Room 505A
Hubert H. Humphrey Building
200
Independence Avenue, S.W.
Washington, D.C. 20201
Call to Order, Welcome and Introductions, Review of Agenda, Dr. Don Detmer
Update from the Department, Mr. Jim Scanlon
Don Detmer, Chair
Marjorie Greenberg
James Scanlon
John
Lumpkin
Jeff Blair
Richard Harding
David Takeuchi
Lisa
Iezzoni
William Braithwaite
Richard Suzman
Paul Newacheck
Michael Fitzmaurice
Barbara Starfield
Kathleen Fyffe
Simon
Cohn
Ed Sondik
Deborah Tress
Ms. Serkes, audience member
DR. DETMER: I would like to call us to order. It is nice to see all of you. I hope that you have had a good summer and that the school year is underway in fine shape.
We have a full agenda, as usual. We had a switch in the agenda from what we had originally anticipated and started at 10:00 a.m. today instead of 8:00 a.m., to get the Standards and Security group time to have a working session. As a result of that, Dr. Eisenberg, who had intended to meet with us, was not able to work us into her schedule, and on short notice Dr. Eisenberg was not able to come. So, our update, actually, from the Department will be by Jim Scanlon.
In addition, John Fanning, who normally is here to talk about the privacy work from the Department side, is in Europe, and Bob Gellman, also one of our committee members, is also at the same meeting in Europe. What we should anticipate at our November meeting is an update on what they report from the circumstances actually over there. So, we will get into that and then move on through the rest of the agenda.
Part of my welcome in particular today is to David Takeuchi who has joined us, and we are delighted to have him as a member of the committee. He has three areas of expertise. He is a sociologist. He has been at UCLA and actually is in transit to the Department of Sociology at the University of Indiana. He is a full professor there. His areas of expertise are mental health, race and ethnicity issue and quality, and I think all of those are very important to this group, and so we are particularly pleased to have him here.
What we will do, as we normally do, is go around the room and introduce ourselves, and David, feel, please, free to tell us a little more about yourself when your turn comes. And then we will go around the room as well with introductions. Then I will come back to talking a little more about the agenda and we will get underway.
I am Don Detmer. I chair the committee and in my non committee life I am a university professor at the University of Virginia.
MS. GREENBERG: I am Marjorie Greenberg from the National Center for Health Statistics, and I am the Executive Secretary to the Committee.
DR. LUMPKIN: I am John Lumpkin. I am the director of the Illinois Department of Public Health.
MR. BLAIR: Jeff Blair, vice president of the Medical Records Institute and I am a member of the committee.
DR. HARDING: Richard Harding, a member of the committee, and child psychiatrist from South Carolina.
DR. TAKEUCHI: I am David Takeuchi, and one of the areas that I study is in stress and mental health, and, as you know, moving does create a lot of stress, and I am trying to maintain a positive mental health.
MR. STREIMER: I am Stewart Streimer with the Health Care Financing Administration, and I am a liaison to the committee.
DR. IEZZONI: I am Lisa Iezzoni. I am professor of medicine at Harvard Medical School and Beth Israel Deaconess Medical Center in Boston.
MR. SCANLON: I am Jim Scanlon from the Data Policy Office here at HHS, and I am the Executive Staff Director for the committee.
DR. BRAITHWAITE: I am Bill Braithwaite from the National Center for Health Statistics and detailed to the Assistant Secretary for Planning and Evaluation and supporting this committee.
DR. NEWACHECK: Paul Newacheck, committee member from the University of California at San Francisco.
DR. FITZMAURICE: Michael Fitzmaurice, senior science advisor for information technology at the Agency for Health Care Policy and Research, and liaison to the committee and, with Bob Mayes, lead staff to the workgroup on computer-based patient records.
DR. STARFIELD: I am Barbara Starfield, member of the committee and university distinguished professor with appointments in pediatrics and health policy at Johns Hopkins University.
MS. FYFFE: Kathleen Fyffe, member of the committee. I work at the Health Insurance Association of America.
DR. COHN: I am Simon Cohn. I am the National Director of Data Warehousing for Kaiser Permanente and a member of the committee.
MS. WARD: Elizabeth Ward, a member of the committee and administrator with the Washington State Department of Health.
[Audience introductions, off microphone.]
DR. DETMER: Thank you. I introduced Paul Newacheck actually at our last meeting in some detail, but, as I recall, I am trying to remember, were you actually in Europe or at our last meeting?
DR. NEWACHECK: I was not able to attend the last meeting.
DR. DETMER: Well, that is what I thought.
DR. NEWACHECK: I made it to the March meeting.
DR. DETMER: Anyway, we are happy to have you here, obviously, as well.
Okay, we are going to have the update from the Department. The item following that has to do with our member guidelines for dealing with the media and other external organizations. You will recall at the end of our last meeting the Executive Committee was asked to relook at this issue, and that will come back for discussion today and then possible action tomorrow. We have some items that follow on NPRMs specifically relating to security, and perhaps other issues.
And then the afternoon will be spent in breakout groups; the privacy and confidentiality group, I think, working session is going to be mostly a round table on fraud, as I believe, and then the workgroup on computer-based patient records will work until the building closes, or drives them out, or which ever comes first, and then the populations group will also be meeting. I think the locations of these will be clear before we break.
Tomorrow we reconvene at 9:00 a.m., and have also some discussion of the concept paper on sharing health dimension for the national information infrastructure. You will recall that we have talked about that. It is back in a revised form and I think the question is, is that ready to pass forward to the Data Council, then to start working iteratively with them on a work program on that.
We then have presentations on ICB-10CM and PCS and then Mike Fitzmaurice is going to give us an update on the President’s Advisory Commission and its follow-up. And then we will have a report and come back to deal with our action items, a brief discussion of a workshop that Marjorie will bring us up to date on, and then look at future dates and agendas.
Are there other items? Mike?
[Temporary loss of audio; text lost.]
MR. SCANLON: Actually, the HHS Department Data Policy Advisory Group advises the Secretary and serves as a forum for data policy issues within HHS, and the Council celebrated its third anniversary this August, which is actually significant in terms of survival for an internal data committee -- any committee.
The Council, to remind you, has been working on about five major themes in the area of data policy and privacy. Let me just remind you of what they are and then I will describe four specific activities that John and Peggy were --
DR. DETMER: Could you get a little closer to --
MR. SCANLON: Sure. There are several items and areas that the Data Council has been working on, and continues to work on, very familiar to you. The first is the data standards area, both HIPAA and other data standards as well.
The second area is dealing with health information privacy issues. The third area is dealing with broad HHS data collection strategy, including our HHS Survey Integration Plan, but other data collection plans and strategies as well.
The fourth area is the Council serves as a focal point for relationships with this committee, obviously, and receives the recommendations and reports from the NCVHS. And the fifth area deals with the national health information infrastructure and the Council is awaiting the report and the recommendations of this committee in terms of moving forward on that broad issue, particularly on how health applications can be made a major part, a stronger part, of the national information infrastructure.
And finally, the Council serves as an internal policy coordinating body within HHS, both on domestic issues and international issues, including EU type issues. You are going to hear a report later this morning from Bill Braithwaite on the progress of where the various data standards required by HIPAA stand, and I think that is encouraging news. And I will give you a very short report on privacy, where things stand on HIPAA-related privacy issues in a couple of minutes.
But let me turn to four specific items that the Council has been working on and has, there has been some movement, and to pass them on.
First of all, you will recall that the Department was considering a new statistical standard for age adjustment of mortality rates. The NCHS brought this issue to the Data Council. The Council considered it and made a recommendation to the Secretary to adopt this new standard for Department-wide use. As you know -- I will just briefly recount sort of what the issue was -- there were several different standard populations that are used now to adjust mortality rates, age adjust mortality rates, including, I guess what is used most, the 1940 U.S. population in the U.S., and this situation has caused a fair amount of confusion and extra work.
So, this was discussed. A proposal was advanced for the Data Council to look at this proposed standard population and see if we couldn’t do better. I should mention that the state health departments, too, that deal with vital statistics have had a problem with using the 1940 and other standard populations as well. In consultation with them, and you will recall Joyce Van Amberg, previously on the committee, as well indicated that it would be a very positive move to move towards a standard population.
So, the standard that has been adopted is the following. Rather than using the 1940 population distribution for age adjusting mortality rates, the new standard involves the year 2000 projected population, and it begins with deaths occurring in 1999. This policy goes into effect, I believe, I believe it goes into effect this month, and agencies have been encouraged to implement it in connection with their normal data policy planning and analytic cycles. So, I think the, I know that Lisa’s subcommittee was briefed on this issue, along with some other statistical standards, and I am happy to report that this has now gotten to the point where it has been issued.
An implementation team will be formed within the Department to work on educational material and some dissemination material to make this a little bit easier, but, in fact, the Secretary did adopt a proposed standard and everybody seems really pleased. This will have some effect on, it will, the rates constructed based on this population, age adjusted rates, will differ some what from the race, specific race and other rates that were constructed using the 1940 population, and that will be part of the educational material as well.
The second item, the Data Council has begun an update of the HHS-wide Directory of Data Systems. I think some of you are familiar with this document. It is on the Data Council’s web site, and it is an attempt to include virtually all of the data collection systems and analytic data bases of major interest that are sponsored by HHS. The directory was last updated in 1995, and the Council asked one of our working groups to begin an update for this year, 1998. The previous emphasis in the inventory, although it was an attempt to include all of the major data collection systems, the emphasis there was on race ethnicity data. Did the system include race ethnicity data? What was the detail? How was the information analyzed? What were the capabilities? What were the categories used?
And this year similar data will be collected, but it is taking the form more now of a broad, multipurpose inventory of major data collection system within HHS. It does not include internal systems like administrative systems, but largely, virtually all of the general purpose data systems would be included. This will probably be completed in the next month or so, and we will probably put it up again on the HHS web site.
There is also a proposal -- it needs to be worked out -- to develop some links from the agencies and the data systems included in the inventory to actual data or planning information about the various data systems where that exists.
In terms of survey planning, the Council has developed a five-year advance plan of surveys. This was developed in connection with budget planning, and everyone was asked to take a look and identify any major survey activity, whether in the planning stage or the analytic stage, and it will take place over the period fiscal 1997 through 2002. You are all familiar with the long lead time for many of these surveys, even changes in the surveys, so you really have to work on them on a very long lead time basis.
The purpose of pulling this together was really an attempt to look at what the plans were for major surveys at HHS. This was not only intended to make sure that data needs were addressed and coordinated, but it was intended to identify any potential resources problems at an early stage to minimize duplication.
In addition, the Council has been working with the HHS Budget Office looking at the year 2000 budget. As you know, the Federal Government’s fiscal year begins on October 1st. That is when the 1999 fiscal year will begin. So the budget planning is already directed at the year 2000.
There were a number of survey initiatives proposed by agencies in the year 2000 preliminary budget submissions. The Council pulled them all together from a Department-wide perspective, and made some analysis and recommendations to the Budget Office in terms of how they should proceed. We hope to have the advance plan of surveys -- this is pretty much a tabular listing with descriptive information about each of the surveys -- up on the Data Council web site, too. We are just working on some details. There are some entries that probably do not need to be there.
Fourth, you are all familiar with the HHS Survey Integration Plan, I think, to varying degrees. The first phase of the Survey Integration Plan focused on the major population based surveys at HHS, including the Health Interview Survey, the MEPS, the National Health and Nutrition Examination Survey, and so on. That phase has been largely implemented. There are still some areas to work on.
