[This Transcript is Unedited]
Hubert H. Humphrey Bldg.
200 Independence Avenue, SW
Washington, D.C.
Committee Discussion
DR. ROTHSTEIN: Good morning, everyone. This is Mark. We are not on the Internet, so we can I think be informal, and no need for introductions; everybody knows who they are here. But we will introduce ourselves, just so Gail and Richard, who I assume are on the line, can know who is here.
Gail, are you there?
MS. HORLICK: Yes, I am, Mark. Good morning.
DR. ROTHSTEIN: Good morning. Richard?
DR. HARDING: Yes, I'm on the line, and if everybody could please talk directly into the mike, I'd appreciate it.
DR. ROTHSTEIN: We will certainly attempt to do so. Just for your benefit, we will go around the room and let everyone introduce themselves, so you know who is at the hearing.
John, would you start?
DR. HOUSTON: John Houston.
DR. GREENBERG: Marjorie Greenberg, NCHS, CDC.
DR. FYFFE: Kathleen Fyffe, staff to the Privacy Subcommittee.
MR. FANNING: John Fanning, Office of the Assistant Secretary for Planning and Evaluation.
DR. ZUBELDIA: Kepa Zubeldia with Claredi Corporation.
DR. WILLIAMSON: Michelle Williamson, NCHS, CDC.
DR. ROTHSTEIN: Good morning, everyone. Let me see if I can propose an agenda for you for this morning's meeting that is a little more detailed than the pro forma agenda in your book.
What I would like to do is go over some of the materials that are in the memo that was prepared by Kathleen to summarize the conference call that we had on September 9. I think it is an excellent memo. That is basically our agenda. I think there are extra copies of that available.
Do you have a copy of that, Richard and Gail?
DR. HARDING: I will go back to September 9 or right after that, and I'll find it and make a copy. I have it on my e-mail.
DR. ROTHSTEIN: Gail, do you have a copy? Well, at any rate, you both were on the call.
MS. HORLICK: I have it.
DR. ROTHSTEIN: Thanks. Just for the benefit of Kepa and Marjorie --
DR. GREENBERG: I was on the call.
DR. ROTHSTEIN: Oh, you were on the call. Kepa, so you get a personal briefing. For all of us, just a recap of where we are.
We talked about the topics to be discussed at the November hearing. We had basically ten nominations, of the people who were in attendance. We approved the three topics, numbers one, two and ten, first, a public health session, second, a research session and number ten on the list, an open session in which we invite various people from affected industries and consumer groups, et cetera, to talk about issues in general. We will come back to that, because I want to discuss and ask for your recommendations on various topics and speakers.
In addition, we firmed up the following day and a half, full day on November 19, half day on the 20th. In addition, we are probably -- at the end of the meeting I would like to talk about additional topics for our February hearing, and then we'll explore some dates later.
We will not be able to get the Humphrey Building for our hearing on November 19 and 20, so Marietta is going to try to locate a hotel in the city and let us know as soon as she gets that firmed up.
DR. HOUSTON: Is this going to reserve a block of rooms, too, or at least set aside --
DR. ROTHSTEIN: That's a good question. Marietta, the question was whether when you line up the hotel you will reserve a block of rooms for us? Okay.
What I would like to take up first is the specific topic of public health. This will probably be half a day, and we don't know yet which half day. So we will probably have two panels. What I would suggest perhaps is that we have a more general panel in which we invite people from public health organizations to testify, and then perhaps the second panel, invite experts on various specific aspects of public health, such as newborn screening, immunization, cancer, STDs and so forth.
I'll start, and then let people chime in with their views. I think some of the groups that we should definitely invite to present to us are from ASTHO, the Association of State and Territorial Health Officers, NCHS, and I'm not sure who there from the CSTE, the Council of State and Territorial Epidemiologists, the American Public Health Association. So I think those would be four.
Kathleen, did you come up with others on your list?
DR. FYFFE: Not yet, no.
MS. HORLICK: NACCHO maybe?
DR. ROTHSTEIN: NACCHO is a possibility, the National Association of City and County Health Officers.
DR. FYFFE: Right, it is just the local level.
DR. GREENBERG: Many if not all of the organizations you mentioned are members of the public health data standards consortium, which does have a privacy and confidentiality work group. So it is possible. They in fact are doing a project for HRSA right now on privacy issues for local health departments. It has just gotten started.
DR. ROTHSTEIN: Is there a contact person there?
DR. GREENBERG: We'll provide that. But they are having a conference call shortly, I think, and we could see if they are interested in providing some testimony.
DR. ROTHSTEIN: Any other organizations that we might be -- Simon, we are talking about first the public health hearing. We discussed some national organizations as well as NCHS that we should consult with.
I also want to talk about some specific topic areas perhaps for some of the other part of the hearing, which will probably be in two panels.
I was at a newborn screening meeting last week, and there were several state representatives there who run state newborn screening programs. They were lamenting that they can't get information on newborn screen followup because of quote, HIPAA problems. So these are the agencies that supervise the labs that do the state screening, and it is very important for them to do followup and get information from the pediatricians of the kids that have gone through newborn screening, and the pediatricians are refusing to give them the followup information because they think HIPAA prohibits that.
So that is an area that I wouldn't have even thought there would be this defensive aspect of HIPAA. I gave to Kathleen the names of two people, one who does Ohio and another who does their New England states. We can get one of those people to testify.
Gail, have you located anybody on immunization?
MS. HORLICK: No. You are talking about reporting specifically registries?
DR. ROTHSTEIN: Correct.
MS. HORLICK: No. I'm working on it. I also got yesterday -- I was out of town all last week in Salt Lake, but I also got the names of several people in cancer. I'll just make some inquiries with the other registries here in CDC.
DR. ROTHSTEIN: Okay, excellent.
MS. HORLICK: I'm looking in the CDC people, but for the immunization registries, I'm going to look towards the states.
DR. ROTHSTEIN: Right. So anybody from one of the states who could relate to us what the issues are and what the problems are, what they think needs to be done, et cetera.
MS. HORLICK: Right. I was just going to mention, with the newborn screening, when you said New England, I don't believe that is a problem in Rhode Island. They have an integrated information system, and it may be because of the way their state law is written, but I know the people there well. Maybe they have something they could offer to the people in those states, not necessarily at the hearing, because they are not having a problem.
