Hubert H. Humphrey Building
Room 303A-339A
200
Independence Avenue, S.W.
Washington, D.C.
Committee Members:
Hortensia Amaro, Ph.D.
Jeffrey S. Blair, MBA
Simon P. Cohn, M.D.
Kathleen
A. Frawley, J.D.
Daniel J. Friedman
Kathleen Fyffe
Richard K.
Harding, M.D.
Kathryn L. Coltin
Robert M. Gellman, J.D.
Lisa I.
Iezzoni, M.D.
John R. Lumpkin, M.D.
Clement Joseph McDonald, M.D.
Barbara
Starfield, M.D.
M. Elizabeth Ward
Liaison Representatives:
Robert Moore
Harvey Schwartz, Ph.D.
James Scanlon, HHS Executive
Staff Director
Marjorie S. Greenberg, Executive Secretary
Call to Order, Introductions -- John R. Lumpkin, M.D.
Future Meetings and Agenda Topics
Report on Confidentiality and Genetic Data Issues -- Dr. Bill Raub
Reports on Subcommittee Work Plans
Public Education -- Ms. Elizabeth Ward
DR. LUMPKIN: Good morning.
Unfortunately, Don Detmer had a death in the family and had to go home. So, he has asked me to chair today's session.
I would like to remind everybody that we are going live over the Internet. So, when you speak, to state your name in full and I will start by doing so. My name is John Lumpkin and I am -- that is my name.
Maybe we can go around the room and do some quick introductions and then proceed to go on with the business of the committee.
I am going to ask for the audience to introduce themselves first and the we are going to introduce the committee and what I would like to do is when the committee introduces themselves, I want to take a sort of a poll of when people have to leave, just so I can manage the quorum.
[Introductions of audience off microphone.]
DR. FRIEDMAN: Dan Friedman, Massachusetts Department of Public Health. I should leave around 4:00 or 4:15.
DR. HARDING: Richard Harding, South Carolina. I will stay until the bitter end.
DR. COHN: Simon Cohn, Kaiser Permanente. I am leaving with Elizabeth. So, I don't know what time we are both going to go.
MS. COLTIN: I am Kathy Coltin, Harvard Pilgrim Health Care. I will be leaving at the morning break.
MR. MOORE: Bob Moore, HCFA.
MR. SCANLON: Jim Scanlon, HHS.
MS. GREENBERG: Marjorie Greenberg, NCHS.
DR. STARFIELD: Barbara Starfield, Johns Hopkins. Flexible.
DR. BLAIR: Jeff Blair, Medical Records Institute. I need to leave at around 3:45 or 3:30. If somebody is going to leave at 3:00 and I can tag along, that would be nice.
DR. GELLMAN: Bob Gellman, privacy and information policy consultant, at your disposal.
MS. WARD: Elizabeth Ward, Washington State Department of Health.
MS. FYFFE: Kathleen Fyffe, HIAA. I am available until 4:00 p.m.
DR. LUMPKIN: Great. And welcome aboard.
Okay. Our first speaker has a little problem with her handouts. So, she will be with us momentarily. So, let's take care of a couple of business items.
Did you want to --
MS. COLTIN: This is a message from your Planning and Implementation Work Group. We have put together a list, Lynnette has, of all of the sort of outstanding or loose end types of activities that the committee has engaged in, going back to 1990. And we have gone over it and made some recommendations as to where these particular issues should be referred within our subcommittee structure.
These are going to be distributed to each of the subcommittee chairs, along with the documentation for the report that is referenced in terms of some action that was taken by the committee that might or might not warrant follow-up.
What we are looking for is to have each of the subcommittee chairs look this over and come to the Executive Committee meeting prepared to make some recommendation as to whether this has been referred to the right place, first of all. If so, is it already addressed within your existing work plan? If not, do you believe it should be added to your work plan and you will bring it up at your next meeting? Or do you believe that it is an issue that at this point should be put to rest?
So, Lynnette is passing those out to the subcommittee chairs.
Thank you. That is it.
DR. COHN: Can I just make an announcement?
I think most everyone is familiar with this, but the National Conference on Terminology for Clinical Patient Description, which the NCVHS is one of the conference planning organizations for, is occurring next week, November 12th through 14th in Washington.
Speaking there includes Don Detmer, Bill Braithwaite. I will be talking for a couple of minutes. Obviously, I think it will be of major value to the committee and, obviously, just urge everyone who is interested in these items to come and join at the conference.
DR. LUMPKIN: Does that conference extend until Thursday?
DR. COHN: It extends until Friday, 12 through 14th.
DR. LUMPKIN: Would that be the one I was speaking at?
DR. COHN: John, I am sorry. Yes, we believe Dr. Lumpkin is speaking there, too.
DR. LUMPKIN: Let's skip down to the last item on the agenda, which is future meetings. We would like to review the dates of those and if there are agenda topics that anyone may want to -- feel that we need to address -- I except that there will be some suggestions from the subcommittees. So, we will take those up at the subcommittee reports. But if there are other agenda items that we would like to place on future meetings -- I know taking this out of order may just kind of catch you all cold. I do want to catch people who may be leaving to give them an opportunity to toss stuff into the hopper.
MS. GREENBERG: Is everyone clear on the dates of the 1998 meetings?
PARTICIPANT: I am sorry. I did the list and it is being copied.
DR. LUMPKIN: Okay. We will get those dates. You have got to watch out, you put me in charge and I start getting sneaky.
The other thing I would like to do is to perhaps
-- maybe we can pick some dates in April. The suggestion from the -- will be coming out of the Subcommittee on Health Data Needs, Standards and Security, is recommending that there be a hearing in April on unique personal identifier. Don suggested before he left that he wanted to see that happen.
I understand that the Committee on Population Specific Issues is recommending that that be a committee- wide hearing. We are not exactly sure of the auspices that we want to hold it under because just wanting to deal with quorum issues, but whatever it is, we would like to encourage all of the members of the full committee to attend that hearing.
So, if we could perhaps identify some dates in April for a hearing in Chicago.
MS. GREENBERG: We have the Subcommittee on Population Specific Issues has actually scheduled a -- probably a site visit on April 21st and 22nd.
DR. IEZZONI: That is right, in Boston.
DR. GELLMAN: John, this hearing is going to be in Chicago. Is that the plan?
DR. LUMPKIN: Yes.
DR. GELLMAN: Why?
DR. LUMPKIN: Well, there is a whole host of reasons. The first reason being is that we would like to give people around the country to come in and we know that when we held hearings on the West Coast, there were people who weren't present and Chicago being a centralized location, it is easier for folks on the West Coast to make it.
The second reason is is that I can't leave Illinois in April and May.
DR. GELLMAN: House arrest?
DR. LUMPKIN: Yes. No, that is the last two months of our legislative session.
DR. GELLMAN: Let me just make a comment. I don't really care that much. I just think it means -- I mean, this happens wherever you hold a meeting. It means that some people will be excluded because they won't be able to come.
I also think that the identifier issue cuts very broadly and that I think if we are really serious the hearings and trying to get a lot of views, we are going to need more than one meeting.
DR. LUMPKIN: I agree. I think we will probably need to look for another one probably in May or June. We are hoping -- and I think we all agree that this won't be a one-shot deal.
DR. STARFIELD: We probably ought to identify the later date as well to get it on --
DR. LUMPKIN: Okay. Any preference whether we do a Monday/Tuesday or a Thursday/Friday in April?
DR. STARFIELD: What is the matter with the middle of the week? It is easier to travel, not on Sunday night, not on Friday night.
PARTICIPANT: Wednesdays are the days that Vince cannot make it. He has said that.
DR. LUMPKIN: Okay.
DR. STARFIELD: Well, travel-wise, I guess, Monday and Tuesday are better. Friday night is terrible.
DR. LUMPKIN: So, we have the 6th and 7th.
MS. GREENBERG: Are you talking about a Monday and Tuesday?
DR. LUMPKIN: That is a Monday and Tuesday.
DR. STARFIELD: I can't make it.
DR. LUMPKIN: The 13th and 14th?
Okay. We can set that tentatively for the 13th and 14th. We do need to --
DR. COHN: I guess I am trying of saying this sensitively, but there is a whole number of holidays that occur that weekend before the 13th and 14th and then coming from the West Coast, you basically have to leave the day before.
MS. GREENBERG: That is Easter weekend, right?
DR. LUMPKIN: Is that Easter weekend?
DR. COHN: Passover, Easter and everything else.
MS. GREENBERG: Sunday being Easter, that probably is not good.
DR. LUMPKIN: Okay. 20th and 21st.
DR. STARFIELD: Well, that overlaps with the population committee.
MS. GREENBERG: We can't do those.
DR. LUMPKIN: 9th and 10th, even though Fridays are bad days?
DR. STARFIELD: That is Good Friday.
DR. LUMPKIN: The 10th is a good Friday? No, it is a bad Friday.
[Multiple discussions.]
PARTICIPANT: John, is the 31st of March and 1st of April --
DR. LUMPKIN: Let's look at that.
PARTICIPANT: You mean the 30th and 31st of March?
DR. LUMPKIN: Of March.
PARTICIPANT: I will be on vacation.
DR. LUMPKIN: In Chicago? It is a wonderful place to come.
MS. GREENBERG: The advantage to being a little later is that we didn't want to have it until we were sure the notice of intent was out. Inching back to March, it may not be --
DR. LUMPKIN: Well, we want it out and have people have a chance to see it.
MS. GREENBERG: Have people have a chance to read it and maybe to comment on it.
DR. LUMPKIN: Let's try the 27th and 28th. Is there a problem there. Of April.
DR. IEZZONI: You know, once you get a little bit later, academic schedules aren't going to be as important. So, maybe Vince can do a Wednesday.
DR. LUMPKIN: 4th and 5th of May. Going once, going twice. Okay.
PARTICIPANT: Will this be sent on the e-mail, too, all the schedule things?
MS. GREENBERG: Yes. We are passing out and we will update it.
DR. IEZZONI: Can I correct for the Population and Specific Issues, we will be in Tucson in February, not Boston. And Boston in April.
DR. STARFIELD: Do you want to get a June date as well for another hearing?
DR. LUMPKIN: How about June --
MS. GREENBERG: The full committee is meeting June 16th and 17th.
DR. LUMPKIN: Do we want to add a day?
MS. GREENBERG: We held the 18th.
DR. LUMPKIN: Do you want to just add the 18th then?
MS. GREENBERG: Maybe that wouldn't be a bad idea.
DR. LUMPKIN: That would be a Thursday.
MS. GREENBERG: Well, the 18th -- unfortunately, the 18th and 19th seems to be the ANSI/HIS(?) meeting.
DR. LUMPKIN: So, who is more important?
DR. MC DONALD: It is possible we could have no space to do anything in life.
DR. LUMPKIN: How many people would that knock out?
MS. GREENBERG: Well, it knocks out the staff and some members.
DR. MC DONALD: Which members does it knock out? It doesn't knock me out.
MS. GREENBERG: I know it knocks out Jeff Blair. Kathleen often is at that and Simon.
DR. COHN: It is a big decision which to go to.
DR. LUMPKIN: Want to do the 15th then?
MS. GREENBERG: Was there a reason why we didn't pick the 15th, 16th and 17th? Maybe because we didn't really like Mondays that much.
DR. STARFIELD: Can we ask Jeff? I mean, Jeff is here.
DR. COHN: I think this becomes an issue that no one knows six months ahead whether or not -- which meetings they need to be at.
DR. LUMPKIN: We are going to sort of light on the 15th and --
MS. GREENBERG: 15th, 16th and 17th of June. Obviously, we will have to check with Don.
So, we have got May 3, 4 -- 4, 5, I mean, in Chicago.
DR. LUMPKIN: And then June 15th.
MS. GREENBERG: And we are thinking that that one might be a day of hearings in Washington on the unique identifier.
DR. STARFIELD: Maybe we should hold the 18th just in case in terms out to be okay and maybe the Monday is not okay with Don.
DR. LUMPKIN: Okay.
Any items for the agenda?
MS. GREENBERG: Kathy had to go, I guess, and get her ID. You may have also noticed that at the back of your agenda book, the very last thing -- that is not where it is. DR. LUMPKIN: I thought we already had that on our agenda.
MS. GREENBERG: What is it you are looking for? Okay. Under F, we have reinstituted the project work plan for -- but in a somewhat different format and trying to -- those of you who were on the committee in the past may recall we had something like this in which we have tried to capture what all the subcommittees have in their work plans and what they plan to do and then action items and results or milestones. So, I just ask you to look at this, see the extent to which it is accurate. Particularly, the subcommittee chairs please review it and the extent to which the information here is useful or helpful or could be improved -- we are just working on it now. This is our first iteration of it.
But we do want to have something like this in the future in every -- you know, for every meeting. So, we really appreciate your review of it and any comments or suggestions.
DR. LUMPKIN: Let's move into the first agenda item, "Presentation on National Vital Statistics Program and Evaluation of Standard Certificates," Mary Ann Freedman.
MS. FREEDMAN: Thank you very much. It is a pleasure to be here and thank you for indulging me this morning. I had a little mix-up with the office.
I really appreciate the opportunity to talk to you about the vital statistics system. I see some new faces at the table. So, I thought I would go back and start at the beginning for a minute.
As you probably know, the U.S. vital statistics system is decentralized. The legal authority for registering births and deaths rests with the states and the territories and there is no federal law mandating the registration of vital events in the United States.
However, we do have a federal law requiring NCHS to produce national vital statistics by collecting data from the states. So, what we do -- our compilation of data has always depended upon cooperation between the states and the Federal Government and a collaborative effort.
This effort really began in the early 1900s and over time it has become more formal. What we are operating under now is called the Vital Statistics Cooperative Program, which is a program through which we obtain computerized data from the states. We have formal contracts to cover partial costs of their expense, but also we work with them collaboratively to develop the program.
It is not a situation where the Federal Government is just going out and buying data. It is a situation where we are really trying to work together with the states to establish and to determine what ought to be in the data and how to best meet the nation's needs.
I would like to mention a couple of things that have happened in the past couple of years. The last time I addressed the committee, the Vital Statistics Program was in transition and we were in the midst of an overview to strengthen the program and streamline it because we had had some major staffing changes.
We have done a few things that I think have improved it in the past couple of years. The most notable is the introduction of the preliminary vital statistics series, which allowed us to release some detailed data approximately a year earlier than we normally release our final data.
