[This Transcript is Unedited]
Quality Hotel Courthouse Plaza
1200 N. Courthouse Road
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DR. LUMPKIN: The first thing that we need to do is a little housekeeping -- did anybody drive here today?
VOICES: Yes.
DR. LUMPKIN: Would anyone who drove and would like to drive home, we have a sheet here for you to sign. Put the type of car, the color and the license plate. If you don't know the license plate, just put the state or the occupied territory if it is D.C. But just put that on this particular form. We are going to be passing those around so we can take it to the management so that they don't think that you are some person who is parking here and working next door or something.
I hope everyone has had a wonderful and productive summer. It is now almost fall. John Fanning is not here. So, I can't point out the significance of that. But Bill is. Where did Bill go? Oh, he is hiding.
Anyway, it is almost fall. So, we will see if there is any new regulations being filed sometime in the near future at the end of summer.
We are going out over the Internet. So, we will start with doing some introductions so that people can hear the voices. We will start with members of the committee.
My name is John Lumpkin. I am director of the Illinois Department of Public Health and chair of the committee.
MS. GREENBERG: My name is Marjorie Greenberg. I am the executive secretary of the committee, NCHS/CDC.
MS. FYFFE: Kathleen Fyffe, member of the committee. I work for the Health Insurance Association of America.
DR. FRIEDMAN: Dan Friedman, member of the committee, Massachusetts Department of Public Health.
MS. FRAWLEY: Kathleen Frawley, member of the committee. I work for St. Mary's Hospital in Passaic, New Jersey.
MS. COLTIN: Kathryn Coltin, member of the committee. I work for Harvard Pilgrim Healthcare in Wellesley, Massachusetts.
MR. GELLMAN: I am Bob Gellman. I am a privacy and information policy consultant in Washington, D.C.
MR. ROTHSTEIN: Mark Rothstein, member of the committee, Health Law and Policy Institute, University of Houston.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and Quality, liaison to the committee.
MS. WARD: Elizabeth Ward, member of the committee, president of the Foundation for Healthcare Quality, Seattle, Washington.
DR. BRAITHWAITE: Bill Braithwaite from the Department of Health and Human Services, staff to the committee.
MR. BLAIR: Jeff Blair, member of the committee. I am vice president of the Medical Records Institute.
DR. COHN: Simon Cohn, member of the committee and national director for health information policy for Kaiser Permanente.
DR. ZUBELDIA: Kepa Zubeldia, member of the committee. I work for Envoy Corporation.
DR. STARFIELD: Barbara Starfield, member of the committee. I am at Johns Hopkins University.
MR. SCANLON: Jim Scanlon, HHS, staff director for the committee.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention. Staff to the committee.
MS. HORLICK: Gail Horlick, Centers for Disease Control and Prevention. Staff to the committee.
MR. FERRANS: Richard Ferrans, Department of Veterans Affairs, staff to the Workgroup for Computer-Based Patient Records.
MR. SMITH: Ken Smith, Veterans Health Administration and chief clinical officer at GCPR Framework Project and staff to the committee.
MS. JACKSON: Debbie Jackson, NCVHS staff.
MS. CAPLAN: Mary Caplan. I am from the National Home Infusion Association.
DR. EDINGER: Stan Edinger, AHRQ and staff to the committee.
MR. HITCHCOCK: Dale Hitchcock, HHS, staff to the committee.
MS. BEBEE: Suzie Bebee, NCHS and staff to the CPR workgroup.
MS. WILLIAMSON: Michele Williamson, NCHS staff.
[Further introductions.]
DR. LUMPKIN: We still have a few other people on the way.
Why don't we perhaps -- I don't see John. Is he coming?
MR. SCANLON: No. Bill is going to give the privacy and I will give the departmental.
DR. LUMPKIN: Oh, in that case, let's move to the first item on the agenda, report from the Department.
MR. SCANLON: Thank you, John.
I am going to give a report this morning on the -- well, Bill Braithwaite is going to give a report on where we are with the HIPAA data standards and privacy -- Bill is going to report on the data standards and privacy work under HIPAA. I am going to give a report on some other activities in HHS, relating to data policy and particularly two things.
I wanted to update the committee first of all, as John asked me to do, on where we are with several sets of recommendations from the committee in HHS. Secondly, I wanted to bring the committee up to date on some data strategy initiatives within HHS.
Let me start with where we are with several recommendations. You will recall that the NCVHS sent in the report that outlined recommendations for standards for patient medical record information. I think it was June and the report contained a number of recommendations. There were basically three kinds of recommendations, I think.
One set of recommendations related to a process for moving forward with the clinical data standards, clinically-related data standards; in essence, the next wave of the HIPAA process.
A second set of recommendations had to do more with national policy and capacity building, such as privacy and frameworks of that nature and then a third set had to do -- and often these were directed at specific agencies -- a third set of recommendations had to do with research development, convenorship roles and so on and the demonstrations relating to moving forward with the capacity for patient medical record information.
John Lumpkin and Jeff Blair made a very nice presentation to the Data Council at the August meeting and I think it was very well received. As a result, the Data Council has asked each of the agencies within HHS to take a look at, number one, the recommendations that pertain to that agency, and you will recall that some were quite specific, HCFA, FDA, AHRQ and so on, and to identify perhaps any activities they were already undertaking or planning to undertake that comport with the recommendations that would support them.
In addition to identifying maybe the three to five highest priority areas that they thought the Department overall should take in the interims of moving forward with recommendations.
I have to say that there -- it is clear that privacy considerations will be a limiting factor in this. I think when everyone looks at the report and the recommendations, there is a lot of enthusiasm for moving forward with the benefits and the capabilities, but I think everyone is still quite concerned about having in place the privacy framework before we move to the next step.
Obviously, the PMRI report included a number of recommendations that recognized this and sort of outlined that as sort of the platform from which other progress would take place.
Other recommendations, the recommendations relating to process for HIPAA, I think we -- at the Data Council we agreed that our Health Data Standards Committee, which Bill Braithwaite and Karen Trudel co-chair, would probably serve as the focal point for the evaluation of any recommendations that the NCVHS would provide along those lines, dealing with clinical data standards. I think everyone agreed that was probably the best approach.
Again, we will have to see what the recommendations look like. I don't think we can make any further commitment at HHS. We will have to see what all of the reactions are, until we actually begin to see what those may be and where we are with privacy. Then the other set of recommendations, where in essence the committee identified specific ideas that an agency should pursue, some of them quite specific. We have the agencies looking at those now, where they are on those and where they think they can be in the year ahead. So, I hope we will have a -- now, what we will probably do is pull all these ideas together and see -- give them a thorough evaluation, see where everything else stands and then maybe perhaps we can pull together some sort of an overall plan in terms of moving forward in a balanced way.
Questions on that before I move on to a couple of reports submitted earlier?
Simon.
DR. COHN: I think maybe I will lead off. I guess what I am hearing in summary is that everything seems very much in process. Is that an apt way of describing the response to the recommendations?
MR. SCANLON: I think so. Everything is being looked at. I think we will see where the agencies are on some of these recommendations specifically and then we will be able to know where exactly we stand.
DR. COHN: Well, recognizing it is in process, let me ask, I guess, two questions about that. I mean, one is how does that relate to your end, budgeting, start of the new fiscal year? How does all of this play into the election and recognizing that there is going to be a transition -- it really has started already with the resignation of Nancy Ann Minda-Perl (?). How does that play into all of this?
MR. SCANLON: Mike, did you want to respond first?
DR. FITZMAURICE: I would speak just for my agency, the Agency for Healthcare Research and Quality. What the report does and the recommendations is let us look at what we are already doing in support of the recommendations and categorize those things. It lets us to be poised to spring initiatives on the new administration or the continuing administration, depending upon your agency and whether your boss is going to be around or not.
So, it is going to help us at least with a good transition into here is why we think these things are important. Here is an august body who says they are important, too.
MR. SCANLON: I can continue. The transition periods are both opportunities and stress points, as you can imagine. You don't want to lose all the progress that was made previously and on the other hand, this is an idea where there may be some -- a time when there may be some receptivity.
We are coming to the close of our fiscal year, as Simon indicated. The end of this month is basically the end of the federal fiscal year and many state fiscal years as well. We have used year end money for some of the activities a little earlier in the summer that were mentioned in the report. For example, one of the recommendations dealt with providing support to the public health community and the health services research community in terms of being able to participate in the HIPAA standards development process.
Actually, we used some of the year end money to provide some support for the Public Health Data Standards Consortium, to be able to do that. But I think the opportunity here is that as October 1st rolls around, we will be doing planning for research and for demonstrations. None of the agencies around the table has a budget yet for fiscal year '01. It is still in play and on the Hill. But I think this gives us an idea of where we might want to direct some effort in the fiscal year '01 plan.
MR. BLAIR: Thank you. Maybe you can help me understand this a little bit. We really pulled together the report and it was addressed to the Secretary of HHS. I am wondering if in one way or another does the report get communicated to Congress from the standpoint of NCVHS being independent and trying to seek bipartisan support for these things so that we could maybe insulate ourselves a little bit from disruption if there is any changes in administration? Or is anything like that happening or should it happen?
MR. SCANLON: The Congress, of course, will turn over completely again this year, too. So, I am not sure there is -- as you know.
MR. BLAIR: Right.
MR. SCANLON: I think the committee wants to be very careful, as you said, Jeff, not to be appear to be a political committee that changes as the -- whose makeup and influence changes as the parties change. I think the committee is regarded as a solid professional expert committee that frames the truth and recommends the truth regardless of politics and clearly you don't want to be. There may be a brief enthusiasm when one associates with one party or the other, but that is usually brief and you don't want to be seen as a partisan.
In terms of Congress, I think we will have to see if we want to -- and we have to be careful here because I see people when they read the report are reacting a little bit to what about privacy and I don't think anyone wants to go to the Hill and start briefing people about this until we know a little bit more about privacy because it just -- it stirs that fear that we are moving forward in electronic medical records and networking, a little bit before we have know exactly what the privacy framework is.
I have seen it happen a little bit already and I don't think anyone is going to step out and say let's go brief Congress until we know a little bit more about where privacy is. I think that is probably -- that is justified. I think that is -- but I think there is a lot of enthusiasm from both sides of the aisle for this notion of moving forward in the health care sector, bringing the benefits of IT networking and so on to the health sector and I think there will be a lot of receptivity, but we may just have to see. We may need about eight weeks or more to see how things -- I might say that the report was very well-received, though in HHS. I think our leadership, who is familiar with these issues, was very receptive and thought that we should forward -- and I think the only concern, limiting factor in a way is the whole privacy side.
I do think that will be a limiting factor until we know a little bit about more about where -- and this is justifiably so.
MS. GREENBERG: Just in relationship to what Jeff was saying, because this was one of the requirements in HIPAA, I don't know whether we directly send it to Congress as well, but certainly in our next annual report -- HIPAA implementation report, we can really highlight it quite a bit in that regard.
MR. SCANLON: This was a report -- this was required by HIPAA. This was a report to the Secretary and it was in essence to -- since HIPAA itself did not deal with the clinical -- you know, moving beyond the administrative simplification side, again, for good reasons and wanted to have a little more time to sort of work this out, the whole approach here was to make recommendations to the Secretary.
Then based on that, I think, there would be a way to -- how to move forward. But I think we may want to consider indicating that -- I think we just need a little more time to see what is going to materialize on the Hill. I don't want this to fall -- it could actually create the wrong -- it could actually cause backlash if it is not done properly. I think you all realize that.
MS. FYFFE: Jim, and committee members, forgive me for not listening more closely, but the three sets of recommendations you were talking about, who made them, from what body to what body and is this on the NCVHS web site?
MR. SCANLON: Yes, the report -- first of all, the full report on the NCVHS web site. It has been on, I
think --
MS. FYFFE: No, no, no. I mean, are those the three sets of recommendations on the report itself?
MR. SCANLON: This is my characterization of the recommendations in terms of how we view them. This is not necessarily the way the -- the NCVHS has ten recommendations and a lot of detailed recommendations. I don't think you are necessarily broken out this way. In terms of how to deal with them, this is the way we --
MS. FYFFE: That is why I was lost. Okay. Sorry.
MR. BLAIR: Can I just clarify because Dr. Lumpkin and myself were presenting it. Simon was on vacation and wasn't able to be there. He didn't want to come back. Dr. Lumpkin presented the ten recommendations that are in the report as it specified. So, there was nothing that was either added or subtracted in terms of the recommendations.
They were presented just as they are in the report.
MR. SCANLON: I am characterizing them the way we would approach them, just in terms of broad categories. Now, we are starting to get responses from some of the agencies already in terms of what they have been doing and are doing in the direction of the recommendations, as well as what they see as what the possible next steps could be. In a way the timing is fortuitous in the sense that budgets are being formulated and presumably there will be a receptive -- a new leadership later this year.
Let me go on to two earlier reports.
Remember that the NCVHS sent -- after a few days of hearings with representatives of the United States insular areas and Puerto Rico and the Virgin Islands, a set of recommendations dealing with information, infrastructure and data needs and issues in these territories and insular areas. That was circulated to the respective agencies back when it originally came, but -- and we got some -- it looks like the agencies have actually taken up on a number of recommendations, but what we asked the agencies to do is we recirculated the report and we asked all the agencies to identify again what progress they have made since the original report. What we are planning to do here, I think at Lisa's suggestion was to -- we will pull all of the agency progress reports and then we will send a nice letter back to the participants from the territories about where things are, invite them to comment further and to Lisa and the subcommittee members.
I have seen of the reports from the agencies and actually it looks like -- this is sort of an unsung activity. I don't think the agencies get much credit and it doesn't have a lot of visibility in the agencies, but it looks like a lot of the agencies are actually providing a lot of infrastructure help in terms of equipment, technical advice and even funding to some of the areas. I think you will remember that some of the areas were in extremely dire straights in terms of infrastructure. They are not worried about software necessarily. They are worried about basic electricity supply and typhoons and things like this.
I shouldn't be condescending. Some of these areas were quite sophisticated. They have censuses of their own. They have sophisticated household surveys of their own and fairly good vital statistics systems. But others were really just beginning and they needed help in terms of building a basic infrastructure for civil registration, for things like that and for health information.
Some of the agencies have really come to the rescue in terms of -- at least in the health side -- of providing some equipment and some advice and some funding. We will pull that together as soon as we can. We are still getting the material from the agencies.
In the third report was just I wish a little further along is the report that the committee sent -- I am sorry?
DR. IEZZONI: How about HHS?
MR. SCANLON: This is HHS.
DR. IEZZONI: So, you are talking about agencies within HHS.
MR. SCANLON: Within HHS.
DR. IEZZONI: I had heard that there were some other departments involved.
MR. SCANLON: That is right. The Department of the Interior, Lisa -- the Department of the Interior was sort of the formal agency that deals with the insular areas and so on. They provide informal assistance every year and they provide -- they have also provided funding to the Census Bureau to assist in the insular areas.
These are only HHS agencies I will be talking about, CDC, NCHS, SAMHSA and so on.
Any other questions on that before I move to the third area?
[There was no response.]
Medicare managed care data, the committee, again, after hearings and a lot of analytic work developed a report and set of recommendations on what data improvements were needed in the whole Medicaid managed care framework. Many of the recommendations were directed towards HCFA, but there were also some directed at states and health plans. This was referred to HCFA quite awhile ago and I know they were looking at it and I, again, had to reassign it. It is now being looked at by the state -- what is it called -- the Center for Medicaid and State Operations, Rachel Block and others, in terms of what they can actually do.
I called yesterday. There was nothing that they could tell me that I could report, but at least it is getting a serious look and I think we will actually have some sort of a formal response from them within the next few weeks.
I might also mention that in terms of the content itself, I am going to talk about this in the next subject, the HHS Data Strategy Committee, but both the Medicaid managed care data report and the report of -- the island and insular area report -- we have included these in consideration of the data -- the HHS data strategy work. I will get to that in a minute, but we have identified the major areas, major recommendations, major data gaps and priorities that have been sent into HHS over the past few years and then longstanding data needs, as well. We are looking at what -- a synthesis of what the data needs are in those areas and then how we could match them up with our current HHS data portfolio and plan as well.
Again, we have included both the insular area recommendations, as well as the Medicaid managed care data report. We have a whole section that we are looking at in terms of data on financing and utilization and the Medicaid managed care data report is being considered there.
Paul.
DR. NEWACHECK: Just a question about dissemination. The Medicaid managed care report, does it go to the state Medicaid agencies, for example, or does it stay within HHS?