DR. FYFFE: Excuse me, Gail. Getting back to the immunization registries, is there an association of state immunization registries?
MS. HORLICK: There is an association of immunization managers, and that is for immunization programs. There is an American Immunization Registry Association. I know people in both of those.
There is an Association of Immunization Managers and an American Immunization Registry Association. In particular, the Immunization Registry Association I know the people. I don't want to say this is not a problem, but I am not hearing it quite as much. Now, I don't know what that means. I just spoke to someone yesterday about it, and I am going to consult back with her and ask her what states are saying.
But I haven't heard about not reporting to registries specifically because of HIPAA as much as I had earlier. I heard other problems, about disclosure to schools, about letting people in to do coverage assessments in provider offices. So I am going to make some inquiries this week, now that I am back in the office.
DR. ROTHSTEIN: I think the issue of disclosure to schools is an important one.
MS. HORLICK: That is a huge one. I know we had that sidebar.
DR. ROTHSTEIN: Yes.
MS. HORLICK: I tried to get in on a conference call yesterday, and ASTHO called, and it was to capacity and I couldn't listen in.
DR. FYFFE: There is the National Association of School Nurses.
MS. HORLICK: Yes.
DR. FYFFE: I had given a speech to them on HIPAA privacy in late June, and they all cued up after the speech because they were having such difficulty getting immunization information from physicians.
MS. HORLICK: Well, the providers don't see it as public health, and they don't want to do it without an authorization. I'm not saying that is not required, I'm saying that is the issue.
But let me make some inquiries. Mark, you were specifically from the CDC perspective and out in the states. You are specifically interested in reporting to registries, be it immunization or cancer, birth defects and so forth.
DR. ROTHSTEIN: Right.
MS. HORLICK: So what I am really not familiar with is the other programs and what they are hearing, but I've got the contact people and I will follow up on it.
DR. ROTHSTEIN: Excellent. The other thing, just to give you more things to do, I think it is very important that we hear from somebody at NCID on infectious disease reporting, because one of the things that is essential to the public health system is the ability to pick up epidemics quickly. If people aren't reporting infectious diseases because of concerns about HIPAA, we are going to get the SAARS or West Nile or whatever the virus of the week is three weeks after the epidemic has started.
MS. HORLICK: Right. In general, are you interested in hearing from people in the states about this concern? I am going to be talking initially to people in CDC about whether they have seen a difference in reporting or heard the issues in the other programs. But are you interested more in the state perspective?
DR. ROTHSTEIN: I don't want it to be too fed centric. I think we ought to have state people who have experienced this problem for sure.
MS. HORLICK: Okay.
DR. ROTHSTEIN: As John Houston mentioned, this is closely related to bioterrorism, too. So maybe some people from BT. Kepa.
DR. ZUBELDIA: In some of these things, we know right now that it has the potential to create a problem. Perhaps it hasn't created a problem yet, but it has the potential to create a problem. I am wondering if we need a hearing on topics like that, or we can just make a recommendation to have some sort of guidance in those areas where we think it could create a problem without having to bring in a hearing.
I don't know what additional information we are going to gain from a hearing that we don't yet know.
DR. ROTHSTEIN: What we can get from a hearing -- and that is a very good question -- is to really get the factual basis for our assumptions. I have heard stories and anecdotes and concerns, and I really would like to get the facts. I think a letter with recommendations to the Secretary from us would be much more powerful if we said, we have heard from state people who are doing newborn screening, we have heard from cancer registry people, we have heard from STD, and they all have this problem.
If we did it the other way, and we get a couple of FAQs, that is posted on the OCR website. I don't know if that is enough. But maybe if we document that this really is a threat to public health, then maybe we will get a more substantial response.
MS. HORLICK: I also think it really -- my limited experience since we started putting these materials out is that that is the way to go. It speaks to the education and the need for it in different formats, because we had a huge problem with public health coming in to do these coverage estimates in providers' offices. When that memo went out and was developed and people could use it, I just spoke to the AFIX woman yesterday and she said it is better, they are using it, they are okay. They just didn't want to do something that wasn't compliant.
DR. FYFFE: Gail, which memo are you talking about?
MS. HORLICK: It was a memo that I worked on with the CDC Office of General Counsel. It went out from the head of the immunization program, Dr. Dorenstein. It is the first in a series of memos. It just basically said that -- it explained the disclosure to public health provision that permitted them to do what they had been doing all along, and how it was okay. This was something that they could mail or give to providers, and it was great.
Likewise in the states, Minnesota has developed several memos. Issues came up with reporting on mothers with hep-B and the baby, and those HIPAA privacy issues and disclosures to schools, and they developed memos related to their specific state laws, and other states are working with them.
So the MMWR is fabulous, but it is a book for a doc who is busy. So to get some targeted information that is sanctioned by HHS, by CDC, that is targeted to those specific areas has been in my experience very, very helpful. Kind of like the FAQs, except people aren't going to the -- the docs aren't going to the FAQs.
DR. ROTHSTEIN: John Fanning had a comment.
MR. FANNING: I think one advantage of a hearing is that it gathers factual information on what the situation is and what the understandings and misunderstandings are that actually assist in developing educational material and other curative measures.
This committee has had a long history of assembling information which informed not just the committee's own recommendations, but also provided factual background for those of us in the bureaucracy who have actually to hammer out policies affecting specific areas.
DR. ROTHSTEIN: Thank you for that comment, John. I think that is helpful, because that will help shape our recommendations as well as our witnesses.
I have just one other comment, and then I'll call on Marjorie. That is, the other area that I think -- one hypothesis that may or may not bear out is that if there is a decline in reporting, it may well be in the areas that are most sensitive, such as domestic violence and STDs. I think we ought to look into those areas to see if we can get some testimony to see if that is in fact the case.
Marjorie.
DR. GREENBERG: I was just going to say that in addition to identifying problems and hearing where people are having problems or anticipating problems, I think just as Gail pointed out, it would be very good to gather information on where problems have been successfully addressed or where people aren't having problems because of materials that they have developed or relationships that they have nurtured, a best practices type thing. I think this is going to vary probably from area to area, et cetera, depending upon how successful people have been to educate and communicate. Despite the fact that we have the national stuff, there is still a lot of variation.
