[This Transcript is Unedited]
Hubert H. Humphrey Building
Room 405A
200 Independence Avenue, SW
Washington, DC
Call to Order, Introductions - Ms. Frawley
Development of Work Plan for 2001
MS. FRAWLEY: We need to started, primarily because the first hour we have to tackle the kind of major project. And then at nine o'clock we do have someone coming to talk with us. And that is Cindy Pellegrini, who is the legislative director for Rep. Louise Slaughter of New York, who has for a number of years, been attempting to get federal legislation passed on the whole issue of genetic discrimination, and has also been a very ardent supporter of the new comprehensive privacy legislation.
MR. BLAIR: Normally, I think of those as a tug of war, where the genetic legislation would be separate from comprehensive legislation. Has she got a way to marry them or something?
MS. FRAWLEY: Well, we'll talk about that. That's the purpose of the discussion. And certainly, in terms of some of the issues with the Human Genome Project, and also, I briefly talked to Cindy in terms of her perspective in terms of the HHS regulations, in terms of the NPRM, kind of their perspective in terms of whether they were comprehensive enough to address some of their concerns on the issue of genetic testing and so forth. So that will be our second hour.
But our first hour is some transitional planning for the subcommittee. So I do want to try to address some of those issues this morning, so that we can at least leave here today with a plan for the future.
The first thing we should do is obviously -- Vickie is new to our group, but just to make sure, we go around and introduce ourselves. And also there are people in the audience. Let's make sure they are introduced. Jeff, why don't we start with you?
[Introductions were made.]
MS. FRAWLEY: We have a tough road ahead of us just because of time constraints. So what I would like to do is just lay out some of the discussion that took place at the Executive Committee meeting on Monday afternoon, talk a little bit about what we need to do this morning as a subcommittee, then obviously we will be turning to our formal part of the agenda, which will be a roundtable with Cynthia Pellegrini on the issue of genetic discrimination, and looking at that issue, and seeing what, if anything, the subcommittee could be doing in that particular area.
The first issue that we need to address, and it's going to seem odd to those coming in new to the group is there was some discussion at our retreat in August when all of the subcommittee chairs and Executive Committee got together, was whether was a need for a formal Subcommittee on Privacy and Confidentiality.
Having worked in the area many years, you know that we spent a lot of time our first two years as a subcommittee, providing advice to the secretary prior to her issuing her report to Congress on her particular recommendations for legislation. And obviously, since Congress failed to act, the department has been working on drafting privacy regulations, which this subcommittee did provide comments to the department on that particular notice of proposed rulemaking.
So over the past year, we have kind of been in a limbo situation, where we have been waiting obviously for the department to release the final rule. And secondarily, there have been some concerns about the fact, and it was really highlighted by our Medicaid managed care report that came out of the Subcommittee on Populations, was the fact that since we have a formal committee, there is no cross-fertilization with other subcommittees.
And though some of us sit on other subcommittees, the problem that we have is that reports are generated by various subcommittees, they come to the full committee. And at that time we raise the privacy flag and say, hey, wait a second, we haven't had an adequate discussion of the privacy issues on this particular data set. Or we haven't had an adequate discussion on some other issues.
We did spend our June meeting, at the request of the Subcommittee on Populations, talking about ICIDH, and whether we had any concerns in terms of that particular classification in terms of appearance, disabilities, and handicaps, because Lisa Iezzoni will be preparing a report to come forward to the full committee.
So we did have some discussion at the August retreat as to whether there was a need for a formal subcommittee, or whether we should have privacy monitors, and whether the expertise of this group should be diffused in other ways. John Lumpkin reminded me on Monday that the subcommittee had never come back with a formal recommendation on that as to whether or not we felt there was a need for a subcommittee. So he did ask me this morning, that we spend a few minutes talking about that.
The second thing is that the full committee for 2001 will be taking as its major theme, the issue of eliminating disparities in the health of the population. And John has asked each of the subcommittee chairs to make sure that their work plan and their agenda incorporates that theme into the work of the subcommittee.
So the Subcommittee on Populations, the Subcommittee on Standards and Security, and this subcommittee have been asked to incorporate that into the work plan. One of the things that came up in our discussion on Monday was that when we went around the room, everyone had a very different interpretation of what disparities were. And obviously it immediately jumped to race and ethnicity, but there are other disparities. So you could start making a list.
So John did ask the Subcommittee on Populations to attempt to come up with a working definition; when we say eliminating disparities in the population's health, what are we talking about? So that we kind of are all on the same page in terms of that particular issue.
And then the other thing that obviously came out of our discussion on Monday afternoon was what our game plan will be in terms of once the regulations are released, what would be the plan, either if there is a subcommittee, to move forward in that area, or what the full committee should be doing. So that is some of the discussion that took place on Monday afternoon.
As you know, I will be leaving the committee today, and Richard has agreed in the interim, to take over the leadership of the subcommittee. One of the things that I wanted to make sure that we did, and we had discussed this at our meeting in September, was try and develop a work plan that was very focused. Like we just didn't have the list that we do, which is a laundry list of topics that are everybody was throwing out that they were interested in.
And be much more focused in terms of a topic, what the particular objective is. And then the format, which could be a briefing, which could be a hearing, which could be a roundtable discussion, which could be a commissioned paper. And try and make sure that whatever we put on our piece of paper, is tied back to the subcommittee's charge, which is in your briefing book under Tab 2.
This really all has to kind of flow together. I mean, that's kind of what we need to do for the first part of the meeting, and then we obviously switch gears. But what I want to do is throw open first the question that John has raised, so I can report back today, whether -- and people have been working very hard for a number of years at this subcommittee -- whether the members believe there is a continuing need for a formal Subcommittee on Privacy and Confidentiality?
DR. COHN: I'm also a member of the Executive Subcommittee, so I had the opportunity to listen to the discussion in August. Unfortunately, I was at a funeral for the first part of the Executive Subcommittee on Monday. This is actually an issue that I think you had brought up about getting rid of the subcommittee. I actually spoke against it. I couldn't think of why we would want to get rid of it.
I guess my own view is I realize there is some frustration that goes on, that we haven't had ongoing major input into the final regulations for privacy, but it seems to me, at least based on work around standards and security, once the privacy regulation comes on, if we choose to be involved in it, which I think is something we need to decide on, and then that's more than a full-time activity. That involving living in Washington, and you wouldn't have to have any other job, period.
So really, to me the big issue is not should we do it, but more how do we mobilize, and what is our role in the privacy final regulation. Now a year from now and if indeed we look back and discover we have no role in the privacy final regulation in any way, then I think it becomes arguable about whether we get rid of it. But it just seems like an odd set of timings. That's one person's view.
MS. FYFFE: A question, can you clarify for me what some people think the role of this group should have been in developing the privacy rules? I'm really confused by that.
MS. FRAWLEY: Well, there was the opportunity on some of the other notices of proposed rulemaking for the subcommittee and members of the committee to be involved in the process within the department. I served as the liaison to the Security Work Group, and I participated in their conference calls, and attended a number of their meetings at NIST, and had drafts of the NPRM as it was drafted in progress, and participated.
You may not have been appointed to the committee at that time, Kathleen, but a number of us were named as liaisons to the particular working groups in the department. There was a structure in terms of who was handling transactions of code sets, who was handling security. There were different people within the department responsible for different areas.
With privacy, our work the first year was to hold obviously a significant number of hearings to hear from a huge cross-section, and obtain information and do data gathering. And then of course there was a fair amount of time spent by Bob Gellman and subcommittee staff and subcommittee members in drafting our report, which went to the full committee in June 1997, and went to the secretary in August 1997, which then became the basis of her recommendations to the Congress.
Then when it became obvious that Congress was not going to pass legislation, the department set up a working group. We had made overtures to Gary Claxton(?), who headed up that initiative within the department, to offer the expertise of the subcommittee to provide input into that process. And that did not happen, even though we had suggested that there were ways we close sessions of the subcommittee, because of some confidentiality concerns, to provide input.
What has happened, is it's happened in informal ways. Several of us sitting around the table have been contacted by the HHS staff, and asked to provide input and guidance through that process. But the subcommittee was not formally involved in that process. So I think that there was some concern that the process kind of moved forward without any input from the subcommittee. We, of course, took the opportunity like everyone else last spring, to provide our comments to the NPRM.
MS. FYFFE: That raises some questions in my mind, and I don't know if this is a legal question. Jim is not here, but is it the role of federal advisory committee people to actually help with the writing of proposed rules?