MR. SCANLON: We sort of defer to HCFA's judgment on this. We could ask the state -- the Center for State Medicaid Operations if they would want to share at least some of the recommendations or perhaps discuss it at one of the meetings with the state Medicaid directors. It has just taken awhile to get to the right place and I am confident now that it is being evaluated at that level, where they could actually do something.
There will also be a letter back to the committee on that. I know the secretary is -- there is a letter in the Secretary's signature on the PMRI report as well, acknowledging that the report has been received and where things stand.
Those are the three sets of recommendations I think we said we would look into and I think we want to keep them moving. Sometimes when they are circulated they -- we lose some time, but I think we have recirculated a couple of these and we have asked the agencies to come forward with where they are in these things.
If I have a couple of minutes, John, let me go to the data strategy activity.
DR. LUMPKIN: Okay.
MR. SCANLON: I think I reported at the June meeting that at our Data Council meeting in early summer we sort of had -- we devoted the entire meeting pretty much to a review of where we stood on various data collection initiatives. I shouldn't say data collection alone -- data collection analysis and dissemination initiatives. This does not deal with the standards or privacy or so on. This is more what the research, statistical and administrative data activities within HHS.
Given all of the initiatives in terms of Healthy People 2010, eliminating disparities, improving data on the health system and providers and so on, we sort of had our survey integration working group look at where we stood on all of these and what was the best way to proceed in terms of integrating the data needs with what our portfolio looks like in terms of data systems and what we thought it might look like in the future and where we might redirect some activities or emphasize.
The upshot of that discussion was that the need was really now to pull all these various strands together and they are quite good. In a place like HHS, sometimes that is the way you have to begin by developing interagency data plans in specific areas. Otherwise, the task is overwhelming but I think everyone agreed that the job now is to pull them all together into an overall framework and overall data strategy that would involve multi-year frameworks and would be linked to the budget process. We have had excellent plans but as you all know, if they are not converted into some sort of resource support, it is simply a plan and we are unable to convert it into an actuality.
So, the council created -- it basically in place of the former survey integration work group, which you recall developed the original HHS survey integration initiative, the Data Council created a Data Strategy Committee, which is now -- which moves beyond the survey integration group. It is going to be data collection and integration more broadly and the goal here is to review the situation, review all the data needs and they are legion, as you know. If anything, they keep increasing and to try to pull these together into a systematic multi-year plan hopefully with the adequate research support and a process for moving forward.
Just as an example of the way the committee is approaching its work, it is sort of divided into two basic thrusts. One is to, as I said, to try to pull together in an overall framework the various data needs that have been identified, including the islands' data needs, Healthy People 2010, a million of data needs in the area of race ethnicity data, state data, data on the health system and providers' capacity, supply and so on, data on special populations.
As you can imagine, these are other areas that you have heard about. In addition to those areas, there are continuing data needs and there are always new areas that HHS is asked to look at and fill. So, the Data Strategy Committee work is now well underway and there are basically -- I will finish with three sort of where the committee is with -- there are now basically three prongs of the committee's work.
The first is actually working on this multi-year data strategy and there there is a -- the work is proceeding on pulling together a synthesis of data needs and gaps, at the same time pulling together a framework for how HHS has -- it is not so much a portfolio analysis of our data systems as a look at how typically HHS responds to the data needs. And it is more than just going out and collecting data, as you know. It is purchasing data. It is working on standards. It is a number of other ways.
Hopefully, those two steps will come together in the next few months and we will at least have the outline of a framework.
The second major area that the committee was asked to work on is the fiscal year '02 budget. As I indicated, the federal agencies are completing their fiscal year at the end of September. That will be the completion of fiscal year '00. Next year is fiscal year '01, but federal agencies like your organizations are always planning a couple of years ahead in terms of budget.
For our fiscal year '02 budget at the Data Council's request and assistance, HHS has made the area of improving information for decision-making an area of special emphasis, along with information technology. So, the agencies are asked to give special attention to needs and improvements in this area to look at it comprehensively in their agencies and to come forward in the budget submissions with enhancements in those areas.
The Data Council and the Data Strategy Committee are pulling together sort of an HHS-wide crosscut, what it is referred to in budget terms, but it is actually looking at in the context of the guidance that was issued to the agencies in terms of priorities for data and the importance of data enhancements, the Data Strategy Committee will be pulling together everything the agencies are proposing. They will be sorting them out, trying to assert some priorities and then that should feed into the overall budget submission, which will probably occur later in the winter or probably even in January.
So, that is how the -- we wanted to create a link with the budget process. Otherwise, we are simply planning without the adequate resources.
Final area, very briefly, the Data Council was asked to undertake a special project, as well, in relationship to the initiative to eliminate disparities in health, racial and ethnic disparities in health and the leading health indicators for Healthy People 2000. I think both of these issues were discussed at previous committee meetings.
The leadership of HHS decided that dealing with 480 or so objectives for Healthy People 2010 and numerous other objectives for eliminating disparities was just a little hard for everyone to get a grip on. While all of those objectives continue in the detailed work, everyone thought that it would be better to focus on perhaps two dozen indicators that met a number of criteria, but at least the people could focus on and you could actually sort of consider it as a little report on how well the United States is doing in these areas.
So, there are 22 measures that have been selected that will serve as the core objectives for monitoring progress on the eliminating disparities initiative, as well as the leading health indicator under Healthy People 2010. They involve about I am thinking 14 data systems to support those objectives and we were asked to look at how do those systems shape up in terms of meeting the needs that everyone says we need to address and what kind of enhancements were needed and can we do this in a way where we don't create another stovepipe or several stovepipes, but where it advances HHS data strategy more generally.
The Data Strategy Committee did not, made some recommendations for how we could do this in a strategic way and where we would have the data to monitor those 22 measures as well. That was reported and, hopefully, budget support will be sought for those as well.
DR. STARFIELD: [Comment off microphone.]
MR. SCANLON: The 22 systems? Sure. And the indicators, sure. I think we have briefed -- if we haven't, we should -- the eliminating disparities initiative. There were six areas and then the Healthy People 2010, I think we had a discussion at the committee on the leading health indicators. I can get the committee a full description of what the objectives are and the data systems are. Again, if we could -- there is sometimes the notion that data is free, you know, that all you have to do is, you know, why can't you have state data, why can't you get data on all the race-ethnicity groups and so on.
In fact, it is quite expensive to do some of this. State data and special population data is quite expensive. It has always been my view -- this is not an official view
-- that we have underinvested in data, this kind of data particularly. Certainly in information technology, we are way below where the industry is. That is my view. That is not an official HHS view.
But at any rate, this is an attempt again to try to say, look, if you promise you are going to have this, this is what it takes.
So, let me stop there.
MS. FYFFE: Just a comment that I sort of agree with Jim's views on that.
DR. LUMPKIN: It may not be the official HHS view, but I think that probably many on this committee would agree that we as a nation in our health systems, as well as our public health systems and our population based health systems underinvested in data collection and analysis because I think that where we do have data collection systems, we tend to short the analysis component of it. We will put it in a warehouse somewhere.
Simon.
DR. COHN: Thank you very much for that, I think, illuminating presentation. I have to say I may have missed how some of the pieces fit together in your presentation. Given the things you were describing, it appeared to me to be so soft and we are going to talk about this and we are going to work on this. If we were to ask somebody to come and talk about a three to five year plan, strategic plan for HHS in terms of its information strategy, is there somebody at this point at HHS that we could ask that? Is this something -- is this what is going on or is this something that is a little more piecemeal than that?
MR. SCANLON: The data strategy that I spoke of here, I think, this was just started in the summer. I think probably in a few months, you would actually have the outline of this. There is an HHS strategic plan, which is going through review stages now, which is sort of an overall strategic plan.
There is an IT plan. The data strategy plan that I am talking about here is probably going to be several months away. We certainly would be willing to talk to the committee about it when it is there.
I guess the thing is it builds on initiatives that the committees has been following, the survey integration plan, the race-ethnicity data improvement, eliminating disparities, improving health system data. But it ties them altogether. So, it is more of how do you pull this into a five year or even ten year framework, including standards, including analytic plans, including working with states and other partners. How do you tie this altogether? That is still several months away.
But the other plans -- and if the committee would like briefings, there is an HHS strategic plan. All the federal agencies are required to have strategic plans. I could certainly get you copies and a briefing on that. That is more of a programmatic plan in terms of goals and overall objectives.
There is also and there has been at least ten years, a five year or so information technology strategic plan that all agencies are required to do and usually our chief information officer prepares that. It is for information technology and related issues. It is not so much the data content area, but, again, we could provide that. It is not easy reading, but maybe we could have the CIO brief the committee at a future meeting in terms of -- I think what we are finding in HHS actually is -- you found it, I am sure in your own organizations that for quite awhile we tended to separate the functional areas of health and human services, the data and the statistics and the research, sort of this content area, the IT area and the internal information infrastructure area.
I think there was always a recognition of what it required to carry out these data activities. Security was probably -- just as it is in the industry, it was probably not a major concern. It was sort of the last thing people thought about. Now I think we are all saying that these actually go hand in hand and we are trying to tie these things together more in HHS, along with GPRA and these strategic plans and program plans.
We are looking at the kinds of infrastructure needed to support these, as well as the content planning as well, you know, in terms of what kind of data do you need to meet these objectives.
DR. STARFIELD: I just got in the mail yesterday this flyer about this information, The Key to Delivering Our Health Agenda, from the National Health Service, the United Kingdom. There is a key conference being organized for the 27th of November 2000 in Birmingham, England and it is put on by the National Health Service and it is clear that they are telling everybody about their information strategy.
Maybe we could send somebody over and look at it as a model.
MS. FYFFE: This is a simple question. I am sure there is not an easy answer, but when you are doing these three to five year strategic plans, are you talking about funding that is in appropriations every year or is there some sort of ongoing permanent funding for such activities or is it both?
DR. LUMPKIN: There is no such thing as permanent ongoing funding. You can argue about the adequacy of the budget process, but that is a topic for another day. Everything is appropriated on a year by year basis and usually it is not appropriated in time, as you know, but there is no such thing as a capital plan for all federal agencies.
The most that any agencies have in terms of flexibility -- again, I am not talking about the trust funds and that sort of thing --
MS. FYFFE: Okay. Because that is what I was thinking about --
DR. LUMPKIN: Very few agencies can do that. It is not a -- it is not the most modern approach to budgeting.
DR. BRAITHWAITE: I have two brief reports. The first one for John Fanning, who apologizes for not being here today, but will be here tomorrow to give you an update on a couple of other privacy things going on around the world. But he wanted me to answer the question on everybody lips. When is the privacy regulation, the final rule for privacy and health care coming out?
The real answer is we don't know. We have more than 50 and less than a hundred people working 180 percent of time, trying to balance between the necessary fact finding, reading the comments, crafting the final rule and analyzing everything to make sure it all comes together. There was a newspaper article not too long ago based on a leak about some decisions that were supposedly made within HHS and I think you should all take that with a great big grain of salt because every decision that we try and make, we put up as a tentative and then a week or two later we have to change it because it turns out that this is an incredibly complex thing, where every decision is interrelated with every other one and it is not possible to make definite decisions in any one of these areas until the whole picture is put together and put to bed and then cleared, which is going to take some time.
The President has promised that this will be out by the end of the year. He didn't say whether that was physical year or calendar year, but it is clear now and not fiscal year because the fiscal year is just about up. The Secretary said something about fall. I think it is possible for us to finish the work that we are undergoing sometime next month, but when it actually sees the light of day is totally unpredictable. As you all realize after the various machinations we went through in getting the transaction rule out, it is just not predictable. There are lots of different points in time, where it can be stalled and altered and changed and there are practical decisions and political decisions and all kinds of other things that overlay this.
So, I cannot give you a date. I will leave it at that.
Any questions about that that I can't answer before I go on?
Okay. As you know, we have our one success. We did, on August 17th, did issue the final transaction rule. The general feedback from the industry about that is quite positive. There are a few flare-ups of worry and concern where we changed some exceptions and people saw that before they saw how else we dealt with the problem as opposed to just taking the exception away. But ow the people are gradually reading it and understanding the full breadth of what we have done, I think. In general, I think, it is a very positive response.
There were a few errors made in the final rule. Some errors were made on the part of the Federal Register who -- don't ask me how they do this because we gave them an electronic copy of it, but some things were -- some minor things were changed in the final publication.
So, we will be fixing those in an errata. There were a couple of things where we made decisions, which we feel were in error, most of which are not substantive, but a couple of which are considered substantive from the rulemaking perspective. So, we will be coming out very shortly with another couple of Federal Register publications. Exactly what form they take, I don't know yet, which will try and correct those errors.
Meanwhile, we have three other final rules, sort of sitting in the wings, waiting to be finalized and cleared for publication; the employer identification rule, the national provider identifier rule and the security rule. The security rule is totally sort of on the table and being altered because it is dependent on and interrelated to the decisions being made for privacy and once the privacy rule is finalized, then we can finalize the security rule and move it forward as well. The other two identifiers could be then be moved forward as well, not because we couldn't do them now. It is just that we don't have any horsepower to do it because everybody is, as I said, working very hard on getting the privacy rule out as the top administration priority in administrative simplification at the moment.
We do expect that all those final rules will be out by the end of the year barring some other unforeseen circumstances. We have a couple of proposed rules that are on the scheds waiting to be put into the same process. Again, stalled for lack of people to review them and clear them; the plan identifier and the claims attachment proposed rules. Hopefully, we will get those out by the end of this year as well, but as you can imagine, that is an incredible work load for a very short period of time and one or more of those may spill over into the next year.
In the next year, we will -- we expect to publish a notice of proposed rulemaking on the enforcement rules for how administrative simplification will be enforced. This enforcement rule will cover both privacy and security.
The standards that we put out, as you know, have a two year implementation time on it. We don't expect the enforcement rule to have any time associated with it. It will go into effect on the compliance date for each of the standards that have been published.
Kathleen, do you have a question?
MS. FYFFE: The enforcement rule would only include those other rules that have been issued as NPRNs or are final. Is that correct? So that if you don't get out the plan ID or claims attachments for awhile, would you have to go back and update the enforcement rule or haven't you --
DR. BRAITHWAITE: The concept is that we would put out an enforcement rule that would cover all enforceable administrative simplification standards. Then as they came on line and the compliance date for each standard passed, then the enforcement rule would go into effect on that standard, but would not be, hopefully, anything too specific about any particular standard in the enforcement rule. It would just be the enforcement process laid out in detail.
MS. FYFFE: I see, and that comes out as an NPRM first?
DR. BRAITHWAITE: It would come out as an NPRM with public comment and then a final rule sometime after that.
MS. FYFFE: Thank you.
DR. BRAITHWAITE: Other questions?
MS. FRAWLEY: I will direct this to either you or Jim. I just read recently the Secretary is getting an office of E Health. What I was wondering was how all of the work that is being done on privacy and security and the work that the committee has done on, you know, computer-based patient records, you know, what this office's focus will be and how our work will, you know, intermesh with the work of that office?
MR. SCANLON: I think you are referring, Kathleen, to a little reorganization in our information resource management shop, where they created -- they did a little reorganization and this will -- it is more E.GOV and even there it is more -- it is a way to strengthen what they clearly as seeing as a growing threat to security. So, it is -- I think they mentioned the word "privacy" in their title, but they renamed the office and it is basically a focus on the IT, internal IT issues, internal security issues. Obviously, no issues are entirely internal in the security area, but it is that kind of a focus. It doesn't mean privacy in this direction. It doesn't mean E-health in the sense that we talk about it. It is more promoting the security and the infrastructure for E.GOV, which is more the transactions and so on that HHS would engage in.
We actually work fairly closely with that office and as I said, the CIO and the deputy CIO are on the Data Council now.
DR. ZUBELDIA: Bill, I have a couple of questions.
Is there a process for coming to the final rule? There is not only some errata, there are some things that maybe the industry may want to change for the next release of the rules or for the next year when things can be changed. Is there a formal process for that or just an informal?
DR. BRAITHWAITE: There are two kinds of final rules. Some final rules allow for public comment as a formal process with the expectation if the public comment comes up with something that requires a change in the final rule, they will issue a new final rule. There are other final rules that are final. Then there is another category, which is the administrative simplification rules, which are final until the next time that we issue a notice of proposed rulemaking, take public comment and issue a revised final rule.
So, there is one for every day of the week. But these final rules are -- that have been issued are not the type of final rules that have a formal process for accepting public comment on that final rule. So, for instance, there are things that need to be dealt with, we have several mechanisms. The first is we have set up on our web page a
-- well, the information is on the web page, but there is an address where you can send questions about interpretation of the final rule and those questions are put through a committee where an answer to the question is put forward and then the question and the answer in a very general sense, not aimed at the specific individual who asked the question, are posted on the web site as answers to frequently asked questions.