We put the 1995 preliminary data out in October of 1996. We improved that and put the 1996 preliminary file out in September of 1997. This is a series that is based on a substantial sample of the records and what we have tried to do is accommodate the most important public health data items at the national level and then a limited amount of state level data as well.
We are also working with the states to speed up the production of final files and the 1995 natality and mortality files, which were released in June, came out at about the earliest that we have seen those come out in recent years.
I think the other point of note because we get into the issues that I think you are most interested in, I would like to just mention something about the ICD and our software products for coding cause of death. All deaths in the United States are coded using software that NCHS provides or NCHS uses. We have an automated system for coding causes and there are several levels of that.
We provide that to the states and their contractors. We also provide it to many other countries throughout the world. Our plan is to implement ICD-10 in 1999 and, of course, to do so, one of our big efforts right now is revising the software, as well as revising the tabular programs and the analytic programs.
One of the things that is of issue, concern to us, is the fact there will be not only massive efforts in our office for this conversion, but there is going to be considerable work required at the state level for this implementation.
However, we have been working with the state registrars and the statistics offices and they are all well aware of the fact that this is coming up.
DR. STARFIELD: You are talking about CM, I gather.
MS. FREEDMAN: No. ICD-10. We do not use CM in mortality.
I understand that you had a few questions about the automated registration systems that are being developed in states. So, I thought I would talk a little bit about that.
While states have automated their data processing systems for many years, automation of registration is relatively new. By that I mean electronic capture of information at the source and transfer of that information to the state and then on to NCHS in electronic form.
What we call the electronic birth certificate started in the early 1980s, basically as stand-alone, PC- based systems that were used in hospital medical record rooms. They were developed independently by states, very often through private vendors and the basic process didn't change the vital registration process exactly. What they did was to impose an electronic system on top of the current birth registration system.
So, often the way it would work at that point in time was that a clerk would interview the mother in the hospital, go to the medical record, find the medical information that was needed, collect the data on a work sheet and then transfer that information into the PC. Originally, hospitals were sending diskettes to states. Now, they are transmitting electronically.
We have made some -- there have been some changes in those systems over the past several years. The edit systems in them have improved and we have moved to more automatic coding with the entry of literals. We have also seen a couple of states who have developed legal -- who have managed to enable the use of electronic signatures at the hospital level, so that there no paper copy needs to flow through the system. The electronic copy becomes the legal component of the record, of the legal record.
There has also been a large expansion of this, of the EVC system. At the moment, 85 percent of births in the United States are registered electronically and over half the states register virtually all their births electronically. Now, many of those states still have a paper met record that travels through the system to meet the legal needs. But the electronic record gets to the state office much more rapidly than it may have a few years ago.
You should be aware that this expansion of EVC is due in parts to the efforts of another federal agency. That is the Social Security Administration. SSA, a few years ago, was interested in developing a mechanism to use birth registration as a vehicle through which parents could order a social security number for their child. That is a project called the Enumeration at Birth.
As Enumeration at Birth matured, SSA recognized the need to speed up the vital registration process and subsequently provided a fair amount of seed money to states to get the EVC system off the ground. I think we probably would not be as far along as we are today with that system without some of those SSA dollars because it is clear that automation does take -- at least does take a fair amount of money. We at NCHS were not supplying that.
A little bit about where we think we are going in the future with EVC. What we envision down the line is a system that would use a computerized labor and delivery record and make the birth certificate a byproduct of this. Ultimately, you could also meld in the postpartum record and the pediatric record.
Last year, Dr. Fred Frigaletto(?), who is the chairman of OB at Massachusetts General, was president of the American College of Obstetrics and Gynecology. As his presidential initiative, Dr. Frigaletto wanted to concentrate on furthering the development of a computerized patient record for obstetrics.
We were very interested in this effort because we saw it as a potential data source for the birth certificate. So, we got together with Dr. Frigaletto just to see how we could meld these interests. As a result, last March, ACOG, NCHS and the Division of Reproductive Health in the Chronic Disease Center of CDC co-sponsored a workshop on options for computerized OB records.
We had a rather broad-based group of people there representing the data providers, data users. The National Committee was represented by George Van Amburg. Dan Friedman was also there. He was representing the National Association for Public Health Statistics and Information Systems.
We thought it was a very successful conference and it was the beginnings of a coalition to further this effort. What came out of that was first the development of a small steering committee and the drafting of a very preliminary plan, a staged plan, for proceeding. ACOG is providing a home for this project and we have received a bit of seed money from the Maternal and Child Health Bureau in HRSA.
We have got a part time obstetrician, who is doing some data gathering at this point in time. We are looking for additional sources of funding so that we can really begin to do some committee work and move the project along.
But we are very excited about the potential of that to improve the birth registration process, as well as to be very productive for the full obstetric record.
DR. STARFIELD: Can I just clarify that? That really is OB, not OB/GYN. It is really just --
MS. FREEDMAN: I am sorry. You are right. It is OB.
DR. MC DONALD: [Comment off microphone.]
MS. FREEDMAN: Yes, it is.
I will talk a bit about electronic death registration. The electronic registration of deaths has been much slower to develop primarily because the process is much more complex and there are so many more players involved. We have far more funeral directors and certifying physicians in the country than we do hospitals.
New Hampshire started experimenting with electronic death registration back in the mid-eighties. Their system was really a funeral director driven system, where the funeral director prepared an electronic record, went and got the medical information from the certifying physician and then entered it into the system and transmitted that record to the state. So, it was a merged system.
It was also a system that was in use in Minnesota at the Mayo Clinic. The Mayo Clinic was working with one funeral director with Mayo preparing most of the record and including the cause of death and then giving it to the funeral director to finish and send on to the state.
But these really weren't typical systems, as one might envision them and one of the concerns that NCHS and the state association had back in the early nineties was that these systems would develop like the birth registration system did with not very many standards in place and with not much consistency among states until after the fact.
So, in 1994, we, along with the National Association of Public Health Statistics and Information Systems, set up a steering committee to look at the death registration process and essentially the charge that we gave to that committee was if you were starting from scratch and you said we have technology as it currently exists, how would you set up a system to register deaths?
The committee was, again, fairly broad-based and with representatives from the providers and users and from the states. They met for about two years and made a final report in December of 1996. The basic recommendations they made, I will just mention a few of them. First of all, they reaffirmed the role of the state in death registration. They said the system should be state-based. The state registrar should have the responsibility ultimately for registration.
Funeral directors should have the primary responsibility for tracking down the information and registering the death. One of the recommendations they made that is different from the way the system operates now is they suggested that information should be reported into the state in two phases, that the fact of death should reach the state within one day with the cause of death and demographics within four.
There were a number of recommendations with respect to data quality, the systems design and implementation and one of the things that they also recommended was that NCHS convene an ongoing smaller oversight group to just assure that EDC didn't die on the vine but that encourage efforts in the registration -- electronic death registration area.
At this point in time now, we do have several states that are pursuing electronic death registration very actively. I will just mention what is happening in a couple of places.
New York State is developing a state-wide system that we think is going to be very interesting and may provide a model for the nation. As its backbone, it has got a statewide Internet that is maintained by the state. The traditional providers are entering data and accessing the system and any of those providers can initiate a record. So, the record can be initiated by the hospital at the time death is pronounced by the funeral director when the body is -- when he receives the body by the certifying physician.
Not only can all of those people initiate them, they can all get into the record and do their parts with the appropriate safeguards, et cetera. New York passed legislation that enables electronic signatures so that there will be no paper record.
They have also incorporated a component into this system which allows for funeral directors to order copies of death records for the family and pay for them electronically through an accounting system.
Their plan is to be in beta tests this winter, go statewide when their beta test is completed. They are hoping that that will happen in the spring. New York City, which is a separate registration area from New York State, intends to become a part of this system once it is fully operational. There has also been interest from some of the other surrounding states. So, that is one that we are watching very carefully.
On a slightly different note, Indiana is developing a system that they are hoping to be up with very soon, but they are basing it on a -- going at it from a slightly different perspective. They are taking a piece of commercially available software called Data Digger, which is a package that funeral directors use and modifying that.
There are between six and ten other states that have activities going on in the area in various stages of development. And I don't mean to slight them, but I think that those two probably give you a general idea of what is happening in this area.
Let me turn now to the issue of standard certificates and where we are going with that. One of our charges at NCHS is to issue recommended standards for states to adopt and the states may adopt -- or would adopt these, of course, voluntarily. Among these standards are mono- laws(?) and regulations, uniform definitions and uniform reporting forms, the reporting forms being the standard certificates in reports.
The states basically will take these standards as models and then design their own vital certificates, first of all, and secondly the standard certificates form the basis for the minimum data set in the VSCP contracts. The first standard certificates of birth and death were developed in 1900 by the Census Bureau. The standards are periodically revised. This will be the 12th revision process.
We are beginning a process now with the expectation that we will implement the new revision in the year 2002. The way the process works is that we appoint an expert panel to produce the revision process. The panel has -- as we have structured it this time around, will have 24 members. This will include state registrars and statisticians, some researchers and some individuals who are representing organizations, such as the AMA, the American Hospital Association, et cetera.
The charge to this panel is to -- essentially, the panel is called the panel to evaluate the standard certificates. So, what they do is start with the current documents. They will be looking at those documents. Their charge is to refine those document to meet the needs of the systems major users over the course of the next decade; also, to educate data users about the basic vital statistics principle, how the system operates, what it can do, what its limitations are and also to suggest alternate data sources because one of the things that we find is that people will come into us and say why don't you add this item, that item or whatever, items that really are specific to certain and would be better to certain research projects, would be better collected through special studies.
So, one of the things that we need to consider is what do we need to have on every birth and every death that is registered in the United States.
The other major issue for the panel is to ensure that their recommendations will meet the system's legal functions as well as its statistical functions. So, we are really addressing more than just the form and content of the certificate. One of the things that I think is important for this time around is that we integrate what is happening on the automation side with the standards certificate development so that we are really not recommending a paper document as we have in the past, but we are recommending a data set and perhaps a mechanism to obtain that data set and then what is needed for the legal component of the vital registration system.
Basically, when the panel looks at data items, it considers two issues. First of all, whether or not the item is needed either for personal identification, for establishing time and place of event or whether it has a high priority among the data needed for scientific or public health programs.
The second criteria that every item on the birth or death certificate must have is that there must be some basis for believing that you can collect that information with a reasonable amount of effort. That has been the one that hangs us quite typically.
The way we get input as a panel is first of all we mail a survey out to a large number of interested individuals and organizations. We have sent the survey out already. There are 1,700 parties on the survey.
We are building a database of those responses. I believe the committee are on our mailing list, but I am not sure that the new ones are. So, we will verify that and get that out to them if they are not.
We also get written testimony from people who are interested enough to provide us with it. We solicit some presentations and we also -- the panel also relies on its own expertise. We expect that the panel will hold about six meetings over the next two years.
We are currently in the process of appointing members. We are planning to have the first meeting in January 1998. We would like to see them finish their work and make recommendations to NCHS by the summer of 1999. Once NCHS has those recommendations, we then proceed with the departmental clearance process, the endorsement from appropriate organizations and then ultimately transmit the final set of recommendations to the states and indicate with an implementation date and indicate what the contractual requirements will be.
So, basically, that in a nutshell is what we are doing on standard certificates, automation and I would be more than happy to answer any questions.
DR. BLAIR: Mary, will the scope of the panel include clinical information, such as DNA information?
MS. FREEDMAN: The panel will include researchers who are clinicians. I don't believe that we have -- are considering DNA information as a potential item at this point in time. That is not that it should not be ruled out.
DR. BLAIR: -- known to be excluded --
MS. FREEDMAN: It is neither within nor outside the scope. There is no one targeted for the panel who was targeted because of their expertise in the DNA area, if that is your question.
DR. GELLMAN: Could you help me clarify some of the rules that apply with respect to public access to this information? What are the policies at the state level with respect to disclosure of birth certificate information and what are your policies?
MS. FREEDMAN: Okay. At the state level, it varies from state to state and it depends -- and both at the state and the national level it depends is the answer to that question.
Why don't I start with the national level first and then we will do the state.
DR. LUMPKIN: I didn't know you were a lawyer.
MS. FREEDMAN: We released a public use data tape of statistical information. That data tape is very detailed but restricted at the geographic level to areas of 100,000 or more. We also delete absolute dates -- day of event and other dates. That is generally available.
If a researcher needs more than that, we have got a couple of other options. We have a three year data tape, which will give you very specific geographic detail, but will not give you the year of the event or we have got a mechanism for you to -- we have got a one-year tape that gives you geographic detail that deletes a couple of other data items so that we do protect confidentiality.
If you need things like day of event, we have got a program where we can provide it to the researcher if it goes through the NCHS confidentiality officer and confidentiality committee.
DR. LUMPKIN: Can I clarify that? Do states send you names?
MS. FREEDMAN: No, they do not, except for the national death index. So, we are not talking about identifying data. We are talking statistical data at the national level. At the state level, I think the policies vary from state to state. If you are looking for -- if you are looking for identified data, all but 18 states restrict access to the names on birth -- to the identifiers on birth records and I think there are 18 states that do not restrict access on death records.
However, they all have provisions for accommodating research needs and those provisions vary and they vary significantly.
DR. GELLMAN: I am a little confused. All but 18 states restrict access?
MS. FREEDMAN: Yes. There are 18 states that are what we would call open record states, where --
DR. GELLMAN: What exactly is open?
MS. FREEDMAN: The entire file.
DR. GELLMAN: The entire birth certificate?
MS. FREEDMAN: The entire birth certificate is considered a public record.
DR. GELLMAN: So, if you expand the categories of information that is collected on the birth certificate, they would presumably become public as well.
MS. FREEDMAN: Unless the law has changed in those states, yes.
DR. LUMPKIN: Can I clarify that?
MS. FREEDMAN: Yes, sure.
DR. LUMPKIN: Because in our state something I just became aware of because we got sued over it, our birth certificate includes information as to number of pregnancies, number of pregnancies that are terminated. In those open states, that information is available?
MS. FREEDMAN: It actually may vary a bit from state to state. In most of them, I would say it is, but there are, I think one or two that where the -- what would be called the medical health information is restricted access.
There is another situation, there are some states, at least two and maybe three, where the record is of restricted access at the state level and open at the county level.