A second focus was on employer surveys. HHS, these are lesser known, but HHS actually sponsors several surveys of employers relating to health insurance, and the second phase of the Survey Integration Plan focused on how we could integrate those surveys, and is continuing on a broader basis what other federal agencies -- such as the Labor Department and the Census Department and so on -- in terms of how we can look at a government-wide approach to integrating those surveys.
The third phase, and this is the current phase of the survey plan, is looking at health care system data. It is looking at our current investment in surveys and data systems related to plans, providers, capacity and resources, and it is looking at what the needs are and how does our current investment survey portfolio in this area address those needs, are there any major changes, and so on.
This is still a work in progress, but I think we will be getting a report from that working group at the next meeting, at the November meeting of the Data Council. This takes quite a while, and it is involving a fair amount of consultation with the industry.
And, obviously the Data Council did a little forward agenda planning, and is looking forward to receiving the report from the committee here dealing with the health applications in the NII over the next few months. We will arrange the agenda for that.
Let me stop there, and I can either take questions or briefly describe some privacy developments.
DR. DETMER: Any questions before he talks about the privacy?
[No response.]
DR. DETMER: Okay.
MR. SCANLON: Privacy, I wish I had more to report. As Don said, the international data protection commissioners -- these are sort of the privacy commissioners in other countries -- are meeting in Spain this week, and both John Fanning, our privacy advocate, and Bob Gellman from the committee are there. Otherwise, there does not seem to be very much happening in the privacy area.
You will recall, in relation to HIPAA, required the Secretary to submit privacy recommendations. It is nearly a year ago that we did submit them to Congress. Congress is now considering various bills relating to privacy, both free-standing bills -- there are probably two or three in the House and the Senate -- free-standing bills dealing with medical confidentiality, and most of the bills dealing with patients’ bill of rights also include some medical confidentiality provisions.
And they range from fairly detailed treatments to fairly short treatments, indicating that plans are to have confidentiality practices in place and release information only to authorized users. So, they range from place holders largely, to fairly detailed descriptions of what protections and disclosures might take place.
It is difficult to predict what will happen on the Hill, but at least there are some free-standing privacy bills and I think it is fair to say that virtually all of the patient bills of rights that are being considered include some privacy provisions as well.
If you recall, the deadline in HIPAA is August of 1999. Congress directed that. If Congress fails to pass medical record privacy legislation by then, then the burden falls back to HHS to develop privacy regulations to protect the information transmitted in connection with the HIPAA transactions. So, we are now looking at HHS at what exactly that provides, what authority that provides for privacy protections, but that is still a ways from now.
I can take any questions. I know many of you around the table follow the privacy bills in Congress and probably know the current status more so than here.
DR. DETMER: Questions or comments? John?
DR. LUMPKIN: Just a follow-up question or concern in relationship to privacy. What is the science of privacy? I mean, is there a scientific base for which we can assess the risk of access to health information in an information system? And I do not pose this just as a random question, but, based upon some things going on in Illinois we have been trying to review the literature on that and it is not there. And I just wonder if perhaps part of our role in working with the Department should be that we would look at some way of beginning to do some research on the risk that is posed in computer systems.
There is a lot of stuff that is out there and none of it is based upon any science. Much of what we do in releasing of data, whether or not we release cell sizes of five or ten or fifteen or twenty, are not based upon scientific evidence. And so as a committee, this is an issue where some science, I think, needs to be brought into this.
MR. SCANLON: I can respond to that. I think you are right. Privacy is largely a normative legal kind of an approach. There is very little empirical basis for the, you know, for what violations may occur.
But on the specific issue you raise, John, there actually is a fairly good basis in statistical literature. There are some accepted standards in terms of when you disclose information of statistical form that is intended to be confidential, there are some standards and statistics that have been worked on, including our own, the Statistical Methodology Committee, that has some guidance for how this works. And NCHS, of course, and some of the statistical agencies, have a long history of what they call disclosure avoidance policies and practices.
But I think your other point about potential violations of privacy and so on, is based, to a large extent, on anecdote, and I do not know that there is any empirical, really population-based empirical information on what does and does not happen. And perhaps that, on the other hand, if there is no literature it is hard to do a literature review so I do not know how -- we are, I might mention, Richard Suzman here from NIA, we are, HHS is proposing to sponsor with the National Academy of Sciences, a one-day workshop -- maybe two days -- on looking at some confidentiality issues associated with research and using large scale data bases. And conceivably, Richard, we might be able to work this issue in as well.
DR. SUZMAN: It is part of the agenda, but we can certainly add to the agenda. It is now, it is a one-day workshop with a report and it is co-sponsored by a fair number of other agencies, both within HHS and outside of HHS, and is designed to look specifically at developing measures of the risk of identification in large scale national data sets with linked administrative data. It is very different when you know geography and have a small, community-level study. That is a very different order of business. But when you do not know geography or you know census region, state, it becomes a different issue.
It is also complicated by the question of what other data sets are out there that individuals could presumably link that data set to, for example motor vehicle registration or health insurance applications, complicates the world. And ultimately one might want some form of legislation that could protect such data sets.
DR. STARFIELD: A clarification. When is this workshop? And, is it open?
DR. SUZMAN: Well, the workshops of the National Academy of Science are always open. A date has not been set. There will be a planning meeting later this fall. We have had one pre-planning meeting. There will be a planning meeting associated with one of the meetings of the Committee of National Statistics, and it will be some time next, I think, spring. I am not sure when it has been set, but we can certainly publicize it. I suspect that it is going to be one of a number of meetings that are held. There was a lot of pressure on us to add various agenda items such as sets of medical records that you might find in an HMO, but I resisted that so we would keep a defined focus. We need their report soon and we see this as simply the first of a series. They have, as you know, already done a number of reports. The last one was something like, Public Data and Private Lives, so this is one in a series.
DR. DETMER: I think that we can make sure that obviously the committee, and all of you in the room, as far as that goes, know about this well in advance. Anything further of Jim? Okay, Bill Braithwaite.
DR. BRAITHWAITE: Well, I will continue with the update here. We talked last time about how successful we were at taking the results of the NCVHS hearings and the discussions that occurred, and the recommendations that you sent to the Secretary, and incorporating them into the Notices of Proposed Rule Making that went out to propose establishment of the standards required under HIPAA. Four of those notices of proposed rule making have been published; the one on the national provider identifier, the one on transactions and code sets and the employer identification number. Those have been published and their comment period has been closed. We are now in the process of counting and summarizing the various comments that we got.
Just as a ballpark, we got comments from hundreds of people. We got thousands of comments because many people, in the legal sense, were associations and organizations that actually sent in binders full of comments on virtually every aspect of each NPRM. So we ended up with many thousands of comments even though there were only hundreds of commentors.
The security and electronic signature NPRM was also published and is currently in its comment period. That comment period closes on October 13, 1998.
The final expected NPRM for this year, the one on a plan identifier, has been drafted. It is in clearance within the Department. We are still having a little trouble with the fact that there does not seem to be a true industry consensus on what a plan is anymore. I guess those have been divided up every which way from Sunday. But we are going to try and come out with something very shortly which will take a stab at identifying a plan. So that NPRM should be out in the next couple of months.
And then, finally, the groups of people, implementation teams, are paging through the thousands of comments that we got and trying to work up a planning schedule for when the final rules, based on those proposed rules and comments, will be coming out. We do not have that schedule yet, but we will certainly let the committee know as soon as we have some sort of idea of when to expect the final rules.
The other publication, not an NPRM but the other publication, the notice of intent, as it was called in some initial discussions, about the individual identifier has been postponed. I do not have a schedule for when that will be actually published. There was a significant amount of reaction from the public and from Congress to the hearings that this committee held in June in Chicago and -- July, actually -- and there were several bills introduced and several amendments proposed by Congress which asked the Secretary not to implement an identifier for individuals until privacy protections were in place.
I do not think any one of those has actually been passed yet, but as long as something like that is pending in Congress, I suspect that the Department will be reluctant to proceed until the situation is a little more clear. That is where we stand at the moment. Any questions about standards and publications?
DR. DETMER: Kathleen?
MS. FYFFE: Dr. Detmer, and also Dr. Braithwaite, one thing that we have not discussed here at NCVHS, and I do not know if we want to get into this at this point, is the concern of the year 2000 and how that might impact the implementation schedule for the HIPAA transaction standards. Do we want to talk about that? Has that been discussed at the Data Council? Can we briefly touch upon that this morning?
DR. BRAITHWAITE: I can tell you in general that the comments we received on the NPRMs addressed that issue. There were quite a few comments on that issue, some of which basically said, as long as we have all of our systems torn up, let’s implement the new standards, so tell us what they are while we have them torn up for year 2000, particularly those standards which affect virtually every data base and every piece of software in the health care arena such as the identifiers.
Other comments had just the opposite which is, we cannot think about anything but year 2000 right now so do not even make us think about it until after that is all over. And several people who even went further, several organizations who went further and said, we do not want you to make us comply with these standards until the year 2005 or 2006.
Now, we at HHS do not have much control over that in the sense that the law tells us exactly when compliance is required by law after the publication of the final rule, but, as you all know, the publication of the final rules have been delayed significantly because of the length of the bureaucratic process that we are going through to make sure that these are, in fact, consensus standards and take into account all of the comments that we have received. Which means that if these final rules are published, let’s say, early in 1999, that no one will have to comply with them legally until early in the year 2001, which ought to take care of the year 2000 problem because that is, at least, a time-limited problem and not one that can slip its schedule like many other computer projects can.
So maybe it is, the problem has been resolved by itself. But we will certainly be taking all of those comments into consideration in coming up with the final rules.
DR. NEWACHECK: Yes, Bill, I wonder if you could comment, for those of us less familiar with the process, a little bit about how you go about shifting through the thousands of comments and deciding which are incorporated and how they are encorporated.
DR. BRAITHWAITE: All I can tell you at this point is that every single comment is read and considered, and that the final publication will summarize all of the comments and what our responses to those comments are and how they are, or are not, and why they are, or are not, encorporated into the final rule.
DR. FITZMAURICE: And Bill, do we not have plans to put all the comments up on the Web so that everybody, all the public can see what the comments were?
DR. BRAITHWAITE: Yes, the comments are public documents. That is, right now you can go into the HCFA document room and look at the binders of comments. But, in fact, to make them more accessible as part of this open process that we have been running for this particular set of rules, we will be posting those on the Web. In fact, they should be up by now except for some technical difficulties in making that happen which hopefully will be resolved relatively soon.
DR. STARFIELD: How many people have to, are required to do this?
DR. BRAITHWAITE: How many?
DR. STARFIELD: How many, yes, how many people do you need to go through all those comments and comment on them? Just to give us the magnitude of the task.
DR. BRAITHWAITE: Well, one person could do it all, but it would take a long time so we --
DR. DETMER: I think it is also a question of how they choose to go through it as well.
DR. BRAITHWAITE: So, you know, the comments are being shifted, basically assigned to the groups of people who have substantive knowledge in each of the areas, and then those teams will be going through and trying to summarize each subject matter of the comments and how many were pro and how many were con and what the nuances of those were and whether or not those nuances are meaningful. And then we will have to write up a summary of that and then the teams will get back together and decide what decisions to make about those. It is not a short, easy process at all, as you can imagine.
DR. DETMER: Let me come back to Kathleen Fyffe’s question. Kathleen Frawley has gone to the last couple of Data Council meetings for me and I have talked to her but I may have missed something. My sense is that the year 2000 issue has, in fact, gotten attention at the Data Council, but how it actually interfaces with the HIPAA legislation is not that clear in my mind, that that has really been a focus as well. Have I missed something or what would you say about that?