So, that is for clarification of interpretations of the rule. That is not only a way to sort of get the questions and the answers posted out there to the world, but it is a way of sort of bringing to the fore issues that need further discussion without there being a formal comment process for this final rule.
The second method is if the question has to do with a sort of technical issue about the standards that we adopted, then the designated standards organizations that we designated have set up a web site and you can post questions and your suggestions to that web site to be dealt with by the people who actually build and maintain the standards.
The third method is the method of the sort of up to annual revisions of each of the final rules under administrative simplification. The process for getting a sort of serious concern into that would be to bring it to the NCVHS, who would then make recommendations to the Secretary and it would be considered in the next round of NPRM comment and final rule for revisions of those standards.
DR. ZUBELDIA: The question I have --
MR. GELLMAN: Can I follow-up on that if you are going to change the subject?
DR. LUMPKIN: Yes, but only if you speak into the microphone.
MR. GELLMAN: You are going to make some changes to the final rule. Does this affect the timetable for the
-- you know, the two months and that two year period. Is that going to get shifted back as you make changes in this immediate round or not?
DR. BRAITHWAITE: I don't know for sure, Bob. That is sort of beyond my understanding of the rules of how those things work. But I believe that there may be a standard or two that get tweaked one way or the other and it would change the timetable for only those standards and not for the others.
DR. LUMPKIN: Okay. Kepa has a second question on a different topic, unless there is a follow-up to --
MS. FYFFE: Yes, I have a follow-up.
This question is for Bill, but maybe someone else in the room can help us with the subtle regulatory process.
Is it my imagination or did I see at one point in the Federal Register some sort of response from the government about a request for an NPRM from an organization? Does that sound -- is it possible for the private sector, for example, to request a proposed rule on something?
MR. SCANLON: Relating to HIPAA now, Kathleen, or are you talking more generally?
MS. FYFFE: More generally.
MR. SCANLON: An industry could request -- can make a request for -- I would have to think about what would be the best regulatory means, but, yes, it can be done. I mean, the agency would have -- this happens in the food and drug area all the time, for example, where there are petitions and so on to open up an approved drug or -- and then it could stimulate hearings and so on. There are other ways as well.
Often, I mean, HHS could hold hearings. Literally, any agency could hold hearings on an issue and publish a notice. They could publish an advance notice, which means that an agency is considering a regulatory action and is inviting information and any comment, prior to initiating the action itself.
As you remember from the HIPAA transaction standards experience, there is a whole set of tools and approaches for regulations. The final regulation is usually the last stage of a long process. There are a number of other actions that could take place in terms of gathering information or comments beforehand.
DR. LUMPKIN: Let me clarify that answer. An industry may request an agency for a proposed rule. That agency will weigh that request, depending upon the strength of that particular industry. They may say we don't even want to deal with it or they may say, okay, we need to have a hearing to at least give it some exposure, but there is no obligation on the part of the agency to act just because a request comes in for a rule.
MR. SCANLON: And, obviously, an industry can't publish something in the Federal Register. These are federal actions.
MS. FYFFE: So, this means that NCVHS could be taken out of the loop or not necessarily be in the loop if a petition is sent by some organization or someone or parts of the industry to the Secretary. It would be up to the Secretary of HHS to determine if NCVHS should even weigh in on this. Most likely it probably would but I guess my point is we now have not only NCVHS, but there are other ways to make a petition or appeal.
MR. SCANLON: Well, if it relates to HIPAA, I think Bill and I could assure you that the committee, this committee will be involved. I don't know -- if it relates to anything else, then it is hard to know in a hypothetical.
MS. FYFFE: Okay. Thanks.
DR. BRAITHWAITE: And we have the legislative backing to do that because HIPAA commands us to rely upon the recommendations of the NCVHS. So, we wouldn't go forward with any major rulemaking in the HIPAA area without such input.
MS. FYFFE: Now, I am going to say some profane words. Advisory opinions and safe harbors. That doesn't get involved in any of this, does it?
MR. SCANLON: We have a long section on advisory opinions and so on. You mean, for -- if they could request an advisory opinion, you know, in terms of compliance with the HIPAA standard, whether theirs is more stringent or less stringent or whether they are -- I have now exhausted my knowledge about this whole process.
But our HIPAA standards do contain provisions for this process.
DR. COHN: I was actually just going to ask Bill
-- hopefully, this follows up on what you were asking, Kepa. You have mentioned, obviously, a number of ways to get clarification and changes and all of this to the final regs. It occurred to me and I guess I would want to have you comment on this also and follow-up, that with an enforcement and compliance NPRM, basically what you are describing in terms of getting comments and opinions and clarifications is what I would describe as almost a little bit more ad hoc. It might be in the compliance and enforcement final regs, there might be a slightly more structured process that would be sort of augmenting any sort of state requests for a clarification or otherwise -- that could occur within that process. Is that correct?
DR. BRAITHWAITE: I think you are right in the sense that the reason why people want advisory opinions is so they can rely upon them so somebody doesn't enforce against them once they take action that is consistent with the advisory opinion. So, it is an enforcement issue, as opposed to an interpretation of what did you mean the kind of issue? We will be talking more about that.
DR. LUMPKIN: I think we hit Kepa's second question.
DR. ZUBELDIA: On the issue of exceptions for a state law, the final rule in the preamble says that the Department will wait until the privacy rules are published to talk and discuss and make the rules about preemption. A concern that I have is that if state laws will be able to overrule or put on even additional non-contrary requirements to the transactions, identifiers and code sets, we could end up with no standard at all. If the states decide that they want to use local codes, not HCPCs, state codes that they invent themselves, that are not contrary to the HIPAA specified codes, for instance, and you can comply with both -- you can comply with the state codes and the HIPAA codes
-- we would end up with the same mess we are in today.
So, I would like to find out what are the plans for preempting the states on the transactions, identifiers, code sets and security as opposed to maybe -- what maybe a plan for privacy.
DR. BRAITHWAITE: It is an interesting question, Kepa, because I suspect that when the law said that the administrative simplification standards, with the exception of privacy, preempt state laws, that people believed that -- at least I have gotten some feedback to indicate that some people believe that that meant that when the HIPAA rules for transactions came out, it meant that no state law could be made or had any effect if it had anything to do with the area of a particular HIPAA standard. It is my understanding that that is not what the legal definition of preemption means, that preemption means that if the implementation of the federal rule is blocked or is contrary to the implementation of the state rule, then the state rule would be preempted, that it would be null and void and you would have to follow the federal rules for doing that. But that a state rule, which could be complied with, in addition to complying with the federal rules, would not be contrary and would not be preempted.
So, that is my understanding at this point, at least, of the distinction between what people had thought of of preemption and the way the lawyers are telling me it actually get implemented. So, if, for example, in the security rule, if the federal law says you have got to have a lock on the door and the state law says you have to have a guard dog at the door, those are compatible and you can comply with both. So, the state law would not be preempted.
However, when it comes to transactions if the industry has written a transaction implementation guide totally, not using optional element, but using situational descriptions, then it would be very, very, very tough to write a state law, which would force someone to do something that was contrary -- that was not contrary to a well-written implementation guide.
So, for the implementation guides, I think total preemption is the same in both cases but for security and privacy, I think, there is room for state law to still have effect. That is sort of the level of my current understanding of this.
DR. ZUBELDIA: How about code sets?
DR. BRAITHWAITE: Code sets are quite specific. That is, there are certain code sets, which are loud in the implementation guide and it says that you have to use these code sets. A state law that says you have to use a different code set would be superseded.
MS. FYFFE: What about state laws that would change the implementation date, either to make it earlier or later, the HIPAA time frame --
DR. BRAITHWAITE: A state law that made it later would be contrary and it would be superseded. A state law that made it earlier would be -- it would be compatible.
DR. LUMPKIN: But judging from the speed in which state government acts, trying to do that within 24 months.
MS. FYFFE: New Jersey moves ahead.
MR. BLAIR: For those of you on the Internet, you have to understand this body language. I am sitting right next to Bill Braithwaite and in order for me to ask this question, I have to lean over to the microphone. So, I am virtually putting my back to Bill Braithwaite as I ask him this question.
Bill, I have had a number of individuals from different areas ask me for clarification on this question and I really wasn't able to do a very good job of clarifying it, but it gets to the wording in the final rule, that refers to the requirement for adherence to data content standards with in an organization, within an entity. I was just wondering if you could just take a minute, you know, in addition to what is written in the rule, just within your own words to clarify what are the requirements within a multi-facility health plan, a plan that might include a payer function along with a provider function.
DR. BRAITHWAITE: That was one of those difficult issues that we dealt with in the final rule. In the proposed rule, we had proposed an exception for transactions within a corporate entity, for lack of a better word. And I say "lack of a better word," because when it came to the final rule and analyzing all of the comments we got, there was no way we could define what a corporate entity was because everybody does it differently and people are being bought up and sold and split and joined and -- what is a corporate entity? It is almost impossible to say. You can come up with a legal definition, but a functional definition, it was very difficult to do. So, no matter what decision we could make about where to draw corporate boundaries, we would be stepping on somebody's toes and making it impossible for them to do business.
So, instead of that, we took away the exception, which meant that the standards applied to internal transmissions, as well as external transmissions. But then what we did was we found the definitions of the transactions, understanding that they can be refined further, if necessary, in the next year or two's revisions of the rule to include things, for example, the claim transaction. It is not just a claim for payment. It is a claim for payment from a health care provider to a health plan.
So, if a transaction is an internal transmission between let's say one agent of a health plan to another agent of the same health plan, it doesn't meet the definition of a standard transaction. So, it doesn't have to meet the standard. So, we tried to tweak the definitions of the standards in such a way that they would apply when appropriate within a large corporate entity and not apply when inappropriate within a large corporate entity and, of course, between corporate entities we would use the same definitions.
Now, we did our best job at taking that approach and we may have to refine it over the next year or two and we understand that, but that was the approach.
MS. FYFFE: When you are talking about one agent of the health plan to another agent of the health plan, we may need some clarification on that. I don't understand what that means. I probably should understand. Before I -- was a lot of this one health plan to another health plan in consideration of the Blue Cross plans, for example. In other words, if you are a member of Blue Cross of Virginia and you happen to be traveling in Minnesota and you are hospitalized, the Minnesota hospital might send that claim to the local Blue Cross plan, who is going to put it through their interplan system so that it will get to Virginia.
To me, that is a practical example of kind of within one plan to another. When you talk about agents of one plan to agents of another plan, I am at a loss to understand that.
DR. BRAITHWAITE: Maybe I shouldn't have used that word. The final regulation uses the term "business associate." It means someone with whom you have a contract to do something on your behalf. Even though that business associate may be a different corporate entity -- like you have hired an IT firm to do your IT work and you have hired a legal firm to do your legal work and you have -- you know, some businesses today have one person and everything else is outsourced.
There is no corporate entity anymore in the usual old sense of the term. So, business associates are doing work on behalf of the central corporate entity, whatever that is, of a health plan, for example. So, communicating between the people who are working for the plan are within the boundaries of that entity, whether they are, in fact, some other corporation not. They are by inclusion under contract. So, that is the concept.
MS. FYFFE: Okay. Thank you.
DR. LUMPKIN: Jim and Bill, thank you for bringing us up to date on where we are. It is a very complex time of not only with the desire to get things out the door, but also a small little thing happening in November certainly complicates the process. Hopefully, we can get as much out the door before everybody else is out the door. That, of course, is independent of the result of the outcome since a change of administration is a change of administration and even within the same party, it can be very dramatic.
We are going to move on to the next item on our agenda, which is the letter to the Secretary on the early implementation of HIPAA transaction standards. We have -- is this what was e-mailed to us? Okay.
Jeff, did you get the latest version of the letter that was e-mailed?
MR. BLAIR: Actually, there was a major breakthrough here and I now am getting the attachments. Jackie and I are delighted.
DR. LUMPKIN: You are getting the attachments even before the NPRM has been published. I am impressed.
DR. COHN: I guess I should comment for everyone who now has copies of this, that the document is with one or two exceptions basically unchanged from what you received in your packet.
For those on the Internet, be aware that we inadvertently sent out in the packet a copy where the editing marks were all still in place. So, what we did was we basically corrected and removed all of the edited comments for the full committee.
I should also comment that there is one typo, which is -- let's see if I can find it on the -- yes, it is the second bullet. It is the last sentence where it says "Those representing our health care segments." It is actually "other" health care segments. There are also wordsmithing changes that occurred during the subcommittee meeting.
I guess I would assume everybody has briefly read this and probably there is not a need for me to read the whole thing. What would be your pleasure on that?
DR. LUMPKIN: That is correct. I think everybody has had it.
DR. COHN: Let me just make the general comments that what we were trying to do is to distill what we heard during testimony in July before the Subcommittee on Standards and Security, issues and concerns in relationship to implementation of the final regs and also very specifically some of the issues around local codes and a couple of other code set issues that we heard from testifiers.
I think we will see that -- it became very apparent to the subcommittee during this process that this is going to be an ongoing process and I think what will be probably contributing to any revisions to the final rules as they get further revised, amended, clarified over the next year, year and a half prior to implementation. It is going to be very important that we hear from the health care industry and the public, all segments as they begin to mull over how they are going to be implementing this.
Getting these concerns in writing and up to the Secretary and to HHS will be a very useful process. So, that was the intent of this letter to try to encapsulate the two days. There are issues around what is best described as internally maintained code sets. In other words, these are code sets that are an implicit part of the transaction standards but not specifically named in the regs and not maintained by any of the bodies, specifically X12. So, those are things that may be maintained by HCFA, but not in the regular processes or by other groups.
One example was taxonomy. Another is place of service, et cetera, et cetera. There are other examples. So, there was, obviously -- testifiers indicated that there was an issue here and we came up around a recommendation that we needed to be looking at the maintenance processes used by the external entities and discuss with the external entities ways to resolve any weaknesses that are found in that process.
So, that is recommendation 1. Should I just go through these very quickly like this or do people about that particular recommendation or the wording of that particular recommendation? Bullet 1. If there is anything on page 1 that people have in relationship to either wordsmithing or comments about the substance, I think it is probably a good time to bring that up.
DR. MC DONALD: One who has worked some on trying to get groups to just come up with solutions, I worry a bit about the idea that these codes in all cases could be requested by a simple say give me this code. I can give you some examples from the AMAS(?) attachment. One of the questions -- there was literally, you know, 30, 50 different variants of the AMAS attachment. So, if each group could say I want exactly these questions because it is a bona fide business need, you are going to have the same 30 or 50 different attachments in some sense.
Then there are issues such as questions that were asked that were not answerable, at least in the context of a group talking about it. One of them was was the patient hospitalized, addressed to the ambulance service. The ambulance service can't know that in many cases because they are gone. The patient is there and they are their way to pick up another patient. So, that question was taken out but that was because it was a group process.
So, I think you really need in a lot of these circumstances some industry representative group process, rather than someone screaming and saying I have got a -- give me my code, if we really want to end up with something that is less chaotic than today.
DR. COHN: Maybe I should read this paragraph. I am listening to what you are saying. I am not --
DR. MC DONALD: Maybe I am ahead. It said that they could submit they could submit the request to a web site as though hit would be a one-way issue rather than a dialogue.
DR. COHN: Okay. Let me read this paragraph over because maybe that is probably the best way to deal with this, just everybody have a sense of it.
These are code sets that are maintained by external entities and by the designated standard maintenance organizations that have agreed to maintain the standard transactions. External code sets include codes for provider taxonomy, place of service, claims adjustment, reason, claim status and our maintenance advice remarks. Testifiers expressed concern with the maintenance process used for the external code sets, must be effective, timely in response to national processes. The advice on the same maintenance principles adopted by the designated standard maintenance organizations. Testifiers stated that these processes should respond to all bona fide business needs, permit participation from across the health care industry and provide a widely available mechanism, such as a web site to receive requests, disseminate decisions and publicize deliberations.
We recommend examination of the maintenance processes used by the external entities in discussion with the external entities to resolve any weaknesses that are found.
So, I think for the web site we were talking primarily that it might be an example of a way to get the information per request to somebody for deliberation.
DR. MC DONALD: With the DISMA(?) web site, there is a cooperative behind it and there is, you know, any number of the participants can weigh in and they can get group discussions, et cetera. But in general if we set it up for the expectation -- if you set it up that the expectation is that an individual or one group from an industry can say give me this because I have a business need and they get it, I think it is the wrong expectation. I think the expectation has to be there has to be some collaboration within the industry to decide what makes sense rather than to say I need a code. I have heard people think this way.