So I think it is really good to hear just what Gail reported, and to get copies of those educational materials and flyers or short memos or whatever has been successfully used, because I think people are crying for that type of material at the state and local level.
DR. ROTHSTEIN: I think that is an excellent point.
DR. HOUSTON: I think it is probably equally as important, if there are no problems, or even if it is just simply out of the box that things worked the way they were intended, I think it is just as important to confirm that. I think part of our role is oversight of HIPAA, the good and the bad, and I think it is equally important that --
DR. ROTHSTEIN: Sure. Suppose we find that there is no problem in cancer reporting, but there is a problem in some other area. Then we need to figure out why that is the case, and to try and help improve the other areas.
DR. FYFFE: John, I'm glad you brought that up, because we don't want to speculate.
DR. HOUSTON: To confirm to the good is probably equally in our purview as to suggest recommendations for improvement, if that is the case.
DR. ROTHSTEIN: That's right. Does anybody else have any comments on the public health proposal, hearing?
Let's move then on to research. I think the obvious people to invite are AAMC. They have been frequent testifiers before us in the past when we had our hearings on research. I think we ought to invite OHRP.
DR. GREENBERG: Who is that?
DR. ROTHSTEIN: OHRP, the Office for Human Research Protections. Also, someone from the pharmaceutical industry, which sponsors a tremendous amount of research, possibly someone from particular universities. I know Hopkins has testified before our committee several times.
Anybody have any other suggestions on people or organizations to invite for research?
DR. GREENBERG: Academy Health, the former Association for Health Services Research.
DR. HARDING: Who is that? Pardon me?
DR. GREENBERG: Academy Health. They were formerly the Association for Health Services Research. They have been holding a number of workshops on this very issue related to health services research and the impact of HIPAA. Actually, someone from Academy Health shares this work group of the public health data standards consortium that I mentioned, John Lausenack. I can't pronounce or spell his name properly, but we can get that to you. But I think they definitely have their hands on the pulse of health services research.
DR. HARDING: Another one to consider would be somebody from NIH who is passing out grants and seeing what they are running into, as they go through grant applications and that kind of thing.
DR. GREENBERG: It crosses over with health services research, but any problems that agencies are having with provider surveys. I know this has been a big issue for NCHS. This was an issue prior to HIPAA, and these are surveys that the government does of hospitals, physicians.
DR. ROTHSTEIN: So do you think we should check with HRSA and AHRQ to see if they have a problem?
DR. GREENBERG: Well, NCHS. Our provider surveys, it has been a big issue for them. Exactly what is happening currently, I'm not sure. They have developed a lot of materials. But they certainly have real concerns about response rates. As I said, even before HIPAA, they were being told HIPAA isn't going to let us respond anymore to this survey.
DR. COHN: Having been in an organization where some of that, there has been concern, I think if nothing else, a clear recitation of how this all relates --
DR. GREENBERG: What?
DR. COHN: Having been in organizations where there has been discussions about all of that, I don't think that one can understate all of this. I think if nothing else, a clear recitation --
DR. FYFFE: Recitation by whom?
DR. COHN: Oh, I don't know. NCHS wouldn't be bad, of what they are doing and the issues that they are beginning to see and what their view of the applicable rules would be, would be valuable.
DR. FYFFE: So you are asking for testimony from HHS, government --
DR. COHN: That is the type of group that does surveys.
DR. ROTHSTEIN: So we can focus on government directed research as well as government sponsored research, and we can also hear from academic medical centers and perhaps one or two specific ones. We can also hear from the pharmaceutical industry and maybe from some biotech companies who actually sponsor the research.
Then from OHRP, we can talk about the issue that has often been raised, and I'm sure you have all heard it too, the relationship between IRB approval and HIPAA and privacy boards and the like.
DR. FYFFE: I want to mention -- and John and Marjorie, please chime in here -- I get the sense that some of the HHS agencies may not feel comfortable in testifying. I have already asked the question of one of them, and they said they could be available to the subcommittee to answer questions, but they are not certain that they would be able to testify.
MR. FANNING: I don't know that there is any rule or that the committee needs to have any rule on it. Obviously if a particular agency doesn't feel like sending someone formally, they don't send them. But we certainly have had before these committees witnesses from our own agencies.
DR. GREENBERG: Yes, I think NCHS would be glad to talk about what they have been doing and what their experience is.
DR. FYFFE: Okay.
DR. ROTHSTEIN: So we wouldn't necessarily be asking them to testify about their practices, but if we had somebody who is let's say responsible for the NHANES survey, it seems to me that they would be institutionally more than pleased to discuss the problems in getting people to participate because of privacy concerns.
DR. GREENBERG: I think there is less of one probably with interview surveys, or where the agency goes directly to the household or whatever. It is a bigger issue with provider surveys, where it is the same provider issue as reporting to registries, although that might be more required by law. These surveys are voluntary, you don't have to participate in them, but generally they had quite high response rates. And of course, we rely on high response rates for the quality of their data. So I think that is where the bigger problem has been.
John has something.
DR. ROTHSTEIN: John.
MR. FANNING: My impression is that NCHS has developed good informational material for those providers who respond to explain clearly what the rules are and how this disclosure is allowable and the like, and some information about those educational and informational efforts would be helpful I think to all of us.
DR. ROTHSTEIN: Yes, if we could find out how that information has helped or not, that would be quite informative.
DR. GREENBERG: And even the process of developing the materials, getting them clear, whatever. This is as John said part of the whole monitoring of how is this thing rolling out and how is it working in the Department and more broadly.
DR. ROTHSTEIN: Other comments on research? Kathleen, are you comfortable?
DR. GREENBERG: Don Steinwachs has been a resource for Hopkins, but he has also been active always in the Academy Health, too, so he might be helpful in identifying some people.
DR. FYFFE: If you could get me his name.
DR. GREENBERG: Don Steinwachs, member of the committee. Don Steinwachs. He is actually a member of the committee. He is not a member of this subcommittee, but he is a member of the committee. He is on the roster.
