Transcript of the September 21, 2011 NCVHS Full Committee Meeting

DR. CARR: I would like to welcome everyone to the first day of a two-day meeting of the National Committee on Vital and Health Statistics. I am Justine Carr, Chair, and I'm with at Steward Health Care and no conflicts.

MR. SCANLON: Good morning, I'm Jim Scanlon, I'm Deputy Assistant Secretary for Planning and Evaluation at HHS, and I'm the Executive Staff Director for the full Committee.

DR. FRANCIS: I'm Leslie Francis, Law and Philosophy at the University of Utah. I chair the Privacy Sub-Committee and am a member of the full Committee and I have no conflicts.

DR. MIDDLETON: Good morning, I'm Blackford Middleton, a member of the full Committee, from Partners Health Care, where I'm the Director for Clinical Informatics, Research and Development, and a co-chair of the Quality Sub-Committee and serve on the Population Committee, and no conflicts.

DR. MAYS: I'm Vickie Mays, Professor of Psychology and Health Services at the University of California, Los Angeles. I'm a member of the Full Committee, and I am a member on Populations and Privacy. No conflicts.

DR. BURKE: Good morning, I'm Jack Burke, Vice President for Compliance Programs at Harvard Pilgrim Health Care in Boston. I'm a member of the Full Committee and have no conflicts.

DR. HORNBROOK: Mark Hornbrook, Chief Scientist at Kaiser Permanente Northwest, member of the Committee, no conflicts.

MR. SOONTHORNSIMA: I'm Ob Soonthornsima, I'm Chief Information Officer at Blue Cross Blue Shield Louisiana, I'm a member of the Full Committee and a member of the Standards Committee and have no conflicts.

MS. DOO: Lorraine Doo, with the Office of the Health Standards and Services at CMS, Lead Staff to the Standard Subcommittee and no conflicts. And Judy's smiling at me.

DR. COHEN: I'm Bruce Cohen, from Massachusetts Department of Public Health, a member of the Full Committee, and a member of the Population Health Subcommittee, no conflicts.

DR. NICHOLS: I'm Len Nichols, from George Mason University, I joined the Full Committee this summer and I serve on the Population Subcommittee and Quality Sub-Committee. No conflicts.

MS. KLOSS: Linda Kloss, Health Information Management Consultant. I'm a member of the Full Committee and the Privacy and Quality Subcommittees, and no conflict.

DR. WALKER: Jim Walker, I'm Chief Health Information Officer at Geisinger Health System, and on the verge of being a member of the Full Committee, no conflicts.

DR. GREEN: Larry Green, member of the Committee, no conflicts, very happy to see all these people that are on the Population Subcommittee.

MS. MILAM: Sallie Milam, West Virginia's Chief Privacy Officer. I'm at the West Virginia Health Care Authority, Member of the Committee, and no conflicts.

DR. SUAREZ: Good morning everyone, I'm Walter Suarez, with Kaiser Permanente, I'm the Co-Chair of the Standards Subcommittee, a member of the Full Committee, looking for some more members on our Standards Sub-Committee, no conflicts.

DR. WARREN: I'm Judy Warren, I'm from the University of Kansas School of Nursing, Walter's Co-Chair on the Standards Committee, and yes, we're recruiting heavily today. And I smiled at Lorraine because she's a great staff person and we've been working very hard, as you will see, on the agenda, and no conflicts.

MS. GREENBERG: Good morning. I'm Marjorie Greenberg from the National Center for Health Statistics, CDC and Executive Secretary to the Committee.

DR. ALBRIGHT: Matthew Albright, I'm with the Office of E-Health Services and Standards at CMS.

MS. JACKSON: Debbie Jackson, National Center for Health Statistics, CDC, Committee Staff.

MS. JONES: Katherine Jones, CDC, National Center for Health Statistics and Staff to the Committee.

MR. QUINN: Matt Quinn, National Institute of Standards and Technology, Staff to the Committee.

MS. GILBERTSON: Lynne Gilbertson, National Council for Prescription Drug Programs.

DR. CARR: Welcome everyone. With that, I'd like to turn it over to Jim Scanlon for an update from the Department.

DR. SCANLON: Thank you, Justine. Good morning everyone. It's a pleasure to see a full complement of members; it's been quite a while since we had all 18 members and we have you for a good duration as well.

So let me give you an update of activities at the Department. You will get other updates from ONC and Standards and so on, but let me give you an update on policy activities, some of our data strategy and data planning activities, many of which I think we've talked a little bit about before. In the areas of policy, I think I talked a little bit at our last meeting about the HHS Strategic Plan. And this is, I think you have a one-page summary in front of you in terms of five goals, and a number of objectives under the goals, and of course, there are a number of action steps under each of those. So basically, these goals reflect some of the overall across departmental activities at HHS, and where HHS invests time and priorities.

We're in the process of updating the strategic plan, and we may modify the goals a tiny bit and update it in terms of things that have happened, and when that occurs, I think I'll bring in our strategic planning folks to give you an update. It just helps you, I think, if you see where, at least the way we publicly express strategic goals, planning and so on.

Now in addition to the overall strategic plan, we have a number of high priority initiatives that are secretarial or other initiatives. Let me just tell you a little bit of what they are. And I think you're familiar with these, but we can certainly brief you more on these. One of these is tobacco control. There's a big effort now to reduce cigarette smoking and so on, and initiation to cigarette smoking, as a major risk factor for a lot of chronic conditions, so we have a number of activities there. On the HIV prevention and services front, we have a number of initiatives as well. We published, about four months ago, an HHS action plan to reduce disparities in health and health care, that's up on our web site. In addition, we're now in the process of implementing many of the action steps there. You'll see from the plan that we have a set of metrics, so that we'll know – these are really metrics that we would try to improve if the plan is working.

And then we've published, about four months ago, the National Quality Strategy and the National Prevention Strategy. Another initiative is in global health; there are a lot of initiatives here – and early childhood health and development.

As a general rule within HHS, we try to see that any major initiative that's started includes some data experts to sort of plan ways that we could measure progress, and to get some indicators, so that we could, instead of just announcing the initiative and then moving along, we could actually see to what extent we're actually achieving some of these measures.

Of course, the other big one we've had in connection with the White House is Healthy Weight, and this is basically initiatives through life style, through education, other means, to reduce obesity and to help people achieve and maintain a healthy weight throughout their life cycle.

Now obviously, health reform is a major priority across HHS, and you have seen a number of regulations and other activities. Many of you are actually applying for various designations in association with the health reform legislation. But I wanted to mention a couple of the data initiatives there as well.

One of the sections of the Affordable Care Act requires the Secretary to adopt data collection standards for sex, race, ethnicity, language and disability. This is self-identified. So we have been busy within HHS working on this. We have a work group under our HHS data council, and we published a draft set of data collection standards in July; I think most of you saw those. They were published for about sixty days. We received over 400 comments from the public on those data collection standards. In general, they seemed to hold up pretty well. They were meant to be minimum data standards. We have to stress this idea. The idea here is not to collect everything that anyone ever wanted about disability or race, ethnicity or so on. This is the idea of a minimum data collection standard.

Once the Secretary adopts these items, they would have to be part of any of our at least HHS-sponsored population health surveys. So again, the strategy here is again not to – for example, we basically proposed one question, that's basically becoming a federal standard now for disability. Six parts to it. Obviously everyone wants more than that, but if you can at least put these basic screeners into most of our population health surveys, you at least have a start. You have a way of linking specialized surveys back to the major survey.

So we are now – we're basically almost finished going through the comments, and we'll propose what those final standards would look like. Our hope is that the Secretary will adopt them and publish them in the next few months, and then the agencies would – again, these are population health surveys, health interview survey, MEPS. The current beneficiary, things like that. They would have to include these standards either at the next revision or certainly any new survey would have to include them as well.

In addition, we were asked to look at the next stage; well, what other variables would folks like to standardize, and the overwhelming recommendation was to look at SES, or socioeconomic status. So we will be looking at measures there. I don't know – there are a lot of dimensions, as you know, to SES measurement. I don't think anyone's looking for one index, so we'll look at how various folks are approaching the measurement of SES, and then we'll – again, we're looking at measures that have actually worked in practice previously, and again, we're looking at a minimum standard, so we'll be looking at this as well.

Associated with that initiative, and with health reform generally, we are looking at ten domains that it is believed health reform or health systems change would have an impact on, and I'll read those ten areas to you. But in each of those areas, we have agreed on a set of about half a dozen or so measures that we will be monitoring and before long, we'll make this available publicly.

So in other words, let me tell you what the areas are. Access to care, cost and affordability, obviously insurance coverage, quality, vulnerable populations, workforce; again this is primary care, and other public health workforce – innovation; in other words, to what extent would the provisions of the Affordable Care Act have a positive or negative effect on innovation, population health, which would be the traditional public health measures, to what extent will we see population health improve or not improve as a result of various measures. Preventive services activities, and finally health information technology.

So for each of these domains, we are identifying five to ten measures, so that we can monitor to see how – sort of like a dashboard, to see how the effort is going. And then there are a number of other activities in terms of implementing both the implementation and the impact of health reform.

A couple other things. The leadership at HHS asked us to take a look at really, in a very short time, take a look at our portfolio data collection systems, both the survey, research, public health and administrative side, and to look at ways that we could improve them in terms of faster turnaround data, quicker data collection, more facile and nimble analytic capacity, sharing the data, making it available, this is in connection with our open government initiative as well.

And particularly to look at are the research, development and technologies for data collection that we could employ, and I'll talk about that in a minute, and we've actually come up with a number of ideas, and some of them we were actually able to get seed money to start moving on.

The other major area was to see how can we assure that the surveys, the public health data, the administrative data and the electronic health record data are, as they progress and move forward, can be done in a way that they are aligned and converge so that we can – other folks have used various terms to describe this – but it's the idea that when we plan any one of these, we are looking at the relationship to the other, and we are thinking of – so that we would be in a place where we would have already thought through what kind of data we would want, how would electronic health records help public health or research, how would administrative data, including all of the new data systems under health reform, including the exchanges and all of the other – the data that would have to be supported to run the system, how could that be done in a way where it's more than just transactional, and that it actually supports a broader vision for data that could be made available, analyzed and shared?

So we sort of look at that as the alignment, or the convergence, side of all this, it's a little longer term, but again, our thinking was this is not going to happen automatically, and in fact, an electronic health record may be analogous, for data purposes, to a paper record, unless you actually know the structure of the data, you know what kind of reports you want, you know how it would be used and how it would be made available.

So we have a number of projects that we're starting. Now we're – in terms of budget, we're sort of finishing the 11 fiscal year; we're a little uncertain about what 2012 will bring, obviously, or 2013. So far, knock on wood, we have been able to protect the data investments, particularly the core surveys and data systems, but you never know. All of these plans rely on obviously having the foundation there. But we have had some very interesting ideas.

For example, we'll be looking at application of web panels, web-based data collection to our surveys, for example. As a stand-alone or as an augmentation to the survey, we're looking at - virtually all of our statistical programs now, are working on early release programs from the health interview survey, I think you already know this. We have quarterly releases now with a six-month lag. We have vital statistics. I think we're looking at how we can make that available.

On the administrative side, CMS has been looking at very innovative ways to make even the administrative data available more frequently. In essence, instead of waiting for the last state to report, there are ways to sort of make available what we have, as long as you understand the limitations of that data.