I mean, they literally say I want this one, the one I always had, even though the goal was to push people to a common way. So, there is a conflict there and I don't know how to find the border that makes it work right. I almost think you need something to have a process, some kind of a collective process in any industry that can be -- that is anticipated there be a group coming together to decide how to do this best.
By mail, by telephone, but they wouldn't just simply send in the request and expect an answer.
DR. LUMPKIN: But this particular sentence goes on to say to receive requests, disseminate decisions and publicize deliberations. So, it does imply a deliberative process.
DR. BRAITHWAITE: It says that -- the key phrase I think is that the process should respond to all qualified business needs. It doesn't say that the response is we accept your request for a code. It says -- it could say we got your request for a code but we disagree. Here is another one. Use this instead because this is the national standard.
DR. MC DONALD: Well, in the early days I think what will actually have to happen is we got your request. We don't understand it. There are three other requests. We have a meeting and sort it out.
DR. FITZGERALD: I think the same sentence says that the testifiers stated that these processes should respond to all bona fide business needs. Maybe they said should consider. Consider may be a weaker word than respond. I don't know what they really said. These are what the testifiers are saying and as a committee, we are saying that we recommend examination of the processes. That is all we are recommending.
DR. MC DONALD: I think that is a good idea.
MS. COLTIN: I am a little puzzled about the chronology or sequence of these three things. I didn't know whether publicize deliberations meant at the end of the decision-making process, tell you what the discussion was about or whether it was in advance, tell you that a discussion was going to occur should you want to weigh in.
So, if it is the latter, that should be the second item in the string of things. If it is the former, then I guess it stays where it is.
DR. COHN: I think we will take that as a friendly amendment.
DR. MC DONALD: It is not possible for me to make a suggestion on the fly, but I still think the concept needs to be a little bit more complicated and there should be an expectation that there would be a deliberative process in which all interested parties could convene because I don't see how else you can do a lot of this.
If the expectation -- if we can find a way to say that that doesn't sound hopelessly complicated, I think we should say it, so we have the -- you know, people can complain now. We want to just send in and get one and sort it out early. There is an idea that you get these things over night, you know. Calling this timely isn't well-defined, but I know in the attachment area, payers have this fiduciary sword, that they feel they have got these questions answered they thought up today tomorrow morning. That can't happen in a collective process.
You know, there has to be some deliberation by the folks who have a say in it.
DR. LUMPKIN: But this paragraph has two pieces to it. Piece 1 is what we heard. Piece 2 is what we recommend. So, I think that if you are concerned about that, the -- what we hear and based upon the expertise of people who are on the committee, we recommend examination and maintenance process used by external entities in discussion with the external entities to resolve any weaknesses that are found. We don't specifically go into the detail of what the weaknesses are, accept everything or they accept nothing, but certainly that we would recommend that that process be looked into to assure that it meets the needs of the nation.
DR. COHN: With that, shall we move onto No. 2? Maybe it just makes more sense for me to read through this section.
Level 3, local codes. According to those testifying, movement away from the HCPC's Level 3 local codes is required by the final rule is possible but will require significant effort and resources. The national Medicaid or electronic data interchange, HIPAA work group is serving as a valuable focal point for Medicaid programs, attempting to consolidate and standardize through use of procedure codes. Testifiers mentioned several shortcomings in the current HCPC's maintenance process that needs to be addressed.
First bullet. The HCPC's maintenance process needs to be communicated more clearly and to a wider audience. There is confusion about the various types of codes, the panel that is responsible for maintenance and how the process works. We recommend that HCFA initiate an effort to educate the health care industry about the maintenance and updating process for HCPC's codes, as well as those of respective code set developers.
One immediate action is for the HCPC's national panel to clarify this kind of information at the web site, but much more needs to be done.
Maybe I should just stop there for a second. Comments?
As I say, when we heard the testifying, it sounded like nobody had a clue -- maybe that is a little strong, but there was widespread confusion about how the whole process worked.
Okay. Second bullet is representation on HCPC's national panel consists of representatives from only the Blue Cross-Blue Shield Association, the Health Insurance Association of America and HCFA. We believe that representation on the panel should be expanded. For example, state Medicaid representation should be considered. The current limited representation on the national panel has led to a perception that requests from small entities or those representing other health care segments will not receive the same consideration as those from national panel members.
So, wider representation on the panel. Comments?
DR. LUMPKIN: I would just think for consistency and format, where it says we believe, it should be we recommend.
DR. COHN: Okay. Great.
Any other commends or changes to that? Okay.
MR. BLAIR: This is out of sequence and I was embarrassed to ask the question, but I will just be embarrassed.
The previous -- I guess it was the first one, used the phrase, "provider taxonomy." Now, maybe that phrase is well understood by everyone, but I kind of tripped over the word "taxonomy." I wasn't really sure what that was referring to. Is it just me, that that is well understood or --
DR. LUMPKIN: I think that is an IRS issue, isn't it?
[Multiple discussions.]
Okay. External code sets includes codes for provider taxonomy, place of service, claims adjustment, reason, claim status and remittance advice.
DR. COHN: We could say provider type.
DR. MC DONALD: It is a specialty code or professional code. I think you could find the right word, with just a few more letters, just to make it more clear.
MS. COLTIN: I know that in our systems it breaks down into two components, provider types and provider specialty or for each type. You might have different types of specialties.
DR. MC DONALD: Well, there is a code and I thought it -- it is under the EXPO(?) web site or something and it is like 800 codes with a hierarchy.
DR. LUMPKIN: Can we maybe use a word for provider descripters?
DR. MC DONALD: It has a name, this code.
DR. COHN: Maybe a parentheses afterwards to describe what it is. I am hesitant to on the fly recommend what it should be.
MS. COLTIN: May a footnote on it.
DR. LUMPKIN: Parentheses, specialty and type.
DR. COHN: Is that okay? Okay.
DR. LUMPKIN: Thank you, Jeff.
We are down to the -- unless there are other changes in that second dot point, we are down to the third?
DR. COHN: That is right. Okay. So, third bullet. Okay.
The process for evaluating and granting requests for new HCPC's codes must be able to accommodate a large number of requests in initial months of HIPAA implementations as organizations request standard codes to replace their local codes.
The process must also be capable of prompt response in order to avoid the need for temporary codes.
DR. LUMPKIN: I have been contemplating that "probably." It would be consistent. We have throughout the document used the term "we recommend and identify" or separate between we have heard and what we want. So, we probably just could start off --
DR. COHN: That would be fine.
DR. MC DONALD: I am not very familiar with HCPC's codes, but I worry in the context of all this rush to add a whole bunch of codes -- I guess I am afraid to ask -- is there any kind of organizational structure or ontology or anything to it that would assure that we didn't enter 500 variants of the same code as each state is rushing to put in their codes.
I mean, I know that some of the code systems have some bad qualities, like they reuse the code numbers. I don't know if that applies to HCPCs, but if we do this -- if we are going to quadruple the codes, it would be nice if we could do it sensibly. I am worried that it can't happen sensibly in a rush without any kind of structure around it.
Does anyone know -- this works just fine and I shouldn't worry?
DR. COHN: I guess I would differentiate two issues. One is process and the other is structure and I think certainly there is a process in place, to consider whether something should be a HCPC's Level 2 code. Now, are you referencing the actual structure of the code set?
DR. MC DONALD: I am just worried about people reading the book where they had trouble finding the right code when there were 50,000 and when it gets to be 300,000, no one will ever find the right code.
DR. IEZZONI: One of the confusions that I have is basically if you look at a HCPC's book, this very first page says the majority of HCPCs is CPT. Okay. The core of HCPCs is CPT. So, a question would be to what extent you are talking here about CPT core of HCPCs.
Then there are specific additional sections for like podiatry, durable medical equipment, types of chemotherapy, dental procedures and so on that are not covered by CPT, which is a very physician driven categorization classification system.
So, I think that it will be necessary at some place, maybe a footnote or whatever, to describe what HCPCs and what components of it you are thinking of this referring to because if, in fact, it is referring a core of HCPCS -- teeny portion of HCPCs or something like that to really clarify for people and then give some examples of what they might look like, like dental services, durable medical equipment, podiatry services, et cetera.
I think that would help with Clem's concern.
DR. ZUBELDIA: Lisa, that may be clarified a little bit in the implementation guides. There is a qualifier for the code that says what is the code. There is a qualifier for CPT and a different qualifier for HCPCs, implying that when you refer to HCPCs, you are referring to the non-CPT, HCPCs.
DR. IEZZONI: That is pretty confusing.
MS. FYFFE: Can I make a technical suggestion?
If this letter is supposed to stand on its own, maybe we need some definitions. You know, what is HCPCs, a few other things because if Lisa, who is supposed to be an expert --
DR. IEZZONI: I have the book on my desk. When I open it up, it says the core of HCPCs is CPT. So, sure, you can that this is --
MS. FRAWLEY: Well, the confusion, I think, is that the CPT component of HCPCs is Level 1 and Level 2 codes. I think that we need to make sure that we differentiate that we are not talking Level 1 and Level 2 codes, which is the CPT component of HCPCs and that we are talking about the Level 3 local codes.
The problem that we have is what the letter is trying to get to, is that we don't have a good process for addressing Level 3 local codes. That HCFA representative was when she testified not even able to really clearly articulate the process for us and we had a lot of concerns in terms of, you know, as we move forward, you know, how do we deal with that issue.
DR. IEZZONI: I think we need end notes.
DR. LUMPKIN: Let me suggest a process because I have been kind of struggling with this. My first response when I read the letter was -- it was kind of based upon whether or not the Secretary would actually sit down and read this letter. In which case, the Secretary would probably not have a clue, given the level of detail, but on the other hand, that is what we need to do.
The second is to realize that most of the letters that we do use go up on our web site and when it goes up on our web site, there are people who read it, who really want to understand the issue that we are trying to address with the Secretary.
I think what we are discussing here is maybe something that is more of an approach; that is, independent of this particular letter because I think the letter carries the content that will carry the message to the people who really want to change what they are doing and how they are doing it. The ones who are responsible will understand it.
The approach that I am suggesting that we contemplate is that when it goes up on a web site, we may want to have, you know, highlight at the words that we think would normally be footnoted, but for the people receiving the letter, we don't really need the footnote. The people reading it would be, you know, in hypertext, it would allow them to click on HCPC's Level 3 and we would have some definition of that. Other areas where we think that there may be some concern would allow this to be much more easily read by people who are not as deeply imbued in this as the people for whom this is directed to.
DR. MC DONALD: I would make an alternative suggestion, that Lisa would draft up one sentence --
DR. IEZZONI: Obviously, I don't have as good an understanding as I thought I did. So, I think that perhaps Kathleen from her experience -- because I actually do think, John, that this might be a situation where you do want an appendix to the letter because people in reading this through quickly, it is not just that the Secretary isn't going to read it. The people who need to read it are probably going to read it quickly and initially be confused unless we say that there is an appendix that describes this a little bit better.
DR. MC DONALD: Well, I still don't think -- I mean, I am still arguing for just another phrase or a sentence and maybe Kathleen -- I don't think it is going to need -- if you do put it underneath, it won't get seen.
DR. IEZZONI: A couple of sentences. It could actually be a little short paragraph, so it kind of stands out.
DR. COHN: I guess I was going to make a couple of comments. I think any sentences to help clarify this are well appreciated. Remember, this is draft. This is why we are bringing it up for discussion. I think despite our best efforts -- and this is really Draft 4 -- this is a technical area and we have struggled to try to make this understandable.
I hear a couple of things. I hear, one, that there needs to be something here that sort of indicates that some sort of a discussion of Level 1, Level 2, Level 3. I am also hearing that we probably need to be -- when we talk about HCPCs generally here, we need to be talking about HCPC's Level 2 as opposed to HCPCs.
I don't think there is a clarification there. There is probably also a note for another bullet that relates specifically to CPT, which is Level 1, that says, gee, CPT ought to also prepare for increased volume because some of these things may very well go to the CPT editorial panel, eventually.
DR. IEZZONI: I agree. That is why I am confused because when I have done research using CPT, there are gobs of local curves in there. CPT is a core set. Okay? But then Massachusetts Medicaid might add little codes on to the end of it or another state's program might add little codes onto the end of it. It is not technically, quote, local curves, but that is what they end of being and it gets extremely confusing. That is why I read it the way that I did because from my experience, the CPT component has had all sorts of little curves added on to the end of it. So, I think that that is a very good suggestion, to kind of raise that as an issue as well.
DR. COHN: So, Kathleen, you are going to try to write a paragraph -- okay. For this section. We can try during our breakout to come up with another -- couple of further pieces of clarification and something that relates to CPT.
DR. LUMPKIN: Tomorrow we can then --
DR. COHN: Yes.
DR. STARFIELD: I understand what Lisa's saying. Lisa is saying that our comments should relate not only to Level 3, but also to Level 1 and 2. Is that what I hear?
DR. IEZZONI: Yes, I think that is what you are hearing.
DR. COHEN: I guess what I am hearing is maybe something a little different. What I am hearing is is that we need to make comments that recipients of these local codes as they go away, need to be both Level 1 and Level 2 and that those processes need to be augmented to handle the increased volume. Is that --
DR. IEZZONI: I have been since 4:00 traveling. My brain can't quite get its hands around the linguistic distinctions that you just tried to make.
I think the basic point is that some of the Level 1 CPT codes are added to by local entities and that has been a problem in the past. So, there has to be -- if it is appropriate within the context of your hearing in July, there should be some recognition of that somewhere in the letter.
DR. COHN: Okay.
The final bullet is the current process for considering a request for a new HCPC's Level 2 code, including a criteria requiring a demonstration of a significant frequency of use. We are recommending that that criteria be dropped.
Comments?
DR. MC DONALD: Just a question. Those kind of criteria aren't awful in and of themselves, you know. The 80/20 rule, the 90/10 rule. So, what is the argument for having no criteria -- are there other criteria that would do just as well?
DR. COHN: Bill, do you want to make a comment on that one?
DR. BRAITHWAITE: Well, the testifiers said that there isn't a mechanism to adopt a new code before somebody had used it several thousand times. There is no mechanism for adopting a code that had been used, you know, a few times, but expected to have -- there was a criterion that said it had to have been demonstrated to be used -- I forget the exact numbers, but some significant amount before it could be considered to be added. They felt that that criterion was inappropriate and it should be open for discussion for a code, no matter how much it has been used in the past.
DR. FITZGERALD: I wonder if it refers to frequency of use in the past or expected frequency of use in the future. I don't remember --
DR. ZUBELDIA: The testifiers specifically said in the past. You have to prove that you used it -- I don't know what the number was -- maybe 50,000 times in the past year before she would even consider adding a new code.
DR. LUMPKIN: So, perhaps addressing the issue that Clem raised earlier, because this almost looks -- because it is not clear that we are recommending that -- it doesn't really matter how many times we project that a code will be used, it should be adopted. I don't think we are saying that. We are saying that how many times in the past. So, I think we would recommend that a retrospective criteria be dropped or whatever the term --
DR. COHN: Maybe we should change that to demonstration of significant frequency of use in the past.
DR. LUMPKIN: Correct.
MR. ROTHSTEIN: The people who are reviewing this are not going to have necessarily access to what the testimony was. I think it would be a good idea if we just added a sentence indicating why this is our recommendation. What is the basis for it.
DR. FITZGERALD: Is the basis that it is not the past use that is most important, but the expected future use that is important.
DR. MC DONALD: I think the way that John stated it would -- is what we want to say. We are not trying to prescribe how they pick it. We are saying they should pick it.
DR. ZUBELDIA: Part of it was that to request a new code, you have to demonstrate that you have used it so many times in the past year for Medicare or Medicaid services. That was part of the problem also. She would not consider codes that were used or were proposed to be used for lone Medicare and Medicaid services. I think it is associated with that number. You have to get to a number of past uses before the new code can be approved and that precludes experimental programs and things like that.
MS. FRAWLEY: I would like to just bring some information to the committee.
I think the problem that we had when we were at the hearing is that one person has a lot of control over, you know, what is added as a code. We are familiar with other processes, such as the maintenance of ICU9C or how CPT or CDT are maintained. With this, there seems to be a lot of arbitrary decision-making. People aren't clear of the process. You have to demonstrate, you know, significant usage of, you know, a code and it just wasn't clear. I think that is what we are trying to get to in the letter is that we have a process that really needs fixing and that there are people out there, you know, that don't understand the process and it is certainly not representative or inclusive.
You know, it is kind of like of one person running the show the way they see it.
DR. COHN: Any final comments about 2?
DR. ZUBELDIA: This is something that has come up in the last couple of weeks. So, I didn't have time to put it into the draft letter that we worked on at the last meeting, but in the HIPAA law itself, in Section 1174(b)(2)(b)(2), there is an additional rule that says if a code set is modified under this subsection, the modified code set shall include instructions on how that element of health information that were encoded prior to modification may be converted or translated so as to preserve the information on the body of the data elements that existed before the modification.