DR. BRAITHWAITE: The only thing I can say about that from the internal perspective is that the solving of the year 2000 problem is a very high priority within the Department and particularly within those agencies that run large data systems that are incredibly dependent on data processing being successful. And, there has been some noticeable effect on the people power available to attack this problem of interpreting the comments and writing the final rules. So, I have not yet seen the schedule, but the schedule of publishing the final rules may actually be delayed a little bit by the fact that we do not have the people that we might otherwise have to put on this problem. But I do not know that for sure yet.
DR. DETMER: I guess the question for the group is what kind of a response does the group have to Kathleen’s question as whether the committee should, you know, tie into this one as well? Jeff Blair?
MR. BLAIR: Kathleen, the only time that I recall that we did discuss in the committee year 2000 was at the time when we were making our recommendations with respect to, or deliberations with respect to the transaction standards for financial and administrative claims which, you know, led to the ASCX-12 standards for transactions and NCPDP for pharmaceuticals. And, at that particular time the discussion we had, if I can recall it correctly, was we had in general surmised that most of the implementation of those standards would involve new application software programs, as opposed to institutions that would wind up reprogramming themselves software programs to be able to produce the functions that the standards were addressing. And we felt as if there would be very few situations where there would be retrofitted changes to existing programs, and even fewer where they would be mainframe adjustments.
So, our thought was to not adjust the schedule at the time that we were making our recommendations and see if this perception was correct and see if we did go forward as close to schedule as possible whether there would be a large objection to this perception that we had. From everything that I can tell there has been a rather low level of concern and comment. I do think we do have to respect and look seriously at the objections and the concerns because there may be some institutions, some situations where this is a very serious problem and that, you know, appears to be coming out in some of the comments. But, the perception that I have is that it is a very small percentage of the total health care field that is being affected by this.
DR. DETMER: Simon?
DR. COHEN: Kathleen, as it moves closer to the year 2000, I become more and more sensitive to the issues you are identifying and I think probably the rest of the health care industry is also becoming increasingly sensitized. Now, my view, talking to others in the health care enterprises, has been that it is very important for us to provide clear direction and so I would not want to see standards in any way held up in terms of identification of those standards for year 2000 issues. But, it may be something we may want to consider about what do we want to understand from the health care environment a little better if implementation issues are an issue right now, and whether the timing of the year 2001 will give them sufficient time. I suspect there will be those who will say no matter what date you gave them that it would be too soon, but it still might make some sense to talk a little more to them and understand their issues.
DR. DETMER: In light of this -- I think this has been a good discussion -- maybe what we could do is, Bill, maybe you could get back specifically to us after you have had a chance to look at the comments -- that is a pretty good data base -- and then we could sort of make a determination based on how those comments sort of tend to shake out in terms of how much we maybe should look at that. Does that sound?
DR. BRAITHWAITE: I would be happy to do that.
DR. DETMER: Okay. Any other questions for Dr. Braithwaite?
[No response.]
DR. DETMER: Okay, thank you. All right, what I would like to do before we move to our next item is just see if in Tab P are the minutes of the June 16-17 meeting. I do not know if any of you do have corrections or additions to those, but if you do, either let me know now or soon because otherwise I will end up assuming that they are accurate, unless you have comments, Marjorie.
MS. GREENBERG: They were sent out for comment. We got a few and they have been incorporated. So, they incorporate all the comments that were received.
DR. DETMER: If Deborah Tress could come up, please, to join us. Deborah is our legal counsel for the committee and what we will need to do now is move to items G and H, Tabs G and H. This has been a continuing exercise, essentially, for the committee, and actually Marjorie will lead us through this. You will recall at the last meeting the Executive Committee was charged to go through these guidelines and essentially that is what the Executive Committee did and is coming back with these two documents. As I said, Deborah Tress is here as our legal counsel. She met with us actually at our meeting in Chicago and was very helpful and we appreciate your being here today as well.
So, I think with that as a set of introductory comments I will turn this over to Marjorie and we will just go down through this as we go. And feel free to raise your hands and we will go through these issues as they arise.
MS. GREENBERG: Okay, thanks, Don. As Don said, the Executive subcommittee was asked to look at a number of issues related to disclosure of documents, et cetera, committee procedures, what constitutes a document, and a number of issues were raised at the meeting in June, and asked the Executive subcommittee to address these issues and the Executive subcommittee did when it met on July 22, 1998 in Chicago.
Prior to that, I contacted Deborah Tress and provided her with the previous, with the current guidelines for dealing with the media and other external organizations that I believe were accepted by the committee about a year ago, I think it was in November. And after reviewing those, which she did, we had a full discussion at the meeting. And, although I do not want to speak for Deborah, I think she did, in reviewing them, say that as guidelines for individual members our current guidelines were not in conflict with current law. But when we discussed it at the Executive subcommittee meeting we thought there would obviously be benefit to clarifying the guidelines and, in fact, relooking at them in light of some of the issues that had been raised at the meeting.
So, I just want to walk you through this proposed redraft in G, and then also in having this discussion a number of things came up about general meeting procedures, et cetera, that really were not appropriate in this particular document, which was talking more about dealing with the media and other external organizations in relationship to documents, so we already had a guideline -- which is in H -- for meetings of the national committee, full committees, subcommittees and work groups which was primarily an excerpt from the Federal Advisory Committee Act that actually we had put together a number of years ago. It is in your reference book as well. And so it seemed to me, and working with Deborah and the Executive subcommittee, that some of the additional items and issues that came up really belonged more in this second document.
So, I will, however you want. I can go through both documents, or just as I go through them you can raise questions.
DR. DETMER: Well, why don’t we do them separately? Let’s go through the first one and deal with that and then we’ll do the second.
MS. GREENBERG: Okay. The first document also draws heavily on the current Federal Advisory Committee Act, et cetera, but is somewhat more the committee’s documents than the second one which is more of a committee management one.
What we did was first we put in the beginning of this document actually what the Federal Advisory Committee Act does require. And that is in the first paragraph, obviously that each committee meeting should be open to the public, timely notice of each meeting should be published in the Federal Register, interested persons shall be permitted to attend, appear before or file statements with the advisory committee subject to reasonable rules or regulations and subject to Section 552 of Title V, United States Code, which is the Freedom of Information Act.
The record, reports, transcript, minutes, appendixes, working papers, drafts, studies, agenda or other documents which were made available to or prepared for or by each advisory committee shall be made available for public inspection and copying at a single location in the office of the advisory committee or the agency to which the advisory committee reports until the advisory committee ceases to exist.
And, we added the, that is all directly out of the Federal Advisory Committee Act, and then we added the fact that all documents -- as required by this act -- all documents produced by or for the committee become part of the committee’s official records which are located at the National Center for Health Statistics.
This is no change. I mean the official records have always been located at NCHS, but we had not actually explained that or clarified that in the previous guidelines. So that is completely new added to this but, as I said, from the Federal Advisory Committee Act.
We then discussed the two types of documents that were discussed at the meeting in June; documents that are provided to the committee by the Department, as well as documents that are generated by the committee. As you know -- and we confirmed this -- in your capacity as special government employees by serving on the advisory committee you sometimes receive provisional documents, predecisional documents, draft documents from the Department so that you can participate more fully in some of the discussions. This has definitely been the case during the process of developing regulations.
I think at our earlier meeting this morning it was suggested that possibly that type of getting a lot of input from the Department, and through a number of other means as well, was helpful in preparing the community at large for the NPRMs that were published.
These documents, we did receive, before these documents were provided to the committee we did receive a reading from the, a ruling from the General Counsel that we could provide these predecisional documents to the committee members in that capacity, as special government employees. So, we have reiterated that, but also tried to clarify that requests for these documents, for predecisional Departmental documents, as we actually said before, should be referred to the Executive Staff Director or Executive Secretary. I believe that is all we said in the previous, in the current version of the guidelines, but that these requests will be handled consistent with the requirements of the Federal Advisory Committee Act which is set out above, and that the department or agency freedom of information officer would determine what information must be released or should be withheld pursuant to the Freedom of Information Act.
So, these predecisional Departmental documents, it is not the prerogative of individual members to be then further disseminating these documents because they are not being disseminated to the members as part of the public, but in their role as special government employees, anymore than it is up to me as an individual, as an employee, to decide what documents can be released and which cannot, if they are predecisional.
However, if there is a request and there is some question as to whether they should be released, then it can be referred through the official processes. I should mention that we have had no requests in my experience with the committee, which goes back, I guess, to 1982, to view documents in the committee’s official files or records at NCHS that has been denied. We have no record of that, or no example of that.
Okay, any questions about that, because this has not changed that much. We just, from the previous version, it is just clarified.
DR. DETMER: Any questions?
[No response.]
MS. GREENBERG: All right, moving on to committee documents, again the current guidelines were found not to be inconsistent with the Federal Advisory Committee Act, however, the committee has more latitude in how it wants to make its own documents available, as opposed to documents that are the Department’s. And so the Executive subcommittee looked at that and considered recommending to the membership that there be some additional measures taken to assure as wide a distribution of information as possible, and to make sure that people participating in the meetings of the committee or subcommittees be able to view documents that are being deliberated on by the members. In general, the same policy is recommended that is in the current document. And that is that individual members should not share or discuss with anyone who is not a member or staff of the committee or subcommittee documents that have not been approved by the full committee and transmitted to the Department. Again, this is specifically guidance to individual members. And this includes documents being prepared by a contractor. And this is where the Executive subcommittee now is making a new recommendation at the bottom of the first page. And that is that, however, in the interest of maximum openness, the Executive subcommittee recommends that all committee documents, including those prepared by a contractor, that are deliberated at an open meeting of a subcommittee, work group or full committee, should be made available to persons attending the meeting and others who request these documents, to the extent feasible.
Now, I should point out that people were always able to, as I said, request to view the documents from the official files of the committee -- and that has not changed, obviously -- but here the Executive subcommittee -- and the members can speak for themselves -- but felt that providing copies of the documents to people who were participating in the meeting would facilitate the discussion and the public input. There also was just kind of a clarification about contractor documents that they were only really part of the committee’s records after, or at a point where the committee is really going to discuss them, after they have been accepted by the project officer and the appropriate, with the advice from the appropriate chair for deliberation of the committee. You could get a very preliminary document from a contractor that would not even be, would not even be brought forward to deliberation because it was not consistent with what the committee or subcommittee had requested from the contractor.
Okay, this would be the policy documents that are discussed in a public meeting of full committee or subcommittee would be made available to all the participants in the meeting. Now, if there was some reason why the Chair or the respective subcommittee chair thought that it was not desirable to make such documents available in a public meeting because of issues of confusion or other reasons, then that needs to be conveyed to the Executive Secretary, that a predecisional committee document should not be shared with the public. And it clarifies that this is likely to occur really only in exceptional cases. And then official requests for the document again would be referred to the Departmental Freedom of Information Office for resolution.
The same rule of thumb that is in the current document, the current guidelines and that is that a Departmental or committee document can be freely shared and discussed as soon as it appears on the HHS Data Council or NCVHS Home Page, and that people should be referred, to the extent possible, to this home page for the documents. And also, an agreement that all documents approved by the committee and signed by the Chair for transmittal to the Department will be placed on the NCVHS web site.
So, this web site is the committee’s web site. It is for the committee to choose how to use it. This is how the Executive subcommittee recommends that it be used in this way, to put up documents that have actually been transmitted to the Department. All other documents will, of course, be in the official files of the committee.
That is really where the major changes are in this document. A number of clarifications and then the recommendation of making documents that are being deliberated actually available at the meeting. They were already being discussed at a public meeting but this is actually going another step and making them available.