So we're trying to push all of this forward. And this was really a 90-day kind of an effort. We had some funds this past year so that we could get some of these started; the web panel. At AHRQ they'll be looking at quick response telephone survey and other means for the MEPS. We're looking at, on the dissemination side, how are our research data centers going? Are there – as you know those are, besides our public use files, and publications, the research data centers are the place where research and others can go when you want more or less research confidential data that wouldn't be released publicly, so you work with the research data center and try to work something out. There are very positive developments there that are still, I think, again, folks don't like to work on site, and we still don't have the remote access entirely worked out, but we're looking at how we might do things there.

So at any rate, we have a number of activities that we're working on. The other thing is we're looking at – we're always looking at special populations that we have trouble getting – these are hard-to-reach populations, or populations that are relatively small numbers, so it's difficult to get at them in an actual survey. Even with oversampling, you just – the survey is just not the right – you reach a stage where the survey is not the best way.

So we have proposed a strategy for race and ethnicity data. It gets you ultimately to targeted community research studies for some groups. And we've been asked to look at, in terms of vulnerable populations, we've asked them to look at people with disabilities, particularly, and the LGBT community as well. And we've had a couple – we have a project underway with NCHS to move along towards collecting data here, and we've had a couple of listening sessions as well.

The other thing is, we're looking at what data do we already link, and how do you get access to it, and are there opportunities for linking, again, surveys and research with administrative data, ultimately with EHR data, and we actually have a couple of pilot projects, where we will be looking at to what extent can reports from EHRs, more or less as they exist now, well-established EHR systems, to what extent can they provide – in this case it's provider data – for our surveys?

So again, we're trying to get to the stage where we actually pilot some ideas beyond just the concept of the framework. The other thing is, we've established a working group not only on the disability – well, on the ACA data, but we also set up a work group, we were asked to do this by a couple of agencies, to pull together the Census Bureau, HHS agencies, OMB and others to look at and sort of plan collectively the data we need for health reform, so we've added a number of questions to the health interview survey and other surveys, so we'll be able to monitor a bit better, and we're talking to the Census about items they might add, or analyses they might do as well. And we're also looking, as a second step, at the administrative data that will be resulting from health reform as well. So let me stop there, and take your questions.

DR. TANG: First of all, Jim, it's an incredibly exciting report and I'm wondering a few things. One is, is there a central – the kinds of initiatives you read off, is there a central place to go look for this stuff, and I almost wonder, is it a little bit analogous to the NQF quality data model, where they're trying to create a central place to store our data definitions related to quality measures; is there a repository for data that you want to standardize, so that we can use it throughout the entire supply chain. And as an example, let's say the REL – Race, Ethnicity – meaningful use is going toward IOM granular data – is that already something that you're thinking about?

MR. SCANLON: Different stages, Paul, for different items. For the data collection standards, I think we'll – with any luck we'll have those standards adopted by the Secretary within a couple of months, so that will get them onto our surveys, and then that data will be part of all of our surveys. We hadn't really – the way we were looking at disseminating the data, and I think you raise a good question, are there other ways to do this, and a better way? We don't have one data archive or center at HHS. We sort of – you have to go to ARCQ or NCHS or NIH, for that specific data. What we have done is to pull the data together in terms of inventories, and it will take you as far on the web through a gateway as the data allow, but if you really want individual data, then you're sort of at the – you have to deal with the research data center.

But I'd actually be interested in the NCVHS ideas about this. Maybe we could have – is there a way, because what we emphasized was improving the data, getting it faster, standardizing the data, making it available in new ways, and as you know, we're working with Todd Park – the model there, basically, is whatever data we have that we can release, we would put it into our healthdata.gov website. So that's the notion of a place where you would go for all of our data.

We're still – we probably have over 300 data sets and tools there now, but there's still a lot more. And the surveys, this is tricky – it's difficult; claims data, for example, surveys and research, it's one thing to put statistical information up, summarize data, but when we're looking at individual – even if they're anonymized, we just run into privacy issues. There are folks who say they could reverse engineer and find individuals, so what we've had to do for claims data, for example, we've had to remove a lot of the dates and other material from the claims, so we had to kind of strip them down to make them available publicly.

But again, I think we, if the Committee would be willing to give us some thought, we'd really appreciate that. But we don't have one archive.

DR. TANG: Could I just clarify? I'm referring to one archive for the data itself, but really the data definitions; and the reason is, if we talk about – you talked about minimum standards; sometimes minimum, it gets you a little bit, but if everybody's still collecting something, if they're choosing, we can't compare them. So the race/ethnicity is one of them, if we only collect the original let's say six, then we won't have the rest. The other example is HRT Standards Committee, we used to say, either SNOMED or ICD-10, and that didn't help because – too many standards. They're moving towards one, SNOMED, in case of problems.

So that's the kind of thing, actually, it'll be more prescriptive, and may turn out to be helpful in terms of the kinds of things that HHS is trying to do, but trying to combine the data.

MR. SCANLON: And I think on the race/ethnicity standards, what we proposed for comment, we really increased almost five-fold in detail. Because we've heard, over the years, a number of folks - as you all know, won't get into too much detail, there's five categories that are the OMB standard, and the people have been trying to collect those for years. But the idea was that they can mask important differences among the subgroups. So what we did was look at how have surveys approached this, and what could we do? So we really added both on the race/group sides and on the ethnicity side, we added quite a bit, and we provide for a lot more detail. So that, in HHS, will become the minimum now.

But I think you're right, Paul, we will – I think the idea was get the minimum standard there, get it in all the measured surveys, and ultimately get it into EHRs and administrative data. I think the thinking, interestingly, was for EHRs, you have a lot more flexibility, because there, it's not just a statistical issue for analysis or epidemiology, but there, it's a health care issue, so you would need to know specific languages, and you would need to know what, maybe specific ethnicities. So we'll be working with ONC on a more detailed set.

Much of this comes from the IOM report you reference, Paul, it's basically equality, is the role of race, ethnicity and other standardizing items to improve quality.

So this is the first step. I think the next step will be maybe to, instead of a minimum, maybe a core of demographic data.

DR. CARR: Marjorie wanted to comment on that. We have quite a few questions, and we also have our ONC colleagues joining us, so let me let Marjorie go, and I think we'll go around the room.

MS. GREENBERG: Just in relationship to Paul's question, I think in the past, but of course we have a number of new members, but Mike Fitzmaurice has reported about the US knowledge basis, Health Information Knowledge Base, which is based on, actually, a standard that is used in Australia, and it's an ISO standard as well, but I wondered – we have put all of the data elements for various – all the HIPAA transactions, a lot of different things, in there, and I'm thinking that that could be a repository for these standards as well. Because this, of course, is also something that the vocabulary of the task group or work group of the Standards Committee has looked at as sort of one-stop shopping, so I think all of those are possibilities.

DR. CHANDERRAJ: (starts off-mic) - collection of data – these data sources, especially for race and ethnicity, there are multiple races where this data has been gathered; what we are finding difficulty, it has become a meaningful use criteria, the front office is finding it difficult, and people are very sensitive because, considering discrimination, other things, they're difficult to give our their race and ethnicity, especially when they're scheduling their appointments. I was wondering if one source where they're being recruited into the insurance or the HHS, that data is enough, and we need ASF criteria as meaningful use, because we're finding it very difficult.

MR. SCANLON: No, this is a classic problem. You need the data to sort of measure potential disparities or discrimination, yet at the same time you don't want the very data to be used for selection or other things. So there are various ways in education and in health care, to do that, but what we will be doing, it would be self-identified, so the individual, and the focus here is on basically, population surveys where the individual is there, or the household, in a household or in some other setting, and they're asked, which of these – they can refuse, obviously, but you're absolutely right.

And our administrative data too, claims data and enrollment data. This has been a long-term issue. We have tried to incorporate the five basic race/ethnicity categories, in Medicare data, Medicaid, S-CHIP and even in HIPAA as well. It's hard to get it mandated, but it's one of these things – and we've talked to the health plans and so on, where it's still a sense of issue. But on the other hand, you don't – you can't tell if there are disparities without it. So it's just a difficult issue.

We have collected it, though, for quite a while now in our surveys, and our hospital discharge data, and it's – still a lot of missing items, but basically it's usable --.

DR. CARR: I'm going to continue around the room, and I know we have Jodi Daniel waiting. What I'd like to ask is if you have a question that is relevant to the work of the Committee, let's hear those now, and then at the break, Jim will still be here at 10:15, and if there are more questions to understand in a greater detail, we can do those off line. Blackford?

DR. MIDDLETON: Quick question I had, Jim, basically I agree with Paul wholeheartedly. I think part of the challenge is to move way upstream in data definitions, and to really bind them to standard terminologies wherever and whenever possible, and to make that as coherent a single specification as you can.

USHIK is a metadata repository containing a lot of measure types, but doesn't go so far as the NQF in actually binding them to specific standard terminologies, or recommended terminologies. So that really would be something the NCVHS could be helpful with. I think we could make some strong statements in that regard, et cetera. So look forward to talking about that further.

I think also, we may want to think about EMLS and other kind of standards development organization tie-ins, because if this happens in isolation, it will be at risk always of deviating from kind of the broader ONC and standards development organizations' efforts underway. My key question, though, and maybe for later determination, is, you describe a whole bunch of agencies across government, and we left out even the private sector. How do we actually achieve an effective governance model that says here's how we're going to address these decisions, make compromises around specifications and definitions? Is that something Consolidated Health Informatics, or what is it now that will actually do that? I'd love to hear more about that. And I'll stop there.

MR. SCANLON: Yes, the initial focus was federal, obviously, but – in fact, I think we would look towards industry standards as the starting place for most of these as well.

DR. MAYS: I want to say, I think your report was equally as exciting, as Paul said. I think the issue that I want to raise has to do with the role of NCVHS in some of this, and so I'm going to start with a couple of places that I'm hoping we might weigh in.

One is that, and this kind of gets to what Raj said, and that is, needing to have some advice about the collection of data on race and ethnicity, so I think while it's great that we say this is what needs to be done, I'm wondering if, at some point, we can try and address some best practices for the collection of the data, because that's where, in many places, it becomes quite difficult, and I think we can help solve that.

The other is, if we think about Healthy People 20/20 and the four new areas that have come up for Healthy People 20/20, we need to kind of look ahead and say do we have the data that we're going to need in order to be able to target? So that would take, I think the new areas are social determinants, LGBT, access of care and I know I'm missing one, I think it's blood infections or something like that.

So the question, again, for us, I think might be, particularly when we start thinking about social determinants, that will get into addressing two of the populations that you talk about, LGBT and SES, so again, I think the committee should find a role to be able to do that. Marjorie, I think you sent out an e-mail at one point; I want to know, for the Committee, when I had asked about doing the race and ethnicity commentary, and we didn't have enough time, you said that there might be the opportunity coming up for the Committee to weigh in on SES and LGBT, so it would be good if at some point we could discuss when to do that, so that we don't get – we have to rush or get caught behind the eight-ball.

MR. SCANLON: I think Vickie has a good point, though; maybe it's the Population Sub-Committee, but it would be most helpful, if you're ahead of us, and you have ideas to give us, that we could incorporate rather than – it's just hard for us to stop, because then it's public before it's meant to be public, and then we sort of short-circuit the process, but I think on SES you could – if the Committee wanted to have a workshop or a hearing, in terms of contemporary measures, not the – the old stuff I don't think anybody uses – and how you approach, I know that the National Academy of Sciences did some work in terms of SES.