DR. ROTHSTEIN: So if we are ready, we can move on then to the third topic for our November hearing. That is the open session. I believe it was Simon's suggestion that we agree to on our September 9 conference call, and that was to invite a cross section of health care industry trade associations and professional societies as well as consumer representatives to basically have the floor and to talk about any issues that are of concern to them, because we may have missed stuff in our list of issues.
Probably I think it would be a good idea if it is feasible to do to make this the first session, the general session, and then follow it up by one of the other two, depending on how the schedule works.
Some of the obvious organizations that occur to me to invite would be AMA, AHA, AAHP, AHIMA and EBRI, the Employee Benefits Research Institute. There must be others, so I'll open the floor.
DR. HOUSTON: I know we talked about fundraising separately. I think it might be helpful to get at least somebody from the fundraising side, and I'm drawing a blank on the --
DR. ROTHSTEIN: AAMC.
DR. HOUSTON: AAMC, or there is another one, too.
DR. ROTHSTEIN: There actually is an association of fundraisers. They testified before us at our fundraising hearing.
DR. GREENBERG: I didn't know we had a hearing to raise funds. That might be a good idea.
DR. ROTHSTEIN: We weren't able to raise even money for lunch, but we did have a fundraising hearing.
DR. FYFFE: There is an association of health care organizations.
DR. ROTHSTEIN: They have got quite an endowment too, I understand. Dan?
DR. RODEY: Two groups you may want to consider, and I got stuck downstairs, so there is a third one from the government, I'll speak to that one, for the Social Security Administration, that has been holding a series of meetings on this. They are having significant problems with the privacy law. You may want to hear from them.
DR. FYFFE: Really?
DR. RODEY: Yes. Their data that they have to collect for benefits is becoming a very large issue, even though they spent a tremendous --
DR. ROTHSTEIN: So are you talking about social security disability?
DR. RODEY: Yes.
DR. ROTHSTEIN: So it would be the SSDI program.
DR. FYFFE: Excuse me. For the benefit of the folks on the conference call, the person speaking right now is Dan Rodey of AHIMA.
DR. RODEY: Two other groups would be the American Bar Association -- I just did a session in front of their tort lawyers, who are upset about this, and either the American Association of Chiefs of Police or one of the other law enforcement associations. They have also been very active lately, explaining all the problems they seem to be having.
DR. FYFFE: And we are planning possibly to have future hearings from law enforcement.
DR. ROTHSTEIN: Yes. Let me just -- but I thank you, Dan, for those comments. We might want to hold off on the last one when we get to talk about the issues that we are going to hold over to February. Kepa?
DR. ZUBELDIA: Are we going to bring in the banking issues here or leave that for another meeting?
DR. ROTHSTEIN: Let me just jump ahead to a preview of the February hearings. We forgot on our conference call, when we made our list of topics, to include banking. It was something that we talked about at our last in-person meeting.
So what I would like to do is put that at the top of the list for our February hearing, so do banking, and then there are some others that I am very interested in. We can talk about your views as well. I still think we ought to do something on schools, the HIPAA FERPA problems, as well as the law enforcement issues, which I think are becoming increasingly salient now.
I think if we did a two-day hearing, we would have an opportunity to actually do four topics. So if we wanted to do those three, and then one other, or some other combination of topics.
So let's just put that aside for a minute, just so you know what I am thinking about for February. I'd like to wrap up this open session.
DR. FYFFE: I'd like to have some suggestions from you all about names of organizations representing consumers that we could potentially invite to the open session.
DR. HOUSTON: The privacy project?
DR. FYFFE: The privacy project?
DR. HOUSTON: Yes. I don't know if that is something we want to --
DR. ROTHSTEIN: Yes, the privacy project is -- I don't know, does it still exist?
DR. FYFFE: Yes.
MS. HORLICK: It is much smaller, but it still exists.
DR. FYFFE: It exists.
MR. FANNING: Yes, as a matter of fact, there was a hearing a day or so ago. The Senate Select Committee on Aging had a hearing, and Jenn Laurie Goldman did testify on behalf of the project.
DR. ROTHSTEIN: I know that they had lost a lot of their funding and staff. But we can still get Jenn Laurie for sure.
DR. GREENBERG: Seems untimely.
DR. ROTHSTEIN: So that would be one and AARP would be another. Other recommendations on consumers or consumer groups? One of the things that you might want to do is to check with Stephanie, because she has talked to many of these people in lining up prior hearings, and would maybe have some suggestions as well, as Bob Gelman. He would have some suggestions. We could probably bail those people out and bring them here for the hearing.
DR. COHN: Is this everybody on the same panel together?
DR. ROTHSTEIN: No, I think the idea is to have two panels for each of these topics. So given the usual hour and a half panel, we can do two panels in a half day.
MS. HORLICK: Mark, are you still planning public comments on both days, or one of the days?
DR. ROTHSTEIN: I think what we can do is schedule just one public comment period at the end of the second day, which would be the half day.
MS. HORLICK: Did you say at the end of the half day?
DR. ROTHSTEIN: Yes, that was my thinking, but I'm willing to change. I don't think we need to have public comment on each of the topics.
MS. HORLICK: No, I don't, either, but I think it is at least good to give people an opportunity.
DR. ROTHSTEIN: Sure. Judging from the past, I think an hour for public comments would be more than enough. What I would like to do is build into the second day some time for the subcommittee to have an initial discussion of what we have heard while still fresh in our minds for an hour or so. That will help us get organized to draft our letter, and also to have the public comments, and then we'll take off by train for the Executive Committee.
DR. GREENBERG: I guess maybe Simon's question was related to this open session, which seemed to be pretty varied in the groups that you were talking about inviting.
DR. COHN: There are lots of people.
DR. GREENBERG: At one point, I thought the open session was going to be like public comment, but I think apparently you want to make sure you have some people who are invited as well.
DR. FYFFE: Just adding up here, if we have two panels in the open sessions, that is three hours. Then we would have an hour of public comment and an hour for the subcommittee to talk. So that is --
DR. ROTHSTEIN: If we wanted to open with the open session, I suppose what we could do is, instead of having the public comment period at the end, we could have it after the open session, given that it is a broad range of topics, and then at the end of the third panel on the second day, we would have our hour of subcommittee discussion. So in other words -- would that make sense?