The other sections have not changed in any significant way. In order to, people are still asked to review drafts with the Chair and Executive Staff Director and Executive Secretary of articles that they are preparing for publication in their capacity as committee members. I know we have done that several times. I am not aware of that causing any problem or really slowing down the process, but for those of you who have done so you might want to comment on that.
And we said we would make a better effort to make sure that everyone on the committee received copies of these articles that were published as such. Also, Dr. Detmer asked if I would serve as kind of a clearing house for requests from members to make formal presentations on behalf of the committee. And then either individual members to make such presentations or a general request that comes into the committee as to whether a member would make a presentation at a meeting, that those would just be cleared with Don, but rather than have them come in to several different people, I was asked to serve as a clearing house on that.
I think those are really the only changes and the rest of it reiterated the conflict of interest section, the same as it was before, and it is important for everyone to be aware of not only issues specifically that could create conflict of interest but just to be very aware of what hat one is wearing. I know all of you have responsibilities and professional responsibilities in the areas that the committee discusses, and that is why you were nominated and asked by the Secretary to be on the committee. And it is just important that when you, but on the other hand, people now know you as a member of the committee and are interested in that role that you are playing.
So, it is just important to make clear whether you are speaking on behalf of the committee, although you are, and often people are introduced as members of the committee even though that is not the capacity in which they are participating in a meeting, and so this will give the impression that people are speaking for the committee. So, it is just important to remember that if you are, if you are introduced as a member of the committee but you are not speaking in that capacity, that you just clarify that, in fact, although you are a member of the committee you are not speaking on the committee’s behalf. Or, if you are, to use publicly available documents.
So, that is how this particular document was proposed to be revised. And Don, I hand it back to you.
DR. DETMER: Thank you. In fact, before I open this for discussion, I will make a couple comments of my own. Ms. Tress, do you have anything you would want to add to this from your review and so forth?
MS. TRESS: No, I do not have any comments on this draft, but just, as Marjorie said, the purpose of the document is not to change at all the requirements, that the requirements of the Federal Advisory Committee Act and FOIA and the regulations in the Department and CDC policies will be adhered to, and the purpose of the other language was just to provide some information to individual committee members on the appropriate handling of documents.
DR. DETMER: And, obviously, you have reviewed these and feel they are consistent with --
DR. TRESS: Yes, I reviewed the document, the administrative law division of OGC reviewed the document and the Department committee management officer also reviewed it.
DR. DETMER: Okay, now, I think that it, you know, is a task for us, we will look at these individually. This comes to you from the Executive committee, and I think the question is, what does the full committee wish to do? Obviously, we have had some discussion on it. There are differences in opinion, and some clear differences of opinion whether these are even worth having. So, I think what we are doing here by the Executive committee coming to you today was to have a chance to put some thoughts on the table, but not act today, and then come back and act tomorrow.
So, I think if you have questions for either clarification or comment, we are open for that. Paul?
DR. NEWACHECK: A couple of questions for clarification in the committee document section. Does the first paragraph there imply that we are not to share or discuss draft committee documents with other federal employees, for example, HHS employees? Is that correct?
MS. GREENBERG: Are you asking, is that possible, can you do that?
DR. NEWACHECK: Well, it says that individual members should not share or discuss with anyone who is not a member or staff of the committee documents that have not been approved. I guess what I am asking is would that include, for example, if we are working on a report for the National Center for Health Statistics that we are not supposed to discuss that report with those individuals who would be involved in whatever the activity is?
MS. GREENBERG: I do not know that that was the intent but --
DR. NEWACHECK: I would assume it would not be, I guess, but if I were to read this --
MS. GREENBERG: Usually people who are knowledgeable on the subject have been involved in the discussions, I guess, with the committee already, although, Deborah, would you have any reaction to that?
MS. TRESS: We did not really discuss that. I do not think that was the intention, to limit discussion with appropriate Department --
DR. NEWACHECK: So, could we just add that as a, essentially excluding other, let’s say who is not a member or staff of the committee or subcommittee or other Federal Government employees?
DR. DETMER: Ed, do you want to comment, and then we will take your comment as well.
MR. SONDIK: Since the Department, I mean, the way I look at it, I guess, is since the document is provided by the Department, the policy concerning that particular document within the Department is something that would apply, and there are any number of situations in which there is a document within the Department that for a variety of reasons cannot be shared outside of a relatively small group. But I think it would be clear within the context of the document, who in the Department should be able to see it and work on it and comment on it.
DR. NEWACHECK: I guess my concern is that if I were to read this strictly it suggests that we cannot talk to anybody else about anything we are working on --
DR. DETMER: That is the way it reads right now and I guess the question is, is the language that you are suggesting opening it up too wide, or do we make it, or is it fine? I mean, I think that is really the question.
MS. GREENBERG: Let me just clarify, I mean, there is a difference in being able to talk to people about issues, and this does not refer to that at all. This refers to specifically sharing documents, but I still understand your question.
DR. DETMER: Does anyone want to comment to Paul’s suggested language? John?
MR. LUMPKIN: [Comment is off microphone.]
DR. DETMER: Well, just a moment and I will come to that.
MR. LUMPKIN: Well, I am a little bit concerned that that might be a little bit too wide because I have a brother-in-law who works in the Environmental Protection Agency and I want to give him a copy of the document. The real, and I think we just need to get back to the purpose, and the real purpose here is to assure that documents that are attributed to the committee actually are documents of the committee, and that an individual may write something that could be offensive. And through the committee process those comments would be filtered out. And we do not mind standing up for what we agree upon. It is just a matter of trying to get these rough, rough drafts into some format before they are released.
So, I think when we say staff of the committee that includes a good chunk of the Department, and I would assume if someone is to be involved in the discussion that they would be co-opted into being Departmental staff of the committee even if just for that issue.
DR. STARFIELD: That is my feeling, too, is that anyone in the Department you would want to discuss the document with already has the document.
MR. SONDIK: It should be clear in the context of the document who has it.
DR. STARFIELD: We are discussing committee documents, not Departmental documents. Right now we are discussing committee documents.
DR. DETMER: Well, I think if, in fact, you know, we have this discussion as part of our record, I guess if, in fact, I guess the question is, Paul, would you be comfortable with that or would you rather have some --
DR. NEWACHECK: Yes, I do not mean to be a stickler. I just want to make sure that I understand what we are talking about here, too, and that is fine if we all understand that staff is to be broadly interpreted, that is okay with me.
DR. DETMER: What did you say?
DR. LUMPKIN: I was thinking maybe where it says should be made .... staff or other relevant Department personnel.
DR. NEWACHECK: Sure, that would be fine.
DR. DETMER: Would you like to comment?
MS. SERKES: Yes, at the last meeting when you were discussing this --
DR. DETMER: Would you identify yourself, please?
MS. SERKES: I am Katherine Serkes for the Association of American Physicians and Surgeons. At the last meeting when you were discussing this, most of your discussion centered around your requirements under FOIA as opposed to FACA and just to remind you that this committee is, indeed, subject to FACA, which requires all working documents be made available to the public. And Ms. Greenberg, you said at that last meeting that we should, in considering what to be made public, we should look at what is of value to the public, not just make public everything and that does go, fly in the face of the law which requires that all documents be made public.
Now, we filed a FOIA request on July 14, 1998, asking that we be able to see all of the documents of this committee, and you say to your knowledge no request has ever been denied. Well, it is September, two months later. We have a letter from HHS and they did not provide us with those documents.
MS. GREENBERG: I am not familiar with the FOIA request and I would appreciate a copy of the correspondence.
MS. SERKES: I would be glad to give you a copy of this, but I do remind you that under the Federal Advisory Committee Act, all working documents are to be made public.
DR. DETMER: Ms. Tress, would you want to comment on that?
MS. TRESS: Yes, I think that is consistent with what we said initially with the opening paragraph, that subject to the Freedom of Information Act under FACA the documents are to be made available at the location of the committee or the agency, and that is consistent with what we have set out. I have no knowledge of that specific request and will certainly follow up on it.
DR. DETMER: So there is, it sounds like a misunderstanding, I guess, between what you thought you requested and what we thought was requested?
MS. GREENBERG: I was not even aware of this request. The request, could you tell us to whom the request was made and who the response came from?
MS. SERKES: Well, again, you are talking about all documents, all predecisional documents, and yet FACA requires working documents to be made public, and that would include predecisional documents. Now, and I do have a bit of experience with this through AAPS versus Hillary Clinton and having been through about a half million pages of documents that had to be produced as a result of this law. So, when you talk about predecisional documents, those are working documents which are subject to FACA, and yet again you are saying that predecisional documents are not to be made public, that you cannot discuss them with other than committee members.
MS. TRESS: I think, again, the law says, subject to the Freedom of Information Act, documents will be made available for inspection or copying at the location of the agency headquarters. That is different than individual members having documents and releasing them to whomever they want. So, I do not think there is anything inconsistent here.
MS. SERKES: The inconsistency is that we have asked more than two months ago to be able to see documents and have not been able to do so.
MS. TRESS: And that specific request we definitely will follow-up on.
DR. DETMER: And you are unaware of that request?
MS. GREENBERG: Completely.
SPEAKER: Is she referring to the July 14 letter?
MS. GREENBERG: No. Are you referring to something different than the letter that was sent in to the Department on July 14th concerning your concerns about the operations of the committee?
MS. SERKES: Concerns and also in that was a specific request for the committee to produce all documents.
MS. SCANLON: I do not think anybody read it that way but --
MS. GREENBERG: This is under Tab M. I do not think anyone who reviewed it, including legal counsel, saw in it a request for all documents.
MS. SERKES: All [unintelligible] and documents, predecisional documents, [unintelligible] should be open and made available for public inspection immediately.
MS. TRESS: Oh. Yes, I do not think we read that as a request for copies of all the documents be sent to you. If that is what is requested, we certainly can treat it as a FOIA. There was just a misunderstanding there. We thought it was a general statement on the operations of the committee. We apologize for any misunderstanding.
MR. SCANLON: These records, or these files are to be available, I guess, for inspection --
MS. GREENBERG: They currently are, right. There was no specific request under the Freedom of Information Act, however, to release any particular document.
MS. TRESS: Are you interested in inspection or do you actually want copies of all of the documents?
MS. SERKES: Copies.
DR. STARFIELD: I have a question about that just for clarification. Can anyone just require every single document for ever and ever, or does it have to be a specific document? According to the Act.
MS. SERKES: It is hard to request a specific document when you do not know what documents are available. And if they have not been released to the public, they are just sitting somewhere or someone has a working document that someone is hold close, it is hard to request [unintelligible] you know of. So just as a matter of logistics most FOIAs or many FOIA requests will be broader requests.
DR. STARFIELD: For ever and ever?
MS. TRESS: You can request all the documents in a particular file as of the time that the request is sent in. There is not a continuing obligation on the part of the Department to keep sending documents.
MS. GREENBERG: And, of course, this often, if literally a person wants to inspect all of the possible documents, all of the documents that are in the committee files, there might be a charge for Xeroxing because this would be quite voluminous, and that is allowed under the Freedom of Information Act.
MS. FYFFE: Let me understand something here. Do you say that you did not receive a response from the Department at all?
MS. SERKES: We received a response that says, it says we are essentially in compliance. You do not have a copy of the response.
MS. FYFFE: Yes, yes, we do.
MS. GREENBERG: The response is in your book.
MS. FYFFE: So you did receive a response from the Department?