I think on LGB, this is very tough, as you know, and transgender is very tough. What we have, and we could certainly – we have NCHS testing questions in the health interview survey, and they're trying a couple of different models, so there are more or less two or three pilot studies, each one getting larger and perhaps we could have – it's public, so they could certainly get the view of the Committee or the Sub-Committee, at least, on some of the best thinking there.

Transgender is very, very tough. We had a listening session; it's just very tough. But again, we're trying to see where are the opportunities.

DR. MAYS: My final one has to do with health statistics; that is one of our roles. Again, as we roll this out, the issue is, and I don't know if there's funding to stimulate this, but we actually need to develop better statistics for doing, like small population, weighting, estimates, so rather than us keep worrying about these populations being so hard to reach, we actually need to have some funding to stimulate the development of, I think, better approaches for analyzing that data. So I don't know if NIH can do this, or NSF, or if there's some way that we can also stimulate development of statistics.

MR. SCANLON: I neglected to mention – we've actually started – we're looking at the size of the sample data collection for special populations. Are there ways to make indirect, model-based estimates and so on, so we have a nice project – we're starting with a health interview survey to see to what extent we can make smaller – well that's more local area, state and local area, but we would definitely be interested there. And NIH actually does have – a couple of the Institutes do have grant programs that look at methods in these areas, measures and methods and so on.

DR. CARR: Okay, on the left hand side of the table raise your hand, and if you have a question, Bruce.

DR. COHEN: Again, great report, and one area that I think the Committee can focus on that I think is incredibly neglected both at the federal level and at other levels, has to do with training around data collection. The data are only as good as the training for those who collect it. Particularly for self-report data, both on interviews and in the private sector, and the encounters with providers and state and local government; there's a huge gap in resources from the Feds, from the private sector, and if we expect any of these data standards to be adopted and used and generate meaningful data, we need to focus on training the data collectors better.

There are some models in race and ethnicity, actually in Massachusetts we've developed on-line training to expand our collection of detailed ethnicity data, the encounter for collection of self-identified data is crucial if you want to generate good data. I think the Committee could focus on it, and I'd like to see the Department dedicate and allocate meaningful resources for developing training for, in a variety of settings.

DR. CARR: Anybody else on the right hand side of the table – Walter and then Judy?

DR. SUAREZ: Yes, Walter, as far as, again, very exciting and impressive, just amazing report, with many initiatives. I wanted to touch very briefly on the last aspect of what you mentioned, the assessment of data systems across the organization, and what I wanted to just mention is sort of the new element in the development of harmonized systems, and that is the health information model, developing an enterprise like health information model, that's just one of the new areas that large systems organizations, including our own Kaiser and others, either Mountain and other systems, are moving into, and I wanted just to mention that in the federal government, there's the Federal Health Interpretability and Standards Modeling Initiative under the Federal Health Architecture.

I think in order to achieve true interpretability of data systems and ensure that the data, whenever it's collected, in particular settings and a new data initiative started, they always have to go back and reference a central reference information model. And in addition to the federal effort on developing a health information model, I think to the point made by Blackford, there needs to be a larger interorganizational that involves federal, involves private sector and involves, actually, international work being done on the health information model, and so I just wanted to plant that seed, because I think the message of health information modeling is going to keep coming back to us and I think NCVHS could have an important role in that.

DR. WARREN: I guess I want to tag on with Paul and Blackford. I think when you first start talking about the common data elements for race, ethnicity and language and all of that, that needs to be done with looking at where it's used everywhere, and for me, that's the EHR. And I'm still amazed how many different peoples who are implementing their EHRs choose their own data elements, their own data values for those elements, and place them in different parts of their data model, and we're never going to get anywhere until that happens, and so I think one of the things we need to take on is how do we communicate to the public that there are solutions for this, if we're to go get that information, because I'm not sure that many people know about USHIK.

They're beginning to know about EMLS, because of the problem list, the nursing problem list, that had been developed and posted there, so that's coming out as models that have terminology bound into them, that fit in a certain slot in the EHR. And so I would like for us to do that, and while Blackford mentioned EMLS, I think we need to take a look at the Library of Medicine, and really look at the word "Library". It could be the place where we store the data definitions of all these elements and their terminology bindings, so that now people can go to the library and they can check out the whole package and go put it in their EHR. Don't make each little hospital have to become a terminology expert, HL7 expert and all of that.

MR. SCANLON: In fact, Judy, we designated, actually several years ago, at least within HHS, rather than have every agency decide it was going to run its own standards program, we designated the National Library of Medicine as the core, as the center for not developing standards, but at least maintaining and sort of the focal point for standards, and that would actually be a nice service area for everyone. And there's a network, by the way, as you know, of libraries as well, for a lot of hospitals.

DR. TANG: A very short follow-up to what you said, this whole EHR thing, I don't think we'll ever have a chance like we do now with the certification, because it's one thing to have a standard, it's another thing to make sure everyone uses, by definition, the certification.

DR. CARR: Perfect segue to Jodi - Jodi is on the line from ONC for an update. Are you there, Jodi?

MS. DANIEL: I am here, can you hear me? Is somebody from CMS going to be giving updates on meaningful use, or would it be helpful for me to do that?

DR. CARR: I was trying to be sensitive to your timing, but actually Lorraine was going to give the CMS update, so would you like to hear that first?

MS. DANIEL: No, that's fine, I just won't talk about it. I have the latest on the meaningful use program, but if she's going to do that, then I will just talk about ONC-specific stuff.

Great. Well thank you, I'm sorry I couldn't be there in person, and maybe the next meeting, I will make sure I can move some things around to be there in person.

I just wanted to give some updates on some of our work from our Policy Committee and Standards Committee on the impact on our rights and the timing for that. I was going to talk a little bit about our consumer empowerment program, our consumer eHealth program, which we just launched last week, and a couple of other things, so I'll just get started, because I've got a bunch of things to cover.

So our Policy and Standards Committee has been very active in spring and summer, working on providing recommendations to ONC and to CMS through ONC, meaningful use and standards and certification criteria for certifying EHR technology.

So we received, I know Paul Tang is there, he can give much more detail on this than I could ever, but we received recommendations from the Policy Committee on meaningful use for Stage 2, and so those have been received by the Department, and we are now working on looking at those recommendations and considering them as we work on our next stage of rule-making.

I think one of the most significant recommendations they made was for us to extend Stage One of meaningful use. Farzad Mostashari, our National Coordinator for Health IT, said that he understood the thinking behind that, and was supportive of the recommendation and concept. Of course we have to go through our rule-making process, and so we're considering that very seriously, but there are recommendation letters up on our website with all the details of the different measures and for meaningful use and priorities that the Committee thought HHS should be considering for Stage 2.

There is a meaningful use hearing looking toward stage 3 of meaningful use that will take place October 5^th and 6^th here in DC, and so it's actually a pretty significant hearing, two days, and lots of great folks coming to testify, and so the Committee is starting to already get a jump on Stage 3, even though we're in the process of just trying to think through Stage 2 here in the Department, that's great they're looking forward.

And we have a work group that is going to be looking at data quality and anti-fraud from the standpoint of are there things that ONC should be considering in our thinking as we're coming up with our program, like the certification program in standards, that can have a positive impact on preventing or reducing either erroneous billing or fraudulent activity? So that's just kind of a nutshell on the Policy Committee.

On the Standards Committee, we have a meeting next Wednesday, which I think is actually going to be one of the most exciting meetings of the year for the Standards Committee. They're going to be reporting out from a lot of different work groups, recommendations for standards and certification criteria for Stage 2 meaningful use. The way we have this staged is, we always have the Policy Committee kind of reporting out first and setting the stage for recommendations for meaningful use for the next stage, and then the Standards Committee takes it from there and tries to identify the standards and certification criteria to support those recommendations for Stage 2. So they've had a very active summer, as the summer camp activities, and they've been working diligently to come up with recommendations on standards and certification criteria for certified EHR technology.

So ONC is going to be looking very carefully at the recommendations that come out on next Wednesday, as we put together out standards and certification criteria, rule-making proposed rule, that would align with Stage 2 of meaningful use.

Also, we put out an advance notice of proposed rule-making this summer, on metadata standards. This was in response to the PCAST report that came out last December, I believe it was, that was suggesting some new thoughts and ways of looking at some of the work that ONC is doing with respect to nationwide health information network and health information exchange, and after a lot of input and thinking, and hearing from our policy committee and then work on specific recommendations regarding metadata standards from our Standards Committee. ONC put out an advance notice of proposed rule-making on metadata standards that went out for comment this summer. I think the comment period closes like any day now, I can't remember the exact date, but our expectation is that we would take any comments and input from that advance notice of proposed rule-making and roll it into our notice of proposed rule-making on standards more broadly.

So we wanted to get a little extra input on this, because it was sort of a new approach, and some new thinking, and our expectation, though, was that we would take any ideas that come out of this activity and roll it into our regular standards rule-making activity.

So leading into that, so timing on our regulations. We intend to have proposed rules for standards and certification criteria, as well as working with CMS on their proposed rules for meaningful use, by the end of the calendar year, end of December, early January. Basically, we're working on the same timing that we did for Stage 1, where the rules would come out at about the end of the calendar year, we would have a comment period, process comments and then have final rules out in the summertime. So that's the same timing we did the last go-round of this; we're trying to keep that same approach.

Our CMS colleagues and the ONC folks are working diligently on trying to get those regs put out and coordinated. We're also working on governance rule-making for a nationwide health information network. This has been something that's been a really challenging effort, I'd say, on our part. It's been – some really interesting new issues in thinking through how we would structure a governance mechanism for a nationwide health information network, and we are going to be putting out an advance notice of proposed rule-making again, to get a little bit of extra input before doing a proposed rule on this, and not sure exactly the timing, but we're trying to at least time it with the other rules, and hopefully even get it out sooner. So no promises here, but we'll see how things go.

We also just recently launched a new initiative that folks might be interested in, called Query Help. This is under our S&I framework, Standards and Interoperability Framework Activity. The goal of Query Health is to establish standards and approaches for distributed population queries of electronic health information. So the way that this is being run is kind of similar to the direct project, where we're getting both public and private sector input, a very open and transparent collaborative approach to trying to look at what it's going to take, and what kind of standards and issues we need to address in order to distribute population queries.

This is something that was one of the five goals in our strategic plan, is to focus on a learning healthcare system and use electronic health information as a way to support a learning health system, and so this is a significant activity to step in that direction. We just kicked this off, so folks who are interested in it, I don't have the URL off the top of my head, but I know if you just search for Query Health in an internet browser, you can find it pretty quickly.

Again, it is an open process; they are looking for folks to participate. They have Wikis and things for folks to comment on different ideas that are coming out of that program, so please look forward to engaging in that.

As I mentioned, our strategic plan, exciting that we just got it out. We had put out a draft strategic plan in March. This was based on significant input from our Health IT Policy Committee, significant input from other agencies in HHS and our federal partners it is a federal Health IT Strategic Plan, and there are five goals put forth in that plan. One is focused on adoption and meaningful use, including exchange of information. One focused on outcomes using health IT and health information exchange to focus on improved outcomes, improved efficiency, et cetera, one focused on trust – privacy, security and trust, a fourth was on consumer eHealth and consumer empowerment through health IT and the fifth the advancing(?)the health care system.