MS. FRAWLEY: Well, it wasn't so much the writing of the proposed rules, as much as providing advice.
MS. FYFFE: Okay, so it sounds like we're sort of in a gray area where if the HHS folks or the HCFA folks want our advice, they will take it, but if they don't, they won't.
DR. COHN: Another interpretation would be that they have already received our advice, and pages of it. They used it as a basis for some of the pieces.
MS. FRAWLEY: So that has been a concern that we discussed at our retreat last August, that there wasn't the level of engagement that some of the other subcommittees had with staff on particular projects. So talking to Jim last night, some of it was politics, and we certainly can understand that.
MS. FYFFE: Well, politics and the nature of the personalities involved perhaps.
MS. FRAWLEY: But we were just asked to make sure that we spent some time this morning talking about whether there is a continuing need for the subcommittee. And the reason why we raise that is because the discussion came up somewhat fueled by the Subcommittee on Population, which feels very disenfranchised from the entire committee as to whether there really should be a subcommittee structure.
Whether all of the subcommittees should go away, and maybe there should be a different format. And we talked a little bit on Monday that maybe there should be work groups that have a specific charge, do a project, and then go away. That there are not just ad infinitum kind of thing. So it was looking at the overall structure of the committee.
If you remember when Don Detmer took over as chair, it was a whole restructuring of the subcommittee process. The subcommittees that existed went away, and new subcommittees were formed. And it just was the natural time after four years, to question is this the right structure to move things forward, or is there a better way to accomplish some of the things that need to be done in this area?
Mark, you wanted to say something?
MR. ROTHSTEIN: I have a question. This subcommittee, I take it, it predated HIPAA?
MS. FRAWLEY: No.
MR. ROTHSTEIN: It was established specifically for the purpose of providing input to HIPAA?
MS. FRAWLEY: Yes. There was an individual who was considered the privacy monitor, one individual.
MS. FYFFE: From the National Committee?
MS. FRAWLEY: Yes.
MS. FYFFE: Who was that?
MS. FRAWLEY: It was psychiatrist from the University of Maryland, Jim Thompson. And his term ended about the time the first class was appointed in July 1996. So the Subcommittee on Privacy and Confidentiality was formed in September 1996. And Bob Gellman was appointed the chair, and we drafted a charge for the subcommittee, which is in your book. But there was no formal subcommittee prior to September 1996.
DR. MAYS: I think my question may be getting answered, but this a very helpful discussion. Is this subcommittee's role really just to deal with this particular piece of legislation? Or is it that the subcommittee is to be concerned in general about privacy issues as they relate to research and health care?
MS. FRAWLEY: Yes.
DR. MAYS: The latter?
MS. FRAWLEY: Correct. It's not just HIPAA. There are a number of issues, and I think that's one of the things that we have been struggling with, is that while certainly a lot of this subcommittee's work has been driven by HIPAA, there are a number of other issues that we need to be concerned about. And so that's kind of where the tensions are in terms of how do you adequately address a number of issues.
DR. MAYS: Because if it's that, it would seem that the group has a definite relationship to the other groups. And that it is a matter of trying to figure out either every time something goes through, whether there is a privacy issue, and it comes here as kind of like before you are finished, send it to us, or it's the other way around. And I would think the committee is probably too small for people to have to then also go sit at another meeting.
But if it's broader, then at least from the little bit that I know, then it seems like the committee has a definite life, because these issues I think are getting paramount, rather than diminishing in terms of their importance.
DR. HARDING: I think Vickie said just about what I was going to say, that privacy issues are going to do nothing but increase. But I think there is some element here of asking for marching orders from the department. Because we serve at the discretion of various people, and then we give advice to the secretary. We kind of would like to hear a little bit about what the secretary would like to have advice about, because if it's not something that matters to that individual, whoever that will be, we're going to spend a lot of time spinning our wheels.
That's a little bit of the frustration that maybe we felt before, that we gave information, but at some point it was stopped. And then things continued on by themselves in a freewheeling way. But a little bit of marching orders I think is something that we would benefit from.
I think overall the committee should continue. I think the things that are listed here at the bottom are things that we brought up in the past, the smart cards and the unique identifiers. As John was saying yesterday, the issues will increase.
DR. COHN: What Richard was saying about the desire for marching orders, on the one hand I agree, but anybody who can give marching orders is going to be out of office in 7-8 weeks. I just merely reflect that probably Gary Claxton would be somebody to ask for marching orders. But I believe that he's a political appointee, and so we're going to be in a position where we are really not going to getting very good marching orders, unless John wants to come over the table and give us some marching orders.
But I did just want to reflect on -- and I wasn't going to forget these discussions we had around the table, around the side at the last NCVHS meeting when we were looking through the HIPAA legislation, which by the way is where NCVHS is rechartered in it. So you should look at those couple of pages in just reference, because that's really where the Privacy and Confidentiality Subcommittee came out of, not HIPAA; not HIPAA in the sense of the HIPAA regulations, but HIPAA as NCVHS being rechartered.
I interpret it, and I think John agreed after he relooked at the legislation, we have the same rule regarding privacy final regulations, as the standards and security group has in relationship to the other HIPAA financial and administrative regulations, which is to follow along and become part of a yearly report to Congress on implementation.
As I would interpret it for security and standards, looking at issues that the industry -- and obviously, for privacy this is a very large industry -- the industry is having in relationship to implementation, identifying ways to mitigate those issues. And at least as I interpreted the legislation, it seemed that we really do have a relatively full set of activities on our plate for that.
DR. HARDING: Is this a monitoring role?
DR. COHN: I mean it's monitoring, and it's the part that has to do with the yearly report to Congress on the implementation.
MS. FRAWLEY: We have to advise. So one of the things that this subcommittee will have to do at some point is that once those privacy regulations are published, and the industry has had enough time to absorb those regulations, it would probably be very appropriate for the subcommittee to hold a hearing to receive input from the industry on those regulations, and highlight probably -- at least some of my discussions with the HHS staff has led to some concerns about how you operationalize some of these requirements.
That there are a lot of regulations and responsibilities contained within the regulations. There are a lot of specific requirements placed on individuals who handle health information. But the bigger question is if you are a physician sitting in an office out somewhere, or you are a hospital, or you are a payer, how do you operationalize and handle some of these things?
And one of the questions that came up yesterday kind of indirectly during the discussion was the whole issue of how will you be able to do population-based health research if the current criteria in the NPRM, which is to strip the 19 data elements from the information, how are you going to be able to do population-based health research? Which obviously this committee has a strong tradition of supporting. So there are issues there.
Certainly, it's a big issue. Certainly there is an issue of the privacy regulations. Secondarily, there are other issues coming forward. We heard yesterday the discussion in terms of the vital records system, where people are accessing death certificate data, and publishing articles that are somewhat controversial in terms of the findings.
The whole question comes up that some states have very, very strict statutes in terms of protecting the confidentiality of the vital statistics data. And in other states they are considered open records, and therefore, one is free to have access to that information. So here the question was raised whether there was some role that the subcommittee could play in kind of addressing that issue, and of course that can go on to the laundry list of things.
The feeling that I'm hearing from everyone here this morning is that we would like to go back to John and recommend that the subcommittee continue forward. I don't get the sense that anyone is saying we need to roll up our tent and go away.
MR. BLAIR: Just for an additional confirmation on your observation, just look at how many people around the table here feel like this is an important issue, and will spend their time to be here this morning.
MS. FRAWLEY: We have been very diligent at eight o'clock in the morning. We always ask Simon to give up the two o'clock slot.
Yes, Mark?
MR. ROTHSTEIN: I just wanted to say that if John wants to reorganize the entire subcommittee structure and replace it with working groups or something like that, that's one issue. But to have the privacy committee go away under the theory that there is duplication I think would be a terrible mistake, because one of the problems of privacy in general is that it is an afterthought. You do everything else, and then, oh, I'll have somebody take a look and see if there are privacy problems. And that's where the structural arrive, because privacy is an afterthought and not a forethought.
Regarding the issue of the relationship between the committee and the department, I think we obviously need to be responsive to the requests for advice from the department. But my interpretation of the Federal Advisory Committee Act is that it's supposed to be two way. And that we are supposed to be a conduit to bottom-up input into the department, as other departments, as well as sort of top-down fishing for advice.
And I think within limited parameters, we have not only the right, but the obligation to develop our own research agenda. And even if it doesn't exactly line up with the preconceived agenda of the department, I think the department will give the deference and the consideration to our work that it deserves. And if we come up with any issues that are important and future thinking, and we do good work and raise legitimate issues, then I'm confident that the department would be appreciative of our doing that.