DR. MC DONALD: I wonder if there is a way to get a hold of or we could get a hold of the description of the birth record as currently specified for the automatic collection.
MS. FREEDMAN: We will supply that to you, yes.
MR. SCANLON: Mary Ann, in some states is there not sort of a public part of the record and then below the line additional information that is more or less confidential and only for people to get access to that?
MS. FREEDMAN: Yes.
MR. SCANLON: How prevalent is that?
MS. FREEDMAN: Well, in most states, the entire record is restricted in all but the states with some sort of an open records law. In some of the states with open records law, they do restrict access to the medical and health information.
Now, in a couple of instances in those states, that was being done administratively and if they are challenged, they may not be able to uphold that restriction.
DR. STARFIELD: What about low birth weight information in general. Is that generally in the states where the records are open, is low birth weight usually --
MS. FREEDMAN: Birth weight is an item on the birth record. So, it depends.
PARTICIPANT: Mary Ann, increasingly in at least some of the states, the birth record is being used, obviously, not only for registration purposes but also for real time programatic intervention, identification of virus, infants and so forth. I was wondering if the panel is going to include any representatives from MCHB or any of the --
MS. FREEDMAN: Yes. The maternal and child health affiliate has been asked to name a representative.
DR. LUMPKIN: I think that is also pertinent to a question that Bob Gelman asked, which is that in many states, even states like Illinois, where our records are pretty much closed, a significant birth, one where there may be a child at risk would be referred to a local health department for a visit, for instance. A case manager may go to the home and check the water well if there is a water well to make sure there are not high nitrate levels and other types of interventions.
So, even in closed states, there are referrals of pertinent information to allow intervention that has been determined to be programmatically important.
DR. GELLMAN: I am not disturbed by that kind of activity. I am concerned about -- I mean, the thoughts that have been going through my head, if you look at virtually all of the medical privacy bills to date that have been proposed, they all say whatever position they take on preemption, they all say we don't preempt state vital statistics laws.
I wonder if that is not something that ought to be reexamined in some way. I don't know all the information that is on a birth certificate, but I imagine that in states with open records, that there are direct marketers who collect all of this information so that they have records on everyone from the day they are born with all of them -- and there may be distinctions that need to be drawn between different kinds of information that is public.
And I wonder to some extent if the policies of some states with respect to making these records public wouldn't undermine or have an impact on what information is routinely collected. There might be some information that would be unobjectionable to be collected for health purposes, the things that you talk about John or for other research purposes that would not be suitable to be collected, if they are going to be made public.
Is there anyone from the privacy community who sits on this committee?
MS. FREEDMAN: There is no one per se from the privacy community. However, one of the things that we have done in the past and will do with this revision process is to have a complementary group looking at the model state vital statistics statutes to see if adjustments need to be made to that document, based on what comes out of the revision process.
I think that the issue of how this relates to what is happening in the patient identifier area, et cetera, is important.
DR. GELLMAN: I would just like to follow up with one suggestion that maybe you ought to make a little bit of an effort to educate some of the privacy people about the issues here and what is important and see what happens, you know, after they learn more about it because there aren't very many -- there aren't that many folks --
DR. SCHWARTZ: I was thinking that we could make the birth certificate an attachment --
DR. GELLMAN: I just think some other input would be useful in this process.
DR. LUMPKIN: Do you know if there has been any compilations or analysis of the privacy protections for birth records that could be shared with this committee?
MS. FREEDMAN: We have copies of the legislation from each state and we can do that for you, yes.
DR. LUMPKIN: I think that would be helpful for us to have an idea of what the range is and how many states cover what.
MS. COLTIN: In listening to your description of the activities that you have underway both in the area of automation and in terms of reviewing the content and thinking about what we have been doing and what we will be doing over the next couple of years, it seems that there are at least a couple of areas where coordination would make a great deal of sense.
One that occurs to me is that in terms of the data elements that are contained in these vital records, to the extent that those are the same data elements that are contained in other types of transactions, administrative transactions, for example, we ought to think about making sure that they are captured in the same way, defined in the same way and formatted in the same way.
I think of things like the NPI, for instance, for the certifying physician or whatever. Another thought is that given your timing in terms of revision, I was intrigued with what you were describing around the interface of the OB clinical record with the birth certificate. We are going to be making recommendations around electronic formats for computerized medical records.
It seems to me that that concept could potentially be broadened as we start thinking about how the content from the clinical record could feed the death certificate, as well as birth certificate information.
DR. COHN: I was actually, first of all, surprised. I had thought that ICD-10 for death certificates was already being implemented and I hadn't realized it was going to be yet another year before that happened. Obviously, an ongoing question with all of these changes in coding systems has to do with the quality of the mappings between the previous and current systems.
I am just wondering how good that -- how good a mapping you have currently between ICD-9 and ICD-10 to allow us to maintain the character of our data stores.
MS. FREEDMAN: We are going to be doing -- we are starting a comparability study between the 9th and the 10th revision, using the 1996 data year. So, we will recode 1996 to the 10th revision and do a record-by-record match and publish comparability ratios and cross walks.
DR. COHN: Does that issue concern you and does that have some implications around implementation?
MS. FREEDMAN: Well, every time there is a revision of the ICD, there is a discontinuity in vital data and you have to make the decision as to whether to use comparability ratios for a period of time or whether to just live with the discontinuity.
I think it is probably going to be a fairly sizeable one this year. We have actually another factor that is going to confound it in 1999 and that is that we are -- we have tentatively decided that 1999 -- we are been under a fair amount of pressure to revise the standard population for age adjustment and we have tentatively decided to do that in 1999 and say there is going to be one big discontinuity in 1999.
DR. STARFIELD: Can I just follow up on that?
You know, anyone who has looked at the paper versions of ICD-9 and ICD-10, it looks like another world.
MS. FREEDMAN: It is.
DR. STARFIELD: But you have already made the cross walk?
MS. FREEDMAN: Yes. Essentially, what we are in the process of doing is developing the software to code to the 10th revision so that the front end system is transparent. The coder will not -- the basic multiple cause coders will be entering the same information for both systems and the computer software will make that determination, except in the cases that are rejected by the system, yes.
DR. STARFIELD: I haven't found anybody that knows anything that WHO is doing to make the cross walk between 9 and 10, which is sort of hard to believe.
MS. FREEDMAN: Actually, the U.S. has been doing most of the work in that area.
MS. GREENBERG: At the recent WHO meeting, it was discussed actually that a cross walk has been developed at WHO, but it had not yet been released because they had some other products they wanted to release with it. But it is going to be made available to the collaborating centers. You are right, that nothing has been released yet from WHO, but it is about to be.
MS. FREEDMAN: But at least with respect to causes and codes, we have had to develop that kind of a cross walk in order to revise the software.
DR. LUMPKIN: Follow-up, Simon?
DR. COHN: Yes. I guess I was just trying to decide whether -- how strongly to express my concern. I mean, Europe has been ahead of us in terms of implementing ICD-10 --
DR. LUMPKIN: Just be nice.
DR. COHN: Yes, I will try to be nice -- I am trying to be nice -- in implementing ICD-10. This change is different than many previous changes, only because we have so much more information, computerized and are using the data so much more than we have in previous revisions.
I keep hearing statements that, yes, we have the cross walk or we are going to have the cross walk or whatever, and I guess I get more and more concerned the further down we get to a deadline, such as you are describing, where my sense still is that we really don't have the cross walk to evaluate how secure and comparable our data stores are going to be and I get very concerned when I hear about big -- you know, 1999, suddenly our data is going to be -- is going to have major comparability problems before 1999 to after 1999.
I guess I am just hoping to get some reassurances from you and NCHS that that won't be as big a problem as I am fearful of.
MS. FREEDMAN: Well, we are very concerned about it as well, which is why we put a lot of emphasis on the comparability study. We will not publish anything without publishing comparability ratios with the 1999 data. That is a decision we have made right up front.
The other thing that we are planning to do is to go back as far as the age adjustment issue is concerned, to age adjust back so that we will at least maintain those trends within the standard.
I can't completely allay your fears because it is a real challenge and a difficult problem and they are very, very different coding structures.
DR. BLAIR: [Comment off microphone.]
DR. LUMPKIN: Jeff, is this a follow-up or a different subject? Okay. Go ahead.
DR. BLAIR: Mary Ann, my background is health care information systems. It is not public health. So, you may need to educate me on this, but I wanted to go back to the question that I had first asked because -- and I am not saying that DNA information should or should not be in what your recommendations are, but I would think that the subject should be within the scope of what you do because you have got all of the other related issues being discussed so that I sort of feel this is an issue, which probably won't go away and since it won't go away, it may hit another group and it would be, I think, unfortunate if the subject didn't get the benefit of the deliberations that are going on within your group.
MS. FREEDMAN: Okay. We certainly can make arrangements for the committee to have a briefing and to hear testimony on that. It is not an area that one traditionally thinks of when one thinks of a birth certificate. I guess that is -- and when one thinks of a legally mandated document about a person, that would be my concern.
DR. BLAIR: Okay. So, you don't even feel like it is likely that any time in the next 10 or 15 years there will be special interest groups that will take positions on both sides as to whether that should be included in an electronic birth certificate?
DR. LUMPKIN: I think that the reason why she is struggling and I would struggle with that is it is just hard for me to fathom anybody suggesting or it going anywhere that genetic information would be on the birth certificate. That is just --
DR. MC DONALD: Maybe the sequence but not any real detail. Perhaps in a movie called Gattaca, but not anywhere else.
I just want to get clear, CDC has got a birth certificate system and maybe a death -- how do you relate with CDC, I guess, in those subsystems?
MS. FREEDMAN: You are talking about the Wonder System?
DR. MC DONALD: No, no. There is a birth certificate record I thought that was distributed by CDC maybe in connection with National --
MS. FREEDMAN: Well, we are part of CDC.
DR. MC DONALD: Oh, that explains that. Okay.
The second part of the question is that in -- to really reinforce what Kathy said was that a lot of this data that you are collecting really is in systems. Most births are in hospitals, even if they don't -- and maybe taxis, but they get to the hospitals and they get registered.
I think it is very important that we start to intermingle those interests because there are standards that are being fairly well adapted for hospitals systems that define fields. What also happens if a different group defines them, not deliberately, but always, they make them different. So, we have this extra layer of work that might not have to be done.
MS. FREEDMAN: I couldn't agree with you more and especially if we assume that ultimately this document is going to be created out of those other data collection systems. I think that we are not expecting that this committee will define those fields. We are expecting that they will tell us which data items are important.
DR. MC DONALD: Well, I was really suggesting that not really related to this committee, but that your activity for those fields would reach out to existing -- you know, the vendor committee and the other standards groups to get the right list of codes in there to make it easier for them.
MS. FREEDMAN: Oh, by all means. I don't think we can do it again the way we have done it in the past.
MR. MAYS: I just wanted to bring up a point. Actually a presentation was made to the ACOG steering committee this summer on both HIPAA and the work of this committee. I actually did that presentation, as well as HL7 was there. And we encouraged very strongly and I think were well received this exact idea that the fact is that as this project moves forward, it really needs to move forward in collaboration with a much broader group and that there are other activities.
I think that that is, in fact, their plan is to begin to act in the HL7 context almost as a content specialty group rather than try to deal with some of the more technical transmission issues and things like that. So, they are aware of it and I think that they are going to move forward in collaboration.
PARTICIPANT: How do you deal with non-hospital births?
MS. FREEDMAN: Generally, they are reported through the old traditional system, which is a paper -- well, it depends on who delivers the child. Generally, it is the attendant who is responsible for reporting a birth.
PARTICIPANT: If it is not a licensed individual, who reports?
MS. FREEDMAN: It depends on state law, but the typical law is that it is whoever -- if there was no physician or midwife present, the person in attendance and if there was in attendance, the mother.
DR. LUMPKIN: I have a question, which I will delay.
MS. COLTIN: I just had one more question. We have been going through a lot of the work of this committee and identifying areas where we are not certain what types of follow-up action may have been taken on recommendations that have been made.
One of those has to do with improving cause of death statistics. There were a number of recommendations made at a workshop and transmitted around improving the quality of the information that was being submitted related to cause of death. So, despite the issues of coding and automation, we have to get back to the very beginning, which is actually determining what the causes are that are being listed on the death certificate.
I wondered what activities may have been taken in response to those recommendations with regard to improving the quality of that data and educating physicians and so forth.
MS. FREEDMAN: Well, there have been several things going on. We have an exhibit that we take to all major medical professional meetings on coding cause of death or reporting cause of death, rather, and we tend to tailor
-- we will tailor that exhibit to the profession. So, what we take to the National Association of Medical Examiners might be different than what we take to the oncology meeting, for example.
We have developed some basic guidelines for how-to worksheets and we put them out both as laminated 8 1/2 by 11 pieces and also in a little kind of a note card type thing, pocket card.
We also are just finishing a study. There was a recommendation made about the last -- the standard certificate revision that NCHS look at the format of the cause of death section of the record and see if the format itself was hampering physicians' abilities to accurately report cause of death.
We have been doing a study of that and we are just about to publish those results. So, we have been trying to work in this area. We try to encourage states to do some activities with their physician population. It is a difficult area because there is no formal training for most physicians in how to report cause of death.
MS. COLTIN: Are you aware of any -- either at the state level or at the national level, any audits of this kind of information to assess how accurate it is?
MS. FREEDMAN: Generally, what you might consider audits would be published studies, which typically tend to compare the hospital record with the death certificate and, therefore, may miss the mark on occasion.
I am not aware of anything that is an absolute gold standard type of audit.
DR. LUMPKIN: I would suspect the closest thing is that for statewide cancer registries they do go in and review the hospital record. So, there may be some data that is available from there on the accuracy of the cause of death versus the cancer registry.
There is also -- each state also does a fatal occupational death registry, which is frequently triggered by newspapers or by death records and there is the correlation that could be available looking at those registries also.
MS. FREEDMAN: But part of the issue there is that the death certificate may have been filled out before all the information available to the fatal accident review board is on the table.
DR. LUMPKIN: But it would give some evidence by looking at those of the disparity between the retrospective review and the document that is prepared since there is a normal death certificate.
