR. RUDDY: Dan Ruddy, American Health Information Management Association.
MS. FULLER: Sandy Fuller, American Health Information Management Association.
MR. BURDO: Matt Burdo, National Coalition for Cancer Research.
MS. WHITE: Gracie White, NCHS.
DR. LUMPKIN: Before we get started with the first item on our agenda, I just wanted to review the agenda. Mark, is there going to be any action item from your --
DR. ROTHSTEIN: Yes.
DR. LUMPKIN: Okay. I would like to get a feel for if anyone will be leaving prior to 3 o'clock. There are two.
(Remarks off the record.)
DR. LUMPKIN: Are there any other action items from any of the other work groups? So we should have an adequate quorum for the privacy discussion, so I just wanted to check that. Thank you.
At this time, Ed Sondik is here for a return engagement, a once and frequent visitor to the committee to follow up on our discussion last meeting. Ed?
DR. SONDIK: Thank you very much. It is a pleasure to be here.
There were some questions that came up generated by my presentation, it seems like just yesterday. I guess it was last fall. What I wanted to do was to have an opportunity to delve into some of this. That is point two. Point one was, I really wanted to put in front of you the major challenge that the center faces and ask you your advice. I am sure you will have some advice with regard to that, but I am sure also that we need a process for following up to get some continuing advice on these challenges.
The challenges have to do with something that is facing every one of you as well as us, and that is resources, tightening resources.
Let me if I can summarize some of the things that I talked about last time. The center, I believe, has made an enormous amount of progress in a number of areas over the last decade. For one, we have new mechanisms for collecting our information that range from the SLATES mechanism using the telephone to an entirely new NHANES that has a very advanced information system as part of that.
We have made significant advances in timeliness. Part of this is due to some of the re-engineering that we have done. But for example, the vital statistics now come out within a year of actually having been collected. Some of the data from the health interview survey come out within six months of having been collected. Some of the data from NHANES, which used to take three years to conduct, half of the six-year cycle, so you waited three years for that, plus another two to three years after that to actually get the data. Some of that NHANES data is now available well within one year after having been collected, and some of it even earlier than that. So I think in many respects, the timeliness of the data and the way it is being released I think are real advances. All of this has taken place over the last decade.
Another advance, and we are not alone in this -- you heard about this briefly yesterday, is in our research data centers. This is extremely important in helping us with the tradeoff between making our data as available as possible, but being sure that confidentiality is maintained. In effect, there really is no tradeoff there; confidentiality must be maintained. The question is, how do we make the data available.
We have found that it appears that the research data center is a very viable means for doing this, which does not by any means limit the production of CDs and online mechanisms for allowing individuals to get at the data.
People have also made a lot of progress over the last decade in international activities. I think this was a question that someone had at the last meeting. We have a wide variety of international activities led by Sam Knotsen, who at this moment is in Paris, not on vacation but in a meeting, who really is the spark plug behind what we have been doing internationally.
But there are many activities, some of which I don't think you know about. I'm not sure I mentioned last time that we have been very much involved with summary health measures in the WHO report and now with OECD. In fact, that is where Sam is at this moment. I filled in for the Secretary last fall at a meeting in Canada to talk about summary health measures.
We recently had a very important meeting called the Washington City Group on Disability Statistics. I am looking at Marjorie to be sure I have the title correct. This is the beginning of an ongoing activity that will continue to be called the Washington City Group under the UN rubric of naming these activities over the first city where they occur.
This had a stellar group of disability researchers from around the world, and I do mean stellar, including some very high level officials from right here in the U.S. who attended. The purpose of this is to work on disability statistics so that we can better enable countries to compare disabilities across regions, to put together the kind of information that is necessary so that with a relatively minimum number of questions, or perhaps even more than that in some cases, we can understand the level of disabilities and the nature of disabilities across countries.
Right now, that is a difficult thing to do, although a lot of progress has been made. I mentioned last time the progress that we have made here, or that the U.S. was instrumental in, and Marjorie and her colleagues were instrumental in, was the development of the ICF, the international classification of functioning and disability, that was adopted by the WHO.
So there are lots of areas of progress. Let me talk a little bit about the challenges. Maybe the best way to look at the challenges is to look at a slide. I have got a couple of these.
Let me describe this in terms of the resources and the crunch in resources that we and I think all of our colleagues at CDC and HHS and you all for that matter are facing. We have had -- this slide looks at appropriations from 1992 up through 2002. For the first half of that decade, our appropriation was relatively constant at around $80 million. After that, it increased at a fairly rapid clip, as you can see here, up to about $125 million, roughly speaking.
Now, if we look at this figure and we adjust for inflation, it starts to become clear to me why I continue to feel cramped, despite the fact that we have had this increase. If we look at it in terms of inflation, and what we are looking at here is not the full appropriation, but we are looking at the figure that really is the meaningful figure; it is one that is called technically our ceiling, but it is our operating figure, the one that we actually have to work with.
This has gone in 1992 from a little less than $80 million, around $78 million, up to -- I think it is just around $110 million in 2002, in terms of the actual ceiling. But if we look at it in terms of adjusted figures, and we have adjusted this by the bird pie -- I love to say that, bird pie; it is so infrequent that one gets to say that -- that is the BRDPY, or the biomedical research and development price index, using that, and we are adjusting back to 1992, so the figure from 1992 for that was around $78 million, but the figure for 2002 is around $72 million, more or less.
So what we have is an unadjusted figure that is around $110, but an adjusted figure based on 1992 that is around $72 million. When I look at this, I say this is really terrific, look at what we have been able to accomplish with the set of resources that in effect have actually been shrinking over this period of time.
We really have accomplished an enormous amount. We accomplished HANES being in the field and then leaving the field for several years, being totally revamped and then put back in with a new information system. We have revamped HIS over that period of time. The vital statistics as I mentioned before, the timeliness of that has improved, and a variety of new information activities, data collection activities, areas that we are involved in, all of that really makes me feel good.
On the other hand, we are facing a situation that we really need your help on. We are going to have to make some tradeoffs here. In fact, these tradeoffs have to do with these various areas.
Now, on this graph I am showing the major areas of our budget that include this area called management, which actually includes a good deal more than management. It actually includes support of this committee, but I just lumped it under management, probably inappropriately, but research, vital statistics, the care surveys, the health care surveys, HIS, health interview survey, HANES, analysis activities, and then something that has to do with our contribution to CDC for its central costs. So it is not money that we actually receive, it is money that goes back in general support of CDC, as well as paying some of the freight for NCHS, a central tap, if you will.
If we look at this on a pie chart, the vital statistics plus the care surveys plus HIS plus HANES come up to around 60 percent of our budget. With the budget tightening the way it is, and with the fact that we have picked off a good deal of the low-hanging fruit, our question is, how do we continue to make advances in light of resources that are tightening.
There are a variety of things that we can do, some of which we have started to do. One of our continuing priorities is re-engineering. I am committed to re-engineering the things that we are doing. If we are not doing that, we are going to fall behind, we are going to lose our flexibility. We are not even going to be able to maintain the things that we are doing.
I'm not sure I mentioned this this way, but let me put it to you this way now. One of the really important areas of re-engineering is re-engineering vital statistics. Some areas of vital statistics are in the states, are running on DOS and COBOL. This is great for COBOL programmers who were fully employed at Y2K, but now have fallen out of employment again. So it is great that they have something of a home in some of the vital statistics areas.
But this is not a way to run a system that is so fundamental to our tracking of health and health care in the U.S. So we think it is very important. NASIS, the professional association for vital statistics registrars, certainly agrees with that. We think it is very important that we work to change the system and upgrade it as rapidly as we can, put in a system that is able to use the Internet. I talked about this some at our last meeting.
So re-engineering there, re-engineering in the health interview survey is very important. We have gone to CAPI there, but we need a system, a meta data system that will increase the ability for us to plan and draw information from the HIS. As you know, it is a very complicated, very large survey. NHANES, even though we re-engineered it in the middle of the last decade, will need continuing upgrades to be current with technology.
So in order for us to be able to continue these re-engineering efforts, we need to be able to find ways to increase our resource flexibility. One of the ways that we can do this is for example modifying HIS. We could take a few weeks off of HIS. Rather than do a full year, we could do 48 weeks, for example. In fact, we have done that this year to give us some relatively small, but critical resources that we needed to continue the re-engineering efforts there. We can also make some adjustments in vital statistics. In large part they have been technical adjustments to the contracts, and have not changed the level of effort per se. But they have given us some additional flexibility there. As resources tighten, we need to consider where we should put our resources.
One of the areas that has suffered over the last decade has been in the health care surveys. We have a family here of seven or eight surveys. They have not been in the field at the same time over the last year. This I think is really a problem. It is important as our health care system is changing as rapidly as it is that we have information there that is able to track this system over time. So one of my very high priorities is to find ways to put some of these surveys back in the field and do them more frequently, if not every year, more frequently than we have been able to in the past.
What I would like to do is to get your take on these kinds of tradeoffs. Let me just summarize it if I could here. We collect information on health status, we collect the vital statistics, we collect information on the health care system. We do research and methodology studies that support these various efforts.
Our question is how to balance our resources so that we can continue to supply the information that is critical, but at the same time find new ways of doing this or new frequencies, change the periodicity, for example, at which we collect this information. So these are some of the things that we are thinking about.
I say all of this in the context of something else that I think is critical, and something that relates to the discussion yesterday of bioterrorism and national preparedness. I think we have great potential here to -- and this is reflected in the national health information infrastructure document, and in the vision for a health statistics system for the 21st century.
I think we have great potential here to build a system that is able to give us much more information on health and health care, the factors that influence both of these. I don't want to see us fall back on these efforts. I think what we are doing here particularly with our re-engineering are steps toward realizing this vision, but only some of those steps. So any advice you have on how we can use these resources to best realize these visions, the health information infrastructure and the vision for health statistics, would be very much appreciated.
With that, let me stop and open this for discussion.
DR. LUMPKIN: Dan?
DR. FRIEDMAN: I have a couple of comments. I am struck on the pie chart that less than ten percent of the funds are obligated for analysis, epidemiology, Healthy People and research and methodology.
DR. SONDIK: The HP is that, is Healthy People.
DR. FRIEDMAN: I realize that the continuing obligations to get the surveys in the field, to get the vitals data in and out are just that, are major continuing obligations and need to be rejiggered and improved over time. At the same time, it also seems that the unique value added that NCHS has is not only in the data collection, but also in analysis, epidemiology, particularly the methods, et cetera.
This is an observation rather than a question, but it just seems like a real shame that more of that pie can't go to those analytic functions.
DR. SONDIK: I appreciate the comment. We can do this later in the subcommittee, or I can supply the information to you. I think it is important to look at what actually comes from that. I think it has been very, very productive.
What we are looking at when we look at this pie chart is, we are looking at a combination of the total, that is five percent of the total of our expenditures, or total obligations for 2001. We are looking at essentially staff, whereas when we are looking at the slices above and around that, we are looking at the implementation in the field of some very expensive data collection activities.
So in a sense, the bang from that five percent is much more than is represented by the way it appears on the chart. But I would certainly agree with you. I have said this here, I have certainly said it in almost any forum I can. I think one of the areas that is very important for the health statistics system in general is research. I think all of us -- when I say us, I mean the federal statistics agencies -- should have a significant component of our budgets that is going into continuing resource to evaluate our efforts, as well as to find new methods for enabling us to do our jobs more effectively and more efficiently.
I think that is an absolute critical area. It is interesting, I don't think any of the agencies has a particularly large research budget.
DR. LUMPKIN: Paul.
DR. NEWACHECK: I am struck by the amount of the pie or the size of the slice going to NHANES, 20 percent of the total budget, which basically is almost equal to everything else that is going into surveys, the NIHS plus the care surveys.
It is my impression that some of these other surveys, like in particular the national health interview survey, is used much more frequently than NHANES. At least, I see it cited more often in my own work.
I am wondering, has there been a careful analysis within NCHS as to how much money is going into NHANES versus NHIS versus the care surveys, relative to what is coming out of them in terms of the utility of those surveys and the value of them, a cost-benefit analysis or sorts?