MS. FRAWLEY: I agree with that. And I just want to make sure everybody is clear that there is no intent per se to eliminate the subcommittee. The issue that came up was how we could better utilize the expertise of the subcommittee members. That we could obviously provide assistance to the Subcommittee on Populations, so we don't have a situation that occurred last year, where we held up publication of a report to be able to go back and look at the privacy issues.
And that when the Subcommittee on Standards and Security, or the Subcommittee is Population is starting a new work initiative, that privacy is identified up front, and is focused on, as opposed to work coming out of the subcommittee to the full committee, and then we're all raising the flag, saying, wait a second. You should have thought about this, this, and this. And I think that frustrate lies is how do you utilize the expertise of the committee.
MR. ROTHSTEIN: I think that's not our problem, that's their problem, not to point fingers at other subcommittees. I think they need to anticipate that, and get us involved, or work on those issues themselves. And it's not the problem that we are off in a corner somewhere.
MS. FRAWLEY: Okay. Kathleen?
MS. FYFFE: Let me just throw out a few incomplete thoughts, just food for thought for everyone here. The issue of privacy of health information is a subset of issues related to privacy on all kinds of information. And that has been reflected in the fact that there has been legislation introduced for Internet privacy and other things. So we are not just talking about HHS. We are talking about financial agencies, the Department of Commerce; it gets quite big.
And there is a scope issue here. I think the subcommittee is important, but frankly there might be a need for a federal advisory committee on the whole issue of privacy. And whether that would need to advise simply the HHS secretary or other secretaries, I don't know or Congress. I just don't know, but in order for us to be effective, we have to be concerned about scope.
Otherwise, it could become a recruiting challenge. That people are not going to want to serve on the committee or be able to serve on the committee, because the work just becomes too expansive. So from a management point of view, I think we are going to have to be careful.
I had one other question. Is there somewhere -- and maybe I was just dreaming this -- that there was going to be a committee -- not a committee, but a new division or department within HHS or somewhere that was strictly going to deal with privacy issues? Not just John Fanning, but a whole kind of staff of people, or am I dreaming that?
MR. FANNING: For you it may be a dream. For me, it's a hope. I think there is no thought of it in the form you just described. However, there will have to be an implementation apparatus for the HIPAA regulations.
MS. FYFFE: Okay.
MR. FANNING: They will no doubt develop expertise and so on. But they will have the mission of implementing the HIPAA confidentiality regulation. But that's a fairly specific task. It can't go on in isolation. But it is pursuant to a fairly distinct mandate and so on, as distinguished from the broader thing you are talking about.
MS. FYFFE: Anyway, those are just some incomplete thoughts, food for thought for everyone, because this thing is really much broader than just health. It keeps overlapping and bumping up with the Internet and a number of other issues that are going on right now.
MR. FANNING: I think that is no argument against addressing it specifically here. It's an argument for looking at it broadly, and indeed, this committee held a hearing or workshop where people did come and talk about privacy on health Internet sites, for example. And I think there will be more of that.
MS. FYFFE: Just let me say one other thing, and then I'll stop. On Monday, December 4, there are comments due to the financial agencies on the Fair Credit Reporting Act. And in the preamble to the proposed regulations they talk about something called medical information. Well, how is that defined? How do you define that in the Gramm-Leach-Bliley financial services activities? And then you've got HIPAA.
So you continuously have all of these overlapping pieces of legislation and federal regulations that are coming out, and it is just a real challenge not only to keep track of everything, but to try to get advice from federal advisory committees that may or may not exist in this area.
MS. HORLICK: I think Joy Prince is going to address some of that today in her presentation.
MS. FRAWLEY: Okay, so we have our first answer that we can report on, that we agree that there is a continuing need for the subcommittee, and that obviously that the subcommittee does need to address a number of issues other than just HIPAA-related issues in terms of our work plan.
My recommendation to the subcommittee would be to probably go back and look at the specific charge. And those of you that were on the subcommittee in September 1996, when we formed, we drafted that charge and brought it forward to the full committee for approval. It probably would merit some -- it's four years now, and it probably would be worthwhile perhaps at the February meeting to revisit that charge, and perhaps make recommendations to the full committee on the revised charge.
So I just think that at the time we started the subcommittee, we knew our timelines were very much directed by the HIPAA legislation. And we had X amount of time to get our recommendations together. We started in September 1996, and we had to have a report done by June 1997. And then obviously had it to the department, so that the secretary in turn could make her recommendations to Congress.So I think so much of our early activity was driven by that, that I think it may merit revisiting the charge.
MR. BLAIR: Mary Jo received or distributed an e-mail, and I don't remember the name of the organization -- this was a few months ago. This particular organization was forming because it was very concerned about health care identifiers being a potential threat to the privacy of individuals with respect to their health records.
And we read it, those of us on NHII. And one of the things that was clear is that they never challenged the fact that electronic health records could provide greater efficiency and effectiveness. It appeared to me that this was an opportunity for us to reach out and have them testify to us about their concerns, because that there actually may be a good deal of common ground.
And rather than have some of those advocacy groups view us as not in sympathy or in support, even if we can't be 100 percent in support of exactly everything that they advocate, but that we share a great deal of their concerns, and I believe Mary Jo has scheduled them to testify to the NHII group in January. And my thought is that maybe that's too narrow a focus.
MS. FRAWLEY: Well, one of the problems that I'll bring out is that we did hold hearings in July 1998. They were joint hearings between the Standards and Security Subcommittee and the Subcommittee on Privacy and Confidentiality. So John Lumpkin and I co-chaired those hearings in Chicago. As you remember, Congress then passed as part of an appropriate bill, language precluding the department from moving forward on adopting a unique health identifier for individuals until privacy legislation was enacted.
And one of the discussions that came up as part of that decision in October 1998, which was then incorporated into appropriation bills in 1999, and I don't know what will happen in 2000, is the fact that that also was interpreted to mean departmental funds. Because we had asked whether we could continue to have hearings in this area, to continue to move that forward, and the guidance that we got from the department was that we should not move forward on that particular issue until obviously after we had privacy legislation or regulations in place.
So I think it's a little premature to jump into that issue again, because we were directed not to continue that work effort. So I think that certainly will be important at some point, where obviously the Standards and Security Subcommittee will have to go back at some point, and make some recommendations.
MR. BLAIR: In light of what you just said, we did discuss in NHII, and we thought that because it was respect to a concept and vision and critique and concerns of listening to folks, that this was separate from the idea of getting hearings to establish an identifier. That this was separate. However, it might be a good idea for us to revisit that John Locket(?) just to make sure.
MS. FRAWLEY: It's higher than John Locket. The Commerce has directed the department. We can't just decide as a federal advisory committee within the department that we are going to go do something where the department has been directed by the Congress not to make any recommendation regarding a standard for unique health identifiers.
MR. BLAIR: This was the intent of having them testify to them.
MS. FRAWLEY: Jeff, we have a very limited time schedule. I think that's nice that Mary Jo is doing that. I would question whether that's appropriate.
MR. BLAIR: That's what I'm saying, is that we need to revisit this in light of what you just said, because people will make connections that weren't intended.
MS. FRAWLEY: Vickie, I think you wanted to make a comment?
DR. MAYS: I guess when you had commented earlier about revisiting the charge, that was something I was going to suggest. But I guess I'm concerned, and it may be that again, I don't have enough information, but I think it kind of gets to what Kathleen is saying. As we talk, I keep hearing more things being spun off.
And that is, this group could really handle a huge amount of work to some extent. So the issue of well, what are the priorities? So it may be that the group really does need to do some revisiting, and it needs to revisit in the sense of does it have a priority? Is it going to stay directly in line with those things which are legislative, that are coming down to us? Are there other things that from the activities that we all engage in, that we know should be on the table, but they aren't on the table? So it seems like the scope of work for this group could be huge. That's number one.
Number two, the mechanism for the up and down, as you talked about, needs a little bit of clarity in the sense of are there things that we want to send up, and are there things that are coming down to this group? And how do we keep tracking all these things? The group probably does need some re-engineering in terms of structure, but I think the group probably will be -- it's like, do I want to stay on this group? I'm not sure where --
MS. FYFFE: Hit me with a wet noodle for scaring you. I didn't mean to.
DR. MAYS: No, but once I saw the list, I was like oh, I could probably generate ten other things. So I guess the question really is what is the priority, whether there not there is a charge that you have been given, not that you have generated, but that you have been given, and that has to be your first priority? Which may be why, for instance, populations feels disenfranchised, because they don't see themselves in the charge. Or if it's the group determining the charge, along with what the priorities are for the department.