MS. SERKES: Yes, we did. We request that if you on rare, specific instances where your requests to view or copy documents from the agency files were denied, we would like to know. Well, we saw this letter as being one of the instances where we were denied because we thought we made clear the request for documents.
PARTICIPANT: But it said specific requests so --
MS. SERKES: Okay, we will make a more specific request then.
MR. SCANLON: I think that though to some extent there is a confusion of what the Department’s responsibilities are to make documents available and committee behavior, what the committee, what rules they might want to adapt in terms of dealing with requests. In terms of FACA and FOIA I think you are saying that the committee, by making its documents available in committee files, is complying in every respect with, it has no departure from committee files. Whatever mode of behavior committee members may want to adopt in terms of the way they do business otherwise is somewhat a different issue. I mean, someone should request documents from the Department in most cases.
MS. TRESS: Right, and I think that better serves the purposes of FACA and FOIA because it provides fair and equal access to documents from the public, and that the public’s or the requestor’s rights under the law are protected by going through the channels to access the documents for inspection and copying at the Department, rather than relying on that you have a buddy on the committee, you know, who might share the documents with you. I think this is really a more fair way to deal with it.
PARTICIPANT: And is consistent with the law.
MS. FYFFE: I am going to be a bit pedantic here and read again what has been prepared for the committee because the folks in the audience do not have this paper in front of them. Basically it says here that FACA requires, among other things, subject to the Freedom of Information Act, records, reports, transcripts, minutes, appendices, working papers, drafts, studies, agenda or other documents which were made available to or prepared for, or by each advisory committee shall be made available for public inspection and copying at a single location in the offices of the advisory committee or the agency to which the advisory committee reports until the advisory committee ceases to exist.
So, in practical terms wouldn’t that mean that someone would write a letter to you all saying, I would like to make arrangements to come in and publicly inspect this and make a copy? I mean, is that the practical way you do it rather than suggesting that the committee go to all the trouble and possible time delay of going through and making a whole lot of copies?
MS. GREENBERG: I am not quite sure, you are right that a letter would be addressed to the Department which would then be referred to the Freedom of Information Act officer and that does not change. What is being proposed here is that in order to facilitate the discussion at a public meeting of documents, they would be made available at the public meeting.
MS. FYFFE: Okay, but the Act itself actually says public inspection and copying at a single location.
MS. GREENBERG: That is the requirement of the law.
MS. FYFFE: Okay.
DR. DETMER: John.
DR. LUMPKIN: I think part of our problem is that we are kind of on the cutting edge of technology and change. Meetings shall be open. They are not required to be broadcast on the Internet or CSPAN. There is a requirement that if someone wants to go to an open meeting that they have the access to that meeting. Many of the documents that our committee has dealt with are out on the Internet and Web, that is kind of broadcasting them to the world. There are other documents which would be in our files.
So, while it is true that a requestor may not know which files to request if they are requesting a copy, it does place the burden upon them then to come into the office and take a look and peruse the files and then the documents that they may want, have available for them. But I think the key component of this is that we do not want, nor do we believe our documents should be kept in secret, but there are certain documents that we want to make sure are available, and we do that through the web site.
MS. SERKES: May I just say one more thing --
MS. GREENBERG: Would you please go back to the --
MS. SERKES: The reason that prompted this letter was the discussion at the last meeting about your vote and your decision to keep all the documents around the patient identifiers, to not make those public in any way.
DR. DETMER: I do not think the committee ever said that. One person made that statement but it was not, in fact, ever a committee decision or, in fact, a committee opinion.
MS. SERKES: The motion was to make all working documents as well as predecisional documents surrounding the unique patient identifier public and that was voted down.
DR. LUMPKIN: Let me clarify that. I am sorry, the motion to referred to Departmental documents, not just committee documents. This committee does not have the right, or the authority, to release documents that are under the purview of the Secretary and her operation which would respond to any FOIA request. That is what this particular document says. There are two different kinds of documents. There are those documents that are shared with us and at the time at which they are shared with us we are special government employees and we respond to our boss, which is the Secretary, and she has rules under which documents are released.
There are committee documents, which is what the rest of this talks about, how those are made available, and I think we have to clearly separate those two issues. And so a motion to release all those documents at that time as a single motion was tabled for that particular reason.
MS. GREENBERG: The first motion, referring to Departmental documents, was defeated -- to make all Departmental documents available -- and the second motion, as you said, was tabled and the Executive subcommittee was asked to --
DR. DETMER: Charged to come back and that is what we are doing.
MS. SERKES: With the white paper on the issue and are you considering this today as the white paper? Okay.
DR. DETMER: Okay, further discussion?
DR. HARDING: Yesterday I received by fax a letter from Bob Gellman, who is on this committee, who asked if I would read a statement for him because he is in Spain at the meeting that John is at. After consultation with the Chair and Executive Secretary I would, with your permission, like to read from that letter and give it to Marjorie for her views. That’s okay?
This is a statement from Bob Gellman and I am doing it as a courtesy and I do not necessarily agree or disagree with his statement. And you know that Bob has strong feelings about this subject.
I am quoting now.
I am sorry that I cannot be at this meeting with the NCVHS. I am attending an annual conference of the International Data Protection Commissioners in Spain this week. Before I left I read the proposed new guidelines for dealing with the media and other external organizations that was circulated in advance of today’s meeting. The new guidelines are no better than the old ones. You may recall that I voted against the adoption of the old guidelines. The new guidelines are inconsistent with the requirements of the Federal Advisory Committee Act and with the requirements of the Freedom of Information Act. They continue the regime of secrecy under which this committee has sought to operate for the past two years. The new guidelines would continue to interfere with the ability of the committee members to effectively carry out their responsibilities. They perpetuate the attempted censorship of committee members. I have yet to see a single committee document that could not have been made public without harm to a legitimate public or private interest. The new guidelines, like the old ones, are a charade. The truth is that as a practical matter, all committee documents are available to friends, industry insiders and anyone else who wants to make an effort to obtain them. There is no real secrets in this committee and there is no need for secrecy. We should recognize both the law and the reality by affirmatively making our documents public. There is not a single document in the briefing book for this meeting that could not have been made public in advance. In fact, the Advisory Committee Act requires that all working papers and drafts be made public. If I were present today I would ask that the new guidelines be defeated and propose that the old guidelines be scraped in their entirety. If the committee does not affirmatively make all of its documents public, then decisions about disclosures should be left to the good judgement of individual members. If specific Department documents distributed to the committee members have a need for secrecy the documents should be accompanied by a formal opinion by the HHS General Counsel attesting that the documents are exempt from public disclosure under the Federal Advisory Committee Act and the Freedom of Information Act. That will serve as a signal to members about how the documents should be treated. Otherwise, we should operate in accordance with the presumption and current law that government documents are public unless there is a good reason otherwise.
End of statement from Mr. Bob Gellman who is a member of this committee. Thank you for allowing me to read that.
DR. DETMER: Comments?
MR. BLAIR: Would it be possible for us to get copies of that?
[Response in the affirmative.]
I just want to make sure that I heard correctly that Bob Gellman in his letter there did indicate that there are no documents that he has ever seen that he considered to be secret. Is that correct what he had in there?
DR. HARDING: I can only quote Bob because I did not talk to him about this. This came in a fax to me. It said, quote, I have yet to see a single committee document that could not have been made public without any harm to a legitimate public or private interest, end quote. His statement.
DR. DETMER: I think we have heard, actually, from our counsel that there is a difference of opinion, it sounds like, between Mr. Gellman’s -- who is an attorney -- reading of, in fact, these guidelines and your opinion. And this is one issue. I think there is another issue, as I heard him -- I am trying to hear three issues -- there are charges about how we have acted and I guess a question of how the committee feels about that; the issue of the legality of the prior guidelines and this current draft and then, of course, his own view that we would be better off not having anything, as I hear it, and would urge that we vote, I guess, is that pretty much the three points that you would take out of that or not?
DR. HARDING: I would assume so. I am not an attorney.
DR. LUMPKIN: I am sorry that Bob is not here because one of the points that he made, which I agree with, that there is nothing in this workbook that we have that could not be made public, but I read these guidelines as saying that anything that is going to be discussed at the committee in our workbooks should be made public. Unless there is some individual circumstance where there is a specific document that the committee chair may discuss with, as the procedure is described. So, I am a little bit confused by his statement because I thought we had dealt with that.
MR. SCANLON: I think Deborah, in fact, the obligation on the Department in terms of FACA would be to make any of these documents available largely, were they to request them. It is just consistent --
MS. TRESS: Yes, it is important to keep in mind sort of the two phases. One is the obligation under the law of the Department to make the documents available for inspection and copying. That stands regardless of guidelines of the committee, votes the committee takes, any policies of the committee. You know, the law is the law and it provides what we discussed previously.
The next phase, though, is what documents are affirmatively copied and made available at meetings, copied and disseminated, put up on the web site or otherwise made available, public and that, there is an area of latitude as far as the format and the timing and the extent of the dissemination. And that is where the committee and the Department work together to decide what is appropriate and feasible. But none of that changes the basic responsibility of the Department under the law.
DR. DETMER: Barbara?
DR. STARFIELD: It is a little difficult to discuss an issue when the person purposing the issue is not here, but I guess it really all has to do with how we conceive of our role as advisory committee members. We are free to discuss any issue that we wish, you know, to inform ourselves as to what our position should be. I do not think that requires distributing documents to other people.
And since people who are interested can always request the document anyway I do not, I just do not understand why in the performance of our roles that we would need to distribute documents.
DR. DETMER: I guess I heard, the more I think about it there is a fourth item in this letter that relates to the process by which government documents also would relate. That’s also an issue. He has a recommendation on how those documents should come to us as well.
DR. STARFIELD: Does anybody feel that in order to do our job we need to distribute documents to other people?
MR. SCANLON: Again, I think Bob may be confusing guidelines that members may adopt with the requirement on HHS to make this available. It is a policy of HHS and required by law that if anyone requests these documents, we probably would make them available. There are other government documents, and Deborah is more knowledgeable on this, but it is clearly understood in that light that committees will sometimes see predecisional and otherwise confidential information.
Think of the NIH peer review committees. It is not up to the members of those committees to release that information. If you are interested in obtaining them, you request, you make a freedom of information request or otherwise request that information from NIH.
But, I think we are confusing whatever member guidelines that the committee may want to adopt with the responsibilities of the Department. And I think the Department’s are consistent with FACA. If we are requested to make available documents, we would make them available. And, in fact, we put them up, many of them, affirmatively on web sites. Deborah, do you have any sense of the internal documents, how that policy works, predecisional and -- documents that might be made available to the committee?
MS. TRESS: Well, I mean, under FOIA there is an exemption for predecisional and draft documents. It is a discretionary invention that the Department can exercise and the policy of this Administration is towards openness and that documents will only be withheld under discretionary exemptions if there is some foreseeable harm in releasing them that the exemption was meant to protect. And only the agency or department freedom of information officer can make that determination.
I am not aware specifically, of specific advisory committees, how that process has worked, but that is the basic procedure as set out in the Department committee management policies.
DR. LUMPKIN: I would kind of like to walk through the process in response to Barbara’s question. There are times when I would like to share documents. If there is something on our agenda that I would want to get advice from our chief of data processing or our chief legal counsel or so forth, I would want to be able to share the documents. But it is the process of creating written words that convert them into a document. If we have something and I write it as a draft and I am going to show it to Simon because we are getting ready for a committee meeting. Simon says, you know, you are really barking up the wrong tree here. I would make the following changes.