We just put out a final strategic plan on Monday, last Monday, a week and a half ago, which was pretty exciting. This was based on after we got comments, about 240 comments received, and what I think is really interesting is that in light of open and transparent government and multi-stakeholder input, we're trying to figure out, and we haven't gotten this figured out yet, but we're committed to making this an iterative and living document, so it's not the strategic plan that sits on the shelf, but it's the strategic plan that gets modified as things change, gets modified based on input from others, as we are working toward some of the strategies and tactics that are set forth in the strategic plan. I'm not exactly sure what this is going to look like yet, but we have the support of the folks in the White House to make this the first iterative and living strategic plan.

So we'd really love, once we get that up and running, I can let folks know about it, but we'd definitely love input and contributions from the brain trust that's sitting around the table at NCVHS.

Finally, I just wanted to mention, our other big event, our big event last week during Health IT Week, and I'm sure everybody knows that the President's proclamation of last week as being Health IT Week, which is sort of exciting for us over here. But we kicked off the week with the Consumer Empowerment Consumer eHealth Summit on Monday. We had a cast of significant players here, in the federal government that was participating, the Secretary of HHS, the Surgeon General, Don Berwick from CMS, Aneesh Chopra, and Todd Park, and we also had a significant presence from lots of other organizations that were pledging to engage consumers and empower consumers through health IT.

The focus of our consumer empowerment and consumer eHealth program is focusing on access, attitude and action. We are looking at, and I would say the primary focus of our launch last week was on access, making it easier for consumers to get access to their health information, in a timely fashion. While we know that patients have a right to access their information, we also know that many don't. We know that there are barriers to folks getting access to their information, we know that there are providers that are not inclined to make that readily available, and a lot of the great work and recommendations from our policy committee about patient and family engagement are trying to encourage our meaningful use program, more ready electronic access to information, and so we're building on that, with our event from a week ago Monday.

So the way we're looking at this, the way I look at this, is that we're trying to figure out how to align the public and private sector activities to promote a patient's access to information, not just their right of access, but their actual access to their information, and then making it actionable, and useful to consumers.

So the central piece of this that we announced last week was a pledge program. We now have a consumer empowerment pledge that folks are signing on to. We have a lot of different types of entities that participated in the event, that were our first set of pledgers, but the list is growing, and we have a pledge for data holders and for non-data holders. The data holders to sort of make it easier for patients to get access to their information using direct protocols, or Blue Button or other mechanisms, and for non-data holders to provide education and support for consumers to get access to their information. So that, there's a lot of great ideas that were raised from the initial pledgers, but there was also, I think, a lot of opportunity to really affect the attitudes, and to encourage people who want access to their information to get it; not just because they have a right to, it's because it's useful, because it's easy, because it's meaningful and because they can use it to improve their health.

We also, the Secretary announced proposed regulation to remove regulatory barriers to patient access, specifically a proposed rule under CLIA and HIPAA that would enable individuals to get access to their lab data, directly from laboratories. Right now that isn't a universal right that people have, and there are some places, some states, where it is prohibited, so there's a proposed rule on that that is open for comment now.

And then addressing, once people have had access to their information, how do we make sure that it's protected? As I'm sure folks in this room know, some PHRs are covered by HIPAA, some PHRs are not covered by HIPAA protection. There are some folks who are concerned that the HIPAA protections aren't really designed with the PHR in mind, where it's a consumer-controlled repository of information. And so one of the other things we announced is a PHR model privacy notice, that we've been working on for some time, with the expectation that we were looking at the things that people cared most about with respect to data sharing practices and security measures, and how to communicate it in a way that was understandable to individuals.

So it doesn't replace peoples' privacy practices and privacy notices, it's sort of a layer on top of it that looks exactly the same no matter what PHR you go to, so it enables better understanding of private history practices and comparability across different practices. The goal here is transparency and promoting patient choice, based on information, not setting rules on what PHR vendors can do with the information, and what was really exciting was that the three PHR vendors that were at our event on Monday, Microsoft HealthVault, Dossia and NoMoreClipBoard all pledged to use it, and I think at least one or many of them will have it up on their website this week.

The other exciting thing is that FTC, the Federal Trade Commission, said that the model notice was enforceable if somebody basically did something that was inconsistent with what they stated in their notice, that it's something that FTC can and would be able to enforce, so if an entity said they are not providing information or sharing information for marketing purposes and in fact they do share information for marketing purposes, the Federal Trade Commission has the ability to enforce that misrepresentation.

So it provides some transparency, some accountability and enforcement, as well as empowering patients and consumers to make informed choices based on privacy and security practices.

And then we also announced a challenge grant related to access to information. So this is sort of a new launch. We're really excited about this program, and I'm sure there will be more to come on that.

DR. CARR: Thank you, Jodi. I think Joy is not going to be joining us today. I wonder if you might just say a word, if you could, about the data segmentation initiative?

MS. DANIEL: I don't have a lot of details on it because I have not been involved in the day-to-day. I know they just sent out a notice that this is getting kicked off, with an opportunity for folks to participate; I'm trying to see if I can put my hands on that quickly. If not, I can send it to you, Marjorie; you could share it with – I'd really defer to Joy on that, because I haven't been involved in the development of it.

DR. CARR: Any questions for Jodi? That was great Jodi, appreciate it very much, and we look forward to having you join us in November, if that works out for your calendar.

MS. DOO: I will actually work backwards from where Jodi was talking, because she left off with something about consumer engagement, and we are part of that whole process of freeing the data. What Medicare has been working now, for probably a year and half, is this thing called the Blue Button. Now other than Paul, how many of you have heard about the Blue Button? Excellent!

So MyMedicare.gov has been working on this blue button; most of you are not eligible, but if you were, you'd be able to go on and actually get your stuff, and we have not promoted it at all; we've not done any outreach, we've not done campaigning, it's not been in the My Medicare handbook, but aside from that, we've had over 300,000 downloads. People have actually come to the site, found it and gotten their stuff.

And we have just launched now, where you can actually get your diagnosis and procedure information. We're going to be expanding it from 12 months to 36 months' worth of data, and we're going to be adding the Part D Pharmacy data. So it's really going to continue to become much more robust, and we actually had a meeting with the Deputy Administrator yesterday, and she has agreed that we can begin to really do more outreach, and to begin to promote it.

So tying in with consumer engagement, with giving people access to their information, particularly for Medicare, for the FOIA requests that we get, should really become a very, very rich tool. So we're very excited about that, so it was nice that Jodi ended on that and we could say that there is a definite commitment to it from CMS and I think it's going to get better and better, and we'll keep you updated on our statistics.

And on meaningful use, as she said, we are working very vigilantly with them on that regulation. I actually have some data for you on the Medicare incentive payments, both Medicare and Medicaid, and I can actually get these to you so you can look at them, but Medicare incentive payments go out for actual meaningful use, as you've heard before, and Medicaid is for the adoption, implementation or upgrading, so there's a slight nuance in what those payments are actually based on, and of course there are 23 states that are now participating for the Medicaid incentive payments, so that number is continuing to go up.

So just to give you an idea – first of all, on terms of active registration, so these are people who have filed to apply to be considered for the meaningful use incentives, for Medicare year-to-date there have been 71 thousand eligible professionals that have registered, and on Medicaid it's been 17 thousand. So a fair number of people, eligible professionals, have registered, and 1900 hospitals. And again, these are registrations. So then in terms of payments and people who have gone through and actually been qualified, if you will, to receive them, so year-to-date under Medicare for the eligible professionals is about 2100 eligible professionals and 37 million dollars. Hospitals has been four, but to the tune of 5 million dollars. But the Medicare and Medicaid hospital payments has actually been about 220 million. So there are funds going out; that's on the Medicare/Medicaid side.

On Medicaid incentive payments, year-to-date for eligible professionals is about 4400, 93 million dollars, and for hospitals there were 15, for about 32 million. And again, I'll send this to you, but it gives you an idea of the number that are actively trying to participate, while they are on the Medicaid side or the Medicare side, and there are numbers that are increasing that are actually receiving these incentive payments.

There is an appeals program that is being implemented so that as individuals, say, well I applied and something didn't happen, or something happened to my data and it didn't actually meet the requirements, that there is an appeals process that people will be able to go through and either be judged to be able to receive it or explained why they're not able to.

So the program is moving forward, and I think continues to evolve and grow. So each month, we should be able to bring you more and more data on that.

On the other little side of the world that we work on, under the Affordable Care Act, our small piece is under administrative simplification, which the Standards Sub-Committee, obviously, has been very engaged on. The first regulation went out in July, which is the adoption of operating rules for eligibility and claims status. We received 48 comments, so nothing near Jim's four hundred, and we are working through those; there's a number that are substantive, none that are surprises – we expected those, so we've been prepared, and we'll determine whether we need to put out a final rule that changes any of the regulatory language, or if it's simply what we had goes into effect. So we'll be able to let you know that in the next couple of weeks.

And then we are – Matthew left the room for some reason, but we are working on the next regulation, to adopt a standard for electronic funds transfer, and that should go out by the end of the year. We feel pretty good about it. And then, of course, what we'll be talking about, I think tomorrow, are the operating rules for electronic funds transfer and electronic remittance advice. So a proposal has come forward, the Standards Sub-Committee has that, we've evaluated that proposal, have some feedback and we'll move forward from there.

One thing just to remind everyone; for the electronic funds transfer, in 2008, Medicare made a policy that all providers who accept payments from Medicare would be required to take their payments by electronic funds transfer, and any newly-enrolling Medicare provider must, when they newly enroll, must agree to that. So Medicare has actually been ahead of the game. The percent of hospitals taking electronic funds transfer is like 98 percent; the number of professional providers is probably around 60 percent, and so that's the number, from a Medicare perspective, we really have a big opportunity, and I'm sure those numbers are pretty consistent across industry, so the statute reiterates that requirement for Medicare, specifically.

So we have already begun to do some communication reminding providers, from a Medicare perspective, they must do it, and hopefully the regulation that we publish will help educate about the value add that this can provide, and the efficiencies and the cost savings.

The other regulation that people are probably waiting for is the adoption of a health plan identifier. That will come out by the end of the year. It's, as you can imagine, extraordinarily complex. We have spent a long time really dissecting and working through what the implications would be. Bottom line, it's how it's used in a transaction, but we do not want to mess up what the providers do or what the plans do without really understanding what those implications are from system and business process changes. But that is underway, and then the other one that will come out this year is on compliance certification, so here we are, adopting new standards and operating rules; we have to be able to verify that industry is compliant.

We only are required to require certification from health plans. So we have some thoughts in mind for how we can also engage the providers in that process, but that proposed rule will come out this year as well. So our office, anyway, has been busy.

And I don't know if there's other items that you'd want to know about from CMS, either I can respond or bring them back for the next time. And one last thing – Rob Tagalicod is the new Director of the Office of E-Health Standards and Services; he was planning to be here today but unfortunately he is ill; he will try and get here tomorrow, but he is very, very excited about joining the group and he will talk to you a bit about the strategy now on – you'll hear lots of acronyms using HIE, which are the Health Insurance Exchanges, and then there's Health Information Exchanges, the way Jodi talks about it, and Health Information Exchange, the way we talk about it, and he's got some responsibility for some HIE stuff that's going to be happening at CMS, related to information exchange and consolidations. He'll be able to share an overarching strategy that's coming forward from CMS on that.