MS. FRAWLEY: John?
MR. FANNING: I was just going to comment on Jeff's point, which I think was not simply about hearing people's views on an identifier, but about insuring a dialogue between people who are especially concerned about this, and those -- and this includes everyone here -- who do use a lot of information, and wants to continue using it.
There is widespread misunderstanding and confusion and so on, so the more that can be done to insure dialogue and understanding, the better, although it is a difficult task.
MR. BLAIR: And we do have to be sensitive to it, yes. So it's a balance, and I think that we should talk about it some more and make sure that we're not overstepping the bounds.
MR. FANNING: Certainly, we don't have a universal health identifier, and we're not going to have one, but information is being exchanged, with all the issues that that raises.
DR. FITZMAURICE: At the beginning we started talking about nobody pays attention to us, there is anything to do. From the time that we receive public comments, to the time that the final regulation comes out, we can't take new ideas and put them into the regulation. And so as a department, you can't go out saying give us new ideas for the regulation, although fact finding is always welcome at any time.
I think a year from now you are going to be wanting to climb up on the table thinking is a swamp, and all of the privacy issues are alligators. You are one of the main focal points for the private sector to get information to the secretary about the implementation issues of HIPAA privacy. And those implementation issues are not just HIPAA privacy, but what do researchers do, what do practitioners do, what does the private sector do?
Other concerns, not just for the secretary, although that is where your direction is. Congress is going to have to be considering federal privacy laws. Number one, learned advice on these issues, and that is you. You have to set priorities to decide what you want to take on, keep your ear to the secretary, keep your ear to the department. No new secretary wants to be dodging a cannon that is rolling around on the deck that is not strapped down.
But there are going to be so many issues, that you will have your choice. You will have your choice of hearings. You can schedule as many days for hearings as your time will permit. What you are doing is vital. It's necessary, one of the main avenues to making changes in privacy.
MS. FRAWLEY: What I would like to do -- Cindy Pellegrini, who is going to be part of our roundtable discussion, has arrived. What I would like to do is just spend a few minutes just on the work plan, because we have agreed that: (a) there needs to be a subcommittee; (b) we agreed that the charge needs to be revisited. And I think obviously Gail and Richard and continuing members of the subcommittee can kind of work on that.
DR. HARDING: Maybe we can do in the meantime, before the next meeting, by e-mail and conference call.
MS. FRAWLEY: Right. And then the third thing that we wanted to do is you remember that this committee has never run out of ideas for meetings. We have walked out of every meeting with more topics than we know what to do. Then Gail has struggled with how do put a hearing together, who do we call for witnesses, what's the intended objective?
Because the other question is, well, that was really nice, but what was the purpose of that particular work effort? And what I gave you, which I just made up on the fly, because I just felt an obligation in terms of transition not to walk away today, and kind of leave things just hanging without kind of a plan to move forward, because I know that that would be very helpful to Gail and to Richard.
So what I cast out to you was a one page document which has topic, objective, and format. And what I have on the bottom, which is from our work plan. And for those of you, you might want to remember under Tab 10, each of the subcommittee have their particular plan in the back of the briefing book. And it lays out the different topics, and what each of the subcommittees did in terms of hearings that we had, briefings we had, what letters we sent to the department, what we did on particular issues.
The future issues at the bottom are from our current work plan. So I did not make these up. These are reflected in the minutes of past subcommittee meetings, and are things that are sitting there. But on our current work plan, these are the topics that people kind of blue skied, and say, oh, this would be interesting to address. But we never tied it back to the charge, and really to a more formal what's the objective, and what's the format of the work initiative.
With smart cards, we've had some briefings at the full committee meeting, but we have never really done anything at the subcommittee level. We know we have a continuing obligation under HIPAA with the privacy regulations. We still have the whole issue of unique identifier for individuals sitting out there. We have had discussion about some of the activities that are now ongoing at the state level, linking health information.
We have privacy issues. If you remember, we did have Nancy and Minda Pearl(?) come to the full committee, because of the concerns with the OASIS data set. And if you remember HCFA retracted the initial implementation of OASIS, because there were some concerns about some of the data elements that were being captured. And Nancy did come to the full committee to brief us on what HCFA was doing internally, not only on OASIS, but on some privacy issues. So there was a discussion as to whether we needed to pursue that with some of the other departments.
I know from one of the websites that I subscribe to, there was recently an article out about some of the things that are going on within the Department of Veterans Affairs, raising some privacy concerns. So again, another topic out there.
The whole issue of identifiability, LaTanya Sweeney came to this subcommittee a couple of years ago, and showed us how she was able to take information, using voter registration records, and to be able to link back and identify individuals who had entered the health care delivery system in Massachusetts.
And then of course we have had some work ongoing, employer access to health information. One of the concerns that we had is we've really haven't adequately addressed some of the issues in terms of from the employee perspective, occupational health, employee assistance programs.
And then of course e-health, we did have one hearing on some of the Internet companies that are out there, who are collecting health information.
So those are topics sitting on the current work plan. We have two things we absolutely as a subcommittee have to move forward on, so you could fill in the first two topics. The first one is the privacy regulations. And the second is John's request to all of the subcommittees on the issue of eliminating disparities in the population's health.
In terms of the privacy regulations, I mean our objective there will be really to focus, once those regulations are published, on specific implementation issues. And to be able to give advice to the department based on what I would assume would be a format of hearings to receive information from the industry on specific issues and concerned with those particular regulations.
The problem that we have here is that it's anyone's guess when the regulations are going to be published. So it would be probably premature to even think that the subcommittee could do something at the February meeting.
MS. FYFFE: We really got mixed messages yesterday. Is John here?
MR. FANNING: Yes, soon they are coming out. But that's not really relevant to this. If they came out tomorrow, you still couldn't do anything at the February meeting. They don't go into effect in terms of actual implementation for over two years. So examining its impact is not an immediate task, I don't think.
MS. FRAWLEY: Well, I guess the main thing is we know that we need to address it, because it is part of our charge. And I don't think that part of our charge would be revised. And we know we need to look at what the impact is, and examine some of the issues, and make some recommendations to the secretary. And probably hearings would be the appropriate format.
But it appears based on some informal discussions that Gail and I have had that this would be something probably more suited to a June time frame, and certainly not sooner. So I just want to put that out, so we kind of have like a little bit of a plan in place in terms of that.
The issue of eliminating disparities in the population's health, that obviously has to be directed to some degree by the Subcommittee on Populations, who have been asked to come up with a working definition of disparities for the full committee. But that is John's overarching theme for the full committee for 2001. And so obviously there could be some discussion at the February meeting in terms of maybe how that could be addressed.
Yes, Kathleen?
MS. FYFFE: I'm not on the Executive Committee, but was there any sort of vote taken on why the overarching theme should be the elimination of the disparities?
DR. COHN: I don't remember that being affirmed by the full committee at the meeting yesterday, was it? I think it's a good idea for us to look at.
MS. FYFFE: I think it's important, but it's not the only theme that we should be concerned about in 2001.
MS. FRAWLEY: Well, I understand that, but I'm just letting you know what we were asked.
MR. BLAIR: I think that all of the things that you have laid out in terms of developing a plan, and developing a work plan need to be done. But I think that Michael Fitzmaurice's observation is very correct. And the thing that I have heard Michael say is that we are heading into an environment where privacy issues are going to emerge either from the standpoint of legislation, from the standpoint of -- and Kathleen, you mentioned other legislative bills heading up.
The technology is where we have to deal with Internet consumer health records, and the privacy abuses there. And we had to move very quickly, and we did to begin to work on those issues.
There may be issues that come up as people have concerns. What I'm getting at here is I think that there is going to be a lot of issues that will pop up that will be urgent. And then in addition to the work plan, we need to think about something, and I don't want to call it crisis management, because we may not be in a crisis. We're an advisory body.
But in order to for us to really be out front and respond quickly to issues as they come up, so that we are not marginalized by not being able to respond quickly, I think we have to also consider how do we keep on top of these new privacy concerns, and as a subcommittee, be able to reprioritize our list quickly, and respond quickly? I think that's the environment we are heading it this next year. So that's in addition to the work plan.
MS. FRAWLEY: And I think we have had a tradition of having to do that over the past few years, where we have had to respond very quickly to unanticipated issues that have been raised within the department or by the committee. And we certainly did yeoman's work in January and February, all by e-mail, with only two conference calls to put our response together for the department.