You mentioned in your earlier comments, maybe one thing to do would be to cut four weeks out of HIS as a way of saving some money that could be used elsewhere. But I wonder if there is perhaps a more in-depth process that could be undertaken to examine the cost and benefits of each of the surveys, and seeing whether it makes sense to have the current slice distribution or some other distribution that would make sense.
DR. SONDIK: It will be a challenge. We do not have a cost-benefit analysis. I do think we are going to have to take a very careful look at something along those lines, at what we are achieving, at the benefits that derive from all of these.
I am particularly concerned about the care surveys, as a matter of fact. I think we have to look at this in terms of what it actually takes for us to conduct this and what the marginal gain to HIS would be if more dollars were available to HIS. At this point, we would use those dollars to help the re-engineering. That re-engineering will take us a few years, but then as we analyzed it, that need will fall back to essentially the current need.
So we have got a hump that we need to get over in terms of that re-engineering, and I think we would be relatively okay in that area for awhile.
The surveys produce information that is quite different. For example, NHANES produces this exposure data from a representative sample of the U.S. that absolutely has not been available before. The information that was available was based on samples of opportunity of relatively few people, and lots of important decisions were made on the basis of that.
So this is very important. But that is not all that NHANES is. We recently had a program review with Jeff Copeland, as we do every year. But this year even more than other years, I was struck by the fact that if one looks at particular pieces of information that come from these surveys, particularly HIS, if you look at one piece of information such as the percentage of women who have been screened with mammography, when you focus on that single piece of information, you miss this wealth of covariates that go along with that which are the tremendous value of these surveys. They don't simply collect one item of information, but they collect a large number, which enables you to understand the fabric of health, the different dimensions, the different aspects of it.
So in analyzing what we get out of it, I think we have to take that into account as well, the breadth of this, as well as the specific pieces of information.
So that is longwinded to say, we certainly have not done a formal analysis of this, but I think that we will have to consider that if the resources should continue to tighten. But what you see on this pie chart, 20 percent for NHANES, 12.9 percent for HIS, do not reflect directly what comes out of those surveys.
I wish I had another chart that did that. I'm not sure how to draw such a chart. But those of you who know these individual components have a sense of that.
DR. LUMPKIN: Richard?
DR. HARDING: Ed, I was fascinated by the bird pie. I hadn't heard that term before; I like that. But what it showed me was the importance of exceptional stewardship that you have given to NCHS in the last number of years, and I am appreciative of that.
My question is more having to -- having been involved with various groups in trying to raise budgets for federal agencies such as the NIH and been somewhat successful, I know that he who giveth also taketh away. I was wondering if you have heard, I have not heard, but have you heard what the proposed budget is for NCHS, and is that going to be a help to the process or is that going to be a difficult situation to deal with?
DR. SONDIK: The figure is approximately what the budget is for 2002. CDC's budget overall is less, I have forgotten by what percentage. Maybe Ed knows.
PARTICIPANT: Slightly less.
DR. SONDIK: Slightly less. So what we see with this is a continuing challenge.
Your remark about stewardship, I thank you for that. But let me say that the fact that we have done a great deal more and are doing things in different ways is really due to the terrific staff in all of these areas, who are very much excited by what they do and the opportunities. But we really have reached a point where we are going to have to consider some tradeoffs. It relates back to the prior question about what will we be trading off in terms of some of these activities.
DR. HARDING: But there is no rescue coming in the budget. You are saying it is flat with the inflation factor and so forth.
DR. SONDIK: Yes, the actual figure would be flat, so inflation wise, this would not be a positive situation. On the other hand, the fact is, we are all facing this type of thing, all of us sitting around the table. So it is simply a fact of life.
DR. LUMPKIN: Barbara?
DR. STARFIELD: This is on the same question, what do you think about cutting back. I think you are going to have to cut back something, given the situation.
I guess you could justify the different surveys different ways. You have got to do it because of international comparisons. If you didn't do it, the United States would fall off the map. You have got to have NHIS, mainly.
The second one, you need it for historical trends, so you can't cut that back because you need the trends. The third one is, you need to do it to be innovative. I guess the care surveys fit in that category. There aren't many countries that do care surveys, but they add a lot, because it is pushing the field ahead.
The fourth thing is things that are useful, that Congress would be really upset if you cut them out. Those are the ones I would cut out, I suppose.
But if you look at them that way, I guess I would come out thinking what Paul was alluding to, that NHANES sticks out. It seems that that one from the point of view of your advocacy probably has the greatest advocacy, because you did things like lead levels, which had tremendous impact on our policy. So maybe if you cut out NHANES, you would get the money back in some other way.
DR. SONDIK: Let me talk candidly about NHANES. NHANES was out of the field for several years. The most recent was '88 to '94. It was redesigned with its information system and put back in the field in '99, with the idea being that it would continue to stay in the field, that we would not run it for some number of years and then take it out again.
We gave it a new design or representative sample every year, which adds great flexibility to this. We have teamed with the USDA so that we now have one single nutrition survey, diet and nutrition survey for the U.S., rather than two. There are pluses and minuses to that. It is always good to have multiple things, but those surveys were so similar that we felt that this was a good use of resources, staff resources especially, to have a single survey. But it is conceivable that we could take NHANES out of the field and then put it back in again, so we could go back to what it was we were considering.
We have some spinoffs from NHANES. We have something we call community HANES, which are trailers that we have invested in. They are outfitted and ready to go to a community near you to conduct HANES-like studies on specific populations, not a national sample, but a specific sample, for example, the border populations or other immigrant populations or inner city populations, or the reservations in the Southwest and North Central United States, any number of things like that.
We have made that investment. We can't do it with our budget, but we certainly could do it with resources from other agencies. We are talking with other agencies about doing that.
HANES is really a support to that community HANES, because it is the proving grounds for the methods and that sort of thing. But it was out of the field, and conceivably we can run it for several years, and then take it out of the field again. It would free up a portion of that 20 percent, not all of it by any means. I think the responsible thing to do would be to continue some of the methods development, and use it also to mine some of the information that has come out of it, and then consider what we want to do to put it back in the field again, what kind of program it should have when we put it back in the field again some years after that.
So that is a possibility. All of the things that you have mentioned are things that we have been thinking about. Time trends are important. Are they important every year, though? Perhaps every two years, perhaps ever three years, even every five years.
I think we need to consider what areas of health and health care are changing the most, because for those that are changing the most, we probably want to instrument them, if I could use that term, as heavily as we can, so that we can pick up these changes, particularly the early changes.
So we are considering all of those tradeoffs.
DR. LUMPKIN: Jeff?
MR. BLAIR: Ed, you mentioned that there is already a certain amount of pressure on the budget flexibility that you will have. You also mentioned that the national health information infrastructure proposal from NCVHS might be a potential for help in the future.
During these last two days, we have CDC, Claire Broome and John Loonsk, reference the NEDSS system, and how that begins to potentially meet their information needs. They also mentioned NHII. We also had Helga Rippen present to us on a biomedical f
infrastructure for dealing with bioterrorism. She is from the RAND Corporation.
It seems to me, if I am hearing things correctly, that with the budget pressures plus the common interests that all of you have, that at least are partially reflected in the national health information infrastructure, have you or any of the other agency heads begun to think about working together to see if that national health information infrastructure might be a framework for you to both lower your costs as well as increase the data that you need to be able to meet your needs?
DR. SONDIK: There has been some discussion of that. Clearly, some of the resources that have been going into bioterrorism specifically, the specific dollar resources, have been of some use to us. But there is I think much more that can be done to do what you are talking about, which is linking these activities together into a unified vision.
In fact, after the wonderful panel yesterday on bioterrorism, I caught Jerry Hauer and said that we really need to put our heads together, because I was very impressed at what I had heard. Frankly, -- which is one of the great things about this committee -- I learned more at that point about some of these activities that were going on in bioterrorism than I had known.
I certainly am familiar with what CDC is doing and what NEDSS is doing. In fact, we are working with NEDSS intensively on this re-engineering of vital statistics, because as I see it is very much the model. I believe we have pretty much a unified feeling about that, that that is an excellent model for the future.
So one of the reasons that I feel so strongly about the national health information infrastructure and this vision is that it does provide a template in a way for the various components to talk to one another and to direct.
I think prior to these efforts, we have had a system in which the different components of the system have been running in parallel, but not doing a great deal of communication. I see this as providing a vehicle for more communication. So I think you are right on in doing that.
DR. MAYS: I'll start by seconding what Richard said in terms of the management of these surveys under your stewardship. Everybody knows that this is getting more expensive, more complicated, so the whole notion of looking at ways to re-engineer things with the budget that you have I think is very wise and very useful.
Also though, like Richard brought up, I happen to belong to groups like the other APA and ACE and other groups like that. They have been very successful at for example getting increases to budgets like the NIH, in terms of some of the behavioral science agenda. I think in terms of when we think about a lot of the surveys, the issue of the contextual factors that relate to health, the issue of some of the mental health factors are probably less than some of those surveys, but yet that is where we see some increases for funding, to really look at some of those issues.
The Subcommittee on Populations had a hearing maybe about two weeks ago or something like that, and several of your surveys from MCHS were there. What is really clear after that hearing is, people want more, not less. So I am a little concerned, because we are going to come in with some request probably about the other types of contextual factors, ways to link these surveys.
So I am concerned that we are talking about scaling back, even though I know everybody has to tighten the belt, and wonder if there are some other ways or creative things to do in which the true picture of the contribution of these surveys to other aspects of the Department, like Healthy People 2010, like other initiatives, are actually emphasized.
The budget is a little weird, in terms of how you budget functions not budgeted directly to you, but I am trying to figure out if there are any other thoughts about ways to bring in other resources.
DR. SONDIK: We do collect so-called reimbursable resources from some of the other agencies. They are not reflected in this. In large part, they pay for additions to what you see here, although for NHANES, they comprise maybe 27 or 28 percent of the total cost of NHANES. What you are looking at here is our component, I won't say our contribution, because that gives the wrong flavor, but it is the amount of money that we put in directly. But other agencies add funds to it.
Again, in general, those funds are tied to specific efforts. So for example, if we are conducting an alternative medicine component for HIS, which we are going to do, NIH is going to pay a portion of that, if not all of the marginal costs, of that supplement. Otherwise we couldn't do it. It is not reflected in this.
Let me get to the real point of what you were saying. Like all agencies, we try to muster the best arguments that we can in these difficult times especially, the best arguments we can for our budget. Any guidance, recommendations, needs, that you have are things that we can put into our budget requests. If those budget requests say in effect that we are doing okay, that we are collecting the information that we need to collect and so forth, then the budget is going to remain where it is.
So the insights that you all gain are important to us. So that is certainly one direction in which you can send them, so that we can crank them directly into our budget. It may be that there are other agencies that can join with us, or we can do activities in parallel that meet some of these needs.
I'm not sure I can say much more than that. Certainly it is critical to us to have your assessment as to what needs we are not meeting, and what areas for example we may be putting too many resources in at this point.
DR. LUMPKIN: Gene?
DR. LENGERICH: I too would like to add congratulatory remarks about how you have been a steward for those funds.
DR. SONDIK: I'll say again, it is really the staff.
DR. LENGERICH: I guess I would like to extend that also to the idea of re-engineering the surveys, because I think you have made it much more useful to people, to science as well. I think that that shouldn't be lost in the conversations.
The gist of my comments were what Vickie had to say as well. Looking at the partners and the contributions that have been made by your data as well, and those aren't to be overlooked at all. For example, the hearings that Vickie referred to, there were users matched up with each of those surveys, and they highlighted important ways that they have used those data in contributions that they have made. So I think having that kind of thing on the table is very important.
So since you have already addressed her comment, I would just add, is there a process or an articulation of a process for evaluating the various components and how those might be traded off? We can specifically offer some suggestions to you, but I am also wondering if you have some sort of larger idea about how to solicit that input from additional members from the NIH, from the other agencies of the Department, from other committees or whatever.