DR. GREEN: Lorraine, thank you. I was really struck that 1900 hospitals had applied to be certified and 4 had been approved – can you tell me why those numbers are so different?

MS. DOO: It is possible that they're still validating the data, so it may be that they've submitted what the claims information is. I don't know the day-to-day operation of how that's happening, but I would be happy to find out exactly why there's such a huge delta and send that back. It could be the reporting period is not finished, it's just not mentioned.

DR. TANG: I think it's the number registered versus the number who are testing, right? So these people have registered; they have not applied. So it's not a denial.

DR. FRANCIS: I have a question about the button and how it works from a privacy perspective. What do you do with respect to identity proofing and authentication? So for example, do you require in-person identity proofing, do you do anything about authentication other than knowing a password once you've, say, set up a personal health record? My concern is that if somebody knows somebody's Medicare number, or Social Security Number and date of birth, they can just pop right in and blue button down.

MS. DOO: If anyone knows anything about CMS and Medicare, our security requirements are pretty intensive. And I can only speak for the blue button that exists on Medicare. The VA, to get your pharmacy data, you must do in-person authentication at a local VA office, to get your basic claims information and access that, EHR is not in person, but the VA is doing in-person authentication for pharmacy.

For MyMedicare.gov, in order to get on, you're right; I could get on for my mom, you're 100 percent right, because I know her Medicare number, I know her date of birth and I would know what password she typically picks.

MS. DOO: So there are a number of required fields that you have to enter first in order to get into the system that are not necessarily known or knowable, so before you can even get a password to get into MyMedicare.gov, there are five test questions that you have to answer. Right now, the password is actually mailed to the address on file with Medicare, so you don't get a password immediately. I think they are implementing one where you again, if you have an e-mail on record, they will e-mail you a temporary password and then you go back in, so there are – it's not as easy. And I don't mean to take this lightly at all, but it is not as easy as simply knowing a Medicare number and somebody's date of birth and whether they're A or B. So there is a secure process for that.

DR. CARR: Thank you for the update, Lorraine. It's 10:25, why don't we reconvene at 10:40, okay, 15 minutes. Thank you.

DR. CARR: Next up is a briefing on population and privacy, community health data report, from the hearing workshops that were held in February and May of this year. So, Larry and Leslie and Sallie.

DR. GREEN: This is going to be a quartet; we are not planning on speaking at the very same time; we're going to speak in sequence. We're welcoming Susan Kanaan to the quartet, and she's going to be sitting down here at this end of our table and she will work us through this slide show.

Before we begin, I want to thank Marjorie for Susan. You talked about a difference maker; this was crucial, absolutely crucial.

So we want to anchor our presentation in the conversation we just had. You might just recall that Jim reported to us these five goals – transform care, advance knowledge and innovation, advance health safety and well-being of the people, increase efficiency, transparency and accountability of HHS programs and strengthen the national Health and Human Service infrastructure and workforce.

And we heard about the National Quality Strategy, the National Prevention Strategy, the Healthy Living Strategy, ONC's five-part strategic plan that's just out, and what galvanizes all of these things is they are all about people. And the way they are all about people is all about measurement, and measurement, as all of you know, depends entirely on proper data.

So what that means is that this presentation we're about to go through is actually right at the center of Health and Human Services goals, it is right in the center of the charge of NCVHS and it is a journey, if you will that continues several decades of work of this Committee. So it's sort of like a stop on the trip, is one way we can think about this.

And one other framing statement is, while we didn't know it when we began, we know it now, that this is a shared space for the entire NCVH committee. All of the sub-committees, the way we're structured, are pertinent and relevant here.

So let's go over the first slide here, Susan. These were our guiding questions for what really hit its active phase last February, and as many of you know, we've had a couple of workshops, and those workshops were really focused on those two questions right there. This reminds me of – what we've learned there about community needs and how the federal government can help reminds me of one of Carl White's famous adages – People have problems, universities have departments, governments have agencies.

And another thing we've learned goes back to a famous public health report in the 1960's. We have learned that health is a community affair, and that was actually the title, or the name, of the Folsom Report, published in 1966.

Let's go to the next slide, Susan. So place matters, is another thing that it's quite clear. This can be anchored in work that's over 20 years old. Bill Fogey(?) and Mike McGinnis started this in the early nineties at CDC and Dr. Mark Datus(?) continued to update and refine it. While it's not precise, it's accurate to say that what determines dying before you should have and suffering when you didn't have to? About 40 percent of the explanation lies in behaviors.

Highly personal and highly determined locally. About 30 percent of it is genetic so far, and for the foreseeable future, that's not exactly going to be one of the most changeable possibilities, but behavior can be altered. And then about 15 percent of it is SES stuff, socioeconomic circumstances, social determinants of health. Maybe ten percent of it or so is a 2.7 trillion dollar health care delivery system, and then classic environmental health and environmental determinants probably make up the rest.

And then around this last one, communities as learning systems, this is really --, and it's interesting, it was advertised in advance and followed up at this last meeting with Chuck Friedman, when he was here last time. Remember that interesting little equation he had about meaningful use plus delta equals a learning health system? Where we're headed here, and what we've been learning in these workshops, really fits in with that sort of notion. So we have this emerging vision, and we're just reporting it to the whole committee, like the way station in Washington, DC at the Embassy Row Hilton.

Getting usable data into the hands of communities with capacities to use them is really the vision we see trying to develop and figure out. Susan, I think you're going to go next.

MS. KANAAN: So the line at the top is really the key message here, and Larry's already mentioned it. This project has really deep roots in the Committee's entire history, and of course its population health mission, and I just listed some of the major linchpins in terms of significant vision statements and other reports that the Committee has done. I didn't mention standards and quality, but I could put standards and quality reports and projects up there as well.

This is a cross-cutting project, and you can't help but feel that all roads are converging, in some ways, in this project.

DR. FRANCIS: With all the kinds of increases in the functionality of health information technology, there are forms of data that weren't available in the way they used to be for communities to use, to link in new ways. One of the important opportunities here is the ability to link clinical data with data about what's going on in the community in all sorts of ways from where the grocery stores are to where the pollutants seem to be, and at the same time we've got federal investment in community health work too, so there are massive possibilities for both far more powerful and far more interesting uses of data in ways that can better health on the ground. There are some scary aspects of that too, which is why privacy and confidentiality are also involved, and to make sure, it needs to be done right, in ways that don't, for example, risk community mistrust or the equivalent of redlining. So power and responsibility.

MS. MILAM: So you've heard a bit about our vision; the two committees, Population Health and Privacy, what we wanted to learn about, some of the questions we had. And so now, some nuts and bolts about how we went about our work.

We had two workshops; one in February and then one in May. The workshop in February was broader, where we learned – we focused more on population health, but we heard more about a project at its highest level. Then in May, we took a deeper dive into some of the same projects, but mostly different projects, with more of a privacy, confidentiality and security focus. And so we heard from – they were all community level organizations. Some came from states, representing eleven different states in four different regions within the US, so we really had a nice cross-section of different types of projects. Part of the work in designing the agenda was to draw in communities with different backgrounds, to bring different issues to us, and it was truly an amazing experience to hear from these different communities. Next slide.

These are the report contents. As you can see at the top, you'll be getting a full report to review in November. This is really a preview today, to give you more information about what we did at the workshops, for those of you who weren't there and to get a preview of what the report is going to look like. So when you walk through these different – there are five parts. And really, the first part is about the learnings, the best practices that we heard from these communities.

Then there's a big section on what they need, and there was a lot of commonality in what they need, and where they currently seek help, where they get their resources. We have a section on what the opportunities are in today's environment, and some opportunities are within our grasp and some are beyond us. We have a section about gaps and ideas for future exploration, and then at the very end we have case sketches; you can read, in a paragraph – really, not even a paragraph or two, a single paragraph that talks about what we learned, in very succinct format, about each of the communities, and as I read through these sketches of the communities, it brought back to life what we heard about eight months ago, and I could visualize the presenters and a lot of the discussion, and as you read these sketches, I think it will do the same for you.

What's amazing to me is the work that Susan Kanaan did, not only in organizing the speakers for the first one and the work that Maya did in organizing the speakers for the second, but Susan's work in skimming across all of them to pull out commonalities and to pull out all of these different areas, that's a huge amount of synthesis from a lot of workshop data, and I think the report is well-organized in these sections.

DR. GREEN: Here is a ten-point outline about the messages. As you all know, our memories depend on language. But for humans to learn, they have to have stories. And the stories from these fourteen activated, empowered communities - somebody forgot to send them the memo that we were in a lot of trouble, we were out of money, et cetera, et cetera, you know; they don't seem to know that. They're just beavering away with what they've got under the circumstances that they're living under, and when you listen to the stories, Susan and the committees have distilled these key issues so far. These are sort of themes that keep popping up, that are not unique to a particular place but are cross-cutting. Mark Hornbrook was part of the folks that created the second edition of this new community engagement primer that NIH has supported; it came out through the CTSAs, was released a few weeks ago. It's amazing how congruent the distillation is from these workshops with what is a very elegant, extremely evidence-based review that tracks over decades about this.

So what this really did for us was contemporize it, assure us that it's alive and well, there's a local demand, people are interested in this, and we may beat this to death over the next few months, but underlying these ten things is a message; we are missing an infrastructure.

MS. KANAAN: So the rest of our presentation this morning, before we invite commentary and discussion, is just a quick overview of the contents and structure of the report. It has six big sections at this point. Of course we begin with an introduction, where we give the key concepts and the background and the purpose, and I think kind of a subtext that weaves through the entire report; certainly through the introduction, is the interdependence of three dimensions, and if I'd thought about it I would have made a slide about that. But I want to mention them to you.

Of course this is a data-focused, information-focused report because of the nature of the Committee, and with trust as a very big component of that, or condition of that. But really, in this report we want to talk about three dimensions that are interdependent – collaboration, which is people taking action together, data capacity and knowledge, and the third is trust, involving privacy and stewardship. So I think of those as kind of cross-cutting.

The nature and purpose of the report, as we've mentioned already, is to describe what we believe is a nationwide phenomenon and our vision for it, which Larry has mentioned. And also, particularly, to identify how the federal government can help communities use local data to improve local health, which they're already doing, but they need better data and better analytic capacities and other things that we identify.

And Larry's already talked to you about the other two main contents of the introduction, which you see there in your bullets.

DR. FRANCIS: So one of the hopes is always that if there's a lot of information out about what wonderful things are being done on a smaller scale, people can share and there can be a kind of burble up, which is what the Local Solutions National Scale header on this slide indicates. What the second section of the report is going to do is give an account of how communities have identified priorities, built partnerships, worked together, how they've evolved a variety of citizen and community groups, how new partnerships have been forged with the recognition of how data can be enormously important and used in creative ways, so we will be giving illustrations of how data have been used, not just for are we getting the right number of folks with this particular treatment, did they all get antibiotics before they get surgery or something like that, but with respect to the question of a much broader definition of health and improving the health of the community, linking multiple sources of data, how communities are doing this, how population health data and clinical data, how communities are generating their own data, how communities are displaying data – data doesn't do you any good if it's in a closet somewhere and you don't know what's happening.

How communities are using data to inform action, and several of the more interesting ones are actually town-gown partnerships, and so several of our examples will be town-gown partnerships to improve local health.