I lived in Kinkos in Southwest Florida for a long time, but we were able to do it. We had a process in place, and we were able to, once we knew the ball was in play, what to do, and how to pull everybody's comments together, and it worked quite well. So I think there are certainly ways for the subcommittee to work outside of the formal process, which is the meetings.
The other thing I just want to comment on, Jeff, is that there are only so many days that members can commit to activities. And having sat through the Subcommittee on Standards and Security yesterday, and looking at your work plan over the next 18 months, and knowing the amount of time that you are already planning, you've got dates set up in January, February. You are talking about your March, April, and May dates.
It's a very, very aggressive time line. And a number of the individuals who sit on that subcommittee, sit on this subcommittee. And there is only so much time people can devote to activities.
DR. COHN: Kathleen, I actually agree. I actually think we are not going to be able to come to a resolution on these issues, including the work plan today. I guess I'm wondering, sort of looking at our new -- are you the chair, or are you the acting chair?
DR. HARDING: Interim.
DR. COHN: Interim chair. And I know Gail has been a great support on all of this stuff. I see a lot of this as a mosaic. I guess that's the way the Subcommittee on Standards and Security is sort of seeing the issues, and weave them in at the hearings.
MS. FRAWLEY: It's a three dimensional mosaic.
DR. COHN: It's a three dimensional mosaic, but I think we need to do some e-mail work to look at the issues, to try to figure out how to weave -- I think Jeff brought up absolutely the critical issue here, which is that there is going to be all this stuff happening that we're not going to have a whole lot of control about. If we are going to be players, we need to have the capacity, and not be so rigidly scheduled.
We obviously have issues that we want to move on about. I agree with you, Vickie, we need sit down and prioritize these things, and figure out really what's on the list. But I actually didn't want to speak for the committee. Maybe we should do this by e-mail and come to a conclusion.
MS. FRAWLEY: The only problem with that is, and I will say that is that when we say that, it never happens. And then poor Gail is left holding the bag. At which point she and I start exchanging e-mails and phone calls. So unfortunately, we all have good intentions in terms of we'll send you ideas.
DR. COHN: That's actually not what I'm saying. I'm sorry. What I was saying is that I think the leadership, which as I see it is Richard and Gail, need to posit some things by e-mail, to get feedback on, so it isn't an e-mail of, what do you think? And then I think that it's possible for the subcommittee to give a response. So that was really what I was thinking, because I have not been very satisfied either with some of the e-mails, with just open-ended questions to them. So I guess sort of looking at the two to see if they were willing to do that.
DR. HARDING: We could do that. I think also the use of conference calls. A one hour conference call can get a lot done if there is preparation before. It doesn't have to be just waiting until February to get back together, as opposed to coming to Washington. We're going to minimize that. So the conference calls for an hour, I think can be very effective.
MS. FRAWLEY: Well, so, for the purposes of our meeting this morning, just to bring closure to this discussion, we will be reporting back out that there was unanimous agreement on the continuing of the subcommittee. That the subcommittee will review and revise the current charter, or charge to the subcommittee based on some of our discussions that we have had today.
Obviously, we will, as the time is appropriate, move forward on privacy regulations, on examining the impact of those regulations on the industry, and hearing input from the industry. And that the tentative format for that would be hearings, time to be determined in terms of that.
And obviously, the other issue which we have as a subcommittee is the theme of eliminating disparities in the population's health. And obviously, that will require some coordination with Dan Friedman, who has agreed to serve as acting chair of the Subcommittee on Populations, since Lisa is resigning her position on the committee. And I think that obviously all of our other current issues are there. Certainly, there are others that we can think about adding to the table.
What I would like to do is we never got a chance to introduce Paul Schwartz, who is our newest member. So, Paul, what we did this morning before you were able to join us was just kind of give a brief background of who you are, kind of your interests. So Vickie is new also to the committee. So everyone else has kind of been sitting around the table for a while.
MR. SCHWARTZ: I'm Paul Schwartz. I teach law at Brooklyn Law School. My interest in this area has been longstanding. I have advised the European Union on aspects of their data collection directive. And as part of that process I co-authored a study American privacy law, which was published in 1996. And I have looked closely and published on the specific topic of health care information and health care privacy. I'm also very interested as well in Internet privacy issues.
MS. FRAWLEY: Paul and I had the pleasure of serving on the National Academy of Sciences study for record, which was an interesting experience, to go around having site visits, to look at the adequacy of security for health care information systems. That was a rather startling experience.
But welcome, Paul. We're happy to have you.
What I would like to do now is turn over to the next part of our agenda. We are very fortunate this morning to have the opportunity to have a dialogue. And this is labeled as a roundtable discussion. So the idea is obviously that this is a freewheeling discussion, and may generate some future activity for the subcommittee in terms of its work plan.
But I invited Cynthia Pellegrini to join us this morning. I had the pleasure of working with Cindy for a number of years while I was at AHIMA, often going up on the Hill, feeling like the lone voice in the wilderness, trying to get people to understand the importance of privacy and confidentiality.
I was very pleased to meet Cindy in Rep. Louis Slaughter's office. She is from the state of New York. Rep. Slaughter represents a district in upstate New York. But just by way of background, Cindy is the legislative director for Rep. Louis Slaughter, and she has worked in various positions on Capitol Hill since 1993.
In her current position, Cindy is responsible for developing and implementing strategies to advance the congresswoman's legislative agenda, and overseeing the legislative staff. She also advises the congresswoman on issues including: health care, women's health, Medicare, Medicaid, and women's issues.
Prior to joining Slaughter's staff in June 1996, Cindy worked as a legislative assistant to Rep. Gerald Kleczka, who is from Wisconsin, on issues such as welfare and labor, education, banking, judiciary, agriculture, and consumer affairs. And she previously worked for Rep. Jay Inslee from Washington State, on environmental, agricultural, and human services matters.
She holds a bachelor's degree in public science from the College of Holy Cross, and obviously is very involved in a number of professional and community organizations.
It's a pleasure to have Cindy here, because Rep. Slaughter has been trying for I don't know how many years now, Cindy, is it five? All I know is that I've kind of been out of the picture of a year. I called Cindy and said, I have moved to New Jersey. I'm not with AHIMA anymore. I know you are still like doing the good fight. And I thought it would be helpful to have Cindy come this morning and two fold.
I don't know how many of you saw the October issue of Health Care Informatics, but Robert Fuller, who is the incoming president of AHIMA, works at NIH as a senior policy advisory, particularly as it relates to the Human Genome Project. And as you know, there has been an announcement that the Human Genome Project will be finished sooner than anticipated. And one of the concerns that we have, and certainly has been raised in a number of foras is kind of the whole issue of what is genetic information? And where should be this information be captured and stored? And then what protections, if any are necessary?
And so Rep. Slaughter has been spending a lot of time on this particular issue. There have been a number of states that have kind of taken the ball and moved forward and enacted legislation. I know Joy Pritz(?) from the Health Policy Project, who will be briefing the full committee this morning at 10:45 a.m., will talk a little bit about some of those issues.
But we wanted to have Cindy come and kind of give us her perspective in terms of what's been going on for the last five years in this arena. Kind of where things are going. And possibly, this could lay out some groundwork for the subcommittee in terms of some future work.
So, Cindy, I will kind of let you give the subcommittee a briefing kind of on what you have been doing, and then we can kind of turn it open for discussion.
MS. PELLEGRINI: Great. Thank you, Kathleen.
I am going to give some very brief remarks here at the beginning, because I want to leave lots of time for the discussion of those aspects of this issue that are most important and most useful to this group in particular. I know that this is a highly educated group in health care and information issues, so I'm going to skip all those parts of the speech that I usually give to groups like what is a gene, and why is there discrimination, and why is it a bad thing? I hope we can start from the baseline that genetic discrimination is not a good thing, and move onward from there.
Maybe the most important question starting out is why should this group care about genetic discrimination? This is a Subcommittee on Privacy and Confidentiality. Discrimination issues are really just outside your specific mandate, however, I hope to convince you that this is extremely relevant and important to what you are working on for a couple of different reasons.
Genetic discrimination has one very interesting link first of all to medical records privacy, which is HIPAA. What this committee is looking at right now, the medical records privacy debate, is being driven largely by HIPAA. By the overlooked provision that was put in at the last minute in 1996 saying Congress, if you haven't passed medical records privacy in two years, the secretary is empowered to promulgate regulations.