DR. SONDIK: We will certainly do that. But I would very much like your ideas on how we can gather information from the user community, in other words, where they see the priorities. If everything is a priority, that is great, but of course that is a problem. We really need to understand how we can trade off these different activities, change the periodicity.
Clearly, if there were additional resources, that would be one thing. But I think looking at this realistically, we are dealing with a situation in which we are going to be somewhat limited, so how do we make these tradeoffs. Knowing what the various components of our constituencies are, our user communities, knowing how they see this would be very useful to us.
I think one thing that would be very useful related to both your comments is a report on the hearing that you held a couple of weeks ago. I assume there will be one. That I think will be very, very useful, particularly the way you phrased it, matching the users with the particular components. I think that would be very useful.
DR. LENGERICH: We did talk about that yesterday, but the purpose of the hearing was not specifically to NCHS, but more to addressing particular health issues that NCHS does collect information on.
DR. SONDIK: I think that is really important, though. One can focus on a particular agency, but I think what has the most impact is to focus on what the needs are. Then the question is, how do we meet those needs.
So it relates to Jeff's point about the infrastructure. It may be that what we need to do is re-engineer the infrastructure to make better use of all of the data collection activities that we have, because there are a lot. Go to Jim Scanlon's new site, the test site that has been set up, and you are regaled with an enormous amount of information. The integration of that information is really a challenge, and we need to do better jobs of doing that.
It is wonderful to have that, but it poses a challenge as to how to make sense of all of that. I don't think, although it is always an issue, one can look at these data collection activities and argue that there are multiple activities in the same area; do we need all of those. There have been some that have been looked at in some detail by the Department, with the conclusion that having the multiple activities is actually useful, because it provides a different view of that particular area of health which is important.
i mentioned this when I talked about the change in our nutrition component of NHANES, combining that with USDA. I was very concerned about this. If the USDA component was providing information, ours wasn't, and vice versa, or conducting the survey in a different way. But after looking at it, we concluded that they were so similar, that we were better off by combining them. The health community seemed very positive about that.
There was some concern on the part of the USDA constituency. They were concerned that perhaps the emphasis would change. We have had a number of meetings with both constituencies to talk about what we are doing and how we are doing it.
DR. LUMPKIN: Dan, the final --
DR. FRIEDMAN: John has given me the cutoff sign, so I will try to be really rapid.
Ed, getting back to vitals re-engineering for a minute, it strikes me that as we move to a web-based system and the data come in virtually on a real-time basis, they can also be used on a real-time basis for case management to serve as tracking as a basis for bill payment. To the extent that is going to happen, Medicaid CMS programs, et cetera, the development of their systems are not going to be separable from the development of a re-engineered vital system, and in terms of the support for a re-engineered vital system. You probably thought of this already, that some of it could come from non-CDC programmatic sources.
DR. SONDIK: Yes, we have had some discussion with them. We need to have more. The social security -- and I think I may have mentioned this the last time -- has actually been a significant supporter of this. Every minute delay if you will with which they learn that one of their annuitants, if you will, has died, delay in learning that is money out of the U.S. pocketbook. So they are very concerned about that. They have helped support the initial efforts in this change, at least in the death system side.
There have been significant advances on the birth side, but still much more needs to be done to put together the kind of system that I think this country deserves. But we will pursue, I assure you, the identification of and the pursuit of stakeholders in this.
DR. LUMPKIN: Ed, thank you for coming. I'd like to ask the Subcommittee on Populations to perhaps follow up on this discussion, to the extent that we may need to have some additional recommendations.
I do want to make just one brief comment, and that is about NHANES. That is a national jewel. I learned the hard way in budget negotiations that you don't want to offer up anything that you don't want cut. So I would encourage you to protect that as much as you can. It is the gold standard by which the other surveys can be evaluated. It is the only way that we actually go out and look to be assured that people are the way they say they are when you call them on the phone.
So I would certainly encourage you to think very long and very hard before you would consider scaling back the NHANES.
DR. SONDIK: I just want to follow up something that Barbara said about this internationally. It is a combination of NHANES and HIS that are being considered the standard internationally. This is what WHO is in a sense replicating in its proposed household survey that it would like to see every country mount to some degree. There are components in that that are essentially NHANES, very simple NHANES, but NHANES nonetheless, and others that draw from what is being done every day in HIS.
So these things are important. On the other hand, even though they are important, all of us face this reality of resources. I would very much like your guidance on how we can communicate with our communities, in terms of these various tradeoffs, and understanding what the priorities are.
Thanks.
DR. LUMPKIN: Thank you, and we will be following up. We have another speaker. We are running a little bit late. Dr. Koski, welcome, please, if you would, and if you would identify yourself for the folks on the Internet who are listening in.
DR. KOSKI: Thank you very much. My name is Greg Koski, and I am the Director of the Office for Human Research Protections within the Office of Public Health and Science, within the Office of the Secretary of the Department of Health and Human Services.
Let me begin by thanking you very much for the opportunity to come and brief this group on the Department's progress and our office's progress in the remodeling of our nation's system for the protection of human subjects in research. We have tried actually on several occasions to set this up and schedules haven't worked, and so I am delighted that it has finally worked out.
It gives me an opportunity to share with you many of the steps that are being taken, many of the successes as well as some of the challenges that we still face, as we move toward strengthening this critically important part of our nation's human research enterprise.
Just by way of background, let me briefly mention -- I am sure you are aware of some of the history here, but it was back in 1998 when the Office of the Inspector General issued its report on the status of our nation's system for protection of human subjects. That was not a particularly flattering report.
It noted in particular that over the 25 to 30 years that this system had been developed and implemented, there had been many, many changes in the research environment, but not many changes in the system for protecting the rights, the interests and well-being of the individuals that we depend upon as research subjects if we are going to be able to do this work. They recognized that the system had been challenged by those changes, and that indeed it was time for reform.
Nevertheless, reform doesn't always come easily, particularly when a system has been working for two or three decades. It was really not until the very tragic death of Jesse Gelsinger in a gene transfer study at the University of Pennsylvania back in '99 that we seem to have accumulated the critical mass of energy that is necessary to move some of this forward.
It was at that time that former Secretary Shalala announced the Department's initiatives here to both re-evaluate and take the steps necessary to strengthen the system of protection for human subjects, noting how critically important it was that we do that because of the incredible opportunities that exist in the research world right now, the new tools that we have available, the new questions that we have, as well as the new challenges that we face, that provide us enormous opportunities, but we have to make sure that our systems are up to the task.
So it was in June of 2000 that our new Office for Human Research Protections was created and placed within the Office of the Secretary, in order to give it the position that it would need in order to exercise its authority as well as its leadership opportunities. I was appointed director of this office in June of 2000, and began my responsibilities shortly after Labor Day of 2000.
Almost immediately upon arriving here, I was given an opportunity to lay out the Department's goals in testimony before the House Oversight Committee on Veterans Affairs. I hope that some of you may have had a chance to see that, but it was a simple program that was based very largely on the initiatives that Secretary Shalala had announced, as well as upon the recommendations of the report of the Office of the Inspector General and the General Accounting Office.
It is worth noting that there had been several other reports along the way, starting with the President's Advisory Committee on Ethical Problems in Human Research, back in the early 1980s, as well as the President's Advisory Committee on Human Radiation Experiments in the early 1990s, and other reports. In fact, we have had a host of reports over the years that had recommended ways to strengthen as well as streamline these programs, but it has taken some time for us to develop the momentum to get them underway.
To try and put this in a -- thank you. At this point, you don't have to worry about whether or not something is going to appear there. One of the things that I have learned in my short time here in Washington is that it is much better to have someone pay attention to you and what you are saying than something on the screen. So I have taken that view. I rarely use Power Point anymore, because I find them to be a distraction from the message that I am trying to deliver. So at least this way, I get your undivided attention, and thank you for covering that up.
To try to give you a simple overview of what we are trying to achieve -- and actually, I think I can say what we are achieving at this point, because we are pretty well down the road -- is a real shift in the paradigm of how we have approached this overall issue of human research and protection of subjects.
I think the easiest way to summarize what that shift means is to note what the IG had said, that the way the system had developed, the sole body that had as its primary responsibility protection of human subjects in research, was the thing that we call an institutional review board.
Somehow, if we place all of the responsibility on this group that we call the institutional review board, it provides an opportunity for everyone else participating in the research process to say, I don't have to worry about protection of human subjects, because that is the IRB's job.
From the outset, we have said that is not the way that it should be, it is not the way that it can be. If we are going to do research that involves human beings, everyone who is going to take part in that has a responsibility to make sure that we put the interests of the individual research subjects ahead of all other considerations in the conduct of that work.
So we have begun the migration toward a new model that truly focuses on shared goals and shared responsibilities. Along with that comes a move from a reactive system, of compliance focused oversight and sanctions, to a proactive system that is focused on prevention, education and support.
Of course, part of this mission also has to be to recognize that rarely do government oversight and regulatory systems get simplified; it usually goes the other way, because it is much easier to tack on rather than change. We said that is not good enough. In order to make this work, we have to have an opportunity to simplify the structure, to make it more effective. The resources are too limited, what we have we have to put to good use.
So that gives you a framework for at least the philosophical approach to what we are doing. While that sounds fairly simple, I have to tell you that if you begin to try to do a diagram of how this all fits together, it has to be done in hyperspace, because this is a five-dimensional kind of problem. But to least give you a view of what it would be like if you stepped into this hyperspace, within the United States we work on four different governmental levels. We have our office, which is the smallest nucleus of activities. We then have the Department, which brings in all of the additional agencies within HHS. We have the federal level, where we have to deal at this point primarily with both the executive branch through the individual agencies as well as at the level of the White House, and of course the Congress. I'll talk briefly about some of the activities going on there. But again, the federal government does not operate in isolation. We must also consider the individual states and the specific regulations and processes that they have in place there.
So we have these multiple layers of government that we have to try and both interact with and coordinate with. Within another domain, we have the support domain, which brings in support from the federal government for research, as well as corporate support for research.
Increasingly, we see these two domains of support for research overlapping. They used to be somewhat distinct. That is one of the important challenges that we have encountered over the last two decades. We also have private support for research that may or may not come under federal regulation, depending upon how and where it is actually conducted.
Apart from that, we also have these two broad sectors. We have the public sector that includes all of these government -- and I would include the pseudo-governmental organizations that we work with. Then there is clearly the private sector by itself. But I don't believe that the task of protecting human subjects in research and conducting this research in a responsible manner is one that should be left solely to the government. I think the opportunities for constructive interactions and partnerships between government and the private sector are critical.
This is the complexity of the situation that we deal with in the United States. Add to that now the fact that both our country conducts research internationally as well as the fact that every other country may have its own governmental structures, non-governmental structures, and the common thread of bioethics that runs through all of this. I think it reminds us that this is a very complex system, and we can't expect change to come too rapidly. I think what surprises me most is the rapidity with which change is coming, rather than the hesitation. I am very excited about that.
Let me focus on a few details for you. First, let me talk a little bit about our office, the Office for Human Research Protections. I mentioned the fact that this office was specifically created and positioned within the Office of the Secretary in order to enable it to do what it is supposed to do.
Early on, we began a functional reorganization of the office from its previous structure when it existed as the Office for Protection From Research Risks within the administrative structure at NIH. We entered this reorganization with the idea of optimizing function, which is not a bad idea for any of us. So we set it up along the lines of four specific operational divisions, one dealing with policy and planning, special projects, one dealing with compliance oversight, another with education and another with assurances and quality improvement, each of them established to reflect the activities that they would primarily focusing upon. But then we have linked those with interdivisional committees to insure consistency and efficiency across the board.
We also have a cross-cutting virtual office for international activities that draws upon the specific expertise of the operational divisions. We think that is a model that can allow us to achieve our international objectives in the most efficient way.