DR. FYFFE: I'm a little confused. Are we going to have two panels for the open session?
DR. ROTHSTEIN: Right.
MS. HORLICK: If I could just say, based on my experience with these hearings, the advantage of having the public comments at the end is, if there is not a lot of public comment, you can end early. But if you start your speakers at two or your panel, because you have got an hour of public comment and you don't have the people there, that throws everything off the agenda on the web and when people are arriving. Just something to consider.
DR. ROTHSTEIN: Yes, I know. We usually do that. That would be optimal, I agree.
MS. HORLICK: Especially at this point, I have no idea what kind of response we would get for public comment at this point in where we are.
DR. ROTHSTEIN: Right.
DR. ZUBELDIA: Let me ask a related logistics question. WEDI is meeting the same days here in D.C. Are we going to be meeting in the same hotel or in a different place? We could take a look at the agenda for their meeting and see what would fit best also.
DR. ROTHSTEIN: We don't know yet what hotel is available for us. Marietta is working on that.
DR. FYFFE: By the way, as a followup, Simon had requested that I talk with Jim Schuping of WEDI to let him know that we were going to be having these hearings, and let him know that, and also let him know that we would love to have WEDI testify, but assured him that we would probably also be having additional hearings after the first of the year, which would also give him another opportunity.
DR. ZUBELDIA: Yes, but if we put the open session first, for instance, and it conflicts with the plenary session of WEDI, then it could be a problem. If they want to testify, they may not be able to.
DR. COHN: You don't mean the open session, you mean -- actually, you do mean the open session. You mean the invited session.
DR. ZUBELDIA: Yes, the invited session.
DR. GREENBERG: Do you know where WEDI is meeting?
DR. ZUBELDIA: No, but it would be easy to find out.
DR. GREENBERG: Yes, their website or something. I guess I'm still a little unclear about the open session.
DR. COHN: Which open -- you mean the invited open session?
DR. GREENBERG: The invited open.
DR. COHN: I don't know. Marjorie, I agree with what you are describing, which is an open session in the morning if at all possible, unless there is some major conflict. But I am having trouble imagining -- if we don't get WEDI this time, we'll get them next time. I think the part about the meeting was that it should be member organizations that might want to testify, too. Theoretically, it would probably make more sense for the unstructured open piece -- might be at the end of the first day, and then the next morning have other hearings and a chance for the subcommittee to put things together.
DR. GREENBERG: We could do that.
DR. FYFFE: That is a good suggestion.
DR. ROTHSTEIN: We also need to take up the issue of when we are going to have a letter sent. It seems to me that the timing is not optimal, given the fact that we have our hearings at the end of November or the next meeting of the full committee is not until March, right?
DR. GREENBERG: Have you set the dates?
DR. ROTHSTEIN: We have not set a date.
DR. GREENBERG: But it might be a letter from the two hearings.
DR. ROTHSTEIN: We could do I think.
DR. GREENBERG: Unless something really compelling or of concern comes out, that you don't want to wait that long. But then you could take a letter from both hearings to the March meeting.
DR. ROTHSTEIN: So if we met in February, that would give us plenty of time to draft a composite letter from both hearings.
DR. GREENBERG: Well, the March meeting is the beginning of March, March 4 or 5, so if you met earlier in February.
DR. ROTHSTEIN: So we ought to definitely consider -- we will have an e-mail solicitation or maybe a paper solicitation later today about availability for the first two weeks of February.
DR. ZUBELDIA: Capital Hilton.
DR. FYFFE: November 19 and 20?
DR. ZUBELDIA: November 18 to 20.
DR. GREENBERG: This is the 19th and 20th?
DR. ROTHSTEIN: Right. So before we get to February's hearings, are there any more comments or topics, speakers, on either the invited open session or anything else that we have talked about for our November hearings, research or public health or something that occurred to you?
MS. HORLICK: I guess we might be able to discuss this offline, but just from a logistics perspective, I am going to make some inquiries here. The more I have thought about this immunization, I think that we have gotten the word out it is okay for providers to disclose to registries when they are in public health. That may be why it is less of an issue. To use this as an opportunity to gather whatever other issues may be out there related to HIPAA.
But my question is, I'm not going at this point to be looking -- I want to coordinate with Kathleen and with you to get -- I am going to be gathering some information, but not inviting anyone directly at this point, is that correct?
DR. ROTHSTEIN: Yes.
MS. HORLICK: Okay.
DR. ROTHSTEIN: But Gail, I think it might be valuable to hear from either you or someone else doing immunization if you have been successful in avoiding the HIPAA bottleneck that other people have had in getting public health information. It might be helpful to use immunization as a positive case history.
MS. HORLICK: Right. Well, we can talk more about that. What I am going to do is try to get a sense from the other programs and from the people what issues are out there, but I am not going to invite anyone. When I was working with Stephanie, I did make the overtures, until I have at least talked with you or Kathleen some more, or the full committee, whatever you want.
DR. FYFFE: Okay.
DR. ROTHSTEIN: Without objection, we will move now to consideration of the topics for our February hearing, dates to be worked out hopefully today. Richard?
DR. HARDING: Yes.
DR. ROTHSTEIN: Are you available the first two weeks of February?
DR. HARDING: I will make it available.
DR. ROTHSTEIN: Great. We are going to poll the rest of the subcommittee members today, and then try to agree on some dates, maybe if we are lucky before the close of the regular committee meeting.
DR. HARDING: Would we be talking about the center of the week, or like a Thursday-Friday?
DR. ROTHSTEIN: I think anything is possible, depending on peoples' schedules.
DR. HARDING: Okay, I'll make it happen in those two weeks.
DR. ROTHSTEIN: We'll get back to you. We are going to do a two-day hearing, where presumably we can do four topics, to be determined shortly.
DR. COHN: We should probably try to do it now rather than during the full committee meeting, because otherwise we are not going to have Richard and others on the phone.
DR. ROTHSTEIN: Okay. So Richard, we have a chart that has already been put together by Marietta. We are just going to pass it around and let people cross out dates.
(Discussion off the record regarding meeting arrangements.)
DR. ROTHSTEIN: Let's just circulate this and we'll all get our calendars out while we are taking up the issue of what topics we should consider for February.