MS. WARD: If I could just -- from the state perspective, one of the reasons the center directors are pushing for this change in the time line of the first part of the death certificate coming in and then the later is that they realize one of the reasons they get very bad causes of death is that the physicians, funeral homes, are under tremendous pressure to get the body when there is not an investigation, just manage -- the family has its requirements, but as along as there is no investigation needing to go on, the body can be disposed of by the family and then work to go back a really, truly accurate diagnosis.
Certainly, with the audits, I know in our state and the work that our center director does with medical examiners, coroners and physicians that is what we have discovered one of the causes of a stopped breathing diagnosis and you call back and say that usually happens when someone dies.
They really find that if they can separate those two processes, the quality when people have time to sit down and think about now why am I filling this out and this is for medical reasons, for statistical reasons, not having the family be able to get the body out of the hospital to the funeral home and the process that that family desires in action.
DR. LUMPKIN: Thank you very much.
Okay. We are scheduled to take a break.
[Brief recess.]
DR. LUMPKIN: Can we get back together?
We will reconvene our second portion of our morning session for a report on confidentiality and genetic data issues. Dr. Bill Raub, senior advisor, ASPE.
DR. RAUB: Thank you very much. I appreciate the opportunity to join you.
In consultation with Jim Scanlon, we identified four issues related to this broad topic. Some paper associated with two of them, I believe, is in the briefing book. I will note them as I go through. The others are works in progress and, therefore, don't quite lend themselves to a formal description, but I can share with you some ideas about where those efforts are.
To begin on the general level, my office and others in the Office of the Secretary are engaged in several different activities related broadly to genetics and confidentiality/privacy. I am well aware of the prior efforts of this group with respect to the privacy initiative and the Secretary's role in that for the Executive Branch.
Drawing from that, as a general rule, we have approached the genetics issues with the notion that we will not automatically give special status to genetic information as we work through some of these questions. As a general rule, we view genetic test results as a proper subset of genetic information and, in turn, we view genetic information as a proper subset of medical information in the medical records.
Therefore, other things being equal, look to the broader initiatives and guidance around medical information in the medical record as covering the vast majority of issues that are particular to genetic information or genetic test results.
On the other hand, we are alert that there will be exceptions to that general rule and want to be sure that where they are, we are addressing them in ways that are particular to the special issues and concerns and opportunities raised by either genetic information broadly or genetic test results in particular.
Having said that, I will now spend the rest of my time talking about four exceptions, where we are focusing on genetic information.
One is mentioned in the briefing materials there and this is the topic of genetics and discrimination with respect to health insurance, access and coverage and maintenance. The Department had the lead for the Executive Branch in developing some themes that culminated in the President promulgating a statement of policies in this area at a Rose Garden ceremony recently and in those stated principles also endorsing attention already underway within the Congress with respect to new legislation that would provide important new protections around the use of genetic information.
The issues here, broadly stated, are that when genetic information, whether obtained from medical history or physical examination or actual tests on the DNA, are used to confirm or refine a diagnosis, that is not necessarily a problem. However, when such information is used primarily or exclusively as predictor of disease, especially predictor in otherwise asymptomatic individuals and is raising future risk speculation for either that individual or for siblings or for offspring, then this is a potential area of concern and even abuse in the health insurance system.
The President's stated principles are designed to address that and encourage the Congress to promulgate legislation that is fair to all parties, but, in particular, mindful of the protections that individuals need in either acquiring or maintaining health insurance.
You will find in that material we provided the summary of the position taken by the President.
Underway is a related effort within the Executive Branch on the analogous topic of genetic information and discrimination in the work place. A number of entities of the Department, including the National Human Genome Research Institute, have made strong statements with respect to the importance of attention on the work place questions as well. In this instance the Department of Labor has the lead for a working group across the Executive Branch. My staff and I and others have been participating actively in this effort. This one has many similarities to the discrimination questions with respect to health insurance, especially where future risk predictions are involved.
On the other hand, to my taste, at least, it is more complex in that first and foremost, monitoring activities within the work place, even special removal programs that certain high risk industries have, are a very important thing to continue with respect to protecting workers' safety and health. This department has the lead for research with respect to occupational safety and health and we, therefore, want to ensure that while the protections are in place with respect to employment discrimination, they are not of a form that makes it difficult or even approaching impossible for either employers to provide the kind of protections that workers need for unions to ensure that workers have those protections and for those engaged in occupational safety and health research to be able to carry out the kind of discipline protocols that are needed in this area.
I can't predict how this will culminate. It could take the form of a general statement of principles similar to that in the health insurance area. It could take the form of proposed legislation. Already before the Congress presented by Senator Daschle and others are a number of proposed bills that deal with the work place discrimination questions. And the Department has yet to determine, or has the Executive Branch, exactly what particular policy position it would take, but it has expressed its general concern about and interest in clarifying some of these questions.
The fourth area or the third area, rather, is under the heading of "Genetic Testing of Stored Human Tissue Samples." Again, we don't have a document for you on this at the moment, but I can give you a status report. This activity is underway by the National Bioethics Advisory Commission. The commission was established by President Clinton through Executive Order. I am serving temporarily as the acting executive director of the commission and, so, have more than a passing interest in this particular topic.
The Executive Order gives the commission some broad charges with respect to the protection of human research subjects and, in particular, mentions concerns about the uses of genetic information and goes on to illustrate with patent issues, gene therapy and a number of other questions.
The commission as its first venture in this area, going back a little over a year now, chose to focus on genetic testing of stored human tissue samples and as one of the commissioners, Riley, said, we thought we would start with an easy one. Well, it has turned out to be anything but. In one year and counting, the commission is struggling with the myriad of ethical, legal and social issues around this question.
The summary form of that is that while most of us at some time or another have given a blood sample or a tissue biopsy, most of us, including me, don't routinely think about it. That sample is probably still sitting somewhere in some pathology lab, probably with either an explicit identifier or a readily accessible link to the medical record.
When that was gathered, for many of us there was not an informed consent statement about uses in research or if there was, it was very general and tied to the particular objective for which we were giving the sample in the first place and probably was expressed as a check-off of, sure, you can use this for research purposes.
It had a limited scope on the part of those seeking the consent and certainly a limited scope on the part of those giving it. With the emergence of genetic tests and the I think most of us say eventual and ultimate possibility of being able to look at a blood sample or a tissue sample and with an array of examinations on the DNA, make some rather specific predictions about future risks, again, the individual, siblings, offspring.
The issues of informed consent loom large. At one extreme in this debate are those who feel that uncompromisingly under any circumstances, fresh informed consent must be sought before such testing would go forward on these tissues.
Others have argued for a much more flexible set of rules, making what are often the arcane distinctions among anonymous information, anonymized information and anonymizable information and recognizing that in many contexts now, quite important research with no real or apparent risk to the privacy or confidentiality of the individual could be carried out, so long as appropriate protections with respect to anonymity and confidentiality were in place.
But even with identities masked to the investigators, to the extent that a particular test on a particular sample raises a strong prediction of some future risk, the ethical questions around whether one is then obliged to break that mask and apprise the individual or family members or others has tended to split the witnesses from which we have heard and leave the commission struggling at the moment as to find a path through this tangle of questions.
But the fact that it is central to it, under the broad issue of human subjects protection are not so much the protections from life-threatening, invasive risk, but rather the protections against breaches of privacy, of confidentiality, of inappropriate disclosure to others, including insurance companies and employers, but not limited to that, by any means, makes this a challenge for NBAC and sort of worthy of its commission, in a sense, as it tries to provide some definitive guidance for all the rest of this as to how to approach these questions.
The fourth issue I bring to your attention primarily for completeness, although it feeds many of these in the long term, is the recent report of the Task Force on Genetic Testing commissioned by the Human Genome Project, the joint effort between the National Institutes of Health and the Department of Energy.
The Genome Project, as many of you know, has an ongoing program, whose acronym is ELSI, ethical, legal and social issues associated with human genetics, and under the banner of a joint interagency working group, a task force was commissioned led by Tony Holzman(?) of Johns Hopkins University, that over the last two years has struggled mightily with a thorny set of questions and produced a very thoughtful and rather extensive set of findings and recommendations for the Department and others to consider.
That report was presented officially to the Secretary about two weeks ago. The Secretary's staff has shared copies with all of the components of HHS, requesting comments or issues. In anticipation of the report for the better part of the last year now, I have been chairing an informal working group drawn from the pertinent agencies across the Department with a view to anticipating some of the issues we thought the task force would raise.
Now that the report is in, we have formalized ourselves in the sense of an implementation group, that we will receive the comments that come in from our various components, bring our own knowledge to bear and produce for the consideration of the Secretary and the agency heads here, a set of implementation recommendations of how we might address the issues that have been raised by the task force.
My summary of the task force report is that it is a cautionary commentary on tomorrow. That is, the report comes from individuals who are extremely knowledgeable about and in general advocates of the importance of genetic testing. Now, this is primarily testing on the DNA, but it can also include testing on particular protein products of the genes.
However, the caution comes in in the need to balance the fostering of this technology, its emergence in disciplined research settings, its discipline transfer into uses in medicine and into commerce as that is appropriate, but at the same time providing protections for the individuals who are involved.
Again, here, the protections are not so much protections against some invasive medical procedure, like surgery or drugs that could in the act be harmful, but rather the protections against the breaches of confidentiality, breaches of privacy, misuse of information, inadequate characterization of the nature of the finding and the risk that could lead individuals to take unnecessary or in some cases unfortunate or even catastrophic actions in anticipation of what they see as their impending risks.
Dr. Holzman and the group keyed in on three broad concepts; analytical validity of genetic tests, clinical validity of genetic tests and clinical utility of genetic tests. By the nature of the subject matter, they emphasized the first two heavily and the first two in many ways draw out of the conventional concerns of analytical chemistry; that is, with respect to analytic validity, how do I know that this test is measuring what it purports to measure. What is the nature of the false positive statistics, the false negative statistics, the precision, the reliability, the reproducibility, the robustness under a variety of circumstances.
The task force is rather strong in indicating that in the protection of human subjects that is a very important set of characteristics to know about these emerging tests. Equally important is the notion of the clinical validity. That is, if the finding is made of a particular allele being present in the genome, so what? If the prediction is made, well, you now have a 23 percent risk in the next ten years of x, on what is that prediction based? Is that drawn from very preliminary information as a result of studies of high risk individuals?
Is that based on a really thorough epidemiologic assessment of the incidence of this particular allele in a larger population? And, in general, how does it correlate with the known progression of disease and the other risk factors that obtain?
To that end, therefore, the commission recommends strongly that genetic tests emerge under what I will call research constraints, under constraints of protocol, review boards with associated informed consent statements and general attention to these as what FDA would call investigational devices.
The commission then puts a very formidable challenge before the Department in that, in effect, the Department is asked, and I think appropriately so, to find a regulatory schema here that on the one hand protects the human subjects that are involved here, both those who are involved in developmental phases of these tests, as well as when the tests go into commerce or other routine clinical use, but at the same time foster a very powerful and very exciting technology, not to regulate in a way that quenches initiative, that sets up unnecessary barriers for the translation from development to application to the rare disease area, where there will be little, if any, commercial incentive for some particular test to be developed and, yet, many are, either out of compassion or out of the scientific interest in it and finding ways to ensure that those tests that go into high volume clinical use are properly regulated at the same time that there is incentive and opportunity for tests associated with rare disorders to be achieved.
The task force notes in a number of places in its report that HHS has a substantial array of tools and processes that might be used in some way or other to deal with this. Under the Food and Drug Administration, we have already established legislative authority and an array of regulations with respect to investigational, diagnostic -- I am sorry -- in vitro diagnostic devices and investigational protocols.
That legislation is nominally applicable to this set of tests. At the same time, under the Clinical Laboratory Improvements Amendments, so-called CLIA, we have a program jointly administered by the Health Care Financing Administration and by the Centers for Disease Control and Prevention that deals with overall laboratory quality assurance and in certain selected test areas, substantial programs of proficiency testing for particular tests.
NIH and FDA collaboratively administer an array of procedures affecting the institutional review boards, not only the IRBs at universities, but also sets of private IRBs, many of the latter working actively with the pharmaceutical industry.
Out there in the world, there are an array of genetic counselors and other specialists, too few by the task force's reckoning, but, nevertheless, critical to the emergency of this technology and, last but not least, the need for educational programs, professional education, public education around both the promise and the potentials for misuse of genetic tests.
So, the challenge that the task force has put before us is, in effect, saying you have got a big task here, but you have also got a lot of tools. Find a way to array those tools in some complementary way that provides the protections that patients need, including but not limited to protections of confidentiality and privacy, but also foster this technology.
Its promise for medicine is almost indescribable and the benefits ought to be reaped so long as we can do it without creating some commensurate sort of hazards. We will be struggling with that challenge over the next several months and as it develops, I certainly would be pleased to share our progress or lack thereof with this group if that would be helpful and, otherwise, to have your comments and critique beginning now and really any time as we go.
Thank you.
DR. LUMPKIN: Now that the genie is out of the bottle, do we have any questions?
DR. GELLMAN: I want to ask, some of the proposals that have been put forward -- I don't want to talk about them specifically, but some of the attempts to deal with the issues on proposed restrictions on the ability of various players to collect genetic information, for example, prohibiting, say, an employer from collecting genetic information, one of the problems in this area is that it grows increasingly difficult to distinguish between categories of players. Someone who is an employer may be an insurer in another -- wearing another hat.
The same thing is -- may also be a provider. Providers are also engaged in various roles and at least one proposal that I have seen would restrict the ability of physicians to collect medical histories because medical histories are genetic information, at least sometimes. I just wonder if you could comment on that, how you see that developing, if you think that is a good idea.
DR. RAUB: I can make only general comments at this stage. We have seen many variants of that. In general, most of the response has been, including much of the Secretary's initiative with respect to privacy, was to focus more on the potential for misuse of particular pieces of information and particular contexts, rather than necessarily try to restrict the gathering of the information, recognizing the extraordinary complexity of that and the easy possibility of doing a lot of harm while one is attempting to do good in a particular case.
I can only say that our group and others have been sensitive to it. We don't claim infinite wisdom about it. In the work with the Department of Labor, it has been quite prominent in that a strong case can be made for collection of information, for workers in certain hazardous settings and many of the workers and the unions would like to see that information collected, so long as it is used in a clear cut way, as long as it is within some prior agreement as to the extent of its use and particularly if it is tied to a removal program where the individuals could be removed from a situation of potential hazard to their health, but not lose their employment or not be placed in a role that is somehow compensated at half the previous level and the like.