Part of this process of reorganization also includes process redesign. I am happy to say that we have over the last 16 months developed an extraordinary working relationship with our colleagues at FDA and NIH, CDC and other agencies within the Department. The collaboration with FDA has been particularly important, given the oversight responsibilities that the FDA and our office have shared. Part of that process of reorganization has been trying to move from the previously existing systems to systems that were simpler and could serve us better.
Steps that have been taken are for instance simplifying the assurance process under which we establish our relationships with the individual entities that receive federal support for research, coupling with that a unified federal registration program that allows us for the first time to begin to identify where the IRBs are, how they are constructed and bring them all into a common system, one of the first steps toward establishing a level playing field and establishing an opportunity, a mechanism for convenient interaction and communications with these boards that are such an important part of the process.
There are changes that we have made in those simple areas. They are allowing us to redirect resources that went into what were largely paper processes, toward implementing new programs, particularly a program in quality improvement, which is part of our approach to look forward, to try to focus on making the systems better, making the system work, prevention of harm, rather than waiting until we hear sadly that something has happened. If we use the analogy to the airline industry, it really doesn't do much good to go in after the plane has crashed and people have been harmed; the goal is to prevent plane crashes. Similarly, we need to have a proactive approach in our efforts to promote the responsible conduct of research and protection of subjects.
I will say that we have been the very fortunate recipients of increasing budget support. We have been able to double the number of individuals, more than double the number of individuals working in our office, and have had nearly a tripling of our budget over its first two years. I think that is something that demonstrates the commitment of the Department, as well as the rest of the government to the processes that we are pursuing. That is enabling us to institute some of these new programs, in particular our programs in education, broad education using new mechanisms through the web, through video conferencing, interactive video conferencing, reaching out to the entire research community to establish a new commission or consortium for helping to bring together resources for education and defining what good education programs ought to include. Developing awards programs for these human research protection programs that have demonstrated a unique ability to do it well, come up with new ideas, best practices. Rather than having to read the headlines that always emphasize the failures and weaknesses of the system, it would be nice to read some headlines that say people are doing it right. That means you have to reward and recognize them when they do.
We have implanted new email hotlines and an 800 number that hasn't been announced yet publicly, but there will be a public announcement out there soon. This is part of a developing public education campaign and access program that we are developing. We have implemented a listserv that allows us to in one flick of a button basically send messages out, communicate with tens of thousands of people who subscribe to our listserv and the listservs that ours communicate with.
So all of that I think is very forward looking, and I hope it is going to be productive.
The new programs that we are implementing, both in terms of quality improvement, which draw upon the clearly demonstrated effectiveness of such programs in industry, whether it is in manufacturing or the service industry, as well as surveillance programs to help to do spot checks and increase accountability, are going to lead us to a new approach, where rather than have these reactive interactions with the institutions that are indeed our clients, this is going to be a more service oriented approach that will actually interact with eery program in the country over a five-year cycle, doing up to 60 quality improvement consultations every month, doing ten or more surveillance evaluations every month, very, very different than doing on average two to four site visits for cause each year, just to put that in perspective.
So there is a lot going on there. If we have time for questions, I will gladly be able to give you more details on any of those specific programs.
Another critically important development is the creation and utilization of the national human research protections advisory committee. The issues that we deal with are complex. There are no easy answers. Many of them are trying to resolve critical ethical dilemmas, and that is never easy.
As we develop policy within our office and within the Department, it is important that we have broad public input into that. So we have created a national advisory committee that is advisory to both me as the director of OHRP as well as the Assistant Secretary for Health, and the Secretary.
This is a committee that has the broadly possible representation from the entire human research community. There is no attempt at all to stack the deck with respect to any particular views. Indeed, the goal is to try to incorporate every view from one pole to another, because we think that is the way we get the best informed policy recommendations.
That group has been working handsomely under the coordination of its executive director, Kate Godfried, and its chair, Mary Faith Marshall. We have already received valuable advice from them on issues such as the Department's response to the revisions of the declarations of Helsinki, the participation of children in research as subjects, conflicts of interest and financial relationships in research, third parties, what protections there should be for third parties in research.
Currently, this committee is also considering the appropriate application of the federal regulations to the social and behavioral sciences, where there is a great deal of angst among the research community as there has been some overreaction. We need to with that community.
They will be taking up issues of informed consent, which I think we need to begin to think of in a different paradigm, think of it as informed decision making instead of informed consent. Rather than having a foregone conclusion that the process should lead to consent, the process should lead to an informed decision by an individual as to whether or not they participate. By changing the term, although it sounds semantic, it also changes the focus of the process. It will get us to where we need to be, I hope, in the next decade, as we have to have much broader participation in order to take full advantage of the very promising age of genomics that has now dawned before us.
There are other issues, such as liability, compensation for injury, impaired decision making capability, what special protections should be afforded those individuals. All of these will be activities where the Department will be getting the advice not only from NHRPAC, as this group is called, but also from those trans-NIH bioethics committee, from the FDA and the other federal agencies that are ex officio members of NHRPAC, so that we can work toward harmonized and meaningful policies that are valid across the entire government, rather than just for the Department of Health and Human Services or OHRP.
The Department has fostered important activities outside of its own domain. In particular, one that has been most important is the study that has been funded jointly by several of the operating divisions of the Department, including AHRQ, the CDC, FDA and NIH. We commissioned the Institute of Medicine of the National Academy of Sciences to undertake a study of the human subject protections process, in particular to issue a report within its first six months on accreditation as a mechanism for strengthening the system for protection of human subjects in research.
The Institute of Medicine responded to that challenge, and they did issue their report, Preserving Public Trust, that came out last April. Just yesterday, many of you may have seen the fruits of this report, as we now see the second of two organizations that have implemented private accreditation programs that allow us to go above and beyond the minimal regulatory requirements and instead focus on excellence in the protection of human subjects.
We now are awaiting the second part of that report from the Institute of Medicine, which will do something novel that you might be very interested in; it will actually develop outcome measures for the effectiveness of the human research protections process, develop tools by which we can assess whether or not these programs are doing what they are supposed to do, and if not, rather than wait 30 years in order to make the necessary corrective actions, we want to know about it tomorrow so that we can change it tomorrow, so that we can adapt to the changes in the research environment as they occur, rather than being caught in a position of being unable to respond appropriately.
At the broader federal level, we have worked to revitalize the group known as the Human Subjects Research Subcommittee -- bear with me on this one -- to revitalize the HSRS, which is a subcommittee of the Committee on Science, which is the operating committee of the National Science and Technology Council that operates out of the Office of Science and Technology Policy at the White House. I have been in Washington for 15 months, so that is not too bad.
This has been a critically important group. The Human Subjects Research Subcommittee is actually the current-day incarnation of the group that took the HHS regulations for protection of human subjects and actually achieved the enormous feat of promulgating this as a common federal policy to which 17 agencies subscribe, which becomes now the basis for the so-called common rule and provides the framework through which all of these federal agencies that support and conduct research can work together in order to achieve a more effective and integrated system.
That is exactly what we are trying to do. I frequently joked in similar presentations that although the group had completed that work on the common rule in 1991, they haven't done a whole lot since, because they were probably so exhausted from the experience of getting that done; it was hard to do much else.
But this group has come together in a remarkable way. It is an opportunity to get the input from each of the agencies, to understand how these issues affect them directly, their specific programs and begin to achieve the kind of uniformity and harmonization that is appropriate and yet respectful of the specific disciplines and programs that each of the agencies has to support.
One of the things that I am very excited about is something that we are working very hard to get on board now under the auspices of that committee. It is something that we have called the SUEE task force. SUEE is an acronym that stands for Simplification, Uniformity, Efficiency and Effectiveness. Those are four goals that all government agencies ought to strive for. Our hope is that this task force, which will bring together all the representatives from the federal agencies with members of the research community, will provide an opportunity to look at the system as it currently exists and find opportunities for simplification and greater uniformity, that will make it work better.
So I think that is something that you can stay tuned for in the weeks ahead. We will try our best to keep you informed.
I also hope that that group will be the vehicle for carrying forward a task force to look at research safety on a broader scale, to look at what happens in studies that are ongoing, in terms of monitoring those studies, coordination of IRBs with data safety monitoring boards and medical monitors and adverse event reporting, how does this whole system get transformed from a system of what has been called continuing review, which has been a once a year kind of thing, to continuous review. Again, analogous to the airline industry; we don't just allow planes to take off and hope that they don't bang into each other. We let the planes take off, but we stay in touch with them. We keep track of where they are and we try to make sure that they both get up and come down safely, and when there are problems we should be positioned to deal with those in order to protect the people who are on board.
So we are thinking a new way of how we can deal with research not only on a before and after process, but on a continuous process while it is underway.
One of the areas in our overall spectrum of activities that I think has been the most personally demanding and rewarding to me has been through our efforts to develop a true public-private partnership in all that we are trying to do.
I have personally been on what you might call a national ambassadorial campaign for these last 15 months. You don't want to know the number of hours I have spent on airplanes. I will just tell you, in the last two weeks -- I just calculated this morning, I have been in the air for about 43,000 miles in order to deliver a number of lectures and participate in programs, both in this country and abroad.
But during this campaign, we have interacted with a host of groups to not only support their activities, but to engage their support in our activities, because I believe that is the way that it has to be.
I can't give you an exhaustive list, but just to touch on the highlights, our interactions with the group Public Responsibility in Medicine and Research, or the Applied Research Ethics National Association, that are companion organizations, have been extensive. In fact, we have engaged in a contract with the primer organization to purchase rights to their investigator 101 training program, an interactive CD, so that we can make that available to every organization that has an assurance with our office, and not duplicate that effort, but instead use this public-private partnership to the advantage of both of us.
We worked with the Association of American Medical Colleges and the Association of American Universities on our efforts to develop new guidance on conflicts of interest. The leadership that these organizations have shown, issuing their own reports showing the responsibility and the initiative to take these challenging issues under their own belt and work with us on it has been remarkable.
Working with the American Association of University Professors, the Association of Clinical Research Professionals, the latter group as they have been developing their investigator training and certification programs to complement their existing programs in training for research coordinators and research associates.
Working with NCURA, the National Council of University Research Administrators, doing national television broadcasts that reach out to thousands of individuals in sites across the country at once, to help them in their efforts to build more effective systems at their own sites.
To work with the Society of Clinical Research Administrators, the Society of Research Administrators. The list goes on and on. It extends also into the very important social and behavior sciences community that I mentioned before, working with groups like CSSA, the Coalition of Social Science Associations and their component groups, such as the American Psychological Association, the American Sociological Association, and even the American Historical Association, to work with their groups in order to have them better understand why we need effective protections for human subjects in the kinds of research they do, and help us understand what those effective protections ought to be.
Working with the Association of Independent Review Boards, that group of review boards out there that is actually larger than the group of review boards that operate under federal assurances, to work toward a level platform and to be sure that they are appropriately included in this process.
Indeed, even working with for instance the fledgling new organization that is emerging for the clinical research organizations. All of these are important in the process, and we are working to bring them all together. As I said, we all have shared goals and we all have shared responsibilities.
DR. LUMPKIN: Thank you.
MR. AUGUSTINE: I just want to thank you for your work here. These are all welcome and necessary changes. I have worked in private research for a few years, and I have been very concerned at times that IRBs and principal investigators have not really done the oversight that they needed. I am glad this is occurring.
How is this going to transcribe into the private realm and the different pharmaceutical companies?
DR. KOSKI: It doesn't even have to translate, because it is all part of this. The Department, particularly through the Food and Drug Administration, has oversight for the entire segment of research that is subject to regulation by FDA. That would include all drugs, devices, biologics and other products that are going to be developed, marketed and so on. So that is a very, very broad umbrella.
As I mentioned in my former remarks, we are working hand in hand with the FDA and try to make the approaches that we take as uniform and as closely coordinated as possible. I think we have made great progress there.
So really, all of this is very much coming together. I think Secretary Thompson has stated his interest in working at the Department to achieve our goals and our relationship with FDA is very much along that line.
So the only piece of research that might be missing at this point would be research that involves human subjects, that is supported solely by private monies and conducted solely at institutions or entities that are not recipients of federal support where that research is not going to move to the development of a marketable product.