Any modification to the code set under this subsection shall be implemented in a manner that minimizes the disruption and cost of complying with such modifications. The way I understand that and maybe it is misunderstanding on my part, but if the local codes are removed, that would constitute a modification to HCPCs as we know it today.
In that case the Department would be -- would have to issue instructions on how to use the new codes that remove all of the local codes. And effectively, the Department would have to issue instructions to the Medicare carriers on what to do because -- HCFA would have to give instructions to Medicare carriers on what to do. The Medicare carriers are then going to follow instructions and the rest of the industry should be able to take advantage of the same instructions to follow the same rules as to how to replace those codes.
So, I think the recommendation should be that HCFA comes out with instructions to the Medicare carriers and intermediaries as soon as possible and make them publicly available for the rest of the industry to follow so everybody goes in sync.
Now, the same applies to the J codes. If the J codes are removed and the Medicare carriers are going to use NBC codes, I think that we could ask HCFA to make those instructions publicly available as soon as possible so the rest of the industry can follow the same rules.
DR. COHN: I don't think I -- I generally agree with what you are saying. I am just trying to think of what it has to do with this letter or with the testimony that we heard.
DR. ZUBELDIA: It doesn't have to do with testimony that we heard and this is -- as I said, this is something just was brought to my attention a couple of weeks ago out of another reading of the law and this -- John Broot(?) from the Health Information Network talked to me and said, Kepa, it doesn't matter what happens with the J code because HCFA has to issue instructions to the Medicare carriers and intermediaries and then effectively, the rest of the industry will follow the same instructions as a matter of pragmatical use of the instructions.
So, maybe we need to recommend that those instructions be put out in the public as soon as possible.
DR. COHN: So, Kepa, would you be willing then to put a paragraph, which I think should be probably at the bottom of this area? I guess I am trying to think of --
DR. MC DONALD: It is kind of under 3.
DR. COHN: Is that under 3?
DR. MC DONALD: He is asking if the resources that are implied to be used under the law just be made available -- the product of that work be made available to the whole industry. That doesn't seem like a very radical position, but it is. Some HHS resources will have to be used for that.
DR. ZUBELDIA: It specifically applies to the local codes and the J codes, but it could be under 3 also.
DR. COHN: I don't think it is really 3. I do think it is probably under 2, except that it is also dealing with J codes.
Do you want put together a paragraph that somehow characterizes -- you can say additionally the committee observes dah, dah, dah, dah, dah as opposed to it being on the basis of any testimony that we heard.
DR. COHN: Anything else on 2?
Okay. 3. I think we are on the down slope now. HHS resources in promoting industry HIPAA implementation, a number of experts and industry representatives suggested that HHS should assume a more active role and increase funding to actively promote the implementation of the HIPAA data standards by the industry.
For example, HCFA's Y2K activities were suggested as a possible model. An additional suggestion was for HHS to serve as a point of coordination among the many local or regional HIPAA coordinating organizations. There are a bunch of "e.g.s." We believe that not only should the Department closely monitor the progress of national implementation, but there must be sufficient resources provided to ensure that there is adequate technical support.
Comments?
DR. MC DONALD: Just a clarification question. Although Y2K wasn't that long ago, I don't really know what was HCFA's funding support for that because that is a major force of this is to find some funding and then what does it mean to say a coordinating point? Is that to give them funding? The "funding" word is one -- I think it is probably important to make this happen. So, I am not positive what is supposed to happen here, but I like the idea that something would happen.
DR. LUMPKIN: Whatever it is.
DR. COHN: Our recommendation was not necessarily the coordinating point be the sum total here.
DR. MC DONALD: I just don't know what that means.
DR. FITZGERALD: I think under Y2K, HCFA did a lot of educational seminars. They supported state organizations and getting the word out. There were resources available for doing that and that they coordinated a lot of this effort and put out common educational information on it. I think that may be what this means.
DR. MC DONALD: Would you just add that as a sentence to clarify?
DR. LUMPKIN: I think a lot of people, for example, in respOnse to -- for preparation for Y2K, HCFA did boom, boom, boom, boom, boom. We think that is a good example.
DR. COHN: Okay. So, a sentence, what should be done in relationship to that.
DR. LUMPKIN: And some clarification of the -- what do we mean by a coordination point.
DR. COHN: Comments?
MS. WARD: Yes. I think being responsible for one of those et ceteras and working with those other groups, I don't know what I would expect or do if I were now supposed to do -- have a point of coordination in HCFA about the work that we are doing.
DR. MC DONALD: Are you expecting them to do something or are you expecting them to get something?
DR. LUMPKIN: Or are we suggesting that HCFA work with such organizations in order to accomplish what we are suggesting they do?
DR. FITZGERALD: We say HHS not HCFA and that is probably appropriate, but to have a point of coordination in HHS for here is some common educational material that has been blessed by HHS. Here is the gospel as we know it at this time.
DR. COHEN: Yes. You know, I am actually sitting here looking at this and I am not sure that there is anything added by that, those three or four lines about point of coordination.
That is my going in comment to make.
MS. WARD: I would just say that those of us who are running those organizations will say --
DR. COHN: So what.
MS. WARD: -- so what.
[Multiple discussions.]
DR. LUMPKIN: Anybody want to keep it in?
MS. GREENBERG: I thought maybe you had sort of an idea, more of a clearinghouse so that states or groups who are not being included or not in that geographic area, whatever, could get information maybe from some central point about what is being done.
DR. FITZMAURICE: Maybe HHS should monitor and coordinate where needed among the local and regional organizations.
DR. COHN: Monitor and what?
DR. FITZMAURICE: Monitor and coordinate where needed. If they are doing a good job, let them keep doing a good job.
DR. COHN: That certainly sounds a lot better than what we have there.
DR. LUMPKIN: We need to move on.
DR. COHN: Yes, I know.
DR. ZUBELDIA: Syntax error on that one?
DR. COHN: You can fix it during the subcommittee meeting.
Four is funding to the poor identifiers. Testifiers stressed the need for adequate funding to build the infrastructure and obtain necessary support to employ HIPAA identifiers especially the provider and health plan identifiers, in a timely manner.
DR. LUMPKIN: Do we agree with that?
DR. FITZMAURICE: Are we talking about adequate funding for the testifiers or adequate funding for HHS? I am not sure. Are they saying payment ought to reflect this or are they saying HHS should have adequate funding, in which case it might have been covered up above. Both are true, by the way.
DR. MC DONALD: I would have interpreted that as HHS, that they can actually -- people can get them and know -- they can apply for them, et cetera, et cetera.
DR. LUMPKIN: But I think just in format we need to have the recommendation or we can incorporate it into another portion.
DR. STARFIELD: Do we need to specifically exclude the personal identifier or not?
DR. COHN: I don't think we should even mention that since it is not on the radar screen at all.
We recommend that HHS have adequate funding .
Okay. Testing and compliance. Testing was identified as a critical component of HIPAA implementation. There was concern from testifiers that different private certifying bodies, using different criteria could provide different results to the industry and, thereby, undermine implementation.
The appropriate federal role -- we recommend that the appropriate federal role in providing technical support for testing should be analyzed. The role might include activities such as certifying the certifiers so that purchasers would not be mislead by unsupported claims of HIPAA compliant software or services.
DR. IEZZONI: John, when I read this, I wasn't sure what you meant by -- testing what exactly? That might have been clear in the context of your hearing, but it isn't clear from an outsider just reading this.
DR. COHN: Testing components of software is generally what we are referring to.
DR. IEZZONI: Okay. Then testing software for --
DR. LUMPKIN: We just need to expand it a little bit to make it clear what exactly we are --
MR. BLAIR: You know, testing can be expensive and time consuming. Do we want to go beyond verification of compliance? We might be able to verify it on paper --
Clem?
DR. MC DONALD: We have discussed in other committees that compliance testing of the standard admitted is very important and I think in our last -- that big report. I had thought that is what this was talking about. When they admit the standard, there will be a compliance test. That can be a piece of software if someone would make it. It could be, you know, crunched through and purchasers can see if this works or not. The challenge as this is written is who is going to do it.
I thought there was an organization that was going to do that.
I have two questions. One of them is to me what you are trying to do is test the compliance of these messages that go out because this is what we are talking about, the standard, whether the codes are right, whether they are using codes that are part of the code sets, et cetera.
That, in principle, can be done by software. There isn't a plan in place, but maybe this is attacking that plan to do it through some organization, but I don't know if that is a software program.
MR. BLAIR: Let me modify my comments, that I agree with what Clem has just said if it is in fact getting to wind up verifying a vendor system is compliant with a specific transaction, then, yes, there is a compliance test involved. Maybe we need to clarify exactly what this is referring to.
DR. LUMPKIN: I think the comments are in trying to move this process forward. I didn't hear anyone disagreeing with what we think this intends. We just want to be written -- expanded a little bit so we are explicit that what we are talking about is the verification process, whether that be through tests or some other means and that there is a need for -- that we are recommending that part of the federal role be to assure that those who are holding themselves out to be those verifiers are actually doing it appropriately.
DR. COHEN: Right. And actually we heard during the testimony that there might likely be a number of different organizations providing certification. I think there was some risk that they could be easily certifying differently. So, it is certify the certifier, sort of concept.
DR. ZUBELDIA: There is currently at least EMAC(?) is an organization doing testing of transactions against the implementation guides, but there is also two translator vendors that have products that will test against HIPAA compliant implementation guides and the results are different from all three.
DR. COHEN: Okay. So, this is an issue.
Six. Okay. Six, the vendor issue. The role of software vendors in HIPAA implementation was identified as critical. Providers cannot become compliant solely through use of vendor products and services, but they cannot become compliant without vendors either. Testifiers recommended that HHS continue to assess the progress being made by vendors in making their products HIPAA compliant.
HHS should also consider what the federal should be in encouraging compliant certification of products. The NCVHS will be following these issues closely. There needs to be a "we recommend" in there somewhere, which we will figure out in the subcommittee.
Any comments about that one?
Clem?
DR. MC DONALD: I would almost be inclined to take it out because I don't know that it says enough different than the compliance question. I don't know what it says.
DR. COHN: Well, what we heard during the testimony and this is probably more just a heads up rather than a whole lot of action was is that the whole industry is dependent on vendors modifying their software to support the HIPAA standards and that this is one of their sort of most critical issues along the critical path and we are sort of notifying the Secretary that this is a critical issue. We are going to be tracking it pretty closely but that it is a critical issue. That was really what the whole point of that one was.
DR. MC DONALD: I mean, how can you really track it?
DR. LUMPKIN: Can I maybe suggest that when the subcommittee discusses it, that you come back with a recommendation whether or not that needs to be in.
DR. COHN: Thank you for all of your feedback and input.
DR. LUMPKIN: Okay. And we should see a final version tomorrow.
Because all of the sessions this morning have run longer than scheduled, I am going to suggest that we not take a break, that we work through the break, that if individuals want to or need to take care of anything, that they feel free to do that while we are proceeding to the next item.
There is no such thing as a five minute break. Okay. Having been overruled, let's take a five minute break.
[Brief recess.]
DR. LUMPKIN: Now to the discussion of the Executive Subcommittee retreat. The first issue to discuss is the mission statement, which is under Tab 5 and that mission statement would be the mission of the National Committee on Vital and Health Statistics is to shape a national information strategy for improving the population's health.
Any thoughts on that? Does that seem to ring clear?
MR. ROTHSTEIN: I think it reads very well. It is short and succinct and it gets across the message and it also incorporation that population -- it incorporates the population focus that some of us have wanted to have in the mission statement. Some mission statements get so long that you lose the point after awhile and this one is really nice because it is so short.
DR. LUMPKIN: Thank you. The reason why we are emphasizing using the microphones is not only if you are not speaking directly into them can they not hear it on the Internet, but it makes it very difficult because our minutes are transcribed from that also.
They are available to individuals who may want to try to figure out what we were talking about.
MR. GELLMAN: John, can I ask a question?
DR. LUMPKIN: Please.
MR. GELLMAN: I don't really care about mission statements. I find them totally pointless but my question is what does the statute say our mission is?
DR. LUMPKIN: The charter -- do we have the statute? The charter, I think, is Tab 3. It refers to our authority in the charter.
DR. STARFIELD: I don't think the mission statement is in conflict with anything in Tab 3.
MR. SCANLON: I think as long as it is clear that -- in any advisory committee, obviously, the mission is assist and advise. I think maybe Bob is suggesting that we -- in any mission statement, it is not that the committee carries out these things. It is that the committee is just going to advise HHS and others to carry them out.
The committee should not be seen as an operational -- it is not an operational arm. It is an advisory committee and I think as long as we use the terms "assist" and "advise," we are probably pretty consistent.
DR. STARFIELD: So, would "help shape" do anything for it?
DR. LUMPKIN: To advise in the shaping of a national --
MR. ROTHSTEIN: John, I support the importance of including the advise in there because we don't shape. We advise. So, I think it would be fine if we just put the mission is to advise the Department of Health and Human Services on a national information strategy for improving the population's health.
DR. STARFIELD: Do we need to limit it to HHS?
DR. LUMPKIN: I think that goes to our charter, though, and our authority.
DR. STARFIELD: Because we have done more than that actually, the Pacific Islands and insular territories, as we heard just before.
DR. COHN: Doesn't this get into the customer discussion on the next page where we talk about exactly who it is that we are dealing with, which I agree with you is HHS primarily, but also Congress and I think we have a number of other people that we identified as customers.
DR. LUMPKIN: So, perhaps if we just simplified it to advise and leave out the whom we advise -- okay?
Do we need a motion to adopt this?
DR. ZUBELDIA: Should we pick up on that other word, to "assist" and advise. Or is that too much?
MS. GREENBERG: Do you want me to read it?
DR. LUMPKIN: Yes, please.
MS. GREENBERG: The mission of the National Committee on Vital and Health Statistics is to advise on shaping a national information strategy for improving the population's health.
DR. LUMPKIN: Is there a motion?
[The motion was made and duly seconded.]
The motion has been moved and seconded. Further discussion?
[There was no response.]
All those in favor, say "aye."
[There was a chorus of "ayes."]
Those opposed, say "nay."
[There was no response.]
And those who abstain because they don't believe in mission statements may abstain if they so choose.
[There was no response.]
Okay. It passes.
The second area that we discussed was the roles and customers. Any discussion on that or questions or comments or does that seem compatible with the full committee?
Dan.
DR. FRIEDMAN: I am completely comfortable with the content but to the extent that we -- that this gets distributed further, I think it might be appropriate if we could find another noun instead of "customers." It just has a funny -- sort of has a 1999 ring to it.
DR. ZUBELDIA: How about audience?
DR. FRIEDMAN: That sounds a lot better to me.
DR. LUMPKIN: Roles in audiences.
Okay. Let's move on then. Substantive themes. The first one is refocusing on population health. Second --
MS. FYFFE: Can we discuss something?
DR. LUMPKIN: I threw that one out there. I didn't see anyone even motioning towards their microphone, but you were in my blind spot.
MS. FYFFE: That is okay, John.
Substantive themes. What is No. 3 about? Clarifying a relationship with the National Center for Health Statistics.
DR. LUMPKIN: That gets under the big bullet on the relationship with National Center for Health Statistics. It is a follow-up of the issues that were raised by Ed Sondik about our role. I think we will get into that. I was going to try to cover 1, 2, 3 and then deal specifically with that issue.
MS. FYFFE: I mean, are we going to be clarifying the relationship for the next decade? You know, I am not trying to be disrespectful here, but isn't this sort of like ongoing?
DR. STARFIELD: It is just things that we are going to discuss. That is all.
MR. ROTHSTEIN: It is also just a report of a meeting. This is not a policy document.
MR. SCANLON: You can view this more as a summary report.
MS. FYFFE: Okay. Okay. I understand.
DR. LUMPKIN: Okay. Anything else on refocusing on population health? Okay.
Aligning health information strategies with health strategies. This one came up, particularly was highlighted that there are certain issues that HHS has as major health strategies, which we haven't really addressed as a committee.
MR. BLAIR: These may be better termed health initiatives than health strategies. The kinds of examples that are given are more the activities directed at specific issues. I mean, we could call them health strategies, but they are often viewed as specific initiative, eliminating disparities, children's health insurance program, that sort of thing.
I am just not sure strategy is the right word.
DR. COHN: Actually, I think maybe the problem we are having is that these things are considered initiatives and not strategies. So, rather than overall strategy upon which there are initiatives that may fall of become initiatives and we sort of ask where the strategy is.