So, those concerns are prominent. I really can't share anything more definitive about that now.
DR. MC DONALD: The business about predicting risk isn't limited to DNA or classic genetic information. You know, smokers are at risk and cholesterol predicts risk and there is probably a continuum and it may be in some cases that the protein measure is a better predictor. In some cases, the DNA may be a better predictor.
How are you going to deal with -- is there going to be a major distinction made -- I mean, might not it be better to say avoid this prediction battle against the patient and insurance business, rather than to pick out particular kinds of measures?
DR. RAUB: I think your point is well-taken and many have been struggling with that. I mean, first of all, it was clear to us from the beginning that if we limited it to a genetic test, narrowly defined as a test on the genome, that we were kidding ourselves. We were missing a lot of other issues.
Some advocate the distinction between the symptomatic and the asymptomatic individual, but even there it opens many of the same issues that a bit of patient history or current clinical signs might well be the trigger for some attempt to predict risk. It is quite possible when this settles out, it will be more around the issue of prediction of risk in asymptomatic individuals irrespective of whether it is a genetic test or a protein finding or a bit of family history or the like.
DR. MC DONALD: Sort of as follow-up -- this is just an interesting challenge. I don't know whether a solution is out for it, is that, as I hear it from, say, the life insurance industry, is that they run the risk of sort of unequal balance.
If the patient knows risk and they don't know risk, that is, they could end changing their whole risk formula because the patients would select those $5 million term insurance policies at age 35, which they wouldn't have otherwise bought. Of course, then these are also signals of information, too. So, I mean, it is really hard to stop information flow because the actions become signals.
I don't know how to deal with that dilemma, but is that -- is there a solution? I mean, has someone got some good ideas about how you keep sort of a -- so that you can keep a fair playing field for both sides.
DR. RAUB: I certainly wouldn't assert that there is a solution in hand to that. Much of the debate around the set of principles that the President espoused, as well as the several pieces of legislation now under consideration in the Congress, led by Representative Slaughter's bill, in particular, have been just that.
Patient advocates understandably have been pointing to anecdotes where the very fact that a person requested a genetic test in their view got disclosed inappropriately and then was used in some discriminatory way, irrespective of the actual finding of the test.
Representatives of the insurance industry and some from within the medical community have been eloquent on this issue of it ought to be a level field. And if the patient, or in this case, the candidate for insurance, knows things with some probability that the insurer doesn't know, it changes everything from the formulae to the nature of the investment and actuarial questions.
So, that is -- I can only say that it is hotly -- it is well-engaged by very knowledgeable people and I believe part of the reason that the President stopped short of a specific legislative proposal was the recognition that all of the primary issues are in play with respect to one or more pieces of legislation now under consideration. And he stopped short of endorsing any particular one, highlighted Mr. Slaughter's bill as the closest thing to what most people would see as a prospect for a solution here.
But I think the very fact that he stopped of that indicates the recognition that he and the senior staff in the White House, as well as others, perceive this as to be resolved for the very reasons you say.
MR. SCANLON: Bill, a number of the reports that you referenced this morning seemed to be suggesting that in the research area and the drug and device development area, that the IRB, in essence, play a major role in determining potential risks of disclosure here. To what extent are IRBs equipped now to do this or do it now and are there other changes you envision for the IRB process in this area.
DR. RAUB: The observation of the task force, which I and others share, is nowhere well enough; that is, the IRBs carry a tremendous burden now and many of you, I expect, now or have served on them and so you understand the demands placed upon IRBs.
As we go into this era, first of all, the general working knowledge of genetics and genetic information is not uniform and, therefore, IRB members on the whole need more information and more background with respect to the particulars associated with genetic testing and other aspects of genetic information.
Secondarily, many of the IRBs are oriented historically to the protection against the invasive risk, whether it is the drug or the surgical procedure, and are less systematic or less uniform -- and this is something that the bioethics commission has also observed in one of its parallel studies -- when it comes to the either protection of confidentiality or privacy or the kinds of secondary risks that an individual can occur.
To choose an example unrelated to genetic testing at all, one of the working groups of the bioethics commission has observed that in a number of instances, individuals who are interviewed as, let's say, as part of spousal abuse studies, studies that might have been seen as exempt from IRB review on the rationale that there wasn't an invasive procedure involved. Nevertheless, the fact that they were identified as participating in such a study has made them subject to subsequent abuse or individuals who are victims of crime, who are interviewed as part of follow-up studies, when it became known that they had participated in the study, found themselves further victim of some pressure or intimidation or even actual physical harm.
Then if you extend that to the issues of privacy and confidentiality around genetic information, none of us are assuming that every IRB is ready to hit the deck running when it comes to that more subtle kind of consideration as what are the secondary risks to this individual's livelihood or insurance coverage or relationships with other family members and the like if this information is not protected properly.
DR. HARDING: This is a very fascinating presentation. I appreciate it very much.
I was trying to think of what the issue is outside of discrimination. I think we can all that it could be used to discriminate intergenerationally; you know, my children and their children and so forth, and I can also see the issue of me using that knowledge against the insurance company. I think that is a good point.
It seems like we are caught kind of in the middle of science in that we know how to diagnose or at least we are getting good at that, but we don't know how to treat well and when that part of it comes out, it will be a different game, when we can treat, when we can do something about the defects. But in the meantime, we have to find a way to encourage the continuation of the research and treatment without the discrimination.
Is that kind of where we are at right now?
DR. RAUB: I think you are actually right. I started with the two examples on discrimination because they have been high profile and will continue to be. But I ended with the task force report on genetic testing because it has gone broader than that. It recognizes the discriminatory uses that are possible in information, but it also goes to the heart of some of these -- I will call them medical management questions, where in its formulation, it identifies the concept of certain genetic tests being what the task force calls high dial -- D-I-A-L -- and what they mean by that is tests that ought to be subject to stringent scrutiny and they put on the table some suggested criteria for what would be the threshold for stringent scrutiny.
One of those is, you know, the asymptomatic individual where medicine does not either, you know, an intervention or a cure that is particularly efficacious and, therefore, raising a whole set of issues from medical management to the ethical questions of do I want to know as a patient about some future risk, which I may not be equipped to deal with the probability anyway, when, in fact, there is nothing that I, through my lifestyle or medicine, through some intervention could do.
Again, just as in the discrimination debates, much of the information is anecdotal, but some of the chilling anecdotes have been those of the women who have sought prophylactic double mastectomies on the basis only of the finding of the BRAC-1 or BRAC-2 gene without either family history or other clinical symptoms that might suggest otherwise, that they are at risk for breast cancer and some elements of the testing community that even seem to be promoting such testing.
So, the task force views with alarm the absence of any kind of educational or regulatory framework, given those prospects. I think it was yesterday's newspaper had the article around the gene that has been associated with Alzheimer's disease, which is often found in the course of looking at some of the blood lipid issues and then all the dilemmas about what is the predictive power of this and does the person want to know. They weren't asking for an Alzheimer's gene test. They were asking, you know, about blood lipids and who is obliged to tell whom about what and what about family members.
The bioethicists raised this broader set of questions.
DR. MC DONALD: I am glad that Richard brought that up because I hadn't actually, you know, conceived that idea, but I think I believe that in the next five or ten, maybe, say, fifteen years, it is going to be radically different of what we can fix.
As one who is 30 years out of med school now, I didn't believe we would ever probe this deep in my lifetime. So, it is moving a lot faster. So, there is actually a doubling interest with life insurance companies. The guys make these $5 million term life insurance bets and they are going to lose because there will be a substitution protein, you know, to take care of that within five years. So, the insurance companies will make the money on that.
I really think that -- I mean, we have to be -- we should conscious of this thing. I mean, I just hadn't thought of it. I mean, really -- because 15 years from now, the game is going to be radically different and all this -- you know, we might want to get these tests done to reduce the risk because we can find and eliminate it.
DR. STARFIELD: I actually think the task force dealt with that and I don't think they are so optimistic as you feel about it because of the multifactorial nature of these things and the interactions among genes. It is not going to be a magic bullet. I mean, I think they do deal with that.
DR. MC DONALD: Well, I would make a side bet with someone on it because I made a side bet with my brother ten years ago in the other direction. And I lost. I think I am going to switch it to -- I am going to make it back.
DR. RAUB: The other thing that, at least for me, confounds the kinds of issues that both of you are raising is the issue of when is something genetic information and when isn't it. I mean, some of the early proposals have been well intentioned but naive, as saying we will wall off the genetic information.
Well, one might wall off a test on the DNA when one doesn't wall off a test on, say, blood cholesterol. Francis Collins of the Genome Project is fond of giving the particular example that a test for cholesterol in a child probably has to do with hypercholesterolemia and is, therefore, looking at something that is very much a genetic trait and in that context is genetic information. For most of us, it is not being used as a genetic marker, although the evidence is emerging that, indeed, there is the genetically determined distribution of cholesterol metabolism overlaid by, as Barbara is indicating, these other factors and lifestyle and the like.
So, it can be genetically influenced, but in most contexts not thought of as a genetic piece of information, but in some, such as the hypercholesterolemia, it is very much a genetic test. It creates the almost imponderable issue; therefore, what is the medical record and what is in it and part of our reflex of saying unless there is a good reason to the contrary, we will treat it as if it is an integral part of the medical record is driven in part by that concern.
DR. LUMPKIN: Not to mention the fact that I have tested about 200,000 kids each year for genetic illnesses, as every state does.
DR. RAUB: Sure. Absolutely.
DR. LUMPKIN: Multiple genetic illnesses.
DR. HARDING: Besides PKU, what?
DR. LUMPKIN: PKU, the metabolic diseases, galacticemia(?). Some states do sickle cell testing. I mean, there is a whole host of things that we do in our state lab that is -- and most of it is mandated by state law.
DR. RAUB: But, again, I would be glad to follow up at any time that the group would find it helpful and if either as the group or as individuals you have got some comments or views with alarm or shots across the bow for us, we live in quiet desperation on these questions most of the time. So, I think we would be pleased for whatever insights you would choose to offer.
DR. LUMPKIN: We wish you luck.
DR. RAUB: Okay. Thank you.
DR. LUMPKIN: Thank you.
We are a little bit ahead of schedule, so perhaps we will move to subcommittee reports.
Bob, are you ready?
DR. GELLMAN: Yes.
The Subcommittee on Privacy and Confidentiality met this morning. There isn't really all that much to report. We have sort of been on the shelf since we finished the recommendations on privacy that were approved earlier this year.
The next items on our agenda will be some kind of event possibly in January. We don't have dates. We are just at the very early stages of planning this. The subjects will be what is an identifiable record is one area and the other is the issue of disease registries. What are they? How do we define them? How are they regulated? How do they get access to records? What can they do?
Those are the two general themes and we hope to be able to come up with some dates and some events shortly. We are looking at maybe the second or third week in January depending on how things go for the days.
That is our plan for the immediate future.
DR. LUMPKIN: Any questions or comments?
[There was no response.]
Barbara.
DR. STARFIELD: Okay. The Subcommittee on Health Data Needs, Standards and Security dealt with several issues. First of all was the annual report of the committee. I would remind you what Marjorie has reminded us many times, that this committee now, the whole committee, no longer has to make an annual report to Congress, but we do have to make an annual report about progress on administrative simplification and we had a draft report that we discussed and, by and large, we thought it was extremely well done. We were glad to go ahead with just a few minor changes, which I won't deal with unless anybody asks.
Then we went on to the much more difficult area of our work on claims attachments. And we realized that, you know, none of us really knew what a claims attachment was and that was probably because there was no standard definition of a claims attachment or the contents of claims attachments.
We realized that there are really two aspects of claims attachments. One is what contractors require of providers and the other is what providers then report back to contractors who have asked them all these questions and there are just myriads, hundreds maybe, thousands of different kinds of things, which all boil down to about 28 or 30 categories.
It is probably these that we want to focus on. What we will do -- what we are doing is preparing for a hearing -- that is the February hearing, February 9th and 10th, and we, this committee in particular, this subcommittee, should come up with those 28 or so common issues and how to deal with them.
But we did realize there were a couple of principles. One of them is that the attachment should support the claims as a general principle and we actually came up with the notion that we might want to make a clear separation between administrative issues and clinical issues and in the end might want to take some things that are currently out of claims and put them in attachments and maybe vice-versa as well.
Then we dealt briefly with the issue of data standards, ownership and maintenance and this was for me a rather complex discussion. Bobby Redding led us in that -- from HCFA, lead us in that. And we clearly agree that this is a huge issue but it is probably something that we could put off for another six months or so before dealing specifically with the issues.
The next thing we dealt with was the proposed rulemaking on the unique identifier and it became rapidly clear that this was an issue that was shared by the other two subcommittees and the committee had already made some reference to a hearing that deals, at least in some way, with the identifier, what is an identifier, what is an identifiable record. So, that is an issue that overlaps with our committee and I believe we probably will hear from Lisa about population specific -- do I have that right? But anyway, you now know that we propose a hearing. Did we decide on May? May. And we recognize that this may involve more than just the subcommittee.
We are beginning to think about computerized patient record because we have to deal with that starting next year, at least, and our first step in doing that is to read the 1997 update of the National Academy IOM report. They published a report in 1991. Apparently, a new one is either out or about to be. We all need to be aware of that.
We discussed also the core data elements. We try to keep that on the agenda and discuss it at least briefly at every meeting and we had done, since our last meeting, in September, had done a sort of cross walk between the data dictionary, the transaction set and the core data elements. It turns out to be really quite a difficult challenge to tell whether core data elements are in the transaction set because some of them are there but not easily identifiable.
Some of them are derivable while not there and the question of exactly what is there and in what form is there is something that we are going to have to continually study.
That is about it.
DR. LUMPKIN: Do you have a motion?
DR. STARFIELD: About the annual report?
DR. LUMPKIN: Yes.
DR. STARFIELD: Yes. Okay. The motion that the subcommittee would like to propose is that we go forward with the annual report with a few modifications.
DR. LUMPKIN: Has the full committee seen the annual report?
MS. GREENBERG: I think everybody received it and Dave Smith, who with Judy Ball -- Dave Smith from HCFA and Judy Ball worked on the report. I believe Dave asked that all he receive all comments by November 26. Certainly, earlier would be fine. It would be actually nice if the Executive Subcommittee could pretty much bless the report when they meet on the 18th and 19th.