We don't know exactly what the size of that segment of research is, but to the extent that it raises concerns, there is activity currently going on in Congress that would move to bring federal oversight and protections to all research activities, and we will have to wait and see how that materializes.
Having said that, I will just quickly mention that currently we are aware of two legislative initiatives, one in the Senate, one in the House. On the Senate side, it is through Senator Kennedy's office primarily, and on the House side it is Representatives Daggett and Greenwood. Both of those groups are working on new legislation that would provide additional strengthening and support for our nation in protection of human subjects in research.
I think we will probably be hearing something about those soon, and we are very interested in what they will actually entail.
DR. LUMPKIN: Mark?
DR. ROTHSTEIN: As you know, the HIPAA privacy rule has important provisions dealing with the use of protected health information in research, which are great concerns of the members of this committee. I was wondering whether your office had undertaken any specific efforts to study or react to the possible effects of the privacy rule on research and your regulation of it.
DR. KOSKI: I think the single most important thing that we did was hire Julie Canisherro from the Office of Science Policy at NIH. Julie is sitting here. Julie has actually lived and breathed the HIPAA regulation for the last two and a half years, so she knows more about it than anyone in the whole world at this point with respect to its research provisions. So far be it from me to try to immediately answer your question in her expert presence.
But nevertheless, I will say that there has been enormous discussion around the research provisions. There has been input not only from our office, from NIH, as well as from the coordinated position recommendations from the Human Subjects Research Subcommittee. It included input from all the federal agencies.
This is a complex process. The Department is still considering research provisions. There is also ongoing discussion and action outside of the government. So we don't really at this point know exactly how it is going to come down.
I do believe that even as the HIPAA regulations currently stand, to a very, very large extent, any institutional review board that has been effectively doing its job under the guidance and the requirements of the common rule, is already meeting the requirements of the HIPAA regulations.
So at that level, I don't believe that there is going to be an enormously large new burden even if the regulations were to go forward exactly as they are now stated. That however doesn't ignore the fact that there are some procedural requirements that have raised concerns as to whether or not they would actually strengthen protections of privacy. All of those are under consideration.
So we can't really do a whole lot at this point until we know what the final provisions are going to be, but one of the things that we have done particularly in hiring Julie is to position ourselves to be able to provide the kind of guidance, advice, support that is going to be necessary within the research community to help that community meet its obligations, whatever those ultimately turn out to be.
DR. FITZMAURICE: Greg, I want to compliment you. I have heard Julie Canisherro, and she is truly outstanding in her knowledge of the privacy rule and the privacy issues, and her ability to work with other people. So you have a great employee.
I want to ask you a question. The question boils down to, given all that you have told us, will you be seeking change in the common rule? How soon? And will you try to achieve it, if you will be seeking change, through consensus of 17 agencies or more, through regulation of HHS, legislation, or all three as the tools permit?
DR. KOSKI: I think at this point, we can look at the advice that we received from multiple commissions and panels, including the recent report from the National Bioethics Advisory Commission that is no longer with us.
The concerns have not so much been about the common rule itself, except to the extent that administratively, requirements for having 17 methodology agencies sign off on anything has been characterized as an impediment to change. Inconceivable, isn't it? Our hope is that given the efforts that we have put into strengthening the human subjects research subcommittee, that if we found some part of the common rule that could productively be changed, that it wouldn't take ten years to do it. Indeed, we are working currently with the Committee on Science to actually develop a set of operating procedures and all that would allow for rapid inter-agency clearance of changes that might be proposed. I think that would position us well to be able to be more responsive, if it looked like there were changes there.
But apart from that, the common rule itself is I believe a remarkable piece of regulation, in that it actually is very flexible. It was specifically intended from the outset to accommodate -- be flexible enough to accommodate not only biomedical research, but social and behavioral research. It has enormous flexibilities built into it.
I think our immediate challenge right now is to take advantage of the flexibility and the opportunity that provides to do these things right. So that is where our efforts are focused right now.
But as we go forward, if we again find that there are areas of the regulations that should be changed, then we will certainly take those on with the same amount of energy and enthusiasm that we do everything else.
There are several options to changing the common rule. There are for instance opportunities as we see in HHS to have specific subparts that may be pertinent to one agency and not to another agency. The specific regulations, the subpart governing special protections for children, again provides an appropriate level of enhanced protections for a vulnerable population. It has been adopted either formally or informally by several of the other agencies, such as the Department of Defense. But it may not be particularly important to certain other agencies to do that.
So there are mechanisms there. We don't know at this point the extent to which any pending legislative initiatives would alter the common rule, so we will have to react to that as it comes up.
But as I said, I think right now, our focus may not be on changing regulations, but rather trying to make sure we have within this regulatory framework an effective system that focuses on its real task, which is preventing harm to research subjects.
DR. LUMPKIN: Vickie?
DR. MAYS: During the Clinton Administration, there was the Tuskegee apology. At that time, Clinton also put some funds into the T32 short term training program on bioethics.
Part of the background to that was to insure that what would happen is that researchers would be more attentive to some of the issues for racial and ethnic groups in terms of the conduct of research.
I am wondering -- because I got one of the first T32s, and I have been watching them -- but I am wondering where the Department is specifically in terms of insuring that vulnerable populations like racial and ethnic groups, that there is some continuation of emphasis on education about the conduct of competent research and culturally competent research. We worry about the rates of participation. Part of that rate of participation has a lot to do with some of these unintended abuses that have occurred.
DR. KOSKI: The Department is obviously very supportive and very concerned about that. It is very difficult to conduct meaningful research in the African-American community, as an example, if the people in that community lack the level of trust required to let them feel free and willing to participate.
So I think it is critical that we not only educate researchers, but we also educate the community in this regard. This carries over on an even grander scale in a sense to our international initiatives that I didn't really talk about. But I think in the light of many of the events that we have seen in the press over the last couple of years, the need to conduct our research activities in a manner that is sensitive to the cultural milieu in which they are going to be done is more important than ever, and people are increasingly aware of this. We have to continue every opportunity that we have to expand those educational and outreach opportunities.
We will be doing that as part of the broad public education campaign that we will be carrying out through our office. We look forward to working with the Office of Minority Health and other program offices within the Department to do that, as well as with the other agencies. The grants that were funded by NIH I think were very important. I hope we can continue to see that go forward. Of course, those are the program decisions that NIH would have to make.
But I think we are beginning to see a greatly enhanced awareness of these issues, and we have to continue with the pressure and the efforts. Congratulations on being one of the fellows.
DR. LUMPKIN: Dr. Koski, thank you very much for coming. It has been a very interesting discussion, and we will continue to monitor. There are many issues related to research and research integrity and protection of human subjects that impact the work of the committee. So we appreciate finally being able to have you come.
DR. KOSKI: Very good. Thank you very much.
DR. LUMPKIN: We are going to now adjourn for a lunch break. We have two action items after the lunch break. The first will be privacy, and the second will be the letter to the Secretary regarding NEDSS. We should have a draft for that. So we will reconvene at 1 o'clock.
(The meeting recessed for lunch at 12:05 p.m., to reconvene at 1:00 p.m.)
DR. LUMPKIN: We have four items left on the agenda, which includes reviewing the privacy letter. You have at your place the second or third draft of the letter concerning the preparedness and the NEDSS system.
We will proceed to the report. We received at your place the latest version of the draft letter on privacy related to marketing and to fundraising. Mark?
DR. ROTHSTEIN: Yes, thank you, Mr. Chairman. You should all have a copy of this draft. The structure is the same as that which was distributed to you yesterday. There are some very minor changes in language, but not I don't believe in the meaning. Except the major change that you will see -- there are three of them, one in the specific recommendations under marketing, the second one in the specific recommendations under fundraising, and the third, the concluding language; we added a few new sentences that we can discuss later.
There are seven recommendations under marketing. The first one appeared earlier, and the remaining six have been culled and reformulated, and are based on that list that you were distributed yesterday in terms of the options.
So for the benefit of those on the Internet, let me read those recommendations to you.
The first one is, except as provided in our additional recommendations, marketing should not be considered within treatment, payment or health care operations.
DR. LUMPKIN: Can we stop and see if anyone has any questions about that first recommendation? Okay.
DR. ROTHSTEIN: Number two, the definition of marketing should be clarified such that refill reminders and other treatment related reminders by pharmacists and other providers or their business associates are considered treatment and not marketing.
DR. LUMPKIN: Questions and concerns about that one? Okay.
DR. ROTHSTEIN: Number three. Disease management, the primary purpose of which is not to sell products or services, should be considered part of treatment or health care operations and not marketing.
DR. LUMPKIN: Any questions? My thought was just a format one. I wonder if that maybe ought to be in parentheses.
DR. ROTHSTEIN: After disease management?
DR. LUMPKIN: Yes, disease management and then parentheses, the primary purpose of which is not to sell services or products.
DR. GREENBERG: Yes, I think that is better.
DR. STARFIELD: I still have a problem with that, even with the parentheses.
DR. LUMPKIN: Okay.
DR. STARFIELD: I think the consideration is whether a purpose is to sell products or services. I don't know how one decides in each case of a disease management program whether it is the primary purpose or not the primary purpose. I think most companies that monitor these programs would say their primary purpose is to treat, not to market.
DR. ROTHSTEIN: They what?
DR. STARFIELD: They would see it as their primary purpose to treat, not to market. I think it is disingenuous. I would be much happier to say a purpose which is not to sell products or services. I don't know, giving a prescription, is that an intent to sell? No, so maybe the problem is with --
DR. FITZMAURICE: These are recommendations to the Secretary. When the writers get hold of it, they will get a sense of it from this, and then they will decide how to take care of it.
DR. STARFIELD: I would rather we took care of it. I would feel safer.
DR. SCANLON: When the purpose is not to sell.
DR. STARFIELD: That's right. Jim says when the purpose is not --
DR. SCANLON: I think that would address my concern.
DR. LUMPKIN: So when the purpose -- okay.
DR. ROTHSTEIN: Other comments on number three?
DR. FRIEDMAN: And that would be in commas rather than parentheses.
DR. LUMPKIN: Sure.
DR. ROTHSTEIN: Number four, authorizations to permit health care marketing should be limited to products or services that are directly related to the health of the patient, and should clearly indicate that they are comprehensive and can include sensitive protected health information.
DR. LUMPKIN: Okay.
DR. ROTHSTEIN: In the course of marketing, financial arrangements of the parties involved should be revealed, including any payments to the covered entity that has disclosed the protected health information.
DR. LUMPKIN: Okay.
DR. ROTHSTEIN: Six. Standardized, simplified opt-out procedures should be adopted to ease the burden on individuals who want to opt out of future marketing contacts.
DR. LUMPKIN: That reads a lot better than yesterday. Thank you.
PARTICIPANT: Can we add that requirement to telephone companies? I'm looking for that opt-out option.
DR. LUMPKIN: There are two reasons that that comment did not make it on the Internet. One is that your microphone is a long way from you, and the second one is that the phone company, which carries part of this, bleeped it out. Go ahead.
MS. COLTIN: I think it is on six. If there are no financial arrangements, shouldn't the authorization still reveal who disclosed the information, the party that disclosed the information? Even if there are no financial arrangements. It seems to me the easiest way to opt out may be through the party that disclosed the information, rather than the party it was disclosed to, because it could be disclosed to dozens and dozens of parties, but going to the source may be a more efficient way to deal with it.
So if they at least disclosed -- if the authorization at least revealed who disclosed the information, it might be useful to know for the consumer.
DR. ROTHSTEIN: The authorization would be to disclose the information, but it may not be specific in terms of to whom the information would be disclosed. So in other words, you might be asked to sign an authorization that would allow marketers of health related products and services to contact you.
I think your suggestion is a good one when the contact is made by the marketer. We will recommend that in number four, the marketer disclose any financial arrangements, but we might also add a provision that the marketer has to disclose the source of the contact, where they got your name from.