So, I think that probably -- actually, I think it is fine the way it is.
DR. LUMPKIN: And I would tend to agree with Simon. I think that, for instance, Healthy People 2000, the strategy was to reduce racial and ethnic disparities. The strategy in 2010 is to eliminate them and that really generates a whole different set of initiatives, based upon those strategic approaches.
DR. STARFIELD: We are going to keep strategies.
DR. LUMPKIN: Well, we are actually -- since this is a report from the retreat, I don't think that we need to necessarily adopt these. But if we are comfortable with these as an approach, I think -- I am just trying to make sure that the full committee has a chance to discuss these. If there are any issues that come out of that discussion, then I think we need to discuss them here.
I actually wasn't going to ask for a vote on these particular items, unless the committee would like to. I am easy.
Anything else on 2?
MS. GREENBERG: The long term goal starting with the retreat was to develop the strategic plan for the committee. So, I think, you know, these would be -- these or whatever the full committee agrees on would be incorporated into a type of strategic plan that would then, of course, be reviewed and have further deliberation by the committee.
DR. LUMPKIN: Then that document would be what we would approve.
Okay. 3. Enhancing the relationship with HHS. This sort of gets into some of the issues we discussed about the chief information officer, the plan as Jim was discussing and so forth.
Paul.
DR. NEWACHECK: Can you tell us a little bit more about the logistics of how -- or at least how you guys discussed our relationship with NCHS and the Board of Scientific Advisors -- Counselors -- and how that would work?
[Multiple discussions.]
That is part of 3, though, isn't it?
DR. LUMPKIN: No -- well, it could be, but I was going to try to treat it separately.
MR. SCANLON: I think it is part of 3, John. Again, I think we -- there were a number of activities of a sort of strategy nature that occur in HHS that I think we need -- HHS needs to familiarize the committee with. I think everyone was assuming that the committee was familiar with the HHS strategic plan, with the whole CIO arrangement. Every federal agency has had a CIO probably for a decade at least and there is a whole apparatus that goes with that and then with some other initiatives.
Clearly, I think it is part of the plan from here. We may want to bring those. I think we were assuming that everyone was familiar with those as a backdrop, but that is clearly not the case. So, I think we will have to make it an active part of the reports from HHS in the development of these, to have the committee familiar with them.
I think things fall into place a bit better when you see those.
DR. LUMPKIN: Okay. Anything else on 3A? Up to where we get to the point where we are talking about the NCHS? Okay.
NCHS, let me just sort of summarize what we got on that particular issue. The issue was raised by the NCHS, but as we started to look at it, there was, in fact, more involved than just the NCHS. CDC, for instance, has the NEDSS project, the National Electronic Disease Surveillance System. And they have also adopted a conceptual model for public health informatics. We have not really functioned as an advisory committee to that particular process, even though, obviously, it has some impact upon items 1 and 2 and 3. So, what we tried to do is move the discussion of the NCHS into a more generic arena, which is how do we relate to information policy that is being developed throughout HHS and various other advisory and technical advisory bodies that may exist.
To that point, we seem to get to a realization that we are going to have to look at liasing with them, just as we would with any group that NCHS may create. So, looking at the transformation, which HIPAA really moved us into is focusing on advising the Secretary rather than a subunit.
DR. NEWACHECK: My question was about in terms of sort of how we go about the next steps forward on this. At our last meeting, Ed Sondik invited us to participate and suggested some different models and how we can participate and it looks like you guys had a conversation about how we might do that and perhaps having two members or --
MS. GREENBERG: I think there is an attachment here in which you recall at the June meeting, I guess, a number of questions were raised with Dr. Sondik. So, he came to the retreat with this document in which he had attempted to address those questions. I don't know if you want to walk through those or not.
DR. IEZZONI: However, Marjorie, let me just say I do not think that it was finally resolved at the retreat how we would, in fact, interact in terms of which committee member, for example, would serve also on the board, because as you might have noticed, we are shy one more Population Subcommittee member with the resignation of Andy Kramer. So, it just simply was not resolved at the meeting in August how exactly -- how many people, who would do it. It was just kind of left open that we would do this, but not exactly how and who.
MS. GREENBERG: The how and who might be a little premature in that this board has not been established yet.
DR. NEWACHECK: Do we know when it is going to be established?
DR. LUMPKIN: I assume it is going to have to get through a whole clearance process within the Department of Health and Human Services. It will not be lightning quick.
DR. FRIEDMAN: Paul and others, one thing that Ed Sondik was talking about was a Board of Scientific Counselors, which met I think he said a couple of times a year for perhaps a day, a day and a half. So, I mean, his conceptualization of it is of a body that has somewhat less time commitment and I want to say responsibilities, but substantially less time commitment than this one because one of the issues that was discussed was whether or not it would be logistically possible for anybody to serve on both, whether or not we might be competing against each other, as it were, for the same members.
That limited time commitment seemed to have been something that was really thought through by Ed and his colleagues.
DR. IEZZONI: But I still think that the final decision was made, you know, recognizing Marjorie's point, that the board doesn't exist yet, about how exactly a person would attend two meetings for that person if they are also on the NCVHS and also on subcommittees of the NCVHS.
DR. FRIEDMAN: I agree, Lisa.
DR. STARFIELD: I just interpreted it as Ed would appoint the members of the subcommittee with appropriate arm-twisting if necessary.
DR. IEZZONI: Ed indicated that he had had some preliminary discussions, Barbara, I think, at the August meeting and that there are people out there who would be delighted to join his board. I don't think he has talked to any of the NCVHS members.
DR. STARFIELD: It may be a whole other committee by the time he gets around to it.
DR. IEZZONI: That is right. That may be true.
DR. COHN: Actually, as I remember there were a number of logistic issues, as well as everything -- not logistic, but legal issues having to do with people being on multiple different appointed HHS committees.
[Multiple discussions.]
DR. IEZZONI: But the basic point is that he very much wants somebody from our committee to kind of be at the meeting. So, we can, in fact, know what is going on. You can't unless you are kind of physically there and we still don't know how that would work.
DR. LUMPKIN: As I remember we left it -- the chair of the Standards and Security Committee would have to do that. But, obviously, those are ongoing details that we will have to work out during the process of -- as NCHS moves forward with their Board of Scientific Advisors.
Organizational issues. The first item was evaluating and reformatting internal structure and process. After a fair bit of discussion, the specific suggestions that we would move forward with structural change and that would flow from a deliberate view of issues and committee priorities. What that means is that we need to as a full committee decide -- I mean, there are obviously things that we have no choice in doing, those things which are mandated by HIPAA. There are other issues that come before us, which sometimes are brought forward, whether or not they are consistent with the things that we have decided to begin to use as our approach, which is refocusing on population health, aligning health strategies, information strategies with health strategies, enhancing our relationship with HHS and that that would be the test when a proposal comes forward.
Obviously, there are certain issues that -- summary health measures that we would vet through the full committee. So, the issue isn't -- the committee would say we are going to do this or the subcommittee or work group, rather that the committee would say this is something that needs to be done. Let's either form a work group, give it to an assigned committee to do. So, if anyone has an idea, we vet it first with the full committee before the work begins on that project.
Given that, maybe we can just sort of get some feedback on the specific suggestions that are outlined here. First, to replace the current structure with smaller work groups. There was some concern about our structure not allowing us to deal with issues as they come up and so people tend to work on the issue, based upon what subcommittee they are on, rather than whether or not they have interest on that issue. So, it is looking for a more flexible structure.
Trying to use the full committee to do more work. We have tended to -- many of our agendas tend to be very full of subcommittee work and not much happens at the committee level and try to readjust that.
DR. NEWACHECK: Could you be a little more specific here about what you mean because we already have work groups and subcommittees. We have small groups and bigger groups. So, these would be temporary, short term kinds of groups that might meet just once or twice or something like that?
DR. LUMPKIN: It would depend on the project. It is actually looking as you go through there. For instance, the privacy and -- the Privacy Subcommittee, which has almost a complete overlap with the Security and Standards -- Standards and Security. Yet, many of the problems that we have difficulties in moving documents forward is they get to the full committee level and at that point the issue is raised and frequently appropriately so, privacy appears to be an after thought.
That is because we kind of sequester all the people who have interest in privacy in one area and they are not available for the work of the other subcommittees and work groups. So, we would look at restructuring that in a way. So, it really is beginning to try to -- or trying to look at a more flexible organizational approach, some of which we have already done, but trying to more routinize that approach.
Any questions or discussions about those items listed there?
Systematic process for initiating projects so that we would bring it to the full committee for approval.
DR. MC DONALD: I have two kinds of questions. The one on Item 3, bullet 3, I think is a bad idea and that is -- well, we would have work groups hanging off an executive committee. There is no connection to the whole subcommittee and I just think that there is -- we don't vote the executive committee. It is just an operational committee. So, I don't think that is a good idea.
The other thing is --
DR. LUMPKIN: Can I just sort of -- before you move on -- because there are two pieces to that. This is talking about an organizational chart, hang some work groups off the full committee or executive subcommittee, rather than off subcommittees. So, there are two pieces to it. You are uncomfortable with hanging them off the executive subcommittee, but are you --
DR. MC DONALD: Yes, you are right. The other one is not a problem.
But I think the other thing that we are -- I sort of see in the overall issue, there is really sort of -- we have been given as the HIPAA legislation sort of a full plate. Some of us were invited on probably because of the HIPAA legislation information issues. There has been a committee acting for 30 or 40 years, 50 years, I guess, that didn't have anything to do with HIPAA legislation . I think there is sort of a basic -- pardon? Well, I mean, there is the basic themic issue that the HIPAA informatics stuff is squeezed out in some of these other activities.
I wonder if that isn't sort of the one of the basic underlying themes. Now, the other side of it is saying let's develop this big agenda of all the stuff to do when we are hardly able to keep up with the work load we are being assigned. I just wonder whether that is realistic.
When I was invited on, they said it would be 14 days and I said -- the number that I agreed to was 14 days. I think last year I counted 30 days of meetings I was supposed to go to, which I didn't go to all 30 because I would be fired if I went to all 30.
As members, we don't have any control -- I don't perceive the control over the days -- how many meetings are set up and how much agenda we take on. But I think it is -- I think we have to be realistic that we do have a certain amount of -- you know, we have a ten gallon hat or whatever it is and you can't put 20 gallons into it. So that I worry about trying to -- I think there is definitely a theme I hear and need here that we haven't attended to all the things that the committee historically, the public health issues should have attended to and we should focus on what are those things and seeing how we could possibly get all that done, too.
DR. COHN: I am going to respond a little bit to Clem because I think we all are well aware that the plate is very full. I think the concern that I had and expressed at the Executive Subcommittee was is that there are often times things that are started on and worked on where there hasn't been a vetting process initially to make sure that we are all in agreement, given our limited firepower, that this is one of the five or six things we should do.
So, I think I sort of agree with you, Clem, but I also thought in this process that the idea of an early vetting of the issue before we go down the road, as well as something , which I don't know was really well characterized in here, but which is, you know, sort of minimizing the paper. If we can get away with a letter, let's do a letter, as opposed to a big report, et cetera, et cetera. It might actually help us be a little more effective in what we are trying to do.
I think that is the idea that we were approaching. Obviously, there are a lot of things we have to do. We don't have a choice on.
MS. FYFFE: Yes, I think I agree with Clem and others. We need to do something to prevent scope creep because it seems that the scope of the national committee keeps growing and growing and I think that the people who participate ought to be able to have input to what our scope needs to be.
MR. ROTHSTEIN: I would like to comment on the last bullet, first, as a minor thing. I don't know how Bob feels about this or Kathleen, but I am not crazy about the term "privacy monitor." The last time I was a monitor, my job was to make sure that kids weren't cutting class in high school. But more substantively, I agree with the point about people who have an interest in privacy being dispersed, but I would like to make a case for not doing away with the Privacy Subcommittee. So, I would say that we could privacy specialists if you want, among other subgroups, in addition to having a separate subcommittee because there are certain issues that are especially appropriate for a subcommittee on privacy and yet there ought to be someone, I think, on all the other committees, who is sort of looking at what is going on with that eye, which may be my bias toward keeping people in mind, who have an interest in privacy, as perhaps -- as well as other things when we hire new members, rather than -- recruit new members. You know, instead of having x number of just people who are discrete, quote, privacy nuts, we recruit people who have an interest in privacy and do other things, too.
MR. BLAIR: I think that the conflicts are -- the organization can only -- the way we organize can help to some degree, but, for example, the agenda for these two days, I think, is a good example of -- maybe I am looking at it just from my viewpoint here, but it is a good example of where we have scheduled things to avoid conflicts.
The privacy and confidentiality session tomorrow morning, you know, is not scheduled fairly on account it allows all of us from all of the other subcommittees and work groups to participate. The NHII, again, that pulls from across many of the domains. On the other hand, we schedule the Subcommittee on Standards and Security opposite the Population piece at the end of the day.
I just sort of felt like it is just a thoughtful reflection of the reality and the way things have played out. So, in a sense I feel as if our scheduling of the meetings might be even more effective and helpful to avoiding these conflicts than whether or not it is a particular thing defined as a work group or a subcommittee.
DR. STARFIELD: I actually thought Mark's suggestion was an interesting one is that we take more care about how -- who is chosen to be on the committee, that we pick people not only because they have expertise or interest in one area, but have expertise and interest in three or four of the areas, whatever the committee is dealing with. It seems to me that is the way to go.
DR. LUMPKIN: I think the problem with that and it is a nice ideal to work towards and it is the tension -- and Clem mentioned it and it has come up over and over again -- with our plate being very full, with a lot of activities, there are some people who can delude their employers that this is actually part of their job and there are other folks who, their employers don't really care whether or not they think it is part of their job. There are certain things, which you are hired to do and particularly in the academic arena.
If it doesn't bring in revenue, then it is not necessarily useful towards moving or retaining your position. So, depending a lot upon individuals' time, having the right person who can actually contribute -- we always go through a cycle of members, who every time we bring on a new class of members, there is an individual who thought they could, but couldn't for any host of reasons. So, it is a very challenging thing that we do in trying to get as much expertise as we can, at the same time not completely burn out our members.
So, the recommendation on that is that we would -- as well as operationalizing the population health focus is to -- should follow from a deliberate review of issues and committee priorities and that one of the things that we need to do as an outgrowth of this is to look at what we are doing, look at how we are doing it, the issue that Simon discussed that we had talked about, which is not everything requires a 25 page paper to give advice and then to use that to try to address the issues and priorities.
The third item is trying to make the meetings more purposeful and using the written agenda to convey meeting objectives.
DR. IEZZONI: Do you think we have done the second item adequately?
DR. LUMPKIN: I am sorry.
DR. IEZZONI: It may be a Freudian slip.
DR. LUMPKIN: I don't think so.
Considering how I make my living -- operationalizing the population health focus. I mean, it just seems so logical to me that I -- that is probably why I slipped over it. I didn't see how anyone could disagree with that.
DR. IEZZONI: The basic bottom line is not working very well right now. I hope that I didn't interpret some of the comments a few minutes ago to suggest that the only thing that the committee should really be focusing on is the HIPAA mandate because they are overwhelming and they do take a lot of time and, yes, people who are focused on that are spending a lot of time doing that.
But I think it would be a disservice to our mission and to our committee's history if all we did was to focus on the HIPAA legislative mandates. I think that it is literally true that there are people who are now serving on this committee, who would no longer serve if that is what the focus was going to be.
At the same time, operationalizing the public health focus has not worked very well yet. I think a lot of that has really focused on -- I don't want to say who we have been able to recruit because that kind of personalizes it, but the type of people that we have tried to go after have piles of expertise and as John said, they only have limited time. They tend to be academics, most of the people -- I think all of the people -- when you look at it, all of the people who are on the Population Subcommittee and who resigned -- Hortensia Amaro, Vince Mor, Andy Kramer and David Takiuchi are all academics with very specific interests and they basically felt that their time was not being spent well because they were unable to focus on what their area of expertise is.
So, I think we need to think about this whole issue around recruitment and redefining how we would make this work. I don't know -- I hope that many subcommittee members, Kathy and Barbara and Paul can help us think about this, but I think it really is something that we as a committee need to seriously, seriously think about.
DR. NEWACHECK: I am a little concerned that both of the approaches that are described here would eliminate the Population Subcommittee. I am not sure that that is the right approach. The population focus might then become so diffuse or disappear entirely.
DR. IEZZONI: But it is so ghettoized now.
DR. NEWACHECK: That is true, too.
DR. IEZZONI: We are literally the all other subcommittee.
DR. NEWACHECK: Yes. I think the problem statement is right on target. It is the solution I am not so sure about.