DR. COHN: I presume we can add other dates to this thing?
DR. ROTHSTEIN: Oh, yes. If necessary we will have to go to the third week of February, although that is not optimal.
I had previously suggested three topics for our list. Those topics were law enforcement, banking and schools. The floor I suppose is now open for other nominations of topics that you would like to see included. You can bring back topics from our earlier meeting, of course, or come up with new proposals. John.
DR. HOUSTON: I feel very strongly that we need to get testimony regarding fundraising. If we are only going to do a single individual as part of the open session on fundraising, I think we need to give some more time to that.
DR. ROTHSTEIN: So you think we need more testimony on fundraising?
DR. HOUSTON: We talked about a few minutes ago having somebody from fundraising in the open session, correct?
DR. ROTHSTEIN: Right.
DR. HOUSTON: I don't think that is sufficient, personally. I think there are some real issues or real concerns out there, and I think there is a real impact on fundraising right now. So I think it would be more appropriate to have --
DR. ROTHSTEIN: If the subcommittee agrees with that topic, what we could do is pull the person from the November hearing and have a more extensive discussion in February. So we will put that on the list as a possibility.
DR. HOUSTON: Especially if we are going to wait until March to do the letter. I think then we can take off the open session fundraising, and then put that in a separate breakout. I think that will be time well spent.
DR. ROTHSTEIN: So that is a fourth nomination. Simon, do you have anything?
DR. COHN: Yes. I was actually going to agree with John. I thought obviously, if you don't watch out, that open session will be in two sessions, everything. It is probably better to pay attention to some more general presentations that we can hear in open sessions, and then get into more focused sessions later on.
DR. ROTHSTEIN: Yes. What we might want to do is advise the people that we invite to the open session that we are having specific sessions on the following topics in November as well as February, and if possible, we don't want to go back on our word that this is a quote open session, but ask them if they could address issues other than the ones we are going to --
DR. COHN: I guess my own view of the open session was, I saw it as an opportunity to hear generally from payors, providers, consumers the issues that they were beginning to see or face, rather than a very focused --
DR. ROTHSTEIN: Right.
DR. COHN: I don't know if others agree with that, but that does begin to focus, meaning that it is not open to everything in the world on this.
The other question would be whether or not some sort of open structure should be a feature of each of the sessions, or make an opportunity for one session a second time for another session if we need it.
DR. ROTHSTEIN: Depending on how the open session goes in November, we could readjust our thinking on it. One of the things that we could do is possibly only do three topics in February, leaving another half day open for either another topic that we decide on after the November hearing, or extra time to work on drafting a letter. So that might be a possibility.
Richard, did you have any suggestions on topics? We've got so far banking, fundraising, schools and law enforcement. I see that we have covered the three that got votes from you at the September meeting.
DR. HARDING: I had wanted to combine schools and the issues of minors issues in HIPAA.
DR. ROTHSTEIN: We could do two panels. By putting something on the list, that means that we are committed to two panels. We could do one for schools and one for minors.
DR. HARDING: I think that is too much. I don't mean that minors should have a whole panel.
DR. ROTHSTEIN: Oh, okay.
DR. HARDING: I just think that some of the same issues that involve schools and the rights of minors and their HIPAA rights and so forth are similar to other medical issues. It is all medical health information. But you just get into all kinds of difficulties with 17 and 16 year olds who are seeking treatments for various things, or what to tell divorced parents. There are just all kinds of issues that come up, who has access and so forth.
MS. HORLICK: I would love to hear something about that, because I think it addresses the whole scope of medical privacy, not just in the schools.
DR. COHN: Isn't that as much state law as it is any sort of HIPAA issues?
DR. HARDING: That sometimes is the case, that's right.
DR. COHN: That is part of the confusion about all this, that this is an area where probably 70 percent of this is really state law issues. But of course, it does bring up the issue of the -- I may be overstating this, but there is obviously an ongoing tension that exists between the individual state laws and HIPAA. We noticed that before and have commented on it. Maybe we need at some point to look back and see how that is all working.
DR. FYFFE: I would also like to comment that the HIPAA hotline has continued to receive calls regarding the minors' disclosure issues.
DR. ZUBELDIA: I would like to add something to the list. I don't know, probably as number 11 or number 15 or something like that. But at some point we need to address the issues of insurance brokers and re-insurance companies. They are not payors in the traditional HIPAA term, but in order to do what they do, they have to get the claims themselves, which means they are privy to all the health information anyway.
DR. ROTHSTEIN: So you are talking about health insurance re-insurers.
DR. ZUBELDIA: Re-insurers and brokers.
DR. ROTHSTEIN: And brokers.
DR. ZUBELDIA: Brokers that stand between the employer and the third party administrator, and the re-insurance that start paying once the claims get a certain threshold. For them to know the claims have reached that threshold, they get a copy of every single claim.
DR. ROTHSTEIN: Right.
DR. ZUBELDIA: So it is part of the payment process. I'm not saying that it is not.
DR. ROTHSTEIN: Is it your sense that they are not getting access to the information they need?
DR. ZUBELDIA: They are running into problems where people don't quite understand how it fits in the payment process, and it is starting to sometimes break down.
DR. COHN: Kepa, is this a business partner --
DR. ZUBELDIA: It is business associate of the employer in one case or the third party administrator or the health plan in the other case.
DR. HOUSTON: This is an interesting issue, because in the aggregate with that, when you have an employer or a plan sponsor, the question often arises, who is the covered entity, who is the business associate.
Many people take the position that there are two covered entities, which I have always felt very uncomfortable about, but there is real issues not just with what Kepa is saying, but the whole chain of who is the covered entity. It could be anybody from the employer to the insurer to potentially even the broker, where does he, she or it fit in the process. This is a real quagmire.
DR. ZUBELDIA: The PPOs fit into that mess, where the PPOs themselves are essentially a negotiated contract for providers, and they are not a payor, but the claims go to the PPO first for repricing according to the contract before they get to the payor. So we have this entity that is a PPO processing millions of claims and they are not a covered entity.
I understand they have received some guidance from CMS that says they are not a covered entity, so there is a lot of turmoil, especially in the third party administered claims.