DR. FITZMAURICE: Right. It seems that as the privacy rule applies to covered entities, we would have to direct a covered entity not to disclose or use the information unless the source of that information is revealed to the patient when the patient is contacted. We can't write on the third-party marketer.
DR. LUMPKIN: But the third-party marketer could be a covered entity. There would be no regulatory authority to require that third party entity to do anything.
DR. FITZMAURICE: That's correct.
DR. LUMPKIN: Is that correct?
DR. FITZMAURICE: Yes. The most you can do is direct something toward the covered entity.
DR. STARFIELD: If they had a business associate relationship with the covered entity, that might --
DR. FITZMAURICE: Let's assume that the individual has authorized disclosure of the information for marketing purposes, so the covered entity can disclose it. Then the individual gets a phone call and the individual would like to know what was the source of this information.
So what we are saying here is -- I think you are suggesting that the covered entity may disclose the information, if he or she has an agreement with the receiver to let the patient know if the patient was contacted, the source of the information was that covered entity. We can only address the covered entity, we can't address the marketer.
DR. LUMPKIN: But help me here. I authorized a release from entity A, my health care provider, to entity B, a non-covered entity.
DR. FITZMAURICE: You give consent to your health care provider. You sign an authorization that he may sell it to a marketing company.
DR. LUMPKIN: Right. So she sells it to a marketing company. The marketing company then may subsequently sell it without any restrictions.
DR. FITZMAURICE: Yes.
DR. LUMPKIN: A.k.a. the commercials that have been on related to Internet privacy. So I hear what you are saying and I agree with you, but I'm not sure there is a vehicle for which enforcement could be -- because I would sure like to know.
DR. ROTHSTEIN: But based on what you are saying, it seems that we need to restructure number five. Do you have a way of doing that?
DR. FITZMAURICE: The only thing you can do is direct that the covered entity has to reach an agreement with the marketer, and if the marketer violates that agreement and violates the privacy rule, he can only come back on the covered entity. It may be so distant that it is not workable.
DR. GREENBERG: If a person authorized a provider to give their information to a marketer, when the provide gave the information to the marketer, sold the information or whatever, couldn't that provider require as part of that, that they would not redisclose the information to another party?
DR. ROTHSTEIN: Yes.
DR. FITZMAURICE: Under the laws of that state.
DR. LUMPKIN: Can you explain that?
DR. FITZMAURICE: If you have got a contract with somebody, usually it is governed by the laws of that state. The privacy rule can't come down on the marketer, or can't penalize the covered entity, and the relationship between the covered entity and the marketer is going to be governed by the laws of that state and the contract.
DR. LUMPKIN: So if we were to put restrictions on the covered entity that they would have no ability to enforce, because the laws of the state may not allow that kind of contractual arrangement -- is that what you were suggesting?
DR. FITZMAURICE: They could write a contract so that it could be enforced in all the states. But in the privacy rule, enforcers could only come down on the covered entity.
DR. LUMPKIN: Correct. We have the Ph.D and M.D. arguing law here.
DR. STARFIELD: Maybe by changing of the parties, could that be specified a little better?
DR. FITZMAURICE: I beg your pardon?
DR. STARFIELD: Change of the parties. If we work on that, does that solve any problems?
DR. ROTHSTEIN: How about this? Covered entities -- where are you? This is a substitute for number five. Covered entities permitting disclosures to marketers pursuant to an authorization should condition the disclosure of the protected health information on the marketer's agreement not to redisclose the protected health information, and to disclose the financial arrangements in the course of marketing, something like that. That would replace number five.
DR. LUMPKIN: But again, I think we can go to Mike's comment that this is not regulatory language. This is to convey information to the Department of how we think the regulation should be structured. It may take them a couple of paragraphs in order to say this in regulatory language.
DR. GREENBERG: Or they may say this is advice.
DR. ROTHSTEIN: Number six. Standardized simplified opt-out procedures should be adopted to ease the burden on individuals who want to opt out of future marketing contacts. I don't know that we agreed to move off that.
DR. LUMPKIN: I think we are okay on it.
DR. FITZMAURICE: It seems like another condition we would want the covered entity to put on the marketer who receives the information.
DR. SCANLON: You are suggesting that if someone tells a marketer that they want to opt out of all future contacts, that that marketer would have had to make a commitment to return that information back to the covered entity, so the covered entity would now know?
DR. FITZMAURICE: No, that because of the contract with the covered entity, they would not have to contact that person again.
DR. SCANLON: This is an ability to opt out of all future marketing contacts, not necessarily just from that --
DR. LUMPKIN: If you give authorization to a marketer, if you give authorization to your covered entity to give information to a marketer, that covered entity has completed their obligation.
Now, there may be other laws and regulations that govern marketing, when a person asks not to be involved. I am not sure that -- I think we may be extending this chain of responsibility further than we ought to. If you don't want to be marketed, then don't, but once you say yes, you can't expect your covered entity to assure that the person they release it to when you have changed your mind won't bug you.
DR. SCANLON: But you should be able to go back to the covered entity and say, don't use my name anymore.
DR. GREENBERG: I withdraw my authorization.
DR. ROTHSTEIN: But it would be a lot easier if the Department adopted number five, where the marketer had to indicate where they got your name from. Then you could go back to X provider.
DR. LUMPKIN: Okay, I changed my mind.
DR. ROTHSTEIN: So, Michael, do you think that we need to redo six to make it --
DR. FITZMAURICE: If you make it apply just to the covered entity, and instead of opt out, it would be revocation of authorization. It may be that you can do it with a phone call. I don't know what is easy to opt out.
DR. LUMPKIN: It should ease the burden of opting out of future marketing contacts. That does not preclude -- does not say that you gave your consent and now you are opting out. You can't do that. It just says that at some point, do you want to opt out of future contacts, that should be an easy process. So I think this language actually covers both situations, both initial and subsequent.
DR. FITZMAURICE: All right. I am just concerned about the workability. To whom do you tell you want to opt out of all future marketing contacts? You can only tell your covered entity.
DR. GREENBERG: No, it is not necessarily all. Let's say you give your authorization to be marketed for diabetes supplies or something, and somebody does come forward with marketing, and then you object to this particular marketer. You should be able to opt out of those contacts.
DR. FITZMAURICE: The marketer should honor your request but if the marketer doesn't, you don't have too much recourse. You can go back to your covered entity and say, did you sign an agreement that the marketer has to accept my opt-out. Yet the marketer didn't and he keeps contacting me, would you please sue him on my behalf.
DR. ROTHSTEIN: What about this proposed change? Standardized simplified opt-out procedures and revocations of authorization should be adopted. So it is easy to revoke. Is there such a mechanism in place now, John?
PARTICIPANT: There is an extensive revocation of authorization component to the rule, but it has to be in writing. To suggest simplified in this context might be appropriate.
DR. SCANLON: In the regulation, there is a whole concept of revocation of authorization. Marketing is not the only place where you authorize. There are at least 12 others, as we know. There is a general treatment of revocation. Again, once it is hard to -- once the genie is out of the bottle, you can't pull everything back, but there is a procedure about how you can revoke. But again, it only deals with the covered entity. We don't have any way to reach the others except indirectly.
DR. GREENBERG: I think what we are trying to figure out here is the extent to which the concept of opting out is still relevant once you have required authorization for everything. I don't have the answer to that, but --
DR. SCANLON: Then it is a revocation. It is a revocation of an authorization already given, and it is more general.
DR. LUMPKIN: What I am hearing is that we think a person should opt out and they should be able to revocate. The question I don't think is that; the issue is whether or not the language in six adequately covers both those situations. Or do we need to specifically add in language related to a revocation?
DR. ROTHSTEIN: Well, the current revocation language is adequate. Maybe one of the problems with this proposal as written is that we used the term opt out, which may be misleading. Maybe what we want to say is simplified, do not contact me anymore, that goes solely to that particular marketer. So when somebody calls you to sell you a lift chair, you say don't contact me anymore, that is not an opt-out and it is not a revocation, either.
DR. LUMPKIN: I have maybe a simple solution. If we were to delete the first opt-out, so standardized simplified procedures should be adopted to ease the burden on individuals who want to opt out of future marketing contacts.
PARTICIPANT: I think that is a very good suggestion.
DR. LUMPKIN: Aren't there existing laws that require telemarketers to allow you to opt out?
DR. SCANLON: This is getting a little unnecessary for us to comment on this.
DR. LUMPKIN: But what this language does is, essentially you would contact your covered entity through a simplified form, either initially to say I don't want to be bothered at all, or at some subsequent time down the road, you are treated for a kidney stone, and the stone liptotriptor people keep on calling you even though your stone passed two years ago, you want to go back to that covered entity, because every time you get contacted it is a different company, and say, stop giving my name out, even though I gave you permission before.
DR. LUMWIG: I understand. You need to go back to the covered entity. I think the issue here is, we have been talking a lot about whether you can tell a telemarketer to stop calling you, that you don't want to hear from them anymore. We said we can't really say anything about that, because they are not covered entities and therefore we don't have jurisdiction. I am just wondering, aren't there existing telemarketing regulations that they need to abide by that allow you to opt out already? Not that I think they are all that well executed in any of the telemarketing experiences I have had, but --
DR. LUMPKIN: I know that there are at least state regulations, state laws.
MR. FANNING: Actually, there are a few things. First of all, the marketers have a voluntary scheme where you can write in and give them your number and say, take my name off the list. I think the Federal Communications Commission has some requirement for something along these lines, but the Federal Trade Commission has proposed regulations to cover this and make arrangements for people to opt out and so on.
But I'm not sure that is worth getting into in any more detail. This is not peculiar to telephone situations, and whatever general rule you think should apply, make it apply here, and it would govern mail contacts presumably as well as telephone contacts.
DR. LUMPKIN: Do we have any other modifications to number six? Can we move on?
DR. ROTHSTEIN: Number seven. In marketing pursuant to an authorization on health care reminders and disease management, protected health information should not be disclosed via voice mail, an unintended fax or through other methods of communication that are not secure.
DR. GREENBERG: No post cards.
DR. LUMPKIN: Only if they are encrypted.
DR. ROTHSTEIN: On the fundraising, we have got three recommendations. The introduction has not changed. Number one, HHS should explore procedures for the disclosure of department of service information for use in fundraising, such as simplified authorization or an opt-out procedure for departmental information. These measures should attempt to balance the interests of health care institutions to target fundraising with the privacy interests of patients who could consider departmental information to be sensitive health information.
DR. LUMPKIN: I'm just a little bit confused. When I see language that says department, usually it means Department of Health and Human Services.
DR. ROTHSTEIN: This would be like oncology, disease.
DR. LUMPKIN: We just need to put some sort of qualifier on the term department.
DR. GREENBERG: Clinical department?
DR. FITZMAURICE: Clinical department or service, something like that.
DR. LUMPKIN: Okay, move on.
DR. ROTHSTEIN: Number two. This is a similar one. In fundraising, protected health information should not be disclosed via voicemail, unintended fax or other methods of communications that are not secure.
DR. LUMPKIN: Okay.
DR. ROTHSTEIN: Number three. Transitional rules for fundraising are needed to allow the continued use of protected health information obtained before the effective date of the privacy rule, until first contact with the patient after the effective date of the privacy rule.
DR. LUMPKIN: What is the transitional rule?
DR. ROTHSTEIN: There is a whole section on transitional rules in the current rule, but it doesn't deal with the issue of fundraising. It allows consents that were received prior to the effective date of the rule to be used afterwards.
DR. LUMPKIN: It is the rule to govern the transition from before and after, as opposed to a rule that is filed while you are trying to get the real rule in place.
DR. ROTHSTEIN: Correct.
DR. LUMPKIN: Thank you.
DR. ROTHSTEIN: There is a new paragraph of text that was added at the bottom of the same page. At its hearings on the privacy rule, the NCVHS sensed considerable anxiety based on the perceived complexity of the rule. With the imminent publication of the NPRM, the NCVHS would like to emphasize our belief that public education and outreach are essential in promoting compliance with the privacy rule, in allying public concerns about the nature and effect of the rule.