But it isn't essential, I guess, because the plan is to send the annual report to Congress after the first -- as soon as the first NPRMs, I guess, are published, because it does refer to them and it would be good -- my impression was that we felt we didn't want to send it prior to any of them being published. So, November 26th, get your comments to Dave. D.Smith1@HCFA.GOV
If there any staff to the committee, subcommittees, that haven't seen the report and would like to just check with Jackie Adler and she will get you a copy.
DR. STARFIELD: Well, that raises the question about what we do with this motion. I mean, what is the mechanism for sending --
DR. COHN: I perhaps was proposing a process about handling this because I think it is a difficult issue of -- I mean, we have all looked at it, I think, and I thought it is overall 98 percent fine and have suggested some changes. We will be continuing to look at it and suggesting other additional little pieces.
Perhaps after all that is done -- I mean, I am fine at approving it at that 98 percent but I would like to look at it after all those little changes have been made. Perhaps it can be sent out to the committee for -- to make sure that everything looks okay prior to it being distributed and that would be, I guess, the request.
DR. LUMPKIN: I think that the -- I don't have a problem with doing that. The difficulty is is that there is no mechanism for the committee to approve it under the Open Meetings Act, would be my guess. So that we could take a formal vote to approve it, request that it be sent out to all the members and, certainly, hopefully, your comments would then come to the Executive Committee, but then we would authorize the Executive Committee to approve it. That might be one of the ways --
DR. COHN: That would be fine.
DR. MC DONALD: Clarification maybe from Bill about the law. What you mentioned about the -- we are coming up to the medical record and I am glad we are reminded of that. Is this committee going to develop it or just how to get the data moving back and forth? What does the law say about the electronic medical record in the HIPAA legislation?
DR. LUMPKIN: Before we do that, can we finish up on the annual report?
On the annual report, there is a motion to authorize the Executive Committee to review, to revise the annual report but that this committee adopted in principle and authorized the Executive Committee to forward it on to Congress and the other recipients.
DR. COHN: Second.
DR. LUMPKIN: Is there a discussion on that?
PARTICIPANT: Question.
DR. LUMPKIN: Was there a question?
PARTICIPANT: No, I am calling the question.
DR. LUMPKIN: Oh, okay. We don't need to do that. I thought I saw a hand go up in the back of the room. That is why I was hesitant.
All those in favor, signify by saying "aye."
[There was a chorus of "ayes."]
Opposed?
[There was no response.]
Abstentions?
[There was no response.]
Carries.
Clem.
DR. COHN: The law says that the committee shall report to the Secretary not later than four years after the date of the enactment of the HIPAA bill, recommendations and legislative proposals for such standards and electronic exchange, referring to a previous paragraph that says that the committee shall study the issues related to the adoption of uniform data standards for patient medical record information and the electronic exchange of such information.
DR. MC DONALD: We don't have to build the whole thing.
DR. COHN: Yes, you don't have to build the whole record from scratch, no.
DR. LUMPKIN: Further discussions or questions on the subcommittee's report?
MS. GREENBERG: I wanted to make a comment on the annual report.
DR. LUMPKIN: Okay.
MS. GREENBERG: The whole issue of annual reporting and that is that you also received as a -- all of you, there is a memo on the top from Lynnette Araki -- of the 1997 fiscal year accomplishments of the National Committee, which is an annual requirement to the Committee Management Office of the Department, a report through CDC in this regard. But -- and then a report is put together by the Federal Advisory Committee Infrastructure in the government and sent to Congress actually.
So, this is basically -- what it is, it is about a two and a half page document that you received and it is bullet points and it pretty much mirrors the executive summary of the annual report that this committee used to do on all of its activities.
So, the plan that we discussed yesterday at the subcommittee -- and welcome any additional suggestions, particularly before the Executive Subcommittee meeting -- is that at the time that the report to Congress is submitted on -- the required report to Congress on HIPAA, it will go up on the NCVHS Web site, as well this summary of all accomplishments.
We are just thinking in terms of whether this is adequate then to cover the entire work of the committee, given that the annual report that we used to -- that we prepared in previous years is not currently required anymore in our charter or whether you think something additional is needed.
A lot of the activities of this committee certainly in the last year are certainly picked up through the HIPAA report, but -- and in some ways, one can almost, you know, relate everything to standards. But, clearly, there are going to be a number of areas, such as the quality discussion yesterday and some of the work of the Subcommittee on Population Specific Issues. So, some of it is clearly related to standards -- it is not necessarily HIPAA -- required standards, mandated standards that wouldn't necessarily be in that report.
So, I just -- I think this is something that we will discuss at the -- I know it is something we will discuss at the Executive Subcommittee meeting. I am not looking for a proposal to reinstitute the other report because it was very burdensome. We are looking for administrative simplification, right?
But on the other hand, I want to make sure that there is a good record of the committee's work for those who follow it. So, just any -- you can send me e-mails on that, however you want to react.
But this has actually gone forward, but -- and it was reviewed by Don Detmer. Pretty straightforward.
DR. LUMPKIN: Are there questions or comments in the committee's report?
[There was no response.]
Then we will move on to the Subcommittee on Population Specific Issues. If you don't mind, maybe we will hold that for right after lunch or do you want to go now?
DR. IEZZONI: Go now, please. It won't take me that long. You have five minutes.
DR. LUMPKIN: Well, I don't want to minimize the importance of this --
DR. IEZZONI: Do we feel minimized, those of you who -- no, we don't feel minimized.
You have fulfilled your fiduciary duty to our ego strength.
The Subcommittee on Population Specific Issues has as its major annual initiative this year, looking at Medicaid managed care and data systems to support our knowledge about what is happening out there in the states.
We had a productive meeting on September 29th and 30th, where we brought in researchers, who are investigating contracts of Medicare managed care organizations and looking at requirements for data reporting.
We basically decided that what we are going to focus on is something that NCVHS and its subcommittees do very well, which is trying to hear from the field about what question are around Medicare managed care. We will start by doing that at our January 12th and 13th hearings, where we hope to hear from patient advocacy groups, provider groups, state legislatures and state executives about what questions they mostly have about Medicaid managed care.
We are going to be letting a contract that is currently being written to one of the research organizations, to then try to tie out, tying to what we learn at the hearings in January, what the data reporting requirements are in Medicaid managed care contracts, where the gaps are in terms of our ability to answer the questions that have been identified, given what the contractual requirements are for Medicaid managed care organizations.
And we will be doing two site visits. The one during the cold weather month in February will be in Tucson. This was not I hate to say randomly chosen. And then during a slightly warmer month, April, it will be in Boston, although we have had major snowstorms in Boston before in April.
But anyway, these just happen to be the two states that are repeatedly mentioned as states that have around the country been doing innovative things around Medicaid managed care and data systems around Medicaid managed care and we have gotten that opinion from a variety of different sources. So, those will be the two places that we will be doing the site visits.
So, that is the Medicaid managed care.
We are then tracking a number of other issues. As you know, we sent a letter to the OMB about the Directive 15. OMB finally reported what their final rules are on October 30th and you can get that information off the OMB Web page if you are interested in it. Basically, the recommendations that we made to OMB were paralleled by what the final OMB decisions were, with a couple of slight exceptions.
We will be following up on this primarily around the issue of tabulation and trying to get continuity of data reporting around race and ethnicity issues. So, we are hoping to follow up on that actually with NCHS, maybe later in the spring when we can get that.
You might remember in September that we submitted a letter to HCFA about OASIS(?), which is, for those of you who don't remember, it is the reporting system around home health agencies that HCFA is about to maybe possibly promulgate. The letter doesn't seem to have reached the right person expeditiously. We will not go into this any further, but, hopefully, the letter has finally gotten to somebody who can respond to it.
However, in talking about this issue yesterday, it almost became comical. Bob, I am sorry to say this about your agency, but administrative simplification has not yet hit the post-acute care world and we heard about five different initiatives or six different initiatives to come up with data reporting standards for post-acute care organizations that aren't coordinated in any way, shape or form. And, so, what we are trying to do is, hopefully, have a draft letter that Don Detmer can submit on behalf of our committee to the Data Council because we think that this is a Data Council issue.
The right hand does not know what the left hand is doing on this.
MR. MOORE: If it is about HCFA, it should go to the acting administrator, I think.
DR. IEZZONI: ASPE is also involved in some of this. Let me just summarize it by saying -- I would just summarize it by four words. "It is a mess." So, we are hoping to raise the issue because we think it has not been on the forefront of the agenda.
The implicit understanding of HIPAA thus far, although I don't know whether it has been explicit, is that it has been mostly focused on acute care and standard outpatient care settings and the post-acute care settings really have not been thought about in this way.
MR. MOORE: I do need to weigh in there a little bit.
DR. IEZZONI: Okay. Well, maybe after lunch, Bob.
Second to last, we are still planning to have a subcommittee meeting on data having to do with health care and health services from the territories. However, we have cancelled the December meeting that we had originally planned because it is taking us a little bit longer than we had hoped to put together the right players to come and speak to us about this.
DR. LUMPKIN: Was that a meeting in the territories?
DR. IEZZONI: No. We did not even think about going to the Pacific Islands, you will be happy to hear.
Then finally we had a discussion around the uniform identifier. That was brief. It basically consisted of Elizabeth Ward suggesting and the committee uniformly agreeing that this ought to be a National Committee-wide effort to look at this, that especially some of the members of the vulnerable populations might want to weigh in on this topic. So, it sounds like we are moving in that direction.
That is it.
DR. LUMPKIN: Thank you.
Bob, did you have a --
MR. MOORE: Oh, I thought I was told to wait until after lunch.
DR. IEZZONI: I was teasing, Bob.
MR. MOORE: The letter is at the right place now and I have talked with the people and we will be giving a response back.
I think there is another thing that the subcommittee has to take into account, that we have certain tactical initiatives that we must address, like prospective payment that the Congress has told us to look at and to wait to get a coordinated totally post-acute care documentation of, you know, what we need. I am not sure that it is timely. So, I know that on the OASIS, we are really pushing that we need to start gathering data by July of 1998 in order to get a complete period for the home health, in order to promulgate a rate in October of 1999.
All of those things push a certain part of the house and I think we need to ensure common definitions and other things, but I also -- when I talked with the staff, they look at the issue as looking at it an environment that -- you don't always have the same view when you measure one environment versus another. So, there are a lot of issues that we need to address. So, it is not as clean as --
DR. IEZZONI: Right. No, I had a brief amount of time. So, obviously, I was being a little bit summary and flip in what I was saying. I think we recognize all of this. Nonetheless, Bob, it runs so contrary to the whole effort towards administrative simplification and we are also concerned that the settings of care are shifting constantly and moving around.
It is not clear who is what setting of care at this point. So, I think that what we would like to do is at least weigh in on the need to become involved in understanding the issues. At this point, we can't give you specific advice or comment on it because we frankly, to be quite honest with you, have had difficulty getting information out of your agency about this as well.
So, we need to get a better sense of what is going on and, hopefully, be able to report back with a little bit more information than we had yesterday.
MR. MAYS: Actually, I just wanted to point out if I could -- this is Bob Mays for the Internet people -- that that is -- that was the example that Steve Jencks was actually talking about yesterday. I mean, we recognize the fact that we need to develop a higher level framework within which to look at how to deal with assessment across a wide variety of post-acute settings.
The idea of a single assessment tool that is going to be used in every setting is -- that is not the way things are going to work. It is an impossibility, given the shifting that you are talking about. But what we have lacked is this sort of overall framework and that is an area that we think the committee could be actively involved with HCFA in developing this model, if you will, to give us a framework from which to discuss how to make sure that the pieces of it are comparable or linkable.
DR. IEZZONI: I mean, there is only so much data that you can gather on human beings. So, to say that it is going to be different in different settings is a somewhat, you know -- is a statement that on the surface it sounds okay, but when you think clinically about what you are going to do -- so, I think that it is a very complex topic. We would very much welcome getting more information from you guys because we have been having trouble getting people from HCFA to come and report to our subcommittee about this.
So, if you can help expedite that, that would be very helpful to us.
DR. SCHWARTZ: Related, Lisa, to the Medicaid managed care data needs and issues, the famous Balanced Budget Act of this year contained a lot of revisions that add to the Medicare program and the Medicaid program, but one -- it also contains language that can be interpreted as authorizing reporting of encounter level data to HCFA for both Medicare and Medicaid.
DR. IEZZONI: Right. Yes, we heard that rumor and then it seemed more like a rumor to us. So, I was actually hoping that at this meeting we would have a report on the Balanced Budget Act because we had talked about that at the September 29th/30th meeting, but it looks like we have a big document right here.
DR. SCHWARTZ: But it doesn't contain that level of --
DR. IEZZONI: Okay. Yes. Because we are going to need to factor that in.
MR. MOORE: Can I address that a little bit, too?
DR. LUMPKIN: After lunch.
MR. MOORE: All right.
DR. LUMPKIN: No, go ahead.
MR. MOORE: We are starting to look at what we would need for an encounter set and the people who are working on that are aware that in the HIPAA, that the claim and the encounter set are fairly close to being the same, coming out of the standard organizations.
It is a lot more than I think that we would have ever asked for on an encounter. So, we need to go through and once we go through that process, we can bring that back to the group.
DR. LUMPKIN: Will that be a subject for the March meeting or do you think it will be before that?
MR. MOORE: I don't know if we would have it finished before the -- by the March meeting. I could let you know.
DR. SCHWARTZ: The Data Council will be discussing that issue at next week's meeting, the various requirements for encounter data.
MS. GREENBERG: Bob, when you said you are starting to look at what that might mean, are you building on the McData(?) activity or sort of starting from scratch?
MR. MOORE: No. What we started with is distributing the information that is coming out of the HIPAA and all the elements in there rather than going to the McData.
MS. GREENBERG: That is a lot more expensive.
MR. MOORE: Yes, it is. That is what I said to Lisa. And then we need to look at what is really necessary on an encounter and then at some point in time when we get that narrowed down, bring that out. But I think we are starting with the point that the law started with, when it said there should be an encounter and there wasn't anything on the table.
HCFA got out of the picture years -- you know, a couple years ago when it dropped the McData and didn't come forward. So, we were stuck with what came out of the legislation without having any input in it.