Great. We make the changes. We put them on the committee agenda. At that point it should be available. That is what the guidelines say. But not, you know, I write a letter to Simon and Simon says he is going to show it to everybody to show how stupid John Lumpkin is. That is kind of not how the committee operates because it is not really a committee document, it is my document at that point.
So, what we are trying to do is develop a process in which something happens to this piece of paper and it becomes a committee document. And I think that is at the point where the committee says, okay, we are going to take this work product and discuss it. And our guidelines are saying, when we do that it is available. You can share it as committee members, talk about the agenda book with colleagues or friends or enemies, even. I think that is a very open process.
DR. DETMER: I think the question that the Executive committee -- and all of you need to weigh in on this because this is an Executive committee document brought to us to deliberate to see if it makes our life clearer or not. And if it don’t, we shouldn’t have it.
But I think what was being discussed, was when does a document, in a sense, become a committee document? And the sense was when a couple members or something are working on a draft or something, that has not even come to a subcommittee, let alone the full committee -- hasn’t even come to a subcommittee -- that in that stage, that stage of gestation, is not actually a document because, in fact, the committee or subcommittee has not even had a chance to see it. Now, that is the sense, I think, that actually we are trying to deal with.
The objective of this was to try to avoid inappropriate confusion, not embarrassment to the subcommittee about the language of the thing, if, in fact, something came out and people assumed it was a document of a subcommittee or the full committee before it, in fact, had even actually gone to such a group.
So, the goal in this was to try to, in fact, have more clarity so that when something did come forward you knew it was a working document and obviously at that point it was true. And I will repeat, to our knowledge we have not not acted that way, frankly, all along. So, in that sense we have been in compliance.
I guess the question is, does the perception of this process, you know, seeming like we are not seeking to share information, outweigh the benefits of trying to, in fact, to clarify our processes? I am not sure I am expressing this very well but I think that is the issue but maybe one of the other Executive committee members could clarify it better. Jeff?
MR. BLAIR: From my experience in, I guess, the year and a half that I have been on this committee, I have sensed that beyond our, everyone’s desire to comply with the FACA requirements, the FACA laws, it appears to me as if there is a spirit on this committee that openness is something that we all support.
I have not heard anyone, privately or in the committee meetings, feel uncomfortable with supporting openness. The thing that I might ask is that maybe we could sharpen our focus a little bit here on the administrative procedures for us to be open for example. With the modifications, Marjorie, that you just read to us, do you feel that it would be helpful or appropriate -- or maybe you already have these guidelines in place and I am just not aware of them -- where for those documents that are working documents -- I am hearing whispering so I do not know if --
MS. GREENBERG: I am not saying anything.
MR. BLAIR: Okay, I am sorry. I get distracted since I cannot see what is happening. Do you feel like it is appropriate for us to have a standard clause or phrase that we put on our working documents, our drafts and predecisional documents, something to the effect that would just simply state on every page, this is either a predecisional document, a draft or a working document and has not yet been approved by the NCVHS committee at large? Is that something that would be appropriate, or do you already have guidelines like that?
MS. GREENBERG: I think we do try to always mark everything draft that is draft, and that speaks for itself.
MR. BLAIR: And that is sufficient?
MS. GREENBERG: It has been in the past.
DR. DETMER: I think you raise a good question. I mean, it would help clarify this. Maybe we can work on -- I will talk with you about that and we will see because that might help clarify some of this. Barbara?
DR. STARFIELD: I guess I do not interpret Bob’s letter to be addressing people who request documents. I interpret it as the freedom of individual members to freely share documents, even to those who do not request it.
DR. DETMER: Well, I think he makes a number of points, but I hear, I think he is also saying what you are saying as well.
DR. STARFIELD: Which we do not address that here actually.
DR. LUMPKIN: I think we do address it. We say, once it gets on the agenda, then it is okay, mostly.
MS. GREENBERG: Anything that is being deliberated a public meeting should be made available at the meeting. That is different, I mean, these guidelines do not say anything that is being deliberated at a public meeting members are free to share with anyone they want. Now maybe that is what you want to do. Again, these are all, I think, in a discretionary area because what the law requires is that documents be available for inspection at the, with your official file.
DR. COHN: I have been largely silent on this discussion only because I am very much in favor of the draft proposal, and I think it makes a lot of sense. And if I were somebody who was in the audience today I think I would find this discussion a whole lot more interesting if I had a copy of the draft to reference. I might even be able to make a reasonable comment, which might be of help to the committee or subcommittee or work group at large. So I think it overall makes very good sense.
Obviously, I think Bob makes --
DR. IEZZONI: Simon, I think people in the audience do have a copy --
DR. COHN: Do they have copies of everything?
[Simultaneous comments.]
DR. COHN: Oh, I am sorry.
MS. GREENBERG: The policy has not be adopted by the committee yet.
DR. COHN: This would be the recommendation for everything.
[Simultaneous comments.]
Okay, but what I am saying is just for everything, but, anyway, the -- actually I do not think that is the normal process as I imagine -- what I hear from Bob’s letter is that really what he wants is that all the government documents, unless otherwise stated, should be made available to everyone. And I just do not think that we have the authority to do that. So I do not feel that I can support, you know, what he said either before or at this meeting in his absence.
DR. HARDING: It would require that, he said, if specific Department documents distributed to committee members have a need for secrecy, the documents should be accompanied by a formal opinion of the General Counsel attesting that the documents are exempt from public disclosure.
DR. COHN: Yes, well, I think it is a question of whether we are working with the assumption that things that we receive from HHS are private or whether they are public. I think that is really the basic question.
MS. GREENBERG: I just wonder if -- since this was a new proposal on Mr. Gellman’s part and we were not aware of it prior to this morning’s meeting -- whether, and you do not have to answer this, but, I mean, just as someone trying to think in terms of trying to function in this environment, I wondered, Deborah, if you could just comment whether you think it is practical to have all Departmental documents that staff might want, that staff might want to share with the committee members in their capacity as special government employees, to be reviewed by the HHS General Counsel as to the nature of the document, to get an official ruling on every document.
MS. TRESS: It is not the normal practice for documents to be accompanied by an opinion. In addition, it would only be an opinion of the General Counsel’s Office. The Freedom of Information officer is the one authorized to make the determination whether a document may be withheld. So I do not know if that would really be that useful or serve the purpose.
But, I think it is possible that documents should be, those particular, exceptional documents may need some more explicit header or something indicating their status.
DR. LUMPKIN: Well, I am concerned about that because it has a chilling effect. By and large what we are saying is that we have had a process here and this committee has been asked to play a role.
I am the liaison to one of the working groups that is looking at the unique identifiers and I get information from that working group. I do not believe I am getting information to make it public, but to be able to have some input from an additional person because I am a special governmental employee.
But I can tell you there are times when I have attempted to work with the Department as a director of public health on issues, including the fact that ASTO, our association, has requested a seat on the Data Council. And the response has been that that would make our internal deliberations external. These are not external deliberations.
We are functioning in a special capacity because we are employees. We get these little ID cards. And that is okay. Whether or not that information is released is not our choice. It is the Department’s choice and their interpretation.
So, we operate in two worlds and I think that is part of it. If you do not want the documents, if you are not willing to play by the rules then you should make it clear you do not want the documents. But, if you are going to play by the rules; today you are a special government employee, tomorrow you are an employee of the Illinois Department of Public Health or wherever else you work, then that needs to be made clear, if we want to play that role. But I think that there are documents which we do have control over, and I think those are the ones that we want to make a much looser provision on. We do not have to send anybody to the Department for that. Our committee can set up the guidelines -- basically if they are going to be on the committee agenda, they should be available for people to see.
DR. DETMER: Do others of you have reflections that, you know, struck yourself, as you saw them, including members of the Executive committee who have seen them in this form since we met. I mean, we put down what we thought the Executive committee, obviously, was saying, but are there other views, because I want to move on to the next tab. We will be coming back to this tomorrow to decide what we choose to do about it.
DR. HARDING: It would just seem that there is an issue of should things from the ground up be open and then with specific things held back or protected specially because of their sensitivity and so forth. Or, should things be held back unless released by the committee. Isn’t that kind of what we are talking about?
MS. GREENBERG: Well, we are talking about, when you say held back you are referring to by individual members or by the, official committee documents, because there is nothing in these guidelines that proposes that anything other than what the Federal Advisory Committee requires for official files be maintained.
DR. HARDING: I am not personalizing to any specific person but just the committee.
MS. GREENBERG: No, but there are two really different issues, what a member, it is being suggested what members might do individually and then what the official rules are for official documents in the official files and the right to inspect them.
DR. DETMER: Do you have more to say?
DR. HARDING: I will come back to it.
DR. DETMER: Okay. Jeff?
MR. BLAIR: I am struggling to understand what it is out of the letter that you read us that Bob Gellman wrote to us that he continues to feel uncomfortable with. The only thing that I can think of, and I am really asking for anyone else’s insight here, the modifications that Marjorie just read us to our rules, I think address all of Bob’s concerns with the sole exception of documents which we may be receiving from the Department of Health and Human Services that are not our documents, that are not committee documents. And I get the impression from the letter, Richard, that you just read to us from Bob Gellman that he feels as if those also need to be released, which, of course, most of us feel like they are not ours to release. Is that the only remaining issue that exists in that letter or is there something else in that letter that I just, you know, have been unable to understand is an open issue?
DR. HARDING: I again am reluctant to speak for Bob. He speaks so well for himself and enjoys that. So that my first answer to that is that he is honing in on the issue of committee actions as opposed to Departmental.
MR. BLAIR: Could you maybe help explain to me, to the best that you understand his letter, what it is in what Marjorie has proposed that still fails to meet Bob Gellman’s ideas of what we should be doing?
DR. HARDING: I think that he would say, as he does in the letter, that he would scrap all of the guidelines at this point and then make all of the documents public. And then decisions about disclosure should be left to the good judgement of the individual member. That is a quote from his letter. And then, if there is need for secrecy that should be determined by the General Counsel, because of the sensitivity of an individual issue. In other words, open the process except for those declared to be especially sensitive by the General Counsel.
DR. STARFIELD: I think one of the reasons we are having such difficulty is because there are twelve variables that fall into this box, four of them having to do with the properties of the document and three of them having to do with the properties of release.
The properties of the document are whether they are Department documents or committee documents, and I guess there even might be a third, consultant documents, and then within those there are predecisional ones and post decisional ones.
And then the properties of the release are by the Department on request, which is basically what we have been talking a lot about, and the other two are by the individual member on someone’s request and the third one is by the individual member on the individual’s request -- the individual wants to share them with somebody else, the committee member. And I do not think, I think our Executive committee document does a good job with some of those boxes but not with all of them, and I hear Bob’s letter as raising questions about some of the other boxes. But there are at least twelve boxes that we are dealing with.
MR. SCANLON: I think the other point maybe Bob is trying to make is that there is a symbolic aspect to all of this and that any sort of a, I think he understands that as committee documents, HHS would make available any committee documents upon request. I think he may view these self, the guideline for the individual members, if we were to adopt this, as symbolically appearing to restrict some of the documents. Maybe it is more of a symbolic issue.
I think it should be clear, and Deborah certainly made this, regardless of what the committee guidelines are, if someone requested most or everything that is in here today HHS is obliged to make available. So this really deals with how you as individual members may want to handle requests that you get, other than --
DR. STARFIELD: And then there is also what we want to share because we want to share it, not because somebody requested, which I think is a lot of what Bob is talking about.
MS. GREENBERG: Since words are important and people are quoting from past transcripts, et cetera, I think what you said is that is somebody requested everything would be made available. I would just add, subject to the Freedom of Information Act. That is what the law says.