Therefore, we encourage HHS to redouble its efforts in this regard. Similarly, we encourage HHS to make the revised rule as understandable as possible to the general public.
DR. LUMPKIN: It has been moved by Mark and seconded by Richard that we would adopt the now new letter, which has been revised, if that is okay with you two.
DR. HARDING: I'm not sure if I have to abstain or not.
DR. LUMPKIN: Okay, so we will look for another seconder. Paul? Seconded or thirded. A good thing I checked. The letter is before you. The bulk of the language we saw yesterday. We have gone over paragraph by paragraph all the new language. Is there discussion on the motion to adopt and send this letter?
All those in favor, signify by saying aye.
(Chorus of Ayes.)
DR. LUMPKIN: Those opposed, say nay. Abstentions? When in doubt, abstain.
DR. HARDING: Okay, I abstain.
DR. LUMPKIN: Okay. We have one abstention just because we want to be careful. We appreciate that.
DR. ROTHSTEIN: There is one last thing I would like to raise. That is, the subcommittee would like to propose to undertake to evaluate the NPRM when it comes out. We think that it may well be that the rule will be out and perhaps even the comment period could be over if it were say 30 days before the next full meeting of the committee.
So what we would like to propose is to have the full committee authorize the subcommittee to make recommendations about a response, and that would then be communicated to the full committee and we would then have a conference call to discuss how to respond.
DR. LUMPKIN: So the motion is to adopt a process for interim decision making between the meetings, which would involve the subcommittee meeting by some telecommunications or electronic means, and then subsequently a teleconference of the full committee to address the recommendations coming from the subcommittee. It has been moved by Dr. Rothstein. Is there a second? Seconded by Dr. Harding. Further discussion.
All those in favor, signify by saying aye.
(Chorus of ayes.)
DR. LUMPKIN: Proposed say nay? Abstentions? We have a process in place should the NPRM come out prior to our next meeting.
DR. HARDING: Just to reinforce that last paragraph, I'm sure it doesn't need reinforcing. But there are individuals in the country who go around to hospital medical staffs and whip up anxiety. They are good at it, and they concentrate on HIPAA and NTALA, those two things.
DR. LUMPKIN: Could you speak into a microphone?
DR. HARDING: Sorry. The two groups that tend to whip up anxiety among medical staffs center around anxiety about HIPAA and NTALA.
DR. LUMPKIN: Which is the emergency medical --
DR. HARDING: Labor is involved in there somewhere, which in effect says that if you don't take care of everybody who comes into your emergency department and do it properly --
DR. LUMPKIN: They come to your hospital.
DR. HARDING: Comes to your hospital and parked in the parking lot, or within 200 yards of the entrance, that you can be ruined forever and sued into the ground. The consultants who come around give all of the dire consequences that could possibly happen with HIPAA as well as NTALA.
So that is what we were really trying to push, is to counter those things and to talk a little bit more forcefully and clearly to not only the medical community, but to all covered entities and so forth, to give them something they can have in their hand as well as here that would make them feel a little bit like those two, HIPAA especially, isn't just designed to go after their livelihood, as many people fear it does.
I just wanted to clarify why we put that in there.
DR. LUMPKIN: That was a good addition. Thank you.
DR. ROTHSTEIN: Thank you, Mr. Chairman.
DR. LUMPKIN: We will move on to the second action item. You have in front of you a letter. It is short. I guess I will read it -- This panel discussion coincided with the release of the committee's report, information for health, a strategy for building the NHII.
Over the last year, we have been monitoring the progress of the national electronic disease surveillance system and its contributions to the NHII. A fully developed and implemented NEDSS would enhance the nation's ability to identify and respond to outbreaks of illness due to an act of terrorism or other causes.
We would like to commend the department for leading the effort to upgrade our nation's public health and disease surveillance systems. The electronic collection of disease information from the health care sector and analysis in the public health sector is a key part of our preparedness. We believe that the major commitment by the Administration to funding these efforts through the CDC bioterrorism cooperative agreements with states is an important step.
In our highly mobile society, outbreaks of illness are rarely contained within one political jurisdiction. Early identification of these outbreaks requires the collection and analysis of data from local, state, regional and national perspectives. This level of functionality requires that the implementation of NEDSS based systems in each state be not only standards based, but interoperable.
The CDC has made great strides in defining the national standards that should be incorporated in NEDSS, but the NCVHS believes that more work needs to be done to assure interoperability. The NEDSS standards need to be specific and implemented in a consistent fashion. The implementation should be consistent within each component of NEDSS and from state to state. The NCVHS is concerned that incompatible implementations may occur without clear leadership and guidance by CDC.
Therefore, we have the following recommendations. One, the CDC should fully specify the NEDSS standards. This should be accomplished in partnership with existing standards development organizations and state and local public health agencies. For data elements and transactions that are not covered by existing SDOs, the CDC should develop clear standards and implementation guides with national professional organizations representing states, including ASTHO, NACHO, CSTE and others, Council for State and Territorial Epidemiologists. NACHO is National Association of City and County Health Officials. ASTHO is Association of State and Territorial Health Officials.
Considering the urgent need to enhance our public health preparedness, adequate resources need to be committed to insure that these tasks are completed quickly.
Two, the CDC should develop and implement a system of conformance testing for NEDSS standards. Implementation of standards based systems is a complex and difficult process. Many decisions are made during systems design and development that may impact the ability to share data in a useful and meaningful way with other states or the CDC. A NEDSS reference system should be established by the CDC against which states should verify and correct implementation of the standards and interoperability.
Three. The CDC should allocate resources to assure that ongoing technical assistance is available to states during the NEDSS development and implementation process. States vary in their ability and experience in implementing standards based system development. Technical assistance that is readily available will assure timely help when critical design decisions are being made.
Four. Implementation of NEDSS standards in development of state electronic disease surveillance systems and other federally funded public health information systems with conformance testing should be mandatory. Testimony on February 6, 2002 indicated that while the standards will be strongly recommended, they will not be mandatory for the development and implementation of state based electronic disease surveillance systems using CDC cooperative agreement funds.
We believe that the lack of a mandate will result in some states making design decisions resulting in an inability to share important data with other states and the CDC. Adherence to the standards should not be optional.
NEDSS is an important development and will dramatically improve the ability of the public health system to respond to emerging infectious diseases caused by natural processes or terrorism. These recommendations are offered to improve the quality and timeliness of its implementation. The NCVHS will continue to monitor the implementation of health information component of national preparedness, NEDSS implementation, and the NHII. We also stand ready to provide any assistance that you and the Department may need.
Is there a motion? So moved by Simon, seconded by Dan. Marjorie pointed out there are a couple of words that need to be fixed, but that is like, two results in one sentence, giving that wordsmithing. Jim?
DR. SCANLON: Discussion?
DR. LUMPKIN: Discussion, yes.
DR. SCANLON: You may want to mention, it is not just CDC that would be involved in the decision making here; it would be the Office of Public Health Preparedness that Jerry Hauer represented yesterday. So perhaps we can work in some language that works in the Office of Public Health Protection as well. In fact, they may be the ones who actually approve the plans from the states.
DR. LUMPKIN: Probably in recommendation number three, I think it would fit, that we would add in the Office of Preparedness in recommendation number three.
DR. SCANLON: Yes.
DR. LUMPKIN: For the technical assistance, I think one and two are fairly specific to CDC. A perhaps work it in somehow in number four.
DR. SCANLON: Yes. I think literally OPHP will be approving those plans from the states.
DR. LUMPKIN: The third sentence, the second and the third sentence where we mention CDC bioterrorism cooperative agreements, we should say through the CDC bioterrorism agreements and other funding through the Office of -- and the same thing in the last sentence on four.
DR. LUMWIG: Just a thought, because of your need to explain some of these acronyms --
DR. LUMPKIN: Spell them out.
DR. LUMWIG: Have them spelled out, especially because this goes up on the website. We may assume the Secretary knows what they are, but --
DR. GREENBERG: I know that there also are grants that HRSA is going to -- are those relevant to this standards based approach?
DR. SCANLON: These are grants to the states from another agency for funding to hospitals, regional plans and so on. To the extent that they are IT investments, we may want to recommend a standards based approach there as well.
DR. LUMPKIN: Maybe if it is agreeable, we would add in number five that similar recommendations would also apply to the HRSA preparedness grants, issued through HRSA and the Office of Public Health Preparedness.
DR. SCANLON: Yes, that is good.
DR. LUMPKIN: It is a little bit fuzzier in that area, because the systems haven't been clearly defined. Much of what will probably happen through that will be consistent with HIPAA and the PMRI standards. I think they will cover those, but we should at least mention that that should be part of it. Is that acceptable to the motioner? Okay. Other comments or discussion?
In that case, all those in favor, signify by saying aye.
(Chorus of ayes.)
DR. LUMPKIN: Opposed, say nay? Abstentions? Okay. The next item on our agenda is reports from subcommittees and work groups. I don't think we have anything from the executive subcommittee, do we?
DR. GREENBERG: Just minutes from our conference call. Just for information, we will be having another conference call April 11, I believe.
DR. LUMPKIN: Work Group on Health Statistics for the 21st Century? Dan?
DR. FRIEDMAN: I'll just quickly summarize where we are. A draft of Chapters 1 through 4 of the final report has been developed, reviewed by the work group. Most of the line edits were incorporated and it was distributed to the full committee.
Chapter 1 basically provides sets of definitional framework to the report around health statistics and health statistics enterprise. Chapter 2 posits a model of influences on the population's health and then uses that model to point out a series of gaps in our current information, based in large part on testimony that we received during the public hearings.
Chapter 3 puts forth -- I think we are calling it now a model of health statistics development, and then uses that model to evaluate gaps in the enterprise, again based upon public hearings. Chapter 4 lays out a series of guiding principles for the enterprise, as well as core values, essentially the vision, as it were.
Then Chapter 5, which has been developed in first draft but is currently under review, sets forth a series of recommendations for implementing the guiding principles and for trying to implement the conceptual framework that was laid out in earlier chapters.
That is essentially where we are. We would welcome any additional comments on Chapters 1 through 4. Then sometime in the next month or two, some version of the draft report would be distributed to people who had testified at the hearings, and other interested parties for their review and comments as well.
DR. GREENBERG: With Chapter 5.
DR. FRIEDMAN: Presumably, yes.
DR. GREENBERG: In that case, Chapter 5 will be sent. All the members will also get it at the same time.
DR. FRIEDMAN: The membership of the committee would see Chapter 5 prior to its distribution in draft form for writer comment, just like they have seen Chapters 1 through 4.
DR. GREENBERG: Okay.
DR. LUMPKIN: Any questions or comments for Dan? Thank you.
DR. SCANLON: Conceivably an action item for the June meeting, or you just don't know yet?
DR. FRIEDMAN: Let's put it this way. As one of the authors of the report, I would really hope so. That is my hope, dream and aspiration. We have been working on it for -- that is my hope, Simon.
DR. SCANLON: Is this the 22nd century?
DR. FRIEDMAN: We have been working on it for a long time, and personally I would really like to get it wrapped up, and the other people who have been working on the writing would also like to get it wrapped up and be able to move on and think in terms of implementation and so forth.
DR. LUMPKIN: Thank you. The NHII work group is pleased to announce that we have not had a meeting since our last committee meeting, but the final report is out. We will be having a conference call in the near future for those of you who are members of the work group to discuss our new charge, which will be to monitor the health information policy issues related to national preparedness, and a subsequent hearing, if we need to monitor that.
DR. SCANLON: Dr. Lumpkin, I presented the findings of the NHII report to the Data Council in February, and it is being reviewed now within HHS and probably Dr. Lumpkin will be briefing the Deputy Secretary in March.
DR. LUMWIG: Do you have any comment on how it was received?
DR. LUMPKIN: I thought it was well received. There were some -- particularly the structural ones, which I thought were a little bit on the edge. Surprisingly, there was not much push-back from the Data Council. So I think that they are studying it.
The major question came about issues related to historically disadvantaged communities and the fact that they would be disproportionately impacted because of the digital divide, and some concerns about those issues. But I thought they were good questions.