DR. IEZZONI: We need to have John and the Executive Subcommittee and others help think through what the solution should be.
DR. MC DONALD: At the risk of being one who might have been thought of not thinking that was a good subject, I was really just trying to clarify what the tension is and I think that is what it is, that we have kind of -- the HIPAA stuff has pushed maybe too much of the attention into the HIPAA stuff. I am just trying to describe reality, not trying to take a position on what it should be.
But from someone who hasn't been active in the Population Subcommittee, it seemed to me they produced a fair amount, if I am not keeping track right. So, maybe at great price because of the time. So, I am not quite clear what is not working, the fact that people are quitting, the fact that they don't have the right constituency, the fact that the rest of the committee isn't helping enough, the fact -- because some of the rest of the committee might not be able to be helpful.
DR. IEZZONI: In deference to the time, which this is taking right now, I could describe at some length what hasn't worked and so can my remaining committee members, subcommittee members. I think maybe I will just ask you to trust me on the fact that it really hasn't worked at this point and we can talk about it off line if you would like. But we really, I think, as a full committee need to think though how to address these issues. They are extremely topical and do relate to national commitments on reducing disparities and improving the population.
DR. LUMPKIN: Let me just sort of toss one out. A major priority of the agency that we are charged with advising is elimination of health disparities, racial and ethnic health disparities. We as a committee have not addressed the role that data and information policies would play in trying to clarify, resolve that issue or lead to solutions.
The difficulty of that is that is not just an issue of, quote, populations because as a good friend of mine, Chris Gebbe, once said the medical treatment system and the Public Health System both use the same data. We just look at it differently. So, to the extent that we can marry those two components into collecting data, which is what the NHII is talking about, is the extent that we can enhance our capabilities. But there are certain aspects of that, the discussion that we had about the enrollment form and other forms, how we collect race and ethnicity data, how that is included, was one area where we had some overlap and it wasn't necessarily very fruitful, but it was an important discussion.
So, I think that those are the kinds of things that we as a committee need to look at and it is going to impact not only just the population committee, subcommittee, but also should impact all of the other committees as we have some conceptual idea of what the priorities are and then look at the individual work of the committees.
One of the issues that will come up under standards is where do we go next with HIPAA. I mean, we have done our work. We are waiting for HHS to do their work. There are other additional standards and we are supposed to make recommendations to the Secretary. Well, would those standards reflect population health issues or some other approach? Well, that is, I think, work for the full committee to address.
So, those are the kinds of things, I think, we need to put on our plate in ways that we can do -- using the most efficient use of member time and that really is a major concern.
DR. STARFIELD: I thought that was a good example, I think, of why we put in this recommendation about hanging some things off the full committee. Reducing disparities ought to be a function of the whole committee and not just a subcommittee.
MS. FYFFE: What I am going to say next is from the point of view of someone who is not a doctor, who is not an academic person. But I have always been a little bit curious as to why on this committee there is no one who is or represents purely practicing physicians.
DR. IEZZONI: There are historically.
MS. FYFFE: No, I am talking about people who make their living as a practicing physician. They are not in an academic environment.
DR. HARDING: She is making a correct statement. At the present time, I am a full time academic position. But until about six months ago, I was a quarter time, in effect, and the rest of my practice and so forth was private practice. But at the present time, that is correct.
DR. LUMPKIN: But let me just sort of interject in there that we have to be a little bit careful in the descripters. There are a number of categories of academic physicians. When I was on faculty at the University of Chicago, I was an academic physician, but 80 percent of what I did was clinical work, but your point is is that someone who is actually making their living seeing patients and that is an incredible challenge. I can tell you that many medical associations are trying to figure out the same thing because the people who are doing the work don't have the time to serve on the committees.
MS. FYFFE: Well, that brings me to my next subpoint. Given that the medical associations are trying to grapple with this, would it make sense to seriously consider a representative from a medical association, whose -- and I know that has a lot of political implications, but I would like to -- a few years ago, there was a practicing physician, who wanted to make a comment to this committee about specific uses of data and collecting data and this committee cut that person off from public comment.
I remember that and some other folks remember that and it led me to believe that we just weren't that sympathetic to the people who are actually out in the field with the data themselves. Maybe I am overstepping my bounds here or speaking out of turn, but I think we ought to consider -- reconsider that in terms of membership for the committee.
DR. COHN: Actually, I want you to know that I am actually a practicing physician and I am not an academic. I represent and I am employed by one of the country's largest medical groups but do also continue to see patients. So, I am sort of -- do I resemble what you are referencing or the fact that I am not here because I am --
MS. FYFFE: No, you don't.
DR. COHN: Is that the issue. I guess I would be struggling here to -- I think what you are talking about is somebody who is spending a hundred percent of their time doing clinical care is I think sort of what you are talking about.
MS. FYFFE: Representing somebody who --
DR. STARFIELD: Why do you think that would help, Kathleen?
[Multiple discussions.]
DR. COHN: -- medical groups are not delivering clinical care. Help me with this one, please.
[Multiple discussions.]
DR. MC DONALD: I see patients, too, but I think -- my brother is a private practitioner.
MS. FYFFE: Yes. Occasionally you talk about your brother and --
DR. MC DONALD: There is a different sort of mind set.
MS. FYFFE: That is what I am talking about. If it couldn't be someone out there practicing, I mean you really couldn't ask them to give up the revenue to travel here, you know, 15, 18 days a year. But there ought to be somebody who is very concerned and represents that group.
DR. LUMPKIN: Well, let me just suggest that that is something that we can look at as we are making our recommendations but the difficulty -- and I can tell you having been in national leadership in the College of Emergency Physicians, where this issue practically tore the college apart about 15 years ago, which was who is on the board of directors of this association. Is it the people who run groups or is it the people who are in the trench, emergency docs?
The people who are in the trench, emergency docs, by the time they get to be senior enough to represent their organization, they are no longer in the trenches. The people who are in the trenches could never make it to the meetings unless their group specifically said, okay, now we are going to give you half time to work with the association.
So, it is a very difficult ideal and once we have a representative from a -- if we were to have a specific person who is there from the AMA or so forth, they are going to have the same internal politics, where the person on the street is going to say that person doesn't represent me because they are from the AMA.
MS. FYFFE: Maybe we can never do it.
DR. LUMPKIN: But to the extent that we try to have diversity on the committee and to look for individuals who spend time on the front lines and those who are in managerial academic positions, I think we try to have as much of a mixture and then -- and this is where we ran into a problem before, where we try to have people who testify and the difficulty we had before was an individual who had an issue that was -- I don't believe -- as I remember, it wasn't related to what we were talking about and we need to bring in those individuals who are actually practicing as much as possible to testify in our hearings.
DR. STARFIELD: I asked why you would want such a person. Individual practicing physicians are focused on individual patients and they have great difficulty in focusing on populations because it is a different way of thinking. So, it is not clear to me that just from the philosophy. I mean, they can be on the committee --
MS. FYFFE: I don't even know how to react to what you are saying, Barbara. I guess we are on completely different wave lengths because to me populations are made up of groups of individuals.
MR. BLAIR: I guess that I have -- I resonate with Kathleen's comments, Kathleen Fyffe's comments, in that, you know, I really feel it is very important for us especially to wind up having input and feedback from individuals that are not involved in medical informatics or not involved in public health. So, from that standpoint, I do resonate with Kathleen's comment.
There is a piece where I feel like there is a balance that I think also should be considered and that is as I look around and I know that my ability to look around is not very good, but, you know, this committee -- I can't even give a full count of the number of people who either have been practicing or continue to practice and the thing that I think is helpful is that medicine is not just a single entity or medical domain. It isn't only family practice and as you look around here and you look at all of the backgrounds of the medical profession that are representatives, everything from internal medicine to emergency room surgery to -- and I guess I can't -- to psychiatry, to whatever else I have probably missed and -- so, I think that we do have a very good representation of people with a medical background, even though I would acknowledge Kathleen's comments that it would be nice if it is possible to get somebody who is predominantly focused on family practice.
DR. LUMPKIN: I am going to suggest that we move on.
MS. GREENBERG: I wanted to make a clarification for the record.
DR. LUMPKIN: Okay.
MS. GREENBERG: Just for the record I wanted to mention that associations are not represented on this committee at all. We can ask for representatives or spokespersons from associations to testify at hearings, et cetera. All the associations and any group has the opportunity to oppose somebody for membership, but this committee is not organized in the way to have association representatives. So, I just wanted to clarify that.
DR. LUMPKIN: Are we done with 2?
Clarifying meeting objectives. We talked about that. More member input in planning hearings. That is something that is going to need to be two-sided. We need to make sure that we give it as much opportunity and encourage members to make suggestions on hearing speakers and topics and questions and we also need members to make suggestions and so forth.
Member recruitment and participation. I think we have been discussing that. Are there any additional things we want to throw into this particular hopper?
DR. ZUBELDIA: Do we have new members coming in this year?
DR. LUMPKIN: We have potentially new members coming in every year, but there is always -- the Department looks at the current members, those whose terms are expiring. They look for individuals who can be brought into the committee. They conceptually operate upon a single term with a potential for renewal and then they do their thing and then we have new members show up.
DR. MC DONALD: At the risk of opening up the other discussion, which I don't want to do, the charter does speak specifically to the kind of people we are supposed to recruit. I don't know how much we have to follow that.
MS. GREENBERG: It is pretty broad.
MR. SCANLON: Actually, the committee makes -- in the nomination of members, the full committee usually makes its interests known to the Executive Committee and then made known to HHS in terms of the kinds of areas that are needed. But clearly, we will have at least a couple of vacancies to fill.
DR. LUMPKIN: Okay. Leveraging and supplementing staff time. Supplementing staff with contractors and trying to replace inactive people on staff and needing to have more interaction with Marjorie and with Jim, who are the Department's head staff people.
I think that certainly we need to use Marjorie and Jim as -- if problems arise and to help arbitrate, resolve issues.
Clem.
DR. MC DONALD: Just a compliment to the staff. I mean, they may be overworked, but at least in terms of the physics of moving around and getting here and -- they do a really good job. I think we ought to just recognize that.
[Applause.]
MR. SCANLON: As we mention this supplementing staff time and so on and the ways of getting work done in a more efficient way, we have actually -- with the coming new physical year, we will have to look at what sort of contracting help we will want in the year ahead. But we did create one new mechanism within HHS. We now have a contracting mechanism that is available to the committee where we have expert consultants who sort of are standing by, where we can -- rather than a contractor, we can actually assign -- we can assign analytic tasks to those folks and I can share that with the committee when we are doing work planning, but we just started that this year.
That may help a little bit with the staff supplementation if we have specific analytic tasks.
DR. LUMPKIN: Thank you.
Following through on committee recommendations. Part of this is trying to communicate better with constituencies and looking at the impact, getting more reports, such as the follow-up from the Data Council on our various reports and knowing that the reports that we generate, that we develop, actually do have some impact on decisions that are made.
This is where we got into a discussion as we have talked about before of looking at alternative ways of doing work products that match the work product to the issue that we are trying to address and what needs to be said.
Then the last item, nurturing committee esprit, and just trying to get back into the mode where in the past we tried to gather informally on the evening of the first day for dinner or some other social event and tried to engineer that and as such, there is a happy hour here.
So, when we are done with our day's work at 5:00, we will need -- at 5:30, we will meet in the lounge here.
[Multiple discussions.]
DR. MC DONALD: I think there is an issue there, not that we are unaspreed(?), any committee, and all of us have been on committees, it takes a couple of meetings before people are kind of -- you know each other, study sections, et cetera, but there is -- we are different in two respects. One of them is we don't talk to each other very much in meetings because there is so much testimony time and maybe the idea -- you had mentioned maybe fewer committee members to take testimony, but there is disadvantage to all that. That is a big disadvantage. Now, it seems like we don't really get to decide together very much. We spend time -- which is our role. We are supposed to -- but I think that makes it hard.
I support this esprit thing.
DR. LUMPKIN: One of the things I think the club
-- this kind of thing such as we are going to have this evening -- we will need to play around with this. One of the problems I saw, I remember from the dinners, is that you get at a big long table and you talk to the person to your right and your left and so there if there is more reception type atmosphere, it might be -- so, we will need to play around with this to get a right mix.
Any other additional comments? What we will be doing is over the course, obviously, of the coming year, the Executive Committee will be following up on this and making recommendations and changes and approaches that will go to the full committee for approval, as we do everything else.
We will break at 12:30 for lunch. At 1 o'clock, the Workgroups on 21st Century and NHII will have a joint session in the Roosevelt Room and if you are not on those workgroups and you want to come, feel free.
[Whereupon, at 12:30 p.m., the meeting was recessed, to reconvene at 2:10 p.m., the same afternoon.]
DR. LUMPKIN: We are going to reconvene the afternoon session.
An organization that has not received much public attention in the recent past, better known as the Institute of Medicine -- I have to admit I know of few organizations that issue a report that result in a Presidential response within a couple of days as much as the Institute of Medicine report on "To Err is Human."
They are currently working a project that is entitled, "National Quality Report on Health Care Delivery." Margarita Hurtado is here from the Institute of Medicine to give us an update on that.
Now, as I understand it, this committee is chaired by Bill Roper? Okay.
DR. HURTADO: Well, first of all, good afternoon and thank you very much for inviting me to brief you on the activities of the Committee on the National Quality Report on Health Care.
First of all, I just wanted to mention that the work of this committee is still ongoing. So, whatever I present to you may change and may be transformed by the time that the final report comes out. Many of the elements that you will see here will probably -- at least some of them will be present in the final report.
Very briefly, I am going to go over the origins of the study, the purpose of the National Health Care Quality Report as it is now started by AHRQ and the committee's charge, the progress to date and the next step that the committee is going to going to take to finalize the study.
I want to acknowledge that Tom Riley is here. He is in charge of the National Quality Report at AHRQ and they are the sponsors of the study. So, I am sure that after this presentation, he will be available to answer questions as well, if you have them.
How did this study come about? I am sure you are all familiar with the President's Advisory Commission on Consumer Protection and Quality. In 1998, they issues a series of recommendations. Among those that the quality of health care had to improve and that measurement of quality needed to improve as well. They needed to be provided in a way that consumers would be able to understand that information.
After that, more recently, in the reauthorization of AHRQ, of the Agency for Healthcare Research and Quality in 1999, one of the stipulations of that legislation is that AHRQ has to provide an annual report on the quality of care in the nation, starting in fiscal year 2003. So, in response to that call, one of the things that AHRQ did was commission this study from the Institute of Medicine to provide them with some input on how to go about that mission.
Why a national health care quality report? Well, there are many reasons I am sure you can think of. But first of all, the purpose of this report is to inform Congress as part of this reauthorization legislation; first, inform Congress, to inform policy makers, not just at the national level, but at the state level as well, and to inform the general public. There are other audiences that are important also, such as the providers and researchers, but the two main audiences are policy makers at the national and the state level and consumers.
Second, the purpose of the quality report is to serve as a barometer of quality, to have some kind of indicator, front end indicator, of quality, where you can track how quality is changing over time, to be able to report on system performance and capacity for improvement. It is important to distinguish between the national quality report and other efforts that are already underway because people sometimes think, you know, why a national quality report. Don't we have enough data and statistics as it is?
What this national quality report is that it will not present data on health status. Health United States already does that. It will also not set goals or set a public health agenda. Heathy People 2010 does that. It will just report on the quality of health care delivery.
What is the IOM committee's charge? They have been asked to do four things. First of all, to define the questions that the report should address in order to be able to tell whether quality is improving or not and what the level of quality is.
Second, to define the domains that should be included in the report; that is, the categories of information that should be reported on. Third, to provide some examples of measures for the report. They are not to provide the final battery of measures, but just to provide examples of measures in each of those categories.
Finally, to give some recommendations on the production and update of the report.
Where is the study at today? This is an 18 month study. We are two-thirds along the way, month nine. The committee was scheduled to meet four times. It has already met three times. The final time will be in November. There was a 14 member committee, which as has already been mentioned is chaired by Dr. Bill Roper from the University of North Carolina at Chapel Hill.
The committee roster is included in the materials, I believe, that were distributed to you in your binder. There is a two page summary and one side has just a short description of the study and the other has the committee roster.
One of the big activities that some of you here participated in was a workshop on envisioning a national quality report on health care. I will go into more detail on that. The committee also issued a call for measures in the private sector. I will provide you some more information on that. In their last meeting, they examined potential measures for the report.
As I mentioned, the framework for the National Quality Report is not finalized. One of the first things that the committee did was to look at some possible approaches that are already out there that may be useful in defining that framework. There were two that jumped out and one of them is there is another committee within the Institute of Medicine, the Committee on the Quality of Health Care in America.