MR. SCANLON: Well, as committee documents though, and again, I think Deborah is saying that virtually, as committee documents we would, we are more or less obliged to make them available. There is a case where if requested. There is another case where Departmental predecisional documents were made available which does have to be judged on a FOIA basis. I guess FOIA is always a factor.
MS. GREENBERG: Would you care to clarify that, Deborah, because I thought FOIA was a factor in either case, although there is more of a presumption of --
MS. TRESS: Yes, you are going to have minimal, in normal cases you are going to have a minimal basis for withholding a committee document when it has reached the document file, particularly once it has been discussed in the meetings and it has been included in the briefing books. I mean, there is no, presumably there would be no basis for withholding it except in the very exceptional case.
DR. DETMER: Let’s look at the next tab, too, because I think that is part of this thing and then we may have some additional comment and then we will decide, obviously ultimately, tomorrow what we want to do about this.
DR. HARDING: I do not have any further things from Bob on this.
[Laughter.]
MS. GREENBERG: Okay, this is Tab H, guidelines for meeting of the NCVHS full committee, subcommittees and work groups, and this is really, we shared this also yesterday at the staff orientation which, as Don said, we were really very pleased to have so many new staff for the committee and people who came down for the orientation. And, of course, we will be communicating with all of the staff, whether they were able to attend that meeting or not.
But, in any event this is particularly important, I think, for people who staff the committee but also for members of the committee to understand what the requirements are. First of all, the Federal Advisory Committee Act does require that an officer or employee of the Federal Government be designated -- actually this is the actual language -- to chair or attend each meeting of a federal advisory committee. The individual so designated is assigned specific responsibilities and referred to as the designated federal official in DHHS policy and procedures.
As Executive Secretary for the committee I am the officially designated federal official, but I have never made any attempt to chair a meeting in my experience. But, I guess that is my prerogative.
In that capacity I can name, and I do name, an individual from the staff of each subcommittee to act in my place as the DFO so that the, what we have done is the lead staff person for each subcommittee functions as the designated federal official for that subcommittee at my designation or request, with the caveat that I may override controversial decisions or actions if necessary. And Jim Scanlon, who serves as the HHS Executive Staff Director for the committee also can serve, obviously, as the DFO.
Now, the designated federal official or designate must approve each meeting in advance, approve the agenda, be present at each meeting -- this is why I was given the latitude to delegate this -- and adjourn the meeting when such adjournment is in the public interest. I do not think the latter ever happened in my experience but it is in the law that it is something the DFO can do.
An issue that came up last time is about a quorum and so this clarifies that according to the Act, to conduct a meeting a quorum of the authorized membership must be present. No meeting may be held without a quorum. The law itself does not define what a quorum is, so we have defined it for the full committee as a majority of the NCVHS members and for subcommittees as a majority of the official members of the respective subcommittee.
The official membership of each subcommittee is contained in the committee’s documents, such as under D which gives the full subcommittee list and who the official members are. And that is why we asked all of you to identify with a particular, at least one subcommittee or work group, which I believe all members but one have done at this point.
Members are expected to attend the meetings in full, and this is something now that the Executive subcommittee addressed at its meeting last November and has included in this document, and that is that all members, and this is basically a courtesy and also to know -- because we cannot convene a meeting without a quorum we do need to know who is going to be attending a meeting because if a meeting is scheduled and it turns out we do not have a quorum of the committee or subcommittee, then we are not able to convene the meeting. We would not want to bring people into town and find that out belatedly or ask people to testify, et cetera. So, all members are to notify the Chair of the given meeting, full committee, subcommittee or work group, in writing -- e-mail is acceptable -- if they are unable to attend all or part of the meeting, stating the reason for their non attendance.
It says all or part of a meeting because if a person is just there when the meeting is convened but then the committee is going to conduct deliberations of some type but then the members leave, then you would not have a quorum anymore. Non attendees will be listed in the minutes so it is clear that there was a quorum and who participated in the discussion and deliberations.
In the event of a pattern of non attendance the Chair will speak with the member about the strength of his or her commitment to the committee. I think that is self- evident of the need to make sure that all the members are able, for the most part to participate in the meetings that they have committed themselves to.
Meetings must be conducted in accordance with the approved agenda which, again, has to be approved by the designated federal official. So that although you are free to have any kind of meeting that you want with [unintelligible] John, it is not an official meeting if the agenda is not approved by the designated federal official.
Verbatim transcripts of the meetings should be made when necessary, although not required. And I think I just want to point out here that although they are not required we do make verbatim transcripts of essentially all of the meetings with the exception of some working sessions that are purely discussing subcommittee business and not deliberating documents of any type or receiving any testimony, and that we do make, put those transcripts up, although unedited because we have no capacity to fully edit transcripts, up on the web site almost as, as soon as the Department receives them. We get them between ten and twelve working days after the meeting. As soon as our web master can get them up on the web site those transcripts are put up there.
In addition, however, detailed minutes are kept by the DFO or designate or their agent for each meeting, and our agent, as you know, for the most part is Susan Canon(?) who refers to herself as our reporter, though she may want to now introduce herself as our agent, but in any event we have contracted with her to do most of our minutes and, as a result, I think, have very high quality minutes.
But minutes are required, as well as a transcript is optional, but minutes are required. There has been some question about this in the past as well. And this lists what must be included in the minutes.
I can say that minutes, and this is from attending the Federal Advisory Committee courses and talking to other people, not all minutes of all advisory committees are as detailed and extensive and complete as the minutes of this advisory committee are, but we have always made it a high priority, which is a significant cost, actually, to the Department, to provide full minutes that really are, would not require you to review the transcript unless you wanted to really go through all the detail of how you actually got to where you ended up. And, at least, that is my reading here, and what I have been told by others. But, in any event, we do, obviously, comply with the minutes requirements.
Meetings should be conducted under organized standard rules of order, et cetera. Minutes are to be completed and submitted to the committee and subcommittee work group within a reasonable time. The Chair certifies the accuracy of the minutes by his or her signature. That is what Don or the subcommittee chair does in signing the minutes after they have been sent out for comment and the comments have been incorporated.
The NCVHS Chair designates a chairperson for each subcommittee or work group, and that has been done. In the absence of a subcommittee chair an alternate may be designated by the existing subcommittee chair or by the NCVHS Chair, and I believe that is how we always operate.
Individual experts solicited to present statements to a subcommittee or work group are generally not compensated or reimbursed for expenses they incur as a result of such presentations. This question does come up so we wanted to clarify this here. Generally the Department does not have the budget to pay everybody who would want to come in and make testimony, and most people do not feel that they require that or request it.
However, if special circumstances suggest that the cost of reimbursement for expenses should be borne by the NCVHS, for example because there is no other way to get that kind of input to the committee except by bringing in certain individuals who are unable to support their own travel, then a request for an exception explaining the situation must be received from the subcommittee work group chair by the NCVHS’s Executive Secretary for consideration with the NCVHS Chair and Executive subcommittee at least four weeks in advance of the presentation. And this is the policy we have been following.
First of all, obviously the Executive Secretary has to determine whether the budget is available to even consider this request. If it is, then because it is a limited budget, obviously, the Chair needs to make a determination as to whether this is a request that should be honored given other priorities, et cetera. And we have usually been able to accommodate requests that have been made.
Now, I think most of this was all in the previous document but I am going through it just so that we are all clear about it. We have now added a few things based on questions that came up at the last meeting about e-mail and I think conference calls, et cetera so that it says, except as set out in paragraph 13 -- and I will get to that in a minute -- conference calls used for the committee’s deliberative process will be conducted consistent with the meeting requirements of the Federal Advisory Committee Act, including opportunity for public participation.
What Number 13 does is it quotes from the Federal Advisory Committee, the General Services Administration regulations implementing the Federal Advisory Committee Act as to what is a, constitutes a committee meeting that is covered by the Federal Advisory Committee Act. And it states that -- and I do not think we actually had this available at our last meeting and so we did some research and are providing this here -- that meetings of two or more advisory committee or subcommittee members, convened solely to gather information or conduct research for a chartered advisory committee, to analyze relevant issues or facts or to draft proposed position papers for deliberation by the advisory committee or a subcommittee of the advisory committee are not covered by the Federal Advisory Committee Act and do not have to comply with the notice and openness requirements.
So this, I think, also refers back to the previous document, but the documents that are covered are committee documents, and to be committee documents they do not necessarily cover ones that are just generated by individual members in their discussions among themselves with no deliberative process.
However, as, we just added this, in most cases even these working sessions will be open to the public and produce public transcripts. Because they are not official committee or subcommittee meetings they are not covered by the Federal Advisory Committee Act, they do not require all the requirements of opening the meeting, providing documents, et cetera, but we have always tended to have those as open meetings in any event as an attempt to bring in as much input as the committee could, and, in fact, not only do we have them as open meetings but we usually produce transcripts, and sometimes minutes, although they are not meetings that require that.
What we have said here is that for conference calls, just to clarify, that if a subcommittee wants to use a conference call as part of a deliberative process, that then they would bring to the full committee a decision of that subcommittee or work group, this is what the subcommittee recommends, this is what the subcommittee or work group wants voted on by the committee. And that generally is not the way conference calls are used, but if there was a desire to use a conference call in that capacity, then they obviously must be conducted consistent with the meeting requirements of the Federal Advisory Committee Act, including an opportunity for public participation.
And, we have a process that we can implement, if that is the case, where probably we would put a notice on the web site that this conference was going to be held, and a number to call in order to get the access code for the conference call. We are not really in a position practically, nor required, any more than we are required to hold these meetings in a coliseum, we are not required to have, make it feasible for anyone to just call in. That would be almost impossible to manage. But I have talked with other federal advisory committees and conference calls are really used a lot for deliberative processes because of the lack of budget or other availability of bringing people together, then this process is used and we are suggesting that we use it as well. And so we would have numbers available to those who called in and asked, and until those numbers had been used up we would be able to offer people the opportunity to participate.
Even then, you would obviously want to, as we do now, go through the process in presenting the document to the full committee of the deliberative process that took place. Now, again, except as set out in paragraph 13, which we have discussed, e-mail should not be used for committee deliberations. E-mail correspondence qualifies as a committee document for the purposes of record keeping.
As Deborah pointed out to us, and many of you probably know this as well from your own experience, is that it is really not the form in which the document appears, whether it is e-mail or formal memo or a letter, but what the substantive purpose of the document is. In order to facilitate, because we do use e-mail extensively, though not typically for deliberative processes, but in order to facilitate the process of having these available for inspection, if they were requested, we are proposing that we -- and the Executive subcommittee asked us to -- establish an official e-mail address that could be used by all members and staff to copy to that address all e-mail communication.
DR. DETMER: That is substantive, that is responding to a date for a meeting. We are talking about substantive.
MS. GREENBERG: Right, we are talking about substantive, although when in doubt you could use it in any event because the purpose of this would be for archival purposes and for inspection, if requested, rather than for really communicating with people. If you wanted me or Jim or anybody around this table or anybody who is participating in committee work to actually respond or know about something, you should include them specifically.
This would not be a file that would be monitored. Periodically it would have to be archived because our computer folks will not allow us to keep ten million e-mails on any given file, but that is all that would happen. It would be, periodically it would be archived but it would not be read routinely. But it would be a way to make sure that all of the e-mail correspondence also is kept in one place. It would make it much more practical than everyone trying to keep track of all their e-mails and, furthermore, most people are not allowed to keep that kind of volume on their computers.
So those are, I think, 11, 12, and 13, or 11 and 12, except as set out in paragraph 13 from the Federal Advisory Committee, implementation of the Federal Advisory Committee Act by the General Services Administration, are really what have been added to this document.