That same law included another last minute provision in the portability section dealing with genetic information, where it say insurers, you cannot discriminate based on all of these different pre-existing conditions, pregnancy, et cetera, et cetera. And again, at least minute negotiations, genetic information was added as one of the pre-existing conditions on the basis of which an insurer could not discriminate. This now is the only federal law that discusses or handles genetic information and genetic discrimination in any way, shape, or form.
I'm also going to assume that most of you are very familiar with HIPAA, and the fact that it has numerous loopholes. So that those people with genetic information in their possession, be it predictive information for conditions they haven't manifested yet, or simply either diagnosis information, or information confirming the condition that they already that it has a genetic basis, the protections for these people under HIPAA are still very thin.
There are many, many ways that HIPAA will not cover these folks, or that insurers can manipulate them so that they don't have to offer coverage, or certainly offer affordable coverage to those populations.
The new regulations that are expected to come out soon are not going to address genetic discrimination in any way. That is unfortunate, but understandable, given that there was no instruction in HIPAA that the secretary had any power to promulgate regulations on genetic discrimination. So if the secretary tried, it would clearly be stricken down by a court.
MR. BLAIR: When you say the new regulations, you are referring to the privacy regulations for HIPAA that we are expecting shortly?
MS. PELLEGRINI: Yes. I'm now going to present you with one of the key arguments as to why genetic discrimination is important to this group, and important to all the other organizations out there that are interested in medical records privacy in all of its various forms.
In Rep. Slaughter's view, privacy and nondiscrimination, especially as it regards genetics, are two sides of the same coin. That neither of those things can be truly effective without the other. If we do not have nondiscrimination laws, particularly genetic nondiscrimination laws, privacy becomes an empty promise.
Because we are saying to people, we are going to protect your information, we are going to give you all of these wonderful confidentiality measures, et cetera, et cetera, but if they are violated willfully or not, if they are ignored, there won't be any consequences. You will have no redress. Your information will float around out there. You will never be able to pull it back into the private domain, and there will be nothing that anyone can do about it.
Similarly, if you have nondiscrimination laws without privacy, nondiscrimination ends up being a case where many, many people may be discriminated against, but be unable to prove it, because yes, their information is floating around out there, but if they are subject to discrimination by an employer or an insurer, those entities can simply come forward and say, well, we didn't discriminate based on this information. It was this other reason over here. Or it was a reason that we're not even going to disclose to you at all, but trust us, it wasn't the health information, even though we have that in our possession.
And you have people trying to go to court and prove something that is essentially unprovable. Unless an individual has a memo from their insurer saying, let's not offer so and so coverage, because they have this gene, it is going to be almost impossible in a court of law to prove discrimination.
So again, in Rep. Slaughter's view, privacy and nondiscrimination are two sides of the same coin, and they must both be in place in order for either one to be truly effective. For this reason, we have seen many prominent individuals in the genetics community calling for nondiscrimination laws in the last year or two. Some of these individuals you may have already heard from here, but they include the Human Genome Project Director, Francis Collins, Solaris CEO Craig Venter.
And most recently in the secretary's Advisory Committee on Genetic Testing actually put in its report something to the effect that its entire debate on genetic testing is going to be academic if there are not nondiscrimination laws passed, because people won't take advantage of genetic tests at all if they think the results of those tests can be used to undermine their best interests.
As Kathleen mentioned, Rep. Slaughter has been working on this issue for a very, very long time. In fact, as I said next week, December 7, five years ago she introduced her first bill too ban genetic discrimination in health insurance. She has since expanded that effort over the last year and a half, with her colleague, Sen. Daschle, Minority Leader in the Senate. They have introduced legislation together that would ban discrimination in health insurance and employment.
These bills have -- well, the first one, the older one, advanced just discrimination in health insurance, has 221 co-sponsors at present, which is more than a majority of the House of Representatives. Each of the bills has well over 100 endorsements from various organizations. The second bill that bans employment, as well as insurance discrimination has been endorsed by the Genetic Alliance, which some of you may be familiar with. It has over 200 member organizations that represent various conditions that are genetic.
Rep. Slaughter has sponsored briefings on Capitol Hill for her colleagues and for staff. She has testified on hearings related to other issues such as genetic testing, or medical or privacy. She has met repeatedly with her colleagues. She has circulated letters. She has sponsored letters on this issue to the members of Congress working on managed care reform, on medical records and privacy legislation.
This has been her marque issue now for five years, and yet to date, the House of Representatives has never -- no committee or subcommittee of the House of Representatives has ever held a hearing on genetic discrimination, much less taken up legislation on this issue. Rep. Slaughter tried to offer her bill as an amendment to managed care reform when it came through the House a year and a half ago, and was denied the opportunity to do so by the leadership.
Again, she has worked this issue into related or tangentially related matters as frequently as she can possibly figure out how to do so. Yet the House of Representatives has failed to take action. In June, she went so far as to take the tentative arcane step of filing a discharge petition on her bill, which is a parliamentary maneuver designed to eject a bill from the committee of jurisdiction against the wishes of the leadership, and bring it to the floor of the House of Representatives for a vote.
Unfortunately, a discharge position requires 218 signatures to take effect, which means that you need to attract members of the majority to your effort. Right now the discharge petition has almost 200 signatures. Virtually every single Democrat has signed on to it, but so far no members of the majority have been willing to deliver the insult that their leadership that it would be and sign on.
The Senate has been more progressive than the House in this respect. There have been hearings in the Senate on both genetic discrimination in health insurance, and in employment. Neither of them have actually resulted in a law yet, but what did happen was this July, Sen. Daschle offered the Slaughter-Daschle bill as an amendment to the Health and Human Services appropriations bill, the annual funding bill for this department.
That amendment was defeated in favor of a weaker version of the same proposal sponsored by Sen. Jeffords. The Daschle amendment was defeated in favor of this weaker Jeffords proposal. And then when the bill went to the Conference Committee, even that weak proposal was stripped out of it completely.
And so as we look at the 107th Congress, we are back at square one more or less, where Rep. Slaughter will have to reintroduce her bill, gather co-sponsors again, starting with number one, gather endorsements again, starting with number one, and begin pressuring the majority leadership again to start by at least holding hearings on this issue in the 107th Congress.
And right now there are a couple of factors that cloud the outlook for us. The first is that we do not know who the chairman of the Commerce Committee is going to be. In the House, this is the committee of jurisdiction. Normally, this is not such an open question. There is the seniority system, but there are two members with virtually equal seniority, who have both declared that they are going to fight over the chairmanship. So we are going to have to wait and see who wins that fight before we can start working on that new chairman to hold hearings.
There is some hope that with the lines as close as they are, the margins as close as they are going to be in the House of Representatives, that Rep. Slaughter may be able to frame genetics as one of the things this Congress can do, one of the health issues where we can come together and find a consensus and move ahead.
The one item that could stand in the way of that is the question of penalties and enforcement of genetic discrimination laws, because if for instance we give individuals a private right of action, the right to sue for violations of the law, then that will have spill over implications for the patient's bill of rights debate, where the majority will be looking at the possibility of saying, well, we'll give people a right to sue for genetic discrimination, but not for all of these other items under the patient's bill of rights. So that will be one of the key hurdles that we'll have to overcome in trying to move this forward.
I'm going to stop there, so that we can again, talk about the things that are most important and most useful to you.
MS. FRAWLEY: One thing I just wanted to mention to start it off, if you remember when we drafted our report to the secretary in June 1997, one of the things that the subcommittee and the full committee recommended to the secretary, that in addition to comprehensive federal privacy legislation, we also needed anti-discrimination legislation in this country that whatever scope was crafted either by the Congress or the department, that it would still not address this other somewhat troublesome area.
And now things are even moving on a quicker timeline, just because of this Human Genome Project, and the implications that that raises for society. So I think that some of your comments throw out some very important issues for this subcommittee.
DR. COHN: Cynthia, thank you. I'm a little naive in some of these areas. And I want to say I'm a physician. I'm certainly not a privacy fundamentalist. On the other hand, after being on this subcommittee for four years, I now buy Preparation-H with my own money, and don't use the Safeway Club Card, so I have learned something sitting here.
Having said that, actually in one of my hats I am involved with my organization, which is Kaiser Permanente, in the whole area of Medicare risk. And seeing HCFA begin to pay health plans on the basis of the risk of the populations, and the risks of the individuals. And one observes that anti-discrimination laws are great rites of action. You know what's going on.
You know when you're being discriminated against. It's great to be able to go to court and do something. On the other hand, that probably 1 percent of the real discrimination that occurs.