DR. HOUSTON: And this is compounded by the fact that your typical insurer often plays different roles, based upon the different accounts that they have. In some cases, they are doing all the insurance activities, they are the covered entity. In other cases, you have an employer who is self funded, and they are just simply doing claims administration, and in that realm they are the business associate.
So you have these entities that, depending on the circumstance, act indifferent capacities vis-a-vis HIPAA, and at the same time there is a high level of discomfort because in case of self funded, in many cases they don't understand their obligation under HIPAA. So my point is, there is a lot of confusion.
DR. FYFFE: Two associations that have been very involved in this are the Self Insurance Institute of America, SIIA, and also the Society of Professional Benefit Administrators.
DR. ZUBELDIA: I met with the SPBA a couple of weeks ago during their Washington meeting, and the issue came up again.
DR. FYFFE: Yes.
DR. ZUBELDIA: Because some of the SPBA members are PPOs, and they are saying, we have been told we are not covered entities, we don't have to comply with any of this.
DR. ROTHSTEIN: If you recall our Boston hearings, there was testimony about self insured employers and how it wasn't clear what the relationship between -- how HIPAA would affect the relationship between the benefit plan and the employer and all those sort of issues.
But I think what you are raising is more than just one topic. It is like three or four different ones.
DR. ZUBELDIA: It is an entire branch of the food chain. There are several pieces in the food chain. There is the PPO, there is the broker, there is the stopgap insurance, the re-insurance companies that are three of the five elements in the food chain. The other two is the plan administrator and the health plan itself.
DR. HOUSTON: And the employer.
DR. ZUBELDIA: And the employer. So you have all that entire branch that is really confusing, and they need some clarification.
DR. FYFFE: It is confusing with or without HIPAA.
DR. ZUBELDIA: Yes, I agree.
DR. HOUSTON: The confusion without HIPAA -- I don't think there was confusion without HIPAA, because they frankly did what seemed to make business sense. With HIPAA, because of the fact that there are all these designations, you are either a business associate or you are a covered entity, because of that, I think the issue is that there isn't any uniformity as to how they declare themselves, or in a lot of cases, there is a lot of naivete as to whether -- what even HIPAA is.
So I hear it from our health plan, that they deal with this constantly, where they are really trying to counsel their customers as to what they are and what their obligations are, and sometimes it is successful, and other times I get the sense that there is a lot of ambivalence towards all of this.
DR. FYFFE: Just to be certain my notes are correct, we have got five parts of the food chain, as Kepa has said, the PPO, the broker, the re-insurer, the plan administrator and the employer.
DR. ZUBELDIA: And the health plan, if it is different from the employer.
DR. ROTHSTEIN: What I would like to suggest, if there are no more topics that people want to nominate, is that we approve three now for planning purposes, that will help us in our November invitations, as well as allow Kathleen to start doing some background work.
DR. HOUSTON: Are we having an open session in February, or are we going to have four sessions?
DR. ROTHSTEIN: Here is the thinking. I'd like to approve three topics for February, and leave one session open, and then at the November hearing, at the end decide on what the fourth topic is then. So we may decide that the open session in November was so successful that we need to have another one. We may decide to go back to our list and pick up another topic, et cetera.
I don't want to box ourselves in for February at this early point. Is that okay with you, Kepa?
DR. ZUBELDIA: Yes.
DR. ROTHSTEIN: Richard?
DR. HARDING: Yes.
DR. ROTHSTEIN: Simon seems to have stepped out for a minute, so this is a good time to vote. Let me just go over the list so that everyone knows what they are voting for in advance. The five that I have are banking, fundraising, schools, law enforcement and this last one, the payment issue, starting with employers and going all the way through re-insurers.
DR. HOUSTON: We also say for schools, minors too?
DR. ROTHSTEIN: That was an element. That was not a separate issue. As Richard envisioned it, that would be subsumed within schools.
I guess we will see if we need Simon's vote later. All those in favor of banking, raise their hand. I'll get you in a second, Richard. Banking. Richard, is your hand up?
DR. HARDING: Banking, yes. How many are we going to choose?
DR. ROTHSTEIN: You've got three votes. We are going to vote for three.
DR. HARDING: Only three votes?
DR. ROTHSTEIN: Right, and then we are going to hold open one more.
DR. HARDING: I've got you, okay.
DR. ROTHSTEIN: So is that a yes on banking?
DR. HARDING: Correct.
DR. ROTHSTEIN: So there was three on banking. Fundraising, all those in favor of fundraising, raise their hand. Richard, is your hand up?
DR. HARDING: Yes.
DR. ZUBELDIA: We only get three votes, right?
DR. ROTHSTEIN: Sorry?
DR. ZUBELDIA: We only get three votes.
DR. ROTHSTEIN: You get three votes. Those in favor of schools, raise your hand.
DR. HARDING: Aye.
DR. ROTHSTEIN: So schools gets three. All those in favor of law enforcement, raise your hand. Richard? Oh, you're out of votes.
DR. HARDING: I thought there were only three choices.
DR. ROTHSTEIN: No, no, there are five choices.
DR. FYFFE: Let's repeat the five choices.
DR. ROTHSTEIN: The five choices again -- we'll start all over -- the five choices again are banking, fundraising, schools, law enforcement and the fifth one is the food chain.
DR. ZUBELDIA: The food chain as one topic.
DR. ROTHSTEIN: Right, starting with employers, running all the way through re-insurers. So those are the five.
DR. ZUBELDIA: Mark, I don't think the food chain is going to work as one topic. I think we need to split that into at least two separate ones, one for covered entities that are a part of that food chain, and one for non-covered entities that are a part of the food chain. Their issues are going to be completely different. Their views are going to be completely different.
DR. ROTHSTEIN: Typically what we are going to do is, each topic will have two panels, so we could split it at that stage.
DR. HARDING: I'm ready to vote.
DR. ROTHSTEIN: You're ready now? Now there are five topics, three votes, and four people who are eligible voters at the moment.
DR. HOUSTON: Unless Simon shows.
DR. ROTHSTEIN: Unless Simon returns. So he could make or break a tie, I'm sure.
DR. HARDING: Should we just each give our three?
DR. ROTHSTEIN: Yes.
DR. HARDING: My three would be law enforcement, minors and fundraising.