MS. FYFFE: I have been striving to understand what --
MR. BLAIR: Who is this?
MS. FYFFE: This is Kathleen Fyffe, sorry, Jeff. I have been striving to understand what might have been met by the term secret meetings, and I think that that was referred to in the letter from the Association of American Physicians and Surgeons.
MS. GREENBERG: We have no understanding of that either and that is why I think the Department’s letter requested a clarification.
MS. FYFFE: Okay. Well, paragraph 13 here says that meetings can be convened and are not necessary, do not necessarily have to comply with FACA.
MS. GREENBERG: Excuse me, would you repeat that?
MS. FYFFE: Okay. I guess, playing the devil’s advocate here, does paragraph 13 in some way imply that you can have secret meetings?
MS. GREENBERG: It is not a question of having secret meetings. They are not meetings, maybe you could explain this Deborah, but they are not actual meetings of a committee or a subcommittee. They are working sessions that meet this definition.
MS. FYFFE: Okay.
DR. DETMER: In other words, what we are saying is that if John had a draft that he was talking about with Simon that has not come yet to the committee, so, in a way, it is not a document yet.
MS. FYFFE: Okay. So, let me draw a distinction here. You have FACA and then you have the regulations that implement FACA. And the regulations that implement FACA are from the General Services Administration and those regulations say that these types of meetings or coordination between two or more advisory committee members are not covered by FACA and do not have to comply with notice and openness requirements. Is that correct?
MS. GREENBERG: Yes, that is correct.
MS. FYFFE: All right, thank you.
DR. DETMER: John?
DR. LUMPKIN: A couple things. First, I think we have to be real careful how we use paragraph 13, and I think the provision about open to public and produce public transcripts may actually lead to abuse of that. What I believe paragraph 13 is about is there was a suggestion by Jeff about changing the letter that we are going to present as the next item on the agenda. Simon and I are going to get together tonight to try to draft some language to bring back to the subcommittee. That technically would be a meeting, and so it becomes a paragraph 13 meeting. We are solely getting together to prepare a document for preparation.
There may be a work group overnight of three people who are getting together where we are saying, you know, we have worked on this thing in committee and we just cannot figure out how to get the wording. Let’s not word smith in the committee, let’s ask these three people to get together. There would not be a requirement for notice. You would not actually have a transcript. They are producing a document for the next day.
But I think under a lot of these laws what used to happen is, people would say, well, we’re not having a committee, just four of us are getting together. And so we have to really be very careful how we use that section because it should only be in those instances where a group gets together to meet in the library and to try to find some data, and that would really be the only thing. Everything else ought to be an open meeting that is announced ahead of time.
MS. FYFFE: Actually, you stated much better the point I wanted to make because these are not quote, secret meetings, okay?
DR. LUMPKIN: The second point I wanted to just clarify. In the second paragraph where it says the DFO has a caveat that may overrule controversial decisions or actions, that is by the delegated DFO, not by the subcommittee or committee?
MS. GREENBERG: Right.
DR. LUMPKIN: Okay, because that could mean this(?).
MS. GREENBERG: I think though -- and this may only muddy the water further -- but in relationship to what you are saying, if a committee is purely taking -- or a subcommittee -- purely taking testimony, and there is no deliberative process, that actually can fall under Number 13, but it is not the typical modus operandi.
DR. LUMPKIN: No, I would advise, I would certainly recommend that we not do that because then we are essentially holding a secret meeting because we are not telling people that we are going to take testimony and people may have relevant testimony and may want to come to the meeting, so even though it does say to do research or collect information, I think we should very narrowly interpret that.
MS. GREENBERG: The only thing I would point out is that you do need a quorum to convene a meeting and, as I said, even it is a meeting only to take testimony, whatever, we would still call for a quorum. If, in fact, the quorum unavoidably is lost during the meeting and you have another ten people on the agenda who come in to give testimony, you could continue to receive that testimony in the working session mode, even though there is not a quorum there, is my understanding.
One would want the ability to allow the people who had come in, and this has happened, I mean this has happened where we had members leave.
DR. LUMPKIN: Yes, I would be much more comfortable with saying in our guidelines that if during a hearing the quorum is lost, testimony can continue to be taken and a transcript be written, then to try to use this provision or to even add a separate provision. I am just very concerned that given that concerns have been raised, that we have an escape clause to have a meeting that is not really a meeting.
MS. GREENBERG: Are you arguing against Number 13 being here at all, or just the last sentence?
DR. STARFIELD: Number 13 really does not belong here because we have defined a meeting as something that has a quorum and 13 is without a quorum.
Number 2, to conduct a meeting a quorum must be present. Okay. Number 13 is without a quorum so it is not a meeting.
DR. DETMER: Ed.
MR. SONDIK: I think the point of, 13 is a very important paragraph but I am really concerned about the wording. I would wonder if, going back to looking at FACA and the GSA regulations, whether there is some wording in there that makes it clear as to exactly what the distinction is between a meeting of the committee and a, quote, working meeting. It is certainly not a quorum, so to speak. A quorum in this sense does not even apply, because it is not a meeting of the committee, okay? It may be a meeting of individuals who are on the committee and it could include everyone who is on the committee, for that matter, but my understanding is that that does not constitute a committee meeting because no business takes place there.
In other words there is no decision that the committee can make because the committee is not meeting. It may be drafting something, doing research, whatever, but I think it is very important to get exactly the right words that characterize that meeting because it goes back to the point about secrecy and whether this does constitute something that is secret. Any product from that would go, obviously, to the committee, in which case it would be government, if you will --
DR. DETMER: But I think that is very useful and I think we can add a phrase that would capture that.
MS. GREENBERG: This is the actual language, however, --
DR. DETMER: No, I understand, from them, but what the point is, it says what it is but it does not say what it is not. In other words, this is talking about doing it but it is saying, absent any decisions. The point is, no decisions are made at those meetings.
MS. FYFFE: Yes, really what we are talking about here are about discussions, talking between two members of the committee.
DR. DETMER: Where no decisions are made.
MS. FYFFE: It is not really a formal meeting, it is a discussion.
DR. DETMER: At any rate, I think we can --
DR. HARDING: Just a minor clarification, we have lots of work groups and subcommittees with an even number of people, six. A majority is?
MS. GREENBERG: Four.
DR. HARDING: All right, thank you. It will come up at some point.
MS. SERKES: Maybe this will help clarify. One of the, a good part of the intent of the Federal Advisory Committee Act is to prevent undue influence being exerted from outside groups, and if you have outside advisors, as yourselves, who are coming in as special government employees, that there is always a potential conflict of interest, and that the idea is to have things in the open and out in public so that if there is a conflict of interest it can be recognized, and that as far as the meetings, for example, FACA, the intent of FACA would be to prevent something such as several committee members meeting with an outside group, perhaps a vendor who would, indeed, have an agenda, a self-interest, in promoting a certain agenda. So, for several committee members to meet outside with a vendor would be against the spirit of what FACA was intended to do. So, as you discuss the meetings, that is the type of thing, not where you are sitting to work on a document or for you to sit tonight and work on your language. So, it does, the test is not just whether there are deliberations and a decision made, but the fact gathering, the information gathering is also of concern there. And just to clarify, the reference to secret meetings was because in the packet that was handed out at the last meeting I happened to find a reference to minutes of an Executive committee meeting and we could not find proper notification in the Federal Register on that one. And had I not gotten hold of one of your packets, I would not have known about that meeting.
MS. GREENBERG: We do announce Executive subcommittee meetings on the, even though they are technically working sessions, there are no deliberations made, but we do announce them in the Federal Register and I believe that one was in there, so it is our policy to announce Executive subcommittee meetings in the Federal Register.
DR. DETMER: Obviously, the committee, the full committee, got into this to try to clarify our deliberations and help give guidance to the members on an appropriate and faithful effort to try to meet both our duty, I think, to the broader interest of the public as well as the specific interest of the Department relative to our deliberations. It is tough, clearly, to do this and I think, Barbara, as you point out, it is almost Talmudic by the time you try to deal with every possible potentiality that one faces, and I do not know, I mean, I think that is part of what we need to do as we come back tomorrow. To what extent do these clarify our situation or, in fact, lead to another round or layer of the onion that may also bring tears as well as hopefully enlightenment.
But, at any rate I think it has been a good discussion. We will need to come back and engage this tomorrow. I think there are some ideas we need to follow-up on today to try to bring back. I particularly appreciate Deborah here and I think also particularly appreciate the time she has spent going back through our deliberations and actually concluding that to her review, we have been following procedures, and that these guidelines, as drafted, do also meet those, although it is obvious that not everyone on our committee agrees that that is, in fact, the case on the basis of how I heard Gellman’s letter.
Any other questions? We do need to adjourn fairly soon today because we have, obviously, lunch and then our other meetings, but I do not want to stop, if there is another clear point that needs to be made before we do that. We will be rejoining this tomorrow. Paul.
DR. NEWACHECK: Just one point. I think maybe one of the problems, and this may be why the document was not well received by Bob, is that as I read both of these items they are mainly a list of dos and don’ts for committee members, but there is no sort of overall statement of philosophy of the committee about issues of openness, and perhaps some kind of paragraph at the beginning that would be a preamble that says the committee believes strongly in the openness of its meetings, deliberations, etc., consistent with FACA, would be helpful to at least provide a framework for interpreting all the dos and the don’ts that follow that. It would not have to be long but it would just be a philosophical statement.
DR. DETMER: Good idea, useful. Okay, any other comments.
MS. SERKES: When will this be on the agenda tomorrow?
DR. DETMER: It is scheduled to be, but sometimes agendas move around, but I would encourage you to be here tomorrow, if you want to make sure of that. Right now it is scheduled for 2:30 p.m., but, as I say, we take items as they move so it could be earlier, but it is right now scheduled for 2:30 p.m.
John, I guess you wanted to do something for a minutes or two here before we broke for lunch?
DR. LUMPKIN: Yes, these are draft letters that were prepared by the subcommittee on Standards and Security in reference to the NPRM 0049-P, that was released by the Department. We are actually going to adopt these tomorrow, so we could probably just pass them out and let people look at them and tell you that there is going to be a slight change based upon the committee meeting in the letter that starts out, To Whom It May Concern, and then we will adopt these tomorrow.
I do not know if you would like to ask if there are any concerns about the security NPRM that perhaps our committee needs to deal with by other members of the committee. We did have some discussion and the only issue that we wanted to address was to emphasize, to add in the letter that this is an issue that will be readdressed after the initial rule has been implemented because it was less specific and not as detailed as other standards.
DR. DETMER: Any comments from anyone else today on this? I guess, if so bring them to John so that he will have the benefit of that.
Okay, we will adjourn for lunch and then have subcommittee meetings and working groups this afternoon. Lisa?
DR. IEZZONI: Don, why don’t we have our subcommittees start at 1:15 p.m. just to give people a little bit more time.
DR. DETMER: Where are the various ones meeting?
MR. SCANLON: The Privacy and Confidentiality working session will be here at 1:15, as Lisa said. The subcommittee on Populations will be in Room 440D. This is on the fourth floor near my offices.
DR. IEZONNI: Oh, no, is this the room that is hard to find?
MR. SCANLON: We will have --
DR. IEZONNI: Yes, leave bread crumbs.
MR. SCANLON: And CPR will be back in this room at 3:45 p.m.
[Whereupon the full committee meeting was adjourned for lunch at 12:30 p.m. to reconvene in subcommittees and working groups that same day, September 15, 1998.]