So we're looking at what models there might be to make sure not only that communities trust, but that their trust is warranted, and there are lots of questions here. There's the – some do hold the idea that data ought never to be used without individual informed consent, at least if it's identifiable data. And then there are concerns even about what sorts of data are identifiable, so we're seeing those kinds of issues show up in the advance notice of proposed rulemaking with respect to research.

What we want to do in this section is look at what are some of the models to build warranted trust that make it possible to really use data in ways that help people while respecting people, and so some of them that we're looking at include education efforts, efforts that involve community members and priority setting, data use decisions, community-engaged research. How do folks who are working with health data work with organizations and agencies that are the sources of their data, so that there's ongoing – it's really an iterative process of trust building, about the sharing of data, purpose specification, use limitation and so on; what sorts of governance models, fostering ownership and control, are there.

What does transparency mean? What forms of transparency are there? I've never thought that publishing a notice in the Federal Register was exactly likely to – it's not something I read on the breakfast table, you know – requires somebody else to go find it, typically, although there are often people who call to my attention what has shown up in the Federal Register; that's one model of transparency, but there are many, many others, and so we're looking at that as well.

And the way we're doing this is, we've got fabulous examples of different strategies that communities have tried, and what's worked, and also we've got some examples of communities that have been very resilient; they've tried one thing and it didn't go as well, and so they've tried something else.

MS. MILAM: So the next section of the report, Section Three, speaks to the needs and the gaps that we've heard, and we heard them both in the data, in terms of the data, as well as in terms of the privacy trust and some governance issues.

A lot of the discussion that we had earlier this morning with Jim's report and Vickie's comments particularly, as well as comments of others, are very similar to what we heard from a lot of the community participants and community actors, and I'm thinking it might behoove us to review Jim's report and Vickie's comments, particularly, against some of the workshop testimony.

As you can see, there's a lot of discussion around community indicators and issues with analysis of data, but I'm wondering if we ought to go back and look at the data collection issue and see if we heard about some of that from the communities as well.

A lot of what Jim reported on in terms of HHS's focus really goes to a lot of the issues that we heard. And there's probably a lot of synergy that we have the opportunity to explore, if we assure really tight alignment, I think, between this part of the report and HHS areas of new focus.

Let's go to the next slide. So as Larry said, what we heard, really, in an overriding sort of way, is that we're missing an infrastructure in all of these different areas. Communities are doing well with what they have. Some of them have the internal expertise, a lot of them find the expertise at local universities or from government or from others. A lot of them are going about it in some of the similar ways, through some non-profits that are supporting them; for example, with the health indicators, and there are some really leading examples of how communities have used health indicators, but they're not going about it in the same ways, and so perhaps there's some opportunities to standardize some of these indicators, to standardize some of the data collection.

Some of the recommendations we heard from NAHDO came around standardization of collection of data elements, even down to name, and that's getting difficult. You lose an opportunity for data linkage, as well as others, when everybody is collecting data in different ways.

So you can see this list of all of the various examples of where we need to build better, or better support, infrastructure.

DR. GREEN: The fourth section of the report is organized – they're addressing a federal role here. The verbs that have surfaced so far are seed and harness. These communities that we heard from have no shortage of ideas, and they're absolutely expert in themselves. And that implies what is not a needed federal rule. But the seeding and harnessing of capacity is really a key, key message that we're hearing?

The next slide, there's a longer continuing list of possibilities. I'm just going to call out the third and fourth bullet for your attention. I think, without exception, these communities find that they are stuck doing projects that have a beginning and an end, and that the project has to build relationships, they have to establish trust, they have to find each other, they have to find the right players, and then just about the time they're ready to do something, and they get started, the funding runs out and it stalls, and the support for the organizational framework stalls. So longer funding periods, sustaining funding, and organization that crosses projects and questions is a pretty important issue.

And that fourth bullet about technical(?) assistance; communities seem to lack analytic capacity. Right across the board. And it's a very difficult thing to – this is where the NIH translational research effort with community engagement is plowing fields all across the country right now in 60 different locations. Those are very important messages, and in the fourth section of the report, we're going to try to crystallize those.

MS. KANAAN: The fifth section could be a 200-page report in itself, and I have to say, I think we're still figuring out what to do with that content, because this environment, as I'm sure you all know, is absolutely exploding; there's more history, we're discovering more history as we go along, and Larry mentioned the Folsom Report, some earlier NCVHS work, et cetera; but every day, it seems, or at least once a week, I learn about a new initiative or study or whatever that's going on. I just learned from a colleague at CDC about a new, I think interagency, project on community health needs assessment that the CDC was asked to do by the IRS, having to do with community benefits, so the list goes on, and I think we still need to figure out what it's important for this report to talk about – some of it involves an annotated bibliography, but we don't want the tail to wag the dog in this report, but we definitely need to at least acknowledge some of the main drivers.

Larry mentioned translational, the work on translational research, community engagement, work on community engagement, et cetera. The list goes on.

It's a very exciting environment, and there are many drivers and opportunities. That's kind of the big message there.

DR. FRANCIS: Did you want me to comment specifically on privacy, security and trust questions?

MS. KANAAN: It looks to me like my assignment was number five and your assignment was number six. So you could comment all of them.

DR. FRANCIS: It is really hard to find models about engagement that – well, that looks like genuine trust. There's excitement – oh, look at the cool new things we can do – but we have found some, but there are gaps – one of the knowledge gaps here is whether there are other strategies. The most promising one is the community engaged research one, that we've heard a lot about. That's absolutely clear. But we worry about things like community subgroups, where, and this goes to the health disparities question, where there may be something that has been longstanding alienation in the community. We're working to identify models where health departments have developed longstanding relationships with various community organizations, and so on. Another gap has to do with community resources and limitations on the data that are available and how to try to deal with that, and then we're identifying questions about community health assessment and how to even understand that.

I must confess, I have some law students who are looking at the question of what models people have been using to try to get communities involved in data use questions, and it's a hard slog. It's like a literature vacuum. When you do an environmental scan and you don't find the environment; the hearing in May was not easy to put together, for similar reasons, and so we may end up making up some of it ourselves – or at least suggesting; actually, what I think we'll end up doing is suggesting what may need to be done.

MS. KANAAN: I would just add to what Leslie said that I think the final section 6, in some ways, is what we would be writing about, researching about and talking about if we had two years and a huge budget, and were preparing a many-hundred page report, kind of like, I guess, the future research subject. Some of the questions that we'll identify require deliberation that could happen right here within the Committee. Some of them are research questions, finding out more about what's happening communities. We've barely scratched the surface, although we think we've identified some leading-edge communities, but what else is happening out there is one of the big questions. And who knows how far we can go in learning more at this point.

In terms of the attachments, you can see the list, who I'll call to your attention are the special tailored recommendations from NAHDO that Denise Love brought to the May workshop, that folks thought might be helpful to attach to the report, and then our very own determinants of health model, which was in the 2002 report on the Vision for 21^st Health Statistics, which continues to be a very useful model, and you can see the other attachments there.

DR. CARR: Let me just start by saying what a fantastic job you've done. Having been at the hearings and being awestruck by all of the information, I think you've done an excellent job at categorizing the themes and beginning to make them actionable, which leads me to my next question.

We're putting together a report, but are there – are you also envisioning a letter, and/or actions, steps, coming out of this report, next steps?

MS. MILAM: Those are really good questions, that we will address this afternoon, and we'll get back to you, Justine, if that's okay.

DR. GREEN: But our framing is that this report is a framing document, from which the full Committee can decide about if there's a space and a place where we should move toward a letter or move toward a specific theme. So we think we're being sort of systematic about this – we're trying to distill it, trying to introduce the Committee, a full Committee, to all of it, and then trust the Committee's process to help us know if a letter or a further step is needed, and if so, guide that.

DR. FRANCIS: Certainly with a report, there's a letter of transmittal of a report, but I would really welcome thoughts people have around the Committee with respect to the question of where you see particular areas for ongoing, more specific, committee recommendations and letters. As I was sitting here earlier today, for example, and listening to what Jim was saying about minority health and some of those initiatives, health disparities questions, I think one of the things we are turning up is that the relevance of some of this to addressing the disparities question and how better use of data might – and quite fine-grained small community data might be helpful in that regard, so that might be a place for a quite immediate next springboard.

DR. GREEN: Christine, I'd like to jump in – Leslie's understanding that I don't mean to be presumptuous here, but Leslie could use a co-chair.

DR. CARR: I just want to say one other thing – I did send around to all the co-chairs, or solo chairs, as the case may be, a document, or a figure, that we had put together last spring about the Learning Health system and all of the considerations related to that, and I'll try to get something together at noon that we can distribute that will guide our discussions in the sub-committees, so that we're building on the work already done, and targeting a meaningful impact.

MS. KANAAN: I just wanted, on the subject of actionability, to call your attention to slides 14 and 15. We've already begun to develop a pretty good list of possible recommendations for federal actions.

DR. CARR: Okay, now questions. I started on the left side of the room before, I think I'm going to start on the right, going down.

DR. NICHOLS: Well first of all, fantastic overview of what's coming. And what really kind of hit me was the focus on community, on trust, on stewardship, but then what I didn't see anywhere, and maybe I just missed it, is what I would call, what's the proper role for local health system leaders? How can the federal government help, how can the federal government, how can everybody engage local health system leaders? In my idiosyncratic sojourns around our nation, what I noticed is, people who run hospitals actually pay attention to the population around them, and it's a really good idea to get them engaged.

So I would encourage the Committee, if you haven't already done it, to think about how to go back and extract some of that from the rich material I'm looking forward to reading.

DR. COHEN: I'm very excited about this report, and the opportunity to work with you guys. I want to second what Len said; partnerships are a key to local success, and there are partnerships between community organizations, local government and health care providers. So to the extent that we can encourage systems that connect providers to local community groups, we have a much better chance of success.

Following up that thought is a concern I have in this Committee, and in the federal government and the private sector, we've really been focusing on creating clinical data exchange systems. I don't know any local community coalition that really uses individual level clinical data. My concern is, in our focus on doing all the things we do about clinical data exchange, which really has to do, I think, with government and providers, the need for population health data at the community level and at the aggregate level, gets overlooked, so I really want us to – and I don't think anybody has spent much time thinking about the relationship between aggregate clinical data and community health, so I think this is an opportunity for the Committee, as we move forward with focusing on strengthening our ability to exchange clinical information, how that plays into population health.

I could go on forever, but one other major point. Our focus is on data, and that's totally appropriate for what we do, but at the community level, data is only one minor piece of how decisions get made, and how policy develops. In my experience in working with community and community groups, it's the ability to, as the data experts, how can we make ourselves available and useful and engage and build that trust around data, and have data work for communities to help develop policy, rather than have data come in with the notion data is going to dictate what you do? I think it's a delicate balance, and this is a real opportunity to show how data can help communities in their process, in their political and policy development process. And again, that's part of the trust; I think that should be the frame and context for what we can do.

DR. GREEN: Those are fantastic. Your point about expanded view of clinical data exchange; we heard from Indiana, examples of where that's been achieved, and it's powerful. And we heard from a Denver community in five neighborhoods that's enriched with Latinos and African-Americans, and there is a serious local hypertension problem that is unaddressed. They're into the restaurants and getting sodium content of food down, they're – but you know what they really would like to have is they'd like to know blood pressures.