They are the hones that issued that report that was mentioned, on "To Err is Human." They are working on another report and from early materials that they distributed publicly, it looks like they are going to recommend that the system be directed towards six aims. Those are listed here; safety, effectiveness, patient centeredness, timeliness, efficiency and equity.
The other framework that attracted the attention of the committee is the one from the Foundation for Accountability, which many of you perhaps are familiar with. They have done research, focus group research, to try to define how people think about quality and they wanted to figure out what would be some useful categories to present information on health plans.
They came up with these five categories; staying healthy, getting better, living with illness, changing needs -- changing needs has to do with care at the end of life and disabilities and the basics has to do with the infrastructure of the system, such as access, information that the health plan provides to consumers, that type of thing.
So, those two are the frameworks that the committee is looking at. They are also looking at many other things, but those are the two frameworks that they thought might be most useful. One had the system aims and then the other, the consumer needs for care.
As I mentioned, the Institute of Medicine has a workshop, held a workshop in May. Dr. Starfield -- I don't know if there is anybody else that participated in that workshop -- presented at that workshop. The purpose was to gather information in terms of measures of quality of care and focus basically on three areas.
I wanted to look at how quality was measured in other sectors. Somebody came from the education and talked about NAPE, National Assessment of Progress in Education, and wanted to look also at how quality of health care is being measured in other countries and Heather Palmer reported on some of these efforts in England and in Australia.
The second, we have the speakers provide specific measures in some of these areas, some of these system aims that I mentioned. For the workshop they concentrated on four; safety, efficiency, effectiveness and patient centeredness. So, timeliness and equity, it is not to say that they are not important. They were just not part of the focus on the workshop.
The third topic was to look at several issues in terms of technical issues, data issues, what do you do when you have small numbers and you want to compare population subgroups, for example, in terms of equity and policy issues. Some congressional staff people came to present what they thought would be the aspects that Congress would be most interested in.
One of the things they did say, we don't want anything on health status. We already know that.
The speakers presented many suggestions for the report and I have just summarized these on this slide. On the one hand, they said that the National Health Care Quality Report should provide a stable set of core measures. There should be a permanent set of measures that will be the same from year to year.
There would also be special supplements or special topics that could vary or could rotate periodically, that it should be a report to Congress, but at the same time it should be understood by a broad audience, by consumers, because that is the secondary audience for the report, that it should be policy relevant and that it should provide information useful for quality improvement, that it will be comprehensive, so that it will give a complete picture of the quality of health care in the nation, but at the same time that it be simple so that it can be understood. It is a little bit difficult because you need to have a lot of indicators to present that comprehensive picture, but at the same time have some key indicators that people will be able to understand in terms of what quality is without having to look at the whole broad set.
They have information on subgroups of the population. As I mentioned, equity is a concern, but that the data be valid and reliable for all risk groups that are included. That includes summary measures, such as indices and overall quality index, perhaps, or -- which I think might be difficult or indices having to do with safety effectiveness or whatever the committee is going to come up with in terms of the final framework.
But it should also -- if it has those indices, that it should also provide information on the component measures because that is what policy makers are going to be able to act upon, not upon those gross general summary indicators.
The committee asked the speakers also to provide them with some suggestions, some specific measures that they might use for the report and many were presented. All of the presentations from the workshop are available on the study web site and that is address is in the summary and on your slides and on the final slide I will show that. So, if any of you are interested in going on to more depth in some of these, you can find those presentations available on the web.
So, some of the measures they suggested were in terms of safety, infrastructure measures, structural measures having to do with computerized order entry system. There were portions of hospitals that had these available because there seems to be some link, though it is not completely validated between using computerized order entry systems and improving safety.
For receptiveness, many measures were mentioned. That is probably one of the areas where there is more work and indicators available. That encompassed both appropriateness of procedures and variations in treatment were also suggested as possible measures. John Wenburg was there and went over the issue of variations and how that could be an indicator of quality.
Patient centeredness, aspects having to do with how involved the patients are in their own care for diabetes, asthma, other common conditions. Finally, for efficiency, that was the area where there seemed to be least number of measures that are really available for prime time right now.
There are more in the stage of research, but Margaret Clerman(?) and there was another person as well, they presented several suggestions on this and they have done some preliminary work in costing conditions and looking at that as a measure of efficiency.
After this workshop, the committee issued this call for measures in the private sector. AHRQ is going to be issuing a call for measures among federal agencies later this year. So, the committee's call was restricted just to the private sector. And they asked people to send measures in terms of the system aims; safety, effectiveness, patient centeredness and timeliness. Efficiency and equity are not here and that doesn't mean that they won't be included, but just that they weren't included in the call for measures.
Second, that they would cover one of the four fact categories. The basics categories aren't included because that access infrastructure aspect is part of the aims. The committee has also defined a preliminary set of criteria for selecting the measures. They have defined ten criteria. None of these are something that you haven't seen before because they reviewed criteria that are being used by other groups, such as HEATUS(?). They are grouped in three areas; the importance of their problem, the scientific soundness of the measure and the feasibility of the measure.
Now, it is important to mention that in terms of feasibility that the committee is charged with writing the vision of a national quality report on health care. So, it is likely that some of the measures that will be suggested by the committee are not feasible at the present time, but we would expect that feasibility could be constructed, so it could be put into place in the medium and long term.
I am not going to go through all of these, but the details on this criteria, description of this criteria, is also available on the web in the section that call for measures. The three main areas are the ones I mentioned.
So, the call the measures was issued in June-July. It is not the best time to get submissions from people. People are usually on vacation, doing other things, but we just wanted to get a feel for some of the measures that were out there. The purpose was not to have an exhaustive inventory, but just examples.
So, 138 measures were submitted and some of the organizations that submitted measures are listed there, American Diabetes Association, American Psychiatric Association, Foundation for Accountability, Joint Commission, et cetera.
This is interesting. In terms of the measures that were submitted, as you saw, we had asked people to submit measures in one of the four system aims, in one of the four care needs, consumer categories. As you probably would expect, most of the measure in terms of system competencies, most of the measures concentrated on effectiveness. Two-thirds of the measures of the measures submitted had to do with effectiveness because a lot of little practice guidelines, the work that has been done so far has been looking at quality of care for specific conditions and that is what usually quality has been equated with is effectiveness.
These other aspects of safety, patient centeredness, timeliness are not as common. So, there were fewer measures submitted in those areas. IN terms of care needs, the most common one was living with illness. That has to do with chronic care as I mentioned. But they are more evenly distributed in terms of you have measures in the preventive area for staying healthy and getting better and in living with illness.
But there is a very remarkable absence there in terms of measures of coping with changing needs, coping with care at the end of life and disabilities. There were no measures in that area submitted at all.
To finish, the committee, the next things that they are going to do, they are going to have this meeting in November, as I mentioned. They, obviously, have to finalize the framework and define some central measures and look more carefully at how the report is going to be designed in terms of providing the information to consumers in a way that is accessible to them and maybe, considering that we might need to have different reports for different audiences, policy makers, consumers and also might use different media for those reports.
The report is scheduled for release in the spring of 2001. Anything that is public or descriptive information in terms of the study is put on the study web site because we update that regularly so you can follow the progress on there. We would welcome any comments or suggestions that you might have for the committee because they are very open to that at this point.
If you have any questions, I would be happy to entertain them and, as I said, Tom Riley from AHRQ is here as well.
Is there anything that you want to add at this point?
MR. RILEY: We just want to take this opportunity to thank the IOM for the work they are doing. We really appreciate it and are looking forward to their report.
DR. LUMPKIN: If I can maybe start off with a question.
On Slide 12, one of the criteria is that it permits comparisons. My question is related to that. Obviously, what were you thinking about making comparisons between. The second is to what extent is the unit of measure for health care? Are we talking national? Or were you talking state, I hope? Being a director of a state health department, I might find some utility or even a smaller unit of measure than that.
DR. HURTADO: In terms of the geographic coverage there is, I mentioned that the report will be national but there will be state measures as well. It is possible that in early -- in the first versions in the report might not have the information on all of the indicators for all of the states. But that is the goal, that the information will be available at both the national and the state level, particularly because policy makers and Congress said they want to know about their own state. It will be much more useful in terms of defining policy.
In terms of comparison of groups, in addition to comparing states, that hasn't been finalized, but there is also some thought given in terms of comparing groups by race, ethnicity, comparing groups perhaps by level of income, by whether they have insurance or they don't have insurance as indicators of possible inequities or possible differences among groups.
DR. STARFIELD: You have done a lot of work since May.
One of the few criticisms of the IOM report on medical errors was that it was so focused on hospitals. There is a little bit of that flavor in here, too, particularly in the first two categories, the safety and the effectiveness. Do you see the final report going beyond that?
DR. HURTADO: Oh, definitely. I think there is a very conscious effort to include other health care settings that go beyond hospitals. There is a recognition that a lot of care has moved outside of hospitals. For example, for safety, one of the measures that could be included could have to do with safety of cosmetic surgery, for example, which is almost all ambulatory right now. I don't have the precise indicator but it could have to do with that setting.
DR. STARFIELD: But that is still surgery.
DR. HURTADO: That is still surgery but it is outside the hospital.
In terms of primary care --
DR. STARFIELD: Oh, no. I mean, there is a lot of care that goes on outside of the hospital in terms of medical care for both kids and adults and older people as well.
DR. HURTADO: What I can say right now is that we are -- they do have the intention to cover all different health care settings and they definitely want to move beyond the hospital. There are many indicators in that area and also just in terms of conceptual aspects, as I mentioned, move beyond effectiveness to other areas of quality.
DR. MC DONALD: Just some clarification.
In the old days you would see the distinction between outcome measures and process measures. I could identify a lot that were probably process measures. I wasn't crystal clear whether you looked at outcomes at all. That is No. 1.
The other thing is when you get into efficiency, the other thing is quality and cost. So, the efficiency is sort of is mixing those. So, I wonder if it is a conscious deliberate thing, trying to look at the cost balance or the cost -- the deaths per dollar or something like that.
DR. HURTADO: First, to answer your second question in terms of efficiency, so far the committee is not contemplating efficiency within the quality report because of the reason that you just mentioned. If you want to look at value and you look at quality and cost separately. I think it is beyond the scope of the report, that we can definitely have a complete report just looking at cost of health care.
In terms of the first question of the different types of measures, the committee is looking to include measures in all those three categories, but most of them will be concentrated in the process area, but there is some preliminary work looking at conditions where you would want to link process measures to outcome measures. So, there would be disease specific outcome measures.
It is not clear yet whether you would want to have measures of overall health status or functional status as part of the report, but definitely disease specific health status measures, outcome measures.
MR. BLAIR: Again, at the risk of embarrassing myself because you might be addressing this on your slides, which I can't see, but one of the things that we have been struggling with is the issue of -- we here on the NCVHS -- is the quality of data, the difficulty in getting complete and comprehensive clinically specific data. I am wondering when you wind up talking about some of the things you have mentioned, such as outcomes data, it is difficult to do that if you are not capturing clinically specific quality data.
Are you somehow addressing that in your report?
DR. HURTADO: Yes. Some of the aspects that will be addressed are data sources for these measures that are being proposed and you pointed out several of the problems that exist in terms of that. It is our understanding that AHRQ is looking to expand -- just in terms of national survey data, is looking to expand those surveys to include additional indicators. It is looking to map the Medical Expenditure Panel Survey to look at specific conditions and have oversampling for some of those.
The committee was also presented with the possibility of using patient records as a main data source to be able to look at effectiveness of care, overall effectiveness of care. That was something that was presented at the last meeting by RAND in terms of the QA tools.
DR. STARFIELD: To what extent would you be at delivery system quality?
DR. HURTADO: I could elaborate a little bit in terms of what do you mean by the delivery system --
DR. STARFIELD: There are quality characteristics of primary care, specialty care, that are known to be related to quality, however you measure quality. Are you getting at those delivery system characteristics?
DR. HURTADO: In terms of some of these characteristics has to do with coordination. Perhaps that is one of them. Timeliness, the way that it is being conceived, it is being conceived as party access to care and coordination are two very big elements of timeliness. It is not just going to be waiting time in the doctor's office. It goes beyond that to that system level.
DR. IEZZONI: This is really exciting. I wonder to what extent, though, your quality measures are going to be tied to action and attribution. Because, obviously, if you identify substandard quality in any particular area, you want to know what can be done to improve it.
So, to what extent as you are looking at the different candidate quality measures are you trying to choose those that are actionable and have attribution attached to them?
DR. HURTADO: That is one of the criteria that is listed in terms of the measures that you would definitely want something that is actionable because this is a report to Congress.
The link is not -- since it is a national report and it is not looking at specific facilities or specific providers, the link between the indicator and the action to remedy some of those problems that may exist is not that clear or that close. You also need other efforts at more local levels and at the provider level to be able to do that. But that is something that is being taken into consideration in terms of the criteria.
DR. NEWACHECK: I wonder how you are handling the issue of the developmental stages of life and the age appropriateness of measures. I know, for example, many of the fact measures have been developed separately for children and for adults and the like. But you are also trying to be as concise as you can and not have -- you know, in terms of measures.
Are you going to have different measures for children and adults and the elderly and such?
DR. HURTADO: There is an intention to include measures for children definitely and for the elderly as well, for different population groups in terms of age.
DR. STARFIELD: I know you said you were going to deal with equity, but it wasn't one of the areas you dwell on. Are there particular problems with that one?
DR. HURTADO: No. As I said, the framework is not finalized, but so far the committee is looking at these four system aims and those would be like the core competencies of the system, the requirements so that you can obtain quality. You need a system that is safe, that is effective, that is patient centered and that is timely.
Equity, the committee is viewing that more as a cross cutting issue, that cuts across all of those four areas, safety, effectiveness, patient centeredness and timeliness. So, in terms of the indicators, the measures, what they are, to look at those by population subgroups, whether it is in the area of safety or effectiveness or patient centeredness or timeliness.
MR. SCANLON: To what extent is the patient perspective in terms of satisfaction and other perspectives on care part of the quality framework? Are these going to be largely health care based transaction measures or will they actually include measures that the patient actually gets to respond to in terms of satisfaction or --
DR. HURTADO: The traditional patient satisfaction measure, I don't think that that is one of the ones that is contemplated, but more specific measure in terms of provider/patient communication, in terms of whether the patient has the ability to participate in decision-making, whether they were presented with options, for example, for breast cancer, whether their needs were taken into account in terms of do not resuscitate orders and whether those were complied with or not.
More specific interactions are unclear but the general patient satisfaction so far that wasn't thought to be -- as useful in terms of indicating particular remedies or problems as they may exist in quality of care.
DR. STARFIELD: So, it is really patient experiences rather than their satisfaction.
DR. HURTADO: Exactly.
MR. SCANLON: From whose perspective? Is the patient providing this information or are the transactions the source of the information?
DR. HURTADO: One of the data sources is CAHPS, the Consumer Assessment of Health Plan Survey and that includes a lot of questions that have to do with efficacy, patient centeredness and to timeliness.
DR. LUMPKIN: Thank you very much for coming. We are going to be looking forward, particularly those of us who realize now that our states may be rated, with bated breath for the report in 2001. But I think that certainly to the extent that we can continue to monitor this process, I think it moves us all forward and is consistent with our vision of the information and database measurements of what is going on in our health system.
DR. HURTADO: I just wanted to reiterate if you do have specific suggestions for the committee, we welcome them.
MS. FRAWLEY: You said that initially you are going to be looking at measures without necessarily testing every feasibility criterion because that will enable you to identify some gaps in areas where in the future, you may be able to do something that you are able to do now.
I think that is an area that we are particularly interested in; that is, the issue of gaps and sort of what falls off the table or off your recommendation list because of problems with getting the data or the quality of the data that exists. I think we would like to hear about those lists of things in particular.
So, if it is part of your report, great. If it isn't part of your report, but it is sort of an outtake, that you could bring back and share with us, I think that is something we would like to hear about.
DR. HURTADO: It is going to fall to AHRQ -- they are going to have the responsibility of putting some of these recommendations into place and trying to construct the feasibility for some of the measures.
MR. RILEY: I just want to comment briefly on that. We are anticipating that when the IOM framework comes in that we will identify measures to fit into the cells of the framework. We anticipate that some of those cells will have population measures for them, some of them will not. And the sort of empty cells in there will help guide our research agenda and quality measurement in the agency.
DR. LUMPKIN: Thank you, again.
At this point, we are going to take a break and then we will reconvene in the subcommittee working sessions. The next item that we have scheduled on our agenda is -- for full committee is at 5 o'clock -- we will be meeting at 5:15 in the Club Royal.
[Whereupon, at 2:45 p.m., the meeting was recessed.]