DR. ROTHSTEIN: So fundraising, minors, law enforcement. You are done.
DR. HARDING: I'm done.
DR. ROTHSTEIN: John?
DR. HOUSTON: I'd like fundraising, fundraising and fundraising, but since --
DR. ROTHSTEIN: No cumulative voting.
DR. HOUSTON: My two strong ones are fundraising and the payment process, the food chain. Otherwise, I really do not have any strong opinion about the other three.
DR. ROTHSTEIN: Kepa?
DR. ZUBELDIA: Banking, schools and minors, and the PPO broker-employer food chain.
DR. ROTHSTEIN: I got three votes, and I will vote for banking, schools and law enforcement. So now we are totally, hopelessly deadlocked. Simon is not here, and if he voted for anything but schools, it would cause a tie that could be as many as a four-way tie for three votes.
DR. HARDING: Pretty amazing.
DR. HOUSTON: Maybe I don't understand.
DR. ROTHSTEIN: Yes, you've got another vote. You could help us here.
DR. HOUSTON: Fundraising again.
DR. ROTHSTEIN: You obviously missed our hearing on fundraising that we had last year.
DR. HOUSTON: I wasn't on the committee.
DR. ROTHSTEIN: No, I understand that. Had you been here, you wouldn't vote for fundraising.
DR. HOUSTON: All I know is that I continue to live the fundraising morass, and it is a looming potential, substantial issue to academic medical centers and hospitals because of the limitations on how fundraising --
DR. ROTHSTEIN: We are aware of that issue. We spent a lot of time on it. Simon, you get three votes from the following list. Banking, fundraising, schools, law enforcement and employers, insurers, re-insurers, PPOs, health plans, that whole group.
DR. HOUSTON: The payment food chain.
DR. COHN: I think the food chain.
DR. ROTHSTEIN: One food chain.
DR. COHN: One food chain, one schools and one law enforcement.
DR. ROTHSTEIN: So that makes it easy. So with four votes, schools, with three votes, law enforcement and payment food chain. So we are not going to do initially -- we have one slot left -- we are not going to do initially fundraising and banking, so we might want to include somebody on those issues at the open session, and still leave open the possibility of adding a --
DR. HOUSTON: We have two open sessions, correct?
DR. ROTHSTEIN: No, we have one open session. A public testimony, but anyone can sign up for two or three minutes.
DR. HOUSTON: If we had the open session and we only devoted one panel each to banking and fundraising, would that -- or am I just confusing things?
DR. ROTHSTEIN: No, we are talking about -- the open session is in November. This is the lineup for February.
DR. HOUSTON: I understand that, but you said you have an open session in --
DR. ROTHSTEIN: An undecided slot.
DR. HOUSTON: That is my point. The undecided slot session, if it is a full session of two panels, --
DR. ROTHSTEIN: Correct.
DR. HOUSTON: -- why wouldn't we simply say we have a single panel for banking and one for fundraising?
DR. ROTHSTEIN: That I think is an excellent suggestion, but what I have proposed is that we not decide that until after the November hearing, because we might want to change our minds, based on something that we hear. Some open session testifier might raise an issue that we hadn't thought of that is just so compelling that we need to add it.
DR. HOUSTON: I would think that is fine. I would just like the thought that, absent that, we give some consideration to two panels, one of each.
DR. ROTHSTEIN: I am prepared to have that as our default position. But I think the flexibility --
DR. HOUSTON: We can always after the November stuff --
DR. ROTHSTEIN: We could vote, we could have a recall and decide to change our --
DR. FYFFE: But who is going to adjudicate?
DR. ROTHSTEIN: -- we could change our list. Are there other issues that we need to talk about?
Hearing none, I want to go to our schedule. We circulated a list of the following dates, the 3rd, 4th, 5th, 10th, 11th, 12th and 18th and 19th of February.
(Discussion off the record regarding meeting arrangements.)
DR. ROTHSTEIN: Other items for us to deal with before adjournment? Richard?
DR. HARDING: Yes?
DR. ROTHSTEIN: Anything else?
DR. HARDING: No further items. I'll be on the phone at 1 o'clock.
DR. ROTHSTEIN: Okay. Congratulations on the baby.
DR. HARDING: Thank you. They are doing well. I was just over there last night.
DR. ROTHSTEIN: Gail?
MS. HORLICK: I don't have anything further.
DR. ROTHSTEIN: Thank you. If there is nothing else, thanks for calling in.
DR. FYFFE: Wait a minute, we've got one --
DR. ROTHSTEIN: You are going to brief us on banking?
DR. SANCHEZ: I was asked to come and just say something briefly about banking.
DR. ROTHSTEIN: Yes. Richard and Gail, Linda Sanchez is here. She is going to tell us about what OCR is doing with banking.
DR. SANCHEZ: I am actually not able to say very much. I can say that we have received a couple of letters, a letter from an advocacy coalition and also a letter from the American Banking Association.
DR. HARDING: Right into the microphone, please.
MS. HORLICK: Yes, I can't hear them.
DR. SANCHEZ: I'm sorry. Can you hear me now?
DR. HARDING: Better
MS. HORLICK: Better.
DR. SANCHEZ: We received letters from the American Banking Association and another piece of correspondence from a coalition of advocacy groups regarding access by the banking industry to sensitive medical information. It is an issue that is being discussed at the highest levels here, and we hope to be able to say something soon.
DR. ROTHSTEIN: Say something means a guidance document or FAQs or something?
DR. SANCHEZ: Those are all options.
DR. ROTHSTEIN: Right. Don't want to ask inappropriate questions. But I thank you for raising that for us. I would assume that even an OCR action in this area would not necessarily foreclose all of the issues, because then you have got education issues and training and so on, that we might want to take up at our hearing in February. We might talk about the response to whatever it is that you come up with.
DR. SANCHEZ: Yes.
DR. ROTHSTEIN: Thank you, I appreciate your stopping by. With nothing else, we stand adjourned. We will get back to you, Richard, on the dates just as soon as possible.
DR. HARDING: Good. Talk to you this afternoon.
DR. ROTHSTEIN: Thanks, everybody.
(Whereupon, the meeting was adjourned at 9:35 a.m.)