Well, the people living there only – there's only about 85 thousand blood pressures taken a year for the people living there, and they're totally inaccessible.

DR. FRANCIS: So one of the questions, just to follow up, we heard, particularly from NAHDO, some of the – and this would be, I think, maybe a gap next step, what to think about – what are some of the barriers to optimal linked involvement, because there are some. They range all the way from proprietary interests to concerns about legal barriers, and thinking – you're absolutely right about the importance, and so thinking about why our examples didn't always highlight that, is a really important next step.

DR. CARR: Thank you. Okay, I'm moving now to the left side of the room and starting with Ob.

MR. SOONTHORNSIMA: Very good reports and comment. I just have, listening and looking at the PowerPoint, it appears to me that there are other converging themes, or running themes. For example, I think you talked about it, Larry, but there's only one bullet point around sustainability, perhaps? A financial model of how these committees actually operate. And I imagine what you said, Susan, that you could do 200 pages of this. Obviously there's so many different models with different anchor stakeholders in those communities, who are really, they're funding this or sharing the cost. So those, beyond the data itself, it seems like those might be broader, bigger issues, because at the end of the day, without money you have no mission, so you can go so far as getting good data, getting good standards, getting good inputs, but how do we sustain to ensure that these committees – I wonder, in these 200 pages of reports, or these examples of what you've seen, are there any emerging themes or models that we could make this report more actionable, more useful, for other communities across the country, because every community is different, to your point.

The second point, and this is really not a suggestion, but another thought is that because we focus on data, not so much the government's models and so forth, so I wonder if there are some ways for us to look for examples of common data architecture that could cross these different communities. If there are any emerging data architecture, that could be done more efficiently and effectively across the country.

DR. HORNBROOK: Just three points, which I think the whole Committee may need to weigh on to help the Population Sub-Committee address some of the rewrites.

First, in terms of context, do we want to invoke the single payor systems in Europe, for example, due to the fact that they do have clinical data, they're using clinical data to make resource allocation decisions, they get better health than we get for less money. Or is that in some sense, waving the red flag this Committee doesn't want to wave in front of a population that is a very charged issue.

Clearly, I've seen in the UK where they take the area data on utilization and the areas that have the lowest amounts of use get the highest priority for incremental resources, which happens, in most cases, to be Wales.

MS. MILAN: Susan has, as an example, some indicators from London on how they're centralized. So it's most subtle, not as direct -

DR. GREEN: I think you can leave out the adjective there, Mark – report geographic facts.

DR. HORNBROOK: Then another issue is the state of our state health care departments. Our national statistics system is a federal/state/local consortium. The states, of course, have been under tremendous budget pressures, and they have been cutting, cutting and cutting, and of course just to be micro, at CHR I've hired epidemiologists from the State Health Department because they've lost their jobs. So I've watched Oregon just shrink the Health Department, watched them shed off very experienced epidemiologists, in injury prevention control, in cardiovascular disease, and so also, wouldn't we talk to Georgia Health Department about birth certificate statistics?

The programmer that deals with birth certificates is a part-time contract programmer, not a State employee. That's how much they have carved out of their vital statistics system. So, when we ask to put this data together, the states have been pulling out the resources, and it's very strong. We could say something about that, or we could say it's obvious.

And then finally, a third kind of editorial point, which is does the Committee want to engage in geographic communities only, or do you want to engage in virtual communities? Because what we're seeing in these examples is actually a combination of both geographic and virtual communities, because they're using the virtual community to send their data out; they're on the Web, and people anywhere in the world can see their examples and get ideas and emulate what they're doing, so in some states yes, there's is a tremendous potential here for social networking of various kinds that Web 2.0 supports for engaging voters, patients, family members, whatever, in health improvement.

DR. MAYS: Again this is one of these exciting times in terms of being on the Committee, so I kind of love this initiative. I want to start, and I have three points – I want to start with where Len and Bruce actually were, and that is this whole notion around the kind of state/local health departments, et cetera.

The belief is that the role of the federal government, quite often, in terms of data – it kind of rolls down, so at the federal level there are a lot of rules and initiatives, and the State Department then has to deal with those and the State Department passes it down. The focus of the report seems to be a lot about the community, but yet, what we actually have a greater strength of being able to do is to find the kind of best practices that can be put into state, city and local government, because that's where the difference is made, as far as I'm concerned about the data, because that's where, then, your funding goes. You could tell the community a lot of things but you don't actually have a way to fund the continuation of those things. So it becomes a report, it becomes a set of recommendations that while they can jump up and down, they're going to jump up and down and go back to the Department of Health or back to the state, and the state is not, in any way, suggested, mandated, to do it, then all this great energy and expertise, we've lost.

So I would suggest kind of tweaking the focus to come up with – what the community gave you were the issues and the problems, but what this Committee, which is a federal committee, can do is to tell its entities what is best to do. So if we could have recommendations that really focused on that, I think it would be great.

Second is, you don't want to not include NIH, because very honestly, some of what you heard are problems that already, I think, in the mix of being fixed. One great example is the CTSA, or CTSI, depending on where you are. UCLA alone got something like 21 million dollars. There are – Mark, are there what, how many of them are there now? Exactly.

So the thing that the community is telling you is a problem; actually there are some fixes that are on its way, so you want to make sure that you kind of lift up NIH to ask them to continue to do this, and to kind of push through with maybe accelerating it a bit. For example, Larry, when you said that the community is complaining about they don't have the analytic skill. Well let me tell you, if we want to keep our CTSI money, it's something that we're doing. So you want to encourage, I think, an entity like NIH, to build this into research grants, that we have to give the data; I mean everybody knows if your study is over 500 million you have to make your data public.

Well a good push would be, we usually make it public, but at the level of other researchers. Can we then be asked, and I hate to say this as a researcher, without getting more funds, is that is there also some place and some way to make those things also more accessible to the community?

DR. CARR: We have a couple of other speakers, we have an important thing and we've got to get everybody up to get fingerprinted – so be concise.

DR. MAYS: My third point has to do – I think for the importance of this, maybe we need more time, but -

DR. CARR: You'll have a chance this afternoon in that meeting, so to develop ideas is fine, but to give us some headlines to think about now would be helpful.

DR. MAYS: The other one is the building of trust. I honestly think that – that actually concerns me, I think, to make that a big part of this report. It's saying that the community is distrustful, but it's almost saying it as if there isn't a reason. Again, this is a federal committee, and I think if we talk about building protections, if we talk about procedures and policies and then some kind of accountability, that's more our job. Educating the community doesn't mean that there aren't problems. Educating the community doesn't change – I mean, we can't get into local politics, but I think at a national level, we can provide an advisory of how one should behave, and ways in which if people don't behave, that's there's like consumer protection orientation around data.

This is really terrific, and I'll just underscore all the other comments; that it's exciting to see the grass roots level efforts coming to really bear fruit. Medicine is very local, data is going to be local, but my suggestion – well first a question. One of the things I think we need to do is to frame how to establish criteria, or the principles by which we suggest we move the field forward; in this case, the Community Health Data Initiative and the Learning Health System.

A specific question would be, what determinants of premature mortality do we actually have data for, and what of those that we have data for can we actually do something about? So obviously, guiding data collection, guiding data exchange, based upon the best evidence, so we're doing things which are valuable and useful, from the get-go, is kind of the suggestion.

And then the idea of principles and criteria, which might guide both policy developers and then local implementation. I'm reminded, just very briefly, of what Bruce Blum said years ago, in 1984. Data, when analyzed, results in information. Information, when interpreted, results in knowledge. Knowledge, when acted upon, results in wisdom. So the key part of this that – I don't think you – could be addressed better, is how to build in the knowledge-sharing component for this Learning Health System. Lots of interesting work going on in this regard, we have a big project about sharing knowledge for clinical decision support. I suggest we have to build in from the get-go, kind of knowledge-sharing architecture and considerations that will allow us to actually capitalize upon the learning's at the local level, at the national level.

So the suggestion would be, on slide 16, two specific additional bullets; what are the questions about knowledge sharing that we have to address, so we can capitalize upon and achieve scale in the Learning Health Care System, and what are the questions about knowledge implementation, effective use and measurement, so we can feed back to the local level what is learned across the aggregate system at scale? So two specific things that I hope you'll consider and I'd be happy to help address.

DR. TANG: In my lumping style, one, I thought the couple workshops were truly inspirational, as you've described, and it just showed, I don't think we're short of community resources, people who want and can make a difference. I do think it happens locally, and the biggest thing I think, actually, is trust; that's what makes things happen.

So in terms of – part of what you asked was longer funding; I think the only place that is worse asked than the federal government is the state government, as we've heard. So I just don't think asking for – what I think, it's not that they need money, I think they need this infrastructure that Jim talked about this morning. So I'll go back to your vision, and the thing I was just going to add – so you said your emerging vision is getting usable data into the hands of the communities with the capacity to use them, and I'm just interpreting the width – that's a very small subset if you're saying communities with the capabilities. If we change that to and -- so what we need to get in their hands are standardized data and the tools to use them. I think what they are capable of doing, much more than the folks who already, in a highly-inspiring way, have done, is to just give people who have the yearning for the ability to improve their own communities, the ability to do that.

That's where I think NCVH can play a role, and it really feeds into what Jim was talking about, maybe 2.0 version, you're coming out with stuff and it seems very appropriate for NCVHS, as one of your advisory groups, to help provide that road map to the standardized data, because otherwise, the folks who are so passionate about this have to reinvent everything every time, and that's what I feel very sad about.

The one other thing to speak about the community, I don't know where this quote came from in the report, but it was a lovely definition of community that I just want to read because I think it gives us a bit of insight. It says in your report, "A community is an interdependent group of people who share a set of characteristics, joined over time by a sense that what happens to one member affects them all." And that goes beyond geography, and it talks to – someone else brought up the – this is it. It's interdependent people – that's what gives them passion.

That's what gives them the resourcefulness, and what we need to do, I think, as a national committee, is to get the data in a standardized format with the tools to use them. And they will. So I don't think it's the money, because the money isn't there, it's the things, the tools, the enablement, the empowerment, that I think will bring the most bang for the buck. And I think Blackford and I have agreed to certainly work on that data part in our quality of work subcommittee.

DR. CARR: Excellent, so this is the beginning of a discussion that will continue throughout the afternoon and really, we're welcoming all committee members to attend. I think this is just fantastic.

DR. SUAREZ: Okay, we're going to change gears a little bit. We're going to talk about the tenth HIPAA Report to Congress. Very quickly, first I wanted to just thank everybody that has been involved in developing this report; the top Committee members, the leadership of the Privacy and Security Subcommittee, and certainly, Lorraine and Matthew and our lead consultant that has helped to develop these, Margaret, who helped develop this report.

In your presentation, there's a few slides. This is the first reading for the full Committee of the report, and we're not going to read it, of course, we sent it to you beforehand; it's on your tab 3 of the packet. The idea was to introduce to you the concept, the content, the way we approach the report and then the process we're going to take between now and November to complete the report and present it back to you for your approval before sending it to Congress.

So slide number two, just some background. We are, under the Federal law, required to submit to Congress and make public a report regarding the administrative simplifications provisions of HIPAA. This was encoded into the Federal law itself, as part of our new task. Second of all, they talked about the elements that are needed to be addressed in the Committee report, the extent to which persons are required to comply with HIPAA administration publications are cooperating in implementing the standards. The extent to which entities are meeting the security standards, whether the Federal or state government are receiving information of sufficient quality to meet their responsibilities under the Act, any problems and the extent to which timetables are being met. So there was some general content of expectations.