And when you look at how things work in the health insurance industry, you sort of realize that what the health insurance industry is interested in is not losing money. So obviously what they want to do is be paid for the risk that they are insuring. Now as I say this, this isn't solving the entire problem, but I'm wondering, is there some place that we might get to, or something more sort of changing how we view insurance, and put in more of a risk element based on diagnosis burden, as opposed just doing the outright banning of any sort of discrimination? Is that a piece of this pie?
MS. PELLEGRINI: There are opponents of Rep. Slaughter's efforts who have said what you are really trying to do indirectly is establish ultimately a single payer system. You want to ban medical underwriting. You want to ban all kinds of underwriting, and just say all comers get the same rates period. I can assure you that is absolutely not what Rep. Slaughter is trying to do.
There are a couple of different elements here. The first thing I just want to note quickly is thank goodness Medicare is one area where we never have to worry about this issue, because Medicare takes all comers. It entitles them. But it's Rep. Slaughter's view that all of us are ultimately uninsurable. The more that we learn about our genes, everyone has enough genetic flaws that we're anywhere from 5-30 or 5-50 depending who you are listening to, genetic flaws that predispose you to major, severe illnesses at some point in your lifetime.
And so really what we are doing right now by allowing discrimination to happen is punishing the people with the bad luck to have the genes we have discovered first. So Rep. Slaughter's view is not that we need to go quite as far as you are proposing or spinning out, but that insurers simply need to maintain broad enough risk pools so that this all evens out.
And the last 100 years of the insurance industry, they have managed to do that extremely profitably without genetic information. We're asking them to continue doing exactly what they have been doing since the dawn of the industry.
DR. ZUBELDIA: They do have some sort of genetic information today, like race, sex. It's very limited, but they substantially base the underwriting on things like that.
MS. PELLEGRINI: It's my understanding of the underwriting that that type of genetic information is not as much tagged to specific individuals, as looking at the entire risk pool and saying, this percentage is African American, and this percentage is white, and then from there to the actuarial and go forward. This percentage is going to develop diabetes, we just know that based on this general pool. This percentage is going to have heart disease. This percentage is going to get pregnant and have babies.
But it is not that Cindy Pellegrini is going to get diabetes, and Dr. Fanning is going to have heart disease. This isn't information that is tagged to individuals in a given risk pool. It is population-based.
DR. ZUBELDIA: I think that if I go get a life insurance policy now, I go through a set of medical exams. And if they determine through the questionnaire, the extent that I'm diabetic, I would end up paying a higher premium than if I'm not.
MS. PELLEGRINI: Life insurance or health insurance?
DR. ZUBELDIA: Life insurance.
MS. PELLEGRINI: Life insurance is a completely different issue. Rep. Slaughter is not dealing with that at all, because she does agree that unlike health insurance, which is paid out incrementally over a lifetime, health insurance as a one time end of life payment has to be a totally different paradigm.
MR. ROTHSTEIN: First, I want to thank you for coming, and I applaud Rep. Slaughter's efforts in this regard, and I strongly support legislation in this area. I have been working for it for the last 20 years. Having said that, I think that the bills that are pending in Congress now are fatally flawed, and even if passed, would have not effect whatsoever.
MR. BLAIR: You said the bills. Which bills?
MR. ROTHSTEIN: Oh, there are a whole series of bills. But I'll just discuss the one that you are talking about today. We already have laws enacted in 33 states that prohibit "genetic" discrimination in health insurance, and the HIPAA provision that you alluded to.
The effect of the Slaughter bill with regard to health insurance would basically be to extend the nondiscrimination provision to individual insurance policies, which are currently regulated by the states, not federally regulated, and therefore not covered by the HIPAA amendment.
The state laws that have been enacted so far say essentially the following. This is my assumption that your bill would do the same, and correct me if I'm wrong. It would now be unlawful for an individual health insurer to deny coverage to an individual who was genetically predisposed to some later onset condition, when that individual is currently asymptomatic, which is fine.
However, after the individual has the bad luck of not only being presymptomatic, but becomes symptomatic, then the bill offers no protection whatsoever. So that to take an example, you have a woman who tests positive for a BRCA1 mutation, meaning that she's got let's use the figure 50 percent lifetime risk of developing breast cancer. It would be unlawful for an individual insurance company to deny her coverage. They offer coverage. The coverage is renewable annually.
Three years down the road she has the misfortune of actually developing breast cancer. Then the law would have no effect whatsoever, and her coverage, depending on what the state law required at that point, the premiums could be increased 50 percent, 100 percent, 200 percent, or her policy could even be canceled.
So that's very problematic. Now the only way you can fix that is through guaranteeing renewability, and assuring that even women who have breast cancer of nongenetic causes -- I don't want to make this my speech -- the problem with the Slaughter bill is not that it's proposing a single payer system. It's that it's not proposing a single payer system, because if you want to protect against discrimination.
That's the only logical way that you can do it. There is no other logical way that you can slice the pie and assure people equal fair access regardless of their health status, predictive or current. That's the fact the matter. Now either we want to do it, or we don't want to do it, but this kind of legislation is going to be helpful to the 50 percent of the women who are genetically predisposed to breast cancer and don't get breast cancer, but not the others.
And I have serious questions about whether we want to single out genetic disorders for special treatment. I think this genetic exceptionalism further increases the stigma of genetic disorders. And that we need to, to the extent that we are concerned about these issues and want to do something, we need to regulate it within a broader context of health status discrimination, rather than "genetic" discrimination.
And I don't want to address the employment side of it, because the problems with those bills are even more serious than the health insurance.
MS. PELLEGRINI: I'm glad I took notes, because you ran over a whole bunch of different very important issues, that I want to touch in each briefly. When you first started out, you said that 33 states have passed some form of genetic discrimination in health insurance laws. That is true. The thing that you need to remember, that others need to know is that those 33 states are -- no pun intended -- all over the map when it comes to these laws.
Some have very, very strong laws. Some of the most recent are in Arizona and New Jersey. They are fairly comprehensive. Others are absolutely little more than a genetic privacy provision. Some are somewhere in the middle. Wisconsin has a law that looks great on paper when you read it, and say okay, no genetic discrimination based on this, until you realize that the only thing that they are protecting is a genetic test, defined as DNA sequencing, which nobody is getting. You're getting blood tests, or other forms of --
MR. ROTHSTEIN: Excuse me, Cindy, my point was that none of the 33 are any good.
MS. PELLEGRINI: I want to kind of throw that out there, because when I have looked at some of those laws, I was absolutely appalled that it was abundantly obvious that even states adjacent to one another, or states that had similar governors or assembly structures, or states controlled by Democrats, none of them were talking to each other, none of them.
There was no model law out there. Nobody was looking. They were all reinventing the wheel over and over and over and over. So that people who live across the street on opposite sides of a state line have totally different rights and protections, et cetera.
So one of the things that Rep. Slaughter is trying to do is set is a federal floor at the very least. And we'll bring some states up to it, and we won't mess around with those states that may have decided to go farther beyond it.
You are correct when you said that Rep. Slaughter's bill extends these state protections to the individual market, which many states have not chosen to do. What it also does though, maybe more importantly, because we're talking about a greater number of people, is extending protections to the ERISA plans.
The ERISA plans aren't subject to state law. And in some states more than half the population of insured under 65 is covered by these large ERISA plans. So we are really getting at a huge number of people, and extending the HIPAA protections for those folks, regardless of what their state legislatures have done.
Presymptomatic versus symptomatic people. This is something that we wrestled with. Should we cover only the people who have a gene, but haven't developed a disorder yet? Or should we cover everybody? And Rep. Slaughter has done both, because her first bill covered everyone, regardless of whether you were symptomatic or not. The second bill that she has introduced with Sen. Daschle is narrower, and only covers presymptomatic individuals.
There are two reasons for that. First, we were approached by a number of groups, including breast cancer groups and the epilepsy community, who said look, we have people with genetic forms of the disease, and people with nongenetic forms of the disease. We prefer for you to cover everybody, but if you have to make a demarcation, we would rather you just covered everybody who is presymptomatic, and put the line there, between presymptomatic and symptomatic, because we are a breast cancer group.
It's going to be extremely hard for us to say to our folks, all right you think you're being discriminated against. What you are going to have to do is go and get a genetic test, and figure out if this is genetic discrimination, or nongenetic discrimination, and then you have different options for protections, depending on which it is.
So we made the very difficult decision, believe me, to make that division. The thing that helped us make that decision was an unfortunate, but present political reality that a Republican controlled Congress was never going to pass a law that protected all people regardless of whether they were symptomatic or presymptomatic. So there was that very difficult political reality that folks that we were working with said we don't think we can even get a hearing and a mark-up if the bill covers everybody.