DR. MC DONALD: Well, first, I want to thank Lisa for taking over my role as the chief nettle to Bob Moore.
And, secondly, I would like to reinforce a little bit of it in that these things -- I haven't met committees that don't see things differently that are the same. I mean, that is, you put them in separate rooms. No matter what you do, they come out different.
I would plead -- accepting you have got some deadlines you have got to meet, I would actually plead for letting out some of the stuff before it is done because it is also very hard to change it when it is done.
I think there are some of us on the committee that would be happy to read it over and make suggestions. You could ignore them for good reason or whatever, but I just think these early things, the die gets cast kind of incorrectly. In fact, this could be an attachment, Lord knows. So, I ought to be involved in it.
MR. MOORE: It depends upon whether you look at it as a document. When we talk to the people in reimbursement, even on the MDSS, we started looking at that with nursing home and we started having the providers code what would essentially be the DRG for the case mix index and then do matching later on. It might very well wind up as some kind of attachment to --
DR. MC DONALD: Well, I was teasing a little bit about that, but the --
MR. MOORE: I wasn't.
DR. MC DONALD: Well, the more important issue, though, is not to think of these as solid documents that are fixed. The more important thing is to think of them as coming from a catalog of basic measures.
MR. MOORE: One of the things that, you know, I have heard earlier that we -- HCFA went away and did this OASIS in a closet --
DR. IEZZONI: I know.
MR. MOORE: No, we didn't. We were very much involved with the home health agencies and the home health industry.
DR. IEZZONI: Some home health agencies.
MR. MOORE: Well, I guess that is debated how many we used and where we came from with that.
DR. LUMPKIN: That is why I wanted to do your group after lunch.
DR. MC DONALD: But, Bob, could we ask -- I think -- my guess is Lisa wouldn't mind getting a list of what you are working on. I wouldn't mind. I wouldn't tell anyone, except -- I mean, she wouldn't tell anyone. We wouldn't stir up a big mess, but we could maybe make some suggestions that might or might not be helpful. I don't know whether you are going that far.
DR. IEZZONI: Well, I think the basic requirement is for us to first get a landscape; you know, what is going on at HCFA right now. And it is all rumor and innuendo and report and we just do not have a consistent sense of what is happening there.
I did finally identify the person, quote, from Beth Israel, my institution, that was supposedly working with HCFA on this. Where is Kathleen Frawley? She said this at the September meeting and I was horribly embarrassed because I said I had no clue who this was. But I finally did identify the person.
DR. LUMPKIN: Perhaps it might be useful, much in the way that members of various subcommittees worked with the implementation team if someone might be identified to work with this project in HCFA and to look at some of this stuff as that particular role. That may help facilitate the process. So, you may think about it and individuals who may want to volunteer can do so later.
DR. IEZZONI: Vince Mor will be drafting the letter, but I can't speak for him. I think all of us are extraordinarily busy and overwhelmed.
DR. LUMPKIN: We can ask Vince to do it and he volunteered since he is not here. We will leave that to Don.
DR. STARFIELD: Lisa, I had a comment on the Medicaid managed care. I just wanted to make sure that the committee was aware of the very large number of reports on Medicaid managed care that are stimulated largely by the Kaiser Commission on Medicaid and its contractors. There is just a large literature on benefits and things --
DR. IEZZONI: We are very fortunate. Jason Goldwater is in the room here. We are very fortunate to actually have staff beyond our usual subcommittee staff, who are already overburdened, to help us with this initiative and to have some contract time. So, hopefully, we will be aware of various documents out there that can inform this report.
DR. COHN: I was actually just going to raise the -- you know, we have talked about four or five issues here in the last couple of minutes but one of the issues that is ongoing is this issue of coordination within HHS. Obviously, I am very delighted that there is an HHS Data Council. We began to talk about that yesterday when we had the other departments that were meeting here, but I think there probably would be time in March at our next meeting to maybe spend a little time getting a much greater understanding of how that coordination is occurring.
Some of these questions are HCFA questions, but I think they equally applicable to the full HHS environment.
DR. IEZZONI: Frankly, I think we need to do it in the context of the specific example.
DR. COHN: Oh, you think so?
DR. IEZZONI: Absolutely. You know, it sounds good when they come and talk to us about talking together, but, I mean, yesterday afternoon, Elizabeth -- at the subcommittee, I mean, it was just really astonishing once we began to tease apart what different people knew about different things that were going on.
I think having a very specific example about how would you handle this situation would be very helpful.
DR. COHN: Yes. Actually, Lisa, I agree with you completely. It isn't that we talk at a high level and don't tease out any of our examples, but I think we need to hear and understand better what is being said at the HHS Data Council and then we can begin to question them about things that are real.
DR. IEZZONI: Well, I think, Bob implied something also that we didn't really follow up on and that is that there are legislative mandates for different data reporting sets and different data systems for reimbursement and so on. So, how the council is dealing with the fact that there are legislative mandates around data and reporting and payment issues that have data attached to them --
DR. LUMPKIN: See, but I think it is important for us to recognize the sides of the organizations that we are dealing with in that our role may, in fact, be to raise issues that will either get kicked up to HCFA, if two hands in HCFA don't know what the other one is doing, or to the Data Council where there is multiple agencies because they are not going to know about them.
So, it is very easy to say "yes," the Data Council will function in that way but if I have got a legislative mandate and I am three or four or five layers down in HCFA, I am not going to necessarily let anybody know what I am doing because I want to get my job done. It may never come to the Data Council.
So, I think if we have a discussion, it might better be on how we and the Data Council can work on resolving these issues when we become aware of them rather than listening to how the Data Council would act once they know about these issues.
MR. MAYS: That is exactly right. HCFA is currently trying to develop an enterprise model. I mean, we have literally dozens and dozens of information systems and like most large organizations, they are driven by program dollars, some of which are appropriated, some of which come out of -- so, even our Office of Information Systems doesn't have direct control over all the systems that we have.
So, it is not that there is not an issue, but it is always a big struggle -- it is not that the organizations are not aware of these issues, as well, and actually would hope that we could get outside input into this, but it is pretty complex and it would be hard, I think, to bring up -- it is like you said. I mean, some of these issues are several layers down in the organization and the Data Council, other than -- unless there is a specific cross cutting policy issue is not going to be involved in that.
MR. MOORE: Some of these initiatives -- the OASIS and MDS started before the Data Council was formed.
MR. SCANLON: The Data Council is not a clearance body. It doesn't review individual requests for clearance. There would have to be an interagency issue or some other interagency aspect for an issue even to come before the Data Council. I mean, you know, they meet once a month. They are very senior folks.
The Data Council has to choose what it would work on carefully and I think they decided it would be HIPAA standards and privacy, survey integration and there are some other issues that -- interagency survey kind of activity, but I think identifying the issues to bring to the Data Council -- it doesn't necessarily have to be resolved at the Data Council level. Another work group could be set up. It could be -- HCFA could be asked to do something. But identifying the issues, I think, would be helpful and I think that has been done this morning.
DR. LUMPKIN: Thank you.
If it is agreeable with the group, we will break for lunch. We will resume at 1 o'clock.
[Whereupon, at 12:30 p.m., the meeting was recessed, to reconvene at 1:00 p.m., the same afternoon, November 6, 1997.]
DR. LUMPKIN: I have heard rumors that we have something in our book. What is the tab number.
MS. GREENBERG: The tab number is R.
DR. LUMPKIN: Under Tab R.
MS. WARD: Do you want me to start, John?
DR. LUMPKIN: Please.
MS. WARD: Let me -- I have two issues with my report on public education. One is clearly around managing expectations and I want to make sure this committee understands that we have no staff and no money and I am the committee. And Kathleen has offered to help.
Marjorie has added this to her already very overloaded work load and has done some great begging and working around of helping people help us, but it is not sort of built into how our committee has been working. I am very pleased with what we have been able to put out with Marjorie pulling people together to get something done.
So, when Kathleen and I met with Marjorie and staff -- when was that -- spring?
MS. GREENBERG: July.
MS. WARD: We had one meeting where we got together and we prioritized our objective at that point to be preparing as much of the, quote, unquote, industry for understanding what was going to happen, that these regs were coming. That was our one single objective for communication.
And we are working to get that done with some staff that we have been able to direct, and contractors, but mostly through the Department's own outreach work that has been terrific. So, we keep -- my objective is in the outcome is that people will be more educated and prepared, not that the National Committee has had a particular label or impact or can take a great deal of saying we have made a particular difference. We are working with other people to make sure that that happens.
Based on that, we do have one power point presentation that is -- one of the things that we thought we could get done was to have something that any of us on the committee wanted to use to do public presentations, we would have a produced presentation for you all. That is what Marjorie is going to have demonstrated, isn't it, what we are having here?
MS. GREENBERG: Yes. We have a cable problem.
MS. WARD: If the cable shows up, we will be able to show that.
I think the next one, as Richard pointed out will be what can we do about the public education. And we purposely put that aside when we met in July. I had wanted to have this as a potential subject at the Executive Subcommittee retreat in November. Unfortunately, I am getting called to something in the state, that I can't be at that. So, I am going to be checking with Marjorie about -- and Don about a January Executive Subcommittee to get a more specific expectation about what we could do about education and then we could say for this next round, it is going to be the public and what is really realistic to do. What can we contribute to that public education?
If any of you -- and we may have some conversations around with everyone here about what is really feasible.
The other thing I am requesting to remind you and there is in this -- in your book, you will see what we do know of what people are doing about education. It is mostly what Don has been doing because that is his behavior we are the most cognizant of. But there are many others of you who are doing public presentations. If you would either let me know or Marjorie know what you are doing, then we can have a more correct tabulation of the amount of education that at least we on the committee are doing.
If you are interviewed by phone, if you go to a conference, anything that you all are doing, if you could just let us know so we can keep track of that.
PARTICIPANT: Even if we are not speaking for the committee?
MS. WARD: Yes. If you are -- I would prefer that. I don't necessarily say I am here representing the National Committee. I say I am on the committee, but it is very important for you all to know what is happening and that we are updating. But I don't know whether you want us to do it only if we are officially there, Marjorie, as the National Committee? You want to keep track only of that?
MS. GREENBERG: Certainly when you are asked to present for the National Committee and we have guidelines about that now, we certainly would want to capture that. If you are, you know, generally providing information about -- at this point, as Elizabeth said, the main focus is trying to get the information about HIPAA out to more audiences and more broadly understood, for example, I think, Lisa's editorial may have even said you weren't speaking for the committee, but on the other hand, it is clearly doing God's work, doing the committee's work.
DR. IEZZONI: I said I was a member.
MS. GREENBERG: You are a member, right. So, if you are identified in any way as a member, even if you are not speaking for the committee, I think it would be very helpful to know. If you could just take this matrix here that is in R and just write -- just put it on a piece of paper -- well, what we could do is we could e-mail it to you. That is what we will do.
The matrix in R. It is the public education efforts, 97, 98. The entries are committee member, type of material, date of material, presentation of material. An example: Don Detmer made a presentation on July 9th, 1997, at the Department of Health and Human Services public meeting on HIPAA. So, we will e-mail that to you and let --
we will make sure these headlines or these column headings are really the best ones that make the most sense but are the clearest.
But in any event, we will e-mail it to you and then put your stuff in and e-mail it back. Save the template so that you -- you know, just send it as you have the information and then we will compile it certainly before every full committee or Executive Subcommittee meeting. But I think it is helpful and actually what we are hoping is that the availability of this power point presentation will make it easier for you to accept requests to brief people about HIPAA. We will be able to update it as appropriate, but also, I think, particularly if you have a facility with power point, you can amend it or, I mean, adapt it to your own uses.
One reason we were hoping to be able to present it is to get some feedback from you. We weren't going to go, you know -- weren't going to walk through every slide, but just so you could see it. There is a copy of it under R, but I think -- you know, it loses a bit in translation.
Also, just to remind you or to the new members, that in Tab R we do have the other outputs of this group, which are guidelines for dealing with external organizations and two fact sheets, which we -- yes, two fact sheets, one on HIPAA generally and the other on the status of NCVHS activities and then the list of contact people for the committee who if you get a call asking you to speak on behalf of the committee on, say, privacy and confidentiality of the people, that you can refer them to, and we will make sure we e-mail those to the new members so that you have electronic copies of that.
This group that has been meeting, just to give you a little better understanding of it is, right now we are collaborating with a departmental work group that is co- chaired by Judy Ball, who has been working with the committee also, and Mary Emerson, whom many of you know from HCFA and is one of the co-chairs, I think, of the identifier team. So, these are people who already have their plates very full and agreed to organize this and we actually have a weekly conference call. We have developed a press release
-- when I say "we," I mean, they -- HCFA, of course, has taken on a lot of this and we have the press people, the public affairs people from AHCPR, HCFA and NCHS are working pretty -- and somebody from the Department, too -- are working pretty regularly with this group and we have developed a press release on the national provider ID, which will kind of be the door mat, I guess, for subsequent press releases. So, all we need now is to release them and then we can release the press releases.
We have done a letter and although it is true, we have kind of been begging and stealing and all of these people who are participating are sort of -- you know, again, we have kind of asked them if they will help out with it and they have been generous with their time, but I have identified one additional person in NCHS, who is committing, say, 15, 20 percent of her time, willing to, on this activity.
So, we do have a little dedicated staff to it, but we have just been working collaboratively with this other group. And Phyllis Doulaveris, who is on my staff, did the power point presentation. We have also done a letter, a basic letter, that is going to go out to a huge number of people, basically saying do you know anything about HIPAA. If you don't, you should and this is why.
It is going to go to the NCVHS mailing list as well as just one of the mailing lists that it is going to go to. In fact, some people may receive several copies and I hope they will understand that we are trying to totally eliminate that as your direct mailing people will tell you is more money than for you to just throw out the extra piece of paper.
But we have tailored the letters also to go to the public health audience and we have worked with Elizabeth on that so that it is basically the same basic information, but then it explains -- it is some stuff that will make it more relevant to public health because the basic letter talks more about payers and providers and plans.
So, this is -- the letter has been tailored and we are also going to be sending that to people on NCHS's mailing list on information that we send out to public health constituencies, CDC and other groups.
Now, there are -- the basic letter is going in a NAHDO mailing. I think it is going to be in the National Association of Health Data Organizations with their newsletter. So, that will reach all of their constituents and the -- I don't know if this has been finalized. There was discussion -- well, it is going to have to be, I guess, more than discussion since the public health -- American Public Health Association is meeting next week.