DR. SCANLON: I think the other question, the Council was looking for -- the report to some extent is at the 20,000 level, and I think several questioners tried to see whether -- was there one key specific event in which others would fall into place? What did Bill Raub call that, John? The seed crystal approach. But I don't think there really is. All of the formative things were necessary.
DR. LUMPKIN: Although I might argue now that it would be the automated medical record in the emergency department, but that might be an interesting seed crystal. That was not my response.
DR. LUMWIG: What about the managerial issue, though? Isn't that viewed as a primary --
DR. GREENBERG: Could you speak up?
DR. LUMWIG: It seemed to me that as a seed concept in that report that the managerial issues and the leadership issues were pretty crucial, and everything else had to build on that.
DR. SCANLON: They were looking for a specific -- I think they do that as process. But I might say that even on the organizational issue, we have to be careful that it doesn't get assumed to be a regular IT function or office, because I don't think that is what is envisioned. I'm afraid that would just be the wrong way to go. I think that will probably be our biggest challenge. It really is meant to be something different. It is a different focus and an external focus to some extent.
So I think making those distinctions and some support for that idea -- I have to say, we have found a fair amount of support already. The agencies are beginning to send their comments back. I think the vision clearly resonates with a lot of the agencies and all of our partners, and again, are there specific first steps that could be taken and then in addition, if you do create such a focus within HHS, is it a lead agency, is it some new office, is it largely related to IT. That is probably where the difference of opinion would be.
The other point is, and this is understandable, our agencies which have done much of the fine work in informatics and in the basic areas here up to now, with the creation of what is potentially perceived as the czar office -- sometimes those offices work well and sometimes they don't. They sometimes end up drawing resources away from the very programs that have gotten to use at this point.
This is the complexity of how you actually do this. But I think the idea has a lot of support now. We are trying to figure out ways to basically make it so.
DR. LUMPKIN: Other questions? Simon, any other items since we took care of your action item yesterday?
DR. COHN: No action items, thankfully. However, I did just want to announce that we have two hearings coming up between now and the next meeting. The focus of the subcommittee's hearings at this point are on code sets related to HIPAA mandated code sets, both medical and non-medical, looking at issues related to them, gaps, as well as the need for replacement with newer versions.
On April 9 and 10, we will be looking specifically at the gap issue, as well as talking about the issue of replacement of the older version of the ICD procedure codes, otherwise known as ICD-9, volume three, with the question about whether we should be replacing it with ICD-10 PCS, when, how, what support the industry may need, and other questions along those lines.
In May, which is before the next time we all get together, on the 29th and 30th, we will be talking about the placements related to ICD-CM volume one and two, otherwise known as the diagnosis codes, read from that to ICD-10CM. We will once again be looking at basically the same issues.
Marjorie, do you have any comments?
DR. GREENBERG: No.
DR. COHN: So that is what is coming up. You are all welcome and invited. They should be very interesting sessions.
DR. LUMPKIN: Thank you. Subcommittee on Populations.
DR. FITZMAURICE: Simon, what were the dates in May?
DR. COHN: I have May 29 and 30.
DR. FITZMAURICE: Thank you.
DR. MAYS: Populations has been focused on two issues. One is looking at a lot of our past products and activities. We have gone back through with a first pass at things. We have an archive.
Some of this was stimulated I think by the testimony at the IOM. We realize that we have that Medicaid managed care report, and other things, as we try and move forward to talk about some of the issues. We realize that we made some of these recommendations in '88 and some of these recommendations in '90-something.
What we want to do is look at them and try and analyze what some of the barriers are, and also if we are going to make a set of recommendations that are coming out of some of our hearings, to try and emphasize whether we have made these before, and to point out that there has not been any movement. So that has been part of the work.
The second piece, we had a hearing February 11 and 12, which was focused on looking at the measurement of health disparities in racial and ethnic groups. The hearing was two days. It was well attended, and covered a lot of ground in terms of looking specifically at several of the federal surveys to measure health disparities.
So we are at a point now where once all our material is in from that, the transcripts, et cetera, we will sit down and look at them. In our meeting yesterday, it was decided that we want to find out where some of the gaps are, and based on that have an additional hearing. They want to do that soon, and issue a report. So it is very timely in terms of what Sondik requested.
When we were talking about a report, we were actually talking about a report that also could have a cover letter to specific institutes or groups, based on how pertinent some of the information would be to them. So NCHS was on our radar screen, and so it is even better that he asked for it.
So timeline I'm not sure here, but we will actually try and have this hearing before we meet in June. It may be in April or May.
DR. LUMPKIN: And the timeline for the report, would that be after the hearing?
DR. MAYS: Yes, after the hearing.
DR. LUMPKIN: Probably in the fall, after the fall meeting?
DR. MAYS: I have a hard time with this. They estimated that it is about six months. Probably when I come back here, I'll say I understand why, but I can't do it at six months. So you will just have to see in June when I come in here, what I will say. I am willing to admit defeat. I have no problems with that.
I'm trying to think if there is anything else. Did I leave anything out?
PARTICIPANT: (Comments off mike.)
DR. LUMPKIN: Thank you. Work Group on Quality. Kathy?
MS. COLTIN: We have had two meetings since the last full committee meeting. We held hearings on December 12 with organizations that have been involved with measures of quality related to patient safety to discuss some of the data issues and gaps related to their ability to develop and implement measures in that area.
Yesterday we also had a brief meeting where we reviewed a draft outline for a report that would summarize all of the panels and hearings we have had around data issues and gaps related to measuring quality, focusing particularly on defining the scope of our report as related to measuring quality, rather than reporting on quality, that that was a separate issue.
We identified a couple of areas that we would like to hear more about before we finalize the report. Those two areas were measures of quality for mental health and substance abuse services. We wanted to hear more about activities to measure quality at the level of the individual practitioner.
So we are proposing a panel for the June meeting that would address the mental health and substance abuse quality issues. We are proposing to hold a hearing on the day before the executive committee meeting in July, I think July 26, is that right?
So we are tentatively going to try to organize a hearing for the 25th, that Thursday, which would have two purposes. One would be to take testimony from the various medical specialty societies and boards in particular around activities that they have been involved with in developing and proposing quality measures for individual practitioners.
We have also been asked by AHRQ to hold some hearings to take testimony on a proposed list of topics and measures to be included in the national quality report. That timing works well for them as well. So this will most likely be a full-day hearing. I think what we will try to do is maybe devote the first hour and a half to two hours to the individual practitioner measurement issue and then also keep the specialty societies there to comment on the list of topics for the quality report, and invite some additional stakeholders to also comment on those topics.
So that is our plan. We should have a draft outline for our report that we can share with you at the June meeting, but probably will not have a draft report until the November meeting, and don't anticipate having a final report until the first meeting in 2003 for your approval.
DR. LUMPKIN: Thank you. Any questions? The next meeting is in June, followed by September and November. Do we see any items -- of course, we will cover this in the executive committee conference call, but if there are any items that we need to begin planning for, --
DR. GREENBERG: Kathy just mentioned the panel that we have for the June meeting. Do any of the subcommittees plan to have reports? That is sort of unlikely. We know there is something from populations. I don't know whether there will be any recommendations from the Subcommittee on Standards and Security. One thing you may have discussed in your working session -- I'm sorry I wasn't able to be there -- was a compliance issue. The covered entities will need to submit their extension requests based on a format that is going to be posted by the end of March by CMS, correct? Then the committee is expected to review a sample of those, so you may have something about your methodology or something else to present in June?
DR. COHN: Yes. I have got two statisticians working on that as we speak. There might not be a letter, but we may discuss the methodology by that time.
MR. AUGUSTINE: We talked yesterday about coming up with a study design type paper, a few pages, discussing the analysis plan. We can submit that when it is ready.
DR. LUMPKIN: Just a question. How does the rest of the committee outside those who are on the standards and security subcommittee feel comfortable in the issues related to the various code sets? Do we feel a need to have a general panel to get the rest of the committee up to speed on code sets?
DR. GREENBERG: We did that, but --
DR. LUMPKIN: It has been awhile.
DR. COHN: It has been awhile.
DR. LUMPKIN: If you are going to be bringing something to the full committee, it might be good at some point -- I don't know when you expect that those will be ready --
DR. COHN: These are difficult areas. I think that as you begin to identify the issues, whatever panel you need to have, we will be focusing on the issues and possible solutions, as opposed to just another discussion of code sets out there.
So as we begin to frame all of that, I think we will try to put something together for June or September. I think June might be optimistic at this point.
DR. LUMPKIN: No, that's fine. Richard?
DR. HARDING: It is a little bit different topic.
DR. LUMPKIN: I think we were done.
DR. HARDING: Listening to Ed's talk this morning made me mindful of the issue of money. I am up to my ears in budgets and so forth out in my day job, but the issue is -- and I assume the executive committee discusses this regularly -- are we okay financially, this committee, as far as hearings and the expenses that we call on to put together the good products that we do? Or are we tight, or how should we be thinking as groups for the rest of the year as we think about having additional hearings and so forth? Can you give us a ball park? Are we in the ball park or are we way overspent or under?
DR. SCANLON: We are planning to have the same amount of resources in terms of funding this year as last year, which was about $250,000 a year. So I don't see any diminution.
DR. HARDING: And we are spending that down at about the same rate as the previous years and so forth?
DR. SCANLON: We probably have a reserve from last year. But we are projecting the same level. But that is actually a good point. If there are projects that the committee or subcommittees want to undertake that will require consultants or hearings or other analytic work with contractors, the sooner we identify them the better, and cost them out. But we are hoping to have at least the same amount for those purposes as we did last year.
DR. GREENBERG: Actually we have two pots of money, in a sense. As Ed pointed out, we have the base budget from NCHS, which supports a lot of the logistics and other aspects of the committee and then we have the generous support from the Office of the Secretary, which supports additional hearings.
I have just gotten my tentative allocation for 2002, and it is consistent with last year for the national committee. So I think we are okay.
DR. HARDING: Thank you.
DR. LUMPKIN: I have to say that I have only been turned down for one hearing. That was when we wanted to do a hearing in Arizona in January. Marjorie made us do it in Washington. But other than that, we have been pretty much able to do our work.
DR. SCANLON: I guess the only potentially unexpected -- it is hard to know at this point -- to the extent that the sample analysis of the compliance plans gets to be a major undertaking, where some sort of contractor help is needed, then we will have to factor that in as well. It is just a little early to tell. My guess is that we won't see many compliance plans until right before the due date, which is in October, which is the next fiscal year.
But I think we need to think through how we would approach that at different options levels.
DR. COHN: I am surprised that you didn't pick up on the publishing of best practices as a possible expense.
DR. GREENBERG: My sense is that I would hope we could keep the review of sample -- not that I am trying to influence the designer of the study, but it would be relatively modest. I think the bigger bang for the buck in our limited funds would probably be -- if most of the plans are electronic and we can get some statistics, et cetera, as Karen Trudel has suggested, then what funds we have I would see supporting some best practices solutions, all of that. But we may need some modest funding for the analysis.
DR. COHN: I am sure you are used to these discussions.
MR. AUGUSTINE: I am very used to these discussions, and I will do my best to minimize our outlay of resources and maximize our uses of information.
DR. GREENBERG: Debby Jackson has called to my attention, there are a few issues that we had deferred, that had been raised for full committee discussion and presentations. One was, we had scheduled a presentation from GAO on their record linkage study, and we have had to defer that. But we will try to bring that in in June.
Also, NCHS -- we had been asked to report on international activities. Dr. Sondik mentioned a few of them, but if time permits, we can do that as well, or if there is interest.
DR. LUMPKIN: Okay. I think I am at the end of the agenda. For those who asked, I promised that we would get out by three, so if you would quietly sit in your places.
I don't think you need a motion to adjourn when you have accomplished your agenda. The Chair is enabled to adjourn the body. I just made that up, but --
DR. GREENBERG: It sounds good.
(Whereupon, the meeting was adjourned at 3:00 p.m.)