You mentioned premium discrimination. That a woman with breast cancer is protected until she gets cancer, and then could be dropped or have her premiums raised. Under HIPAA, if she has had coverage and then gets sick, she can't get dropped by the companies --
MR. ROTHSTEIN: This is in the individual market.
MS. PELLEGRINI: Okay, I'm sorry. In the individual market, there are some cases where she can't be dropped under HIPAA, even in the individual market. It's narrow.
MR. ROTHSTEIN: Not where you transfer out. I'm a little business. I want to buy a policy. I'm just subject to state law. They can drop me for all sorts of reasons.
MS. PELLEGRINI: Right. That is one of the things that we are trying to get at with this bill, and the premiums issue, which is possibly even more significant, because some of these insurers, especially in the individual market, are saying, well, we didn't drop the person. We just raised their rate. Well, you raised their rates to like $600 a month. Nobody can pay that. That is another loophole in HIPAA that our bill, Rep. Slaughter's bill would close. It prohibits the premium discrimination in those type of cases.
And then finally, single payer. You said either you want to do it, or you don't want to do it. This Congress doesn't want to do it. That's what we are working within right now, is to improve upon the system as it stands, because it has been made clear to us, both with the defeat of the Clinton health care plan back in 1994, and the absolute difficulty of getting any health-related legislation passed right now, that this Congress is not inclined to even consider single payer as an option.
MR. ROTHSTEIN: I understand the realities. My point in raising these issues was that one should not be happily deluded into thinking that the kinds of small measures that are being proposed would have much of an effect.
MS. PELLEGRINI: We think they are a lot better than the current status quo.
MS. FYFFE: I'll be honest and tell you who I work for. I work for HIAA. The fact of the matter is that often legislation has unintended consequences. And I think that several of the unintended consequences of the type of legislation that you are talking about could affect health insurance, life insurance, disability insurance, long-term care insurance.
For example, there are about 20 of us in the room. If a few of us found out through genetic testing that we had dread diseases, and decided to -- I don't know, something horrible like Lou Gehrig's disease, and I knew that I was going to be very disabled and dead within three or four years, I might load up on a few disability policies, a couple of long-term care policies. I would increase my life insurance to take care of my family.
And the unintended consequence of that is that it could raise premiums for everyone in this room. That is just some of the basics of Insurance 101. So although personally I agree with Rep. Slaughter, the fact of the matter is that often legislation has unintended consequences.
MS. PELLEGRINI: We have been approached by representatives of the life, disability, and long-term insurance industries saying, gee, we're worried that if your bill passes, that the definitions in your bill, or the standards in your bill will be imposed against our industries as well.
And Rep. Slaughter every time that kind of issue has come up, to say that it is her absolutely firm belief that life, disability, and long-term are completely different situations than health insurance or employment. And that they should be addressed as such.
MS. FYFFE: I guess the fundamental thing I wanted to say is that if I as a consumer have knowledge that the insurance company doesn't have, then I have the advantage of loading up on all kinds of insurance that I would pay for, that the insurance company doesn't know -- in other words, they would not be able to underwrite for a fair premium. Well, it's not fair to me, because I know I'm going to be sick, and I don't want the premiums to go up. But it's an unlevel playing field if the consumers have knowledge that the insurance companies don't have.
I hate to -- say it about Kaiser, but how would Kaiser feel if 25 percent of their patients in a certain geographic area really have a dread disease. What are you going to do, if you couldn't adjust the rates? You would run out of money, and not be able to treat everybody.
MS. PELLEGRINI: A couple of quick notes. First, from everything that we have seen, it appears that people who get a diagnosis, and either don't have insurance at all, or try and go out and get it, or want to bulk up their insurance, upgrade their plan or something, are a very, very small number.
Second, with the whole idea that a person -- the vast majority who are out there, are in group plans. And groups plans aren't doing individual medical underwriting. So even if a person gets a dread disease, the insurance has never asked for that information. They don't really care, because they have got a risk pool going. And your coverage is your coverage, and you are going to get what you get.
And so this is a question that we have considered. And it has been Rep. Slaughter's conclusion that we would be talking about a minute, minuscule number of people that would engage in that kind of gamesmanship in health insurance, separate again from long-term care, disability, life.
MS. FYFFE: It's an art -- it can't be separated.
MS. PELLEGRINI: Are you saying because all the same companies offer all the same products?
MS. FYFFE: That could be part of it. But it's probably for another conversation.
DR. MAYS: I was just going to give an example. If you look at what happened in the early days of HIV, what you saw is exactly what she is talking about. Is that individuals who, once they knew that they were HIV infected, and had a sense of all the things they needed to in terms of the course of the disease, and even now with it being a chronic disease, I think the insurance business has gotten very different, but at that point in time, people did load up on a lot of insurance.
MR. ROTHSTEIN: But life insurance.
DR. MAYS: A lot of different insurances, life, disability. Some individuals made sure that when they were in self-employed businesses, they switched them to other jobs before they got too sick, because they were planning about health insurance.
So I think that the issue is that -- I understand what she is trying to do, but I think that there is a bigger picture, which may be part of what's going on, why it's taking so long. I think it's just very complicated. I have fought this discrimination issue in terms of HIV, and it's something about the -- and I want to go to the point about the exceptionalism. Genetics is there. It's almost like we are revisiting it.
But if you look at what would happen if you did that with genetics, you are going to get people with HIV and other diseases who also will then come back and make some of the same demands I think in the field. I think part of what you are struggling against is what has happened in HIV as to why probably some people don't want some of these things to go forward.
MS. PELLEGRINI: On the exceptionalism issue, because it is a very difficult one, it would be certainly be Rep. Slaughter's preference that all medical records be completely private, and all conditions be protected against genetic discrimination -- or excuse me, all symptomatic, presymptomic, genetic, nongenetic be protected against discrimination.
However, that doesn't seem possible in the current environment. And so given the urgency of the Human Genome Project, and the slow but steady growth of genetic tests, and the sensitivity that is out there right now to genetic information as the most personal and private and immutable information, given that gene therapy is still quite a ways off by all accounts.
It is Rep. Slaughter's view that it is appropriate for us to take this kind of action at this time. And in the future -- laws are living entities. We will undoubtedly want to revise it or expand it or appeal or adjust, do many things over the coming decades. This is not something that is going to just sit there in law, in her judgment, and never change.
But this is the right thing for us to do right now given how sensitized people are to genetic information, and the fact that our understanding, even scientists' understanding of genetic information right now is so limited. How much does it increase one's risk? How do environmental factors play in? If scientists can't get a good handle on what having a given gene means, isn't it doubly unfair then to have a human resources professional or a health insurance official discriminating based on that information?
MS. FRAWLEY: Interesting points. Cindy, I would like to thank you for joining us this morning.
MS. PELLEGRINI: Thank you for having me.
MS. FRAWLEY: I certainly think that obviously this is a topic that the subcommittee will probably continue to focus on.
[Administrative remarks.]
Secondly, I would like to thank everyone for their participation and for their support over the past four years, since I leave you. I plan obviously just to do some transition work with Richard and Gail. And I wish everybody the best. I will plan still to be coming to the committee meetings. So I'll just be sitting in the back row, passing notes to people.
But anyway, it's been a real pleasure, certainly for me professionally. Certainly, I think all of us would say that we certainly have learned a lot. I think that's probably again, one of the most enjoyable experiences, being part of this subcommittee, and also the full committee, is just the amount of knowledge that one has gained.
I thank all of your particularly, because of the fact for some reason we were always slated for the 8:00 a.m., and I always appreciated the effort that everyone made to get here to participate. So I would just like to personally thank all of you, and wish Richard well in his interim role.
And also personally thank Gail, who has provided support to us for the last two years, and will continue to provide support to the subcommittee for the near-term, however that plays out, as we always know with the changes in administration and budgets and everything else. But thank you.
DR. HARDING: Kathleen, we would like to thank you too. And I think for the new people on the committee, Kathleen has not only medical records experience, she is an attorney. She has contributed more to this committee, not just this committee, but the entire committee, probably than just about anybody, and has always been there for the tough kinds of decisions that have had to be made. And the background person, and will be sorely missed as a member.
But I hope you really will be coming to those meeting.
MS. FRAWLEY: I sat in the audience for four years before I got invited to the big table, so I'm going back to the audience again.
DR. HARDING: Thank you very much.
MS. FRAWLEY: Thank you.
[Applause.]
[Whereupon, the meeting was adjourned at 10:00 a.m.]