The plan was for that public health letter -- and Hortensia Amaro had suggested this, to be passed out actually at the annual meeting, like the business meeting or whatever, at APHA. So, those are some of the specific activities that we have been participating in, but pretty much collaboratively with the overall departmental effort.
We have also tried to bring sort of more of a public health focus to this as well.
MS. WARD: So, I think I will close by saying as you think about what it would look like and how would we do it on education of the public, please contemplate on that and if you have any bright ideas, that is going to be, I think, our -- it would be a nice objective to think that we could get to, whether we can reach that or not, but I think that is -- it would be nice to be able to feel that we had helped influence that.
So, if you have any suggestions, please send them to me or Marjorie as we try to get that next -- that will be our next hurdle --
MS. GREENBERG: We have actually had some discussions with the public affairs people about this. I mean, really reaching the public on some of these technical issues is not an easy sell. But now -- we also have sort of received a mandate from the Data Council to work with them on the public education around the unique identifier, which I think does resonate clearly with the public. So, I think that is --
MS. WARD: Yes, that is the piece, I think, that we would want -- I mean, that is the subject matter. How we go about doing that is going to be tricky.
MS. GUILFOY: Helene Guilfoy, Catholic Health Initiatives.
Could I suggest that that letter also go to the membership of CHIME(?), that it go to the membership of HFMA and any other organizations, vendor community, specifically HIS vendor community, physician management and vendor community. You can pick up any journal and find out who to send it to.
But those are the people that need to be aware of it and I think, frankly, are not aware of it right now.
MS. GREENBERG: If I could just respond that what would be particularly good is if -- we are still looking into it because this could be a very large mailing -- exactly how this is -- the resource issue around sending this out to as many people as we even currently intend to from our various mailing lists. I mean, it would be great if we could provide the letter to an organization and they could send it out, if they were willing to send it out with their mailing labels.
I mean, another alternative is, you know, send us the mailing labels and we will include them in the mailing, but I am not sure that I can offer that.
Judy, do you have anything to add there?
MS. BALL: I have a couple of things to add. One of the values of having the press people involved in this team is that they have given us very good advice about how to go about this campaign. One of the pieces of advice is that we need to do this in waves. We cannot expect to do it all in one fell swoop.
So, what we are going to be doing probably within the next couple of weeks is reducing the set of mailing lists that we are talking about, looking for areas that we have holes that we haven't covered and then we are going to be, I think, talking more about a medium to longer term strategy.
MS. GREENBERG: Do you have particular thoughts on the suggestion that was just made about these different groups who need to receive it? I mean, our goal, I know, is to get this information out to as many as -- everybody who needs to know about it.
MS. BALL: Yes. I just asked for a card from the commenter, so that we can communicate with her.
MS. GREENBERG: Okay.
MS. BALL: If there are any particular organizations or sets of organizations of organizations that you think we ought to be targeting, if you would e-mail me their names and addresses or the presence of a mailing list that we could piggyback on.
One other thing that you mentioned, Marjorie, is about trying to make an appeal also to the public. This is somewhat difficult and, again, it is another place that the press office folks have really been helpful because they are very good at taking extremely technical information, taking the people who understand the technical stuff and kind of pulling out what it is that is important to real people and then putting that into in this first case a press release that will not be targeted at the technical press. It will go out to the press, The New York Times, The Washington Post, the kinds of places that ordinary people read it.
We are working very, very hard to make sure that we have a message that is simple and clear, but that also points out how these things can be useful for real people.
MR. SCANLON: Just an extension of Judy's comments, the -- I guess I view the information and education activities about the HIPAA data standards per se as sort of one level of educational information. The privacy and unique number issues, I think, are quite another level and they are almost national issues in a way; I mean, debatable at that level really and I would just want us to be very careful that we -- part of it is not education. Part of it is a legitimate -- there is a legitimate difference and you may not be able to educate some of these differences away nor should you.
I mean, part of it is not education so much as a real disagreement in society. I think the secretary probably has -- is probably thinking about some of the ways, as well, that this might be presented. I think we have to be very careful. It is easy to be cute in a way here and actually backfire. So, I think we have to be very careful that what we do in the committee here is coordinated with what is done at another level or it will backfire as quickly as we can do something.
DR. LUMPKIN: Simon.
DR. COHN: Well, first of all, Elizabeth and Marjorie, I think you are doing a great job and I am delighted that there are such activities going on. I am happy actually to help in any way I can just sort of generally.
I think having been raised in a family where my father was a journalist and all that, I am well aware of the importance of the message. And certainly as one who gets five pounds a mail a day on average, I am not particularly hopeful that a letter sent to me from the National Committee is going to have standards coming your way.
MS. GREENBERG: The letter is actually from the Department. It may make even less of an impact.
DR. COHN: Okay. Point made. I guess I am less hopeful that that is going to make a major impact on communication. I guess I have always been persuaded myself that -- I am not speaking of public education. I am speaking of the education of people that really should be concerned and should be aware of what is going on. The message obviously needs to be tailored to the audience, but that it also comes out better in a familiar medium for that audience, which often times is -- if you are dealing with AMIA(?), you are talking to the people that are sending out brochures for AMIA and updates and all that and getting that into the things that are going out.
Every organization has that sort of material. This is also cheaper for us.
MS. GREENBERG: That is like what we are doing with NAHDO.
DR. COHN: Yes, exactly. I mean, it is -- there are all sorts of groups like that, but we just sort of need -- probably that is a better way to get it in a form that is meaningful for the audience than it is trying to deal directly with the audience itself.
Just a thought.
MS. GUILFOY: This is Helene Guilfoy again.
I guess I just wanted to stress that I think that somewhat of the target audience is being missed in these hearings. I talk to my colleagues that are in the health care industry on the information system side and also the people that are on the finance side and I am just not sure that the word is getting out there.
We are the people that are going to have to implement this thing. So, I really want to stress to the committee that the education needs to -- I am not going to say "start," but there needs to be a very strong emphasis on those of us that have to do this. The public health community is -- it is important for them, but we are the ones that are actually filing the claims and we are the ones that have to put the emphasis to our vendors to say we need software changes and we need them in two years.
Within the life cycle of hospital information systems, two years is not a long time, especially when we have got the Year 2000 stuff staring us in the face. So, I just wanted to really put emphasis on the fact that we need to get to the community that actually has to implement this thing, not the people that are -- it is just for information or that are going to use the information.
If we don't send it to you correctly, you can't use it.
Thank you.
MS. GREENBERG: Let me just ask you, Helene, you are saying these organizations that actually have responsibility for implementing them, there really has been very little communication by their leadership? I mean,
what --
MS. GUILFOY: Yes. That is what I am saying.
MS. GREENBERG: Do they have annual meetings? Do they have other venues, newsletters, et cetera, that maybe some of this could get into?
MS. GUILFOY: Sure. They have annual meetings and I believe that there are newsletters. I know that HFMA has a journal. I am not sure that CHIME does. AMIA has a journal. There has not been anything in AMIA, other than peripherally, about the changes that are required by HIPAA. That certainly is a journal that we could get some stuff into with relative ease.
But my concern more is for the people who are actively sitting in hospital information systems departments, who are the ones that are working with their vendors, who are not here. That is my concern is that I don't think that the vendors are aware -- the hospital information systems vendors are aware that these changes are, in fact -- they are ready. Who said yesterday -- Bill said yesterday it is 98 percent ready. Well, if it is 98 percent ready, then our vendors better start looking at what it is going to take to make us ready so that we can send the bills out in two years.
I want to stress with you again, as I have stressed before to the committee, the changes that are mandated by moving from UB-92 to X-12 are not small. They are very major for us and we need to start getting ready for this. We need to at least be aware that it is going to be there so that we can put the stress where it needs to be.
DR. COHN: If I could just make a comment on that because I think what she is saying is very valid. I think what has been lacking and I know -- I have been out communicating. I know Dr. Braithwaite and everyone around her has been talking about this. What has been lacking in all the communication has been what does it mean to x and that is a tough one to communicate.
I mean, it is probably better done by the group, which is why we need to get the information to the specialty group and let them distill it in a way that is meaningful for the audience. Either that or we need to come up with like really good examples, anecdotal examples of really how it is going to affect people and really get out there and be able to talk to it on a group by group basis.
You know, talking about X-12 standards isn't the same as saying, you know, this, this and this is really going to change in your life.
DR. LUMPKIN: But let me add that there is also a shared responsibility. We can talk to some of the groups until we are blue in our faces because a lot of folks who may be working on hospital information systems don't really see the broader picture until it comes up and hits them, but their CEO may and they may participate, for instance, in the hospital association.
All the changes that came in under BUBBA(?) -- what is that -- balanced budget amendment -- all those kind of changes are coming down the pike have been focused, just as with when you look at the Kennedy-Kassebaum bill, they focus much more on the other changes. Their associations need to become aware of the significance of this if we are really going to message to them.
So, it is a much more complex process than just trying to send out notices and so forth. It is just not on their radar screen.
DR. COHN: Agreed.
DR. GELLMAN: I just wanted to offer a comment. This really isn't applicable to all the industry education that you have really been focusing on, but there is some dim awareness, at least in part, of HIPAA on the part of -- I don't want to say the general public, but at least some people and that is the urban myth that the law requires that there is going to be some great health database, electronic health database in sky. And this comes up all the time. I see it on the 'Net and other places all over the place.
I just think that is something -- I don't know that there is necessarily anything directly to be done about it, but I think it is something we all need to be aware of.
MR. BLAIR: Helene, I think you are correct in that there still is some real work to be done because not everybody among the vendors and among the providers are fully aware yet. I think that many of the major vendors, who have testified here are already aware. Bill Braithwaite and others have made presentations at some of the conferences.
There is an article that I just distributed around that is going to be going into Health Care Informatics magazine on standards overall, but, of course, there is, obviously, a section that would be involving what the NCVHS is doing.
In any event, I think you are correct that we have to really organize what we do and make sure that we are addressing each of those groups during the next several months. But I do think that the work has -- it is on its way.
DR. LUMPKIN: Further comments?
[There was no response.]
Thank you.
Let's see, we have covered future meetings.
MS. GREENBERG: I think we may be ready to -- the power point --
DR. LUMPKIN: Is the power point ready?
MS. DOULAVERIS: [Comment off microphone.]
I will try to scroll through these rather quickly just so Dale doesn't have to sit here too long.
As you can see, we are still having technical difficulties. Knowing that many of you are often asked to present about HIPAA and the committee's work, we at NCHS have pulled together a little slide show presentation that may make a little bit easier for you.
We can provide all of you with a disk, which, of course, you can personalize to your audience and to your own content.
The first slide is just an agenda, which, obviously, you will want to change that, depending on where you are presenting. It is just a brief overview of HIPAA and some of the provisions.
You have a hard copy in your presentation agenda and that may be the best way to really look at the content. This is really just more to give you a flavor of the presentation itself. The transaction standards are the next few slides, and the supporting standards. More of the supporting standards in the next couple of slides.
Just a brief overview of to whom the standards do apply and the standards adoption process that has been going on as far as the hearings that have been held and so forth. Then a little bit about the privacy protections and the NCVHS and the role of the NCVHS.
Some of the subgroups and the subcommittees that have been built out of NCVHS. This is the current status of the NCVHS efforts, which, you know, obviously, we will have to update and change as time goes on to reflect the more current work of the committee and the status again.
The expanded role of the committee, the standards adoption process. That is the NCVHS Web site address.
Let me start into the recommendations part that have been made to the Secretary. The first is recommendations for transaction standards. More on the transaction standards.
Then there are current recommendations on the unique health identifiers. And again as this information changes, it can be updated. And the clinical code set recommendations. The NPRMs. Then a couple of slides on health information privacy, the contributing factors to privacy and just some recommendations for the Secretary.
Then a couple of slides of the security recommendations that were developed by the NCVHS. These are the recommendations for federal privacy law. That is a few slides and then some more information and that is the two Web sites that you can refer people to go to if they want more information.
And that is it.
PARTICIPANT: Will these slides be on the NCVHS Web site? I know our slide presentation from the federal side is on the federal Webs.
MS. GREENBERG: Well, actually, what we did do is we -- because we are broadcasting this, we sent it electronically to people to get it on there. So, I guess we could put it on our Web site. Yes. What we wanted to do is just, you know, get any -- since it is for the committee -- get any feedback from the committee and I realize that -- you know, if you want to look at the content, it is pretty straightforward out of the committee's reports, et cetera. But -- and get comments back, say, in a week or something on the content.
If you have any suggestions on the presentation format and then we thought we would finalize it where we are and then provide diskettes to the members. I think it would be more than appropriate to put it on the Web site.
MS. DOULAVERIS: The presentation is about 45 minutes. I timed it last night, doing it properly, and I think it is 33 slides total.
MS. GREENBERG: And you could pick and choose or add things and --
PARTICIPANT: Or talk faster.
MS. GREENBERG: I can get through 33 slides faster than that, but we don't know what anyone comprehends.
MR. SCANLON: I don't think the team, Elizabeth, is actually doing talking points to go along with the slides, but I think we may have something approaching a standard set of talking points soon, more or less, to accompany those. They would have to be tailored, of course, to the individual audience. But we might be able to have sort of a set of talking points to go along with those as well.
MS. GREENBERG: And then we really -- you know, if you do use it -- now we have provided it to Don. I think he is going to use some of it in his CPRI talk. So, we really need feedback and if you identify other things that would be helpful, then I think we will try to fit them into our priorities. But, I mean, we need that kind of feedback from you because we are really basically developing these for the use of the committee.
DR. COHN: Actually, I think it is a fine presentation. I think it needs a couple of joke slides thrown in, but other than that -- it needs something humorous on some level in there, but other than that, I think it is fine.
DR. LUMPKIN: You know, perhaps, in trying to get more information out, Elizabeth, if you could talk to that
-- I can't remember -- a small software company in your state. Maybe they could put like -- include it in every copy of Windows, a little HIPAA notice. Maybe we could talk to the Federal Government and release some other problem they have that they would be interested in.
Okay. On that note, I think we have exhausted our agenda.
I hope everyone has a wonderful set of holidays and we will see you all next year.
[Whereupon, the meeting was concluded.]