So this year, we're taking this particular report as a special milestone, the tenth report. It's not the tenth year of reporting; of course, the tenth year was in 2006, when we met ten years of the HIPAA law. But this is our tenth report. We haven't been doing these reports annually. So we decided to take this opportunity, in this kind of a special milestone, to take a little bit of a more comprehensive view of what has happened with HIPAA over the last 15 or so years.

The report focuses first and foremost on HIPAA administration publications. We don't touch on all the other responsibilities, of course, of the Committee. We try to link as much as we can, elements of the other activity that we do, but our main task is to talk about administration simplification.

Second, we are organizing the report, as I'll mention in a minute, into the journeys that have been taken by the industry toward achieving administrative simplification, where we are today and what is coming, and then thirdly, we wanted to briefly highlight, in the report, some of the key roles that NCVHS has played as the lead advisory board to the Secretary on Administrative Publications, so those are some of the background elements. The process to develop a report, it has been a journey in itself. We started earlier this year. In January and February, the Standards Subcommittee developed a proposed approach and a high level outline that we presented to the full Committee in February, and with some comments and edits, received general approval to continue that outline and approach. The Subcommittee then developed a more detailed outline, a timeline and a task to be accomplished to achieve this completion of the report. We did that in March of this year.

We engaged a lead consultant, Margaret, to conduct all the background research and aggregation of the documentation, review the documentation and then help us develop a draft of the report. And then we started working through the report development itself. We started with the first section of the report and had a sub-committee review between March and June, basically, and then did a second section of development between May and July, and then the last section of the report between June and August, basically. So it was progressively adding content and review by the Sub-committee.

As I mentioned, the Privacy and Security Sub-committee co-chairs and Lisa were involved in reviewing the privacy and security-related content of the report, as well as any other aspects of the report.

Our first full review of the Committee is today and we expect a revised draft, based on Committee input, to be prepared and finalized, again, with the input from the Standards and the Privacy Subcommittees during the month of October, and then in early November, we will present the report to the executive sub-committee in our way to bring it back to the full Committee in November for approval. That's our sequence and schedule.

The outline of the report – I mentioned we wanted to take a broader look at HIPAA, and after 15 years, really, of working on this, look at the journey itself, and that's what we organized as a first section.

We will certainly have an executive summary that will summarize the main findings from the report and an introduction, and I'll mention a few things about those in a minute.

The first section, which is the journey, basically the background of what is HIPAA, administrative simplification, and what has been, the regulations that have been basically promulgated under this law, as well as another legislative initiative, more recent legislative initiative, like the Affordable Care Act, and the provisions in there that deal with administration simplification.

Section Two is where we are now, and what we tried to do was really look at the effect of the various components of HIPAA, the effect that the transactions the identified standards have had, the effect that the Privacy and Security components have had, and the effect of the semantic interpretability aspects of HIPAA, something that not a lot of people knew about back in the early days of HIPAA, and know that it came from, really, HIPAA have had in terms of where we are going with that, semantic interpretability.

And then this Section Three is the journey forward, so basically addressing some of the issues and gaps in each of these areas; in the standards, transactions and causes identified, the Privacy and Security, semantic interpretability, and overall, as kind of a perspective of integration and convergence of administrative clinical quality, all sorts of aspects of – I'll mention a few things in there as well in a minute,

And then the appendices, which we basically include the statutory reporting requirement from HIPAA, description of the transactions and, just some background about those elements.

So very briefly, the Executive Summary and introduction. In the report we include descriptions of the fact that despite enactment of HIPAA in 1996, and the adoption of the first set of rules in 2000, and the initial implementation of those standards in 2003, HIPAA goals remain as current as ever today, and particularly with the new national health IT initiative, there is now an increased interest in the overall concept of the convergence of all these standards and these reporting requirements, and submissions and administrative and business processes, much more integrated with the clinical and quality IT processes. So we kind of highlight that in the Executive Summary.

We provide a brief overview of the report content, the aspects that form the report, and then provide a summary, a very brief summary, of the major initiatives underway, including, of course, the transition into 5010, D.0, 3.0, ICD-10, the HITECH meaningful use and the Affordable Care Act health reform and other things.

And then we are going to be gathering a summary of findings, really, kind of a highlight, bulleted messages of what are the main findings and main themes out of the report itself. So that's the executive summary.

The section one, the journey – as we go along, if you want to stop at any point we can do that. At the end I'll talk about the next step, and certainly, what we want to do today is more listen to your perspectives in terms of the overall structure and reconfirming, basically, that the approach is the right one, and perhaps some ideas of enhancing some of the content, but the detail work you can do off-line and send us, and I'll mention at the end a few steps about that.

So, a journey, section one – we provide a brief, of course, overview and a description of what HIPAA administration simplification is, and categorize it into its core elements, the financial administration transactions and causes, the unique identifiers, privacy and security and the data standards for patient medical record information; that was something that was actually in HIPAA, which now we know as the semantic interpretability, that continues, significantly, under HITECH meaningful use and ONC activities.

And then we start with each of the main sections about the journey, how each of these components has been developed and identified some of the key issues and challenges in this early part of the report, so in the financial administrative transactions and causes, we summarize progress being made in issuing all the regulations in support of HIPAA, the regulations being developed under this new Affordable Care Act legislation, that relates to these transactions and causes of operating rules, standards and the new standard for EFT and claims attachments and other things. And then identify some issues and challenges with the initial implementation aspects of the standards. And then also highlight the role played by NCVHS in selecting and recommending the standard that was probably a critical aspect of what we were doing, which I'm continuing to certainly do with respect to transactions and causes, the standard.

So that's what we include in this first part of the report, we refer to administrative transactions and causes. In terms of the unique identifiers, we again summarized the identifiers being adopted through regulations so far – employer ID, national provider ID, the upcoming national plan ID, which I would think you know here that by the time we put this together, our regulations will be likely out; we heard it's probably going to be a little later than the time frame we have for the report.

And then we discuss some of the limitations in the definition of unique health identifier for individuals. We note the constraints that exist in defining a national unique health identifier for patients.

So that's basically the identifiers part. The Privacy and Security Act, that we describe the process and timeline for adoption and implementation of HIPAA privacy and security regulations, again summarizes some of the NCVHS collective set of recommendations, that were otherwise addressed related to privacy and security. For example, the collection of baseline data for analyzing the effect of privacy rule, the elements of personal health records that were made of recommendations from the Privacy and Security sub-committee harmonizing FERPA and HIPAA, data stewardship, all these aspects. So we highlight some of those as contributions, really, of NCVHS in the process.

And then we review regulatory steps recently taken by HHS to enhance and strength the privacy and security components of not just administrative simplification, but in general health information management. So the delegation of authority of the security rule to OCR from CMS, brief notification of regulations, then the regulation accounting of disclosure, those are recently released rules and actions taken.

And then the last part of the semantic interpretability and other health information technologies; we mentioned how originally HIPAA called for the recommendation for a uniform data standard for an electronic exchange of patient medical record information, PMRI, as we refer to it. NCVHS conducted extensive analysis back in 2003 through 2006 and developed a series of guiding principles for the adoption of these patient medical record information standards. And of course now, all of that has been rolled into the work that is being done by ONC and there's HITECH through the Standards and Policy Committee, the meaningful use program, those things, so really kind of serving, in that respect, as a kernel, as providing some groundwork for this work that is now being driven by ONC.

And then in 2006, NCVHS developed recommendations on the functionality of a nationwide health information network, another component that we highlighted, related to other health information technology aspects of what we do. So that's sort of a quick review of the journey. We include a table; it's the one that's displayed on the screen right now, of all the various letters concerning HIPAA-related matters that have been issued; a total of 73 letters, amazing – and other documents related to recommendations that had to do, somehow, with HIPAA.

All right. So Section Two is really a section that deals with where are we now, and the approach we took with respect to that was really try to assess, try to understand and provide some information about what has been the effect of all these regulations, ultimately. And so we organized it in the same kind of order, the effect that HIPAA transaction identifiers have had, so we mention that while progress has been made, significant progress has been made toward standardization of transactions and causes and business and administrative processes, there are still some concerns, of course. Not everyone is doing electronic transactions, in the first place. And it's important to know that HIPAA allowed providers to choose whether they were going to do or not electronic transactions. It was not a requirement for health care providers to do it.

Health plans were required, by virtue of being required to be able to accept, or submit, electronic transactions, or be helped on how to do them, and clearinghouses were also required to do them, but providers had the ability to say yes, we're going to do electronic transactions or not. So still today, not everyone is doing electronic transactions.

Not all electronic transactions are being used. So there's limited use of certain transactions. We know that claims and claims payment is sort of the bread and butter of administration simplification, but a lot of the other transactions, and there's a total of eight different transactions, and now growing to additional transactions, are not all being used. Eligibility has some limited use, it's being used by some large organizations, but it has some limited use in other smaller organizations, and there's very minimal use of other transactions, like the referral authorization transaction. So that's an important point that we wanted to mention there.

Providers are using other mechanisms allowed in the HIPAA regulations to conduct some of these transactions; something called Direct Data Entry, or DDE systems. So these are the on-line interactive tools that are being offered by payors to allow providers to conduct some of these transactions.

So if I want to enter a claim, I can actually go on a website and enter it, one by one, into the Web, or if I want to check eligibility, I can do it on line on a one-by-one basis. I can also actually upload, via some of these web tools, some of the batch files that have a whole host of inquiries, let's say, for eligibility, but for the most part, these direct data entry are used to interactively conduct some of these transactions.

So that takes us into not everybody using the HIPAA standard type of transaction. The current Version 4010 also was highly customizable, as we know now, through things like payor companion guides. We used to refer to HIPAA as it was good because it provided us with one standard, but there's four thousand different flavors of that standard. And indeed, there are thousands of these companion guides that go along with this 4010, so the good message was that at least we got to a one standard, and now what we needed to do was reduce the variability of the usage of that standard.

Clearinghouses significantly are used today to convert the nonstandard transaction that a provider or payor does to a standard format, and then back to a nonstandard, so if I don't really – my systems internally don't really do, or generate, an actual HIPAA transaction like an 837, a claim submission message, then I can send the file in some electronic format – it could be paper to some clearinghouses, and they will convert them into an 837 and then send it to the payor, or the payor clearinghouse, and the payor clearinghouse will convert that A37 back into the internal system that the payor uses. That is the role of the clearinghouses, and that is what they do. So that created, of course, the sense that that natively, organizations never needed to really have systems to do the electronic transactions, but they could certainly rely upon clearinghouses. So those are some of the kind of concepts that are somewhat different, actually, from what we see in the electronic health record world.

Also a lack of usable electronic remittance advice has shown to prevent providers from using electronic denial management tools and dramatically improved payment recovery, so that lack of the use of that electronic remittance advice has important implications for the limitation of administrative simplification and an improvement in business processes.

There continues to be very limited use of the complaint process, said to drive enforcement. That's a critical aspect that we really want to emphasize, because as much as there is a way to try to enforce this, the enforcement depends on entities complaining of the fact that other entities are not complying with these regulations, but it seems like nobody complains about anybody here. So very limited amount of information about compliance in that respect, and the ability to do enforcement.

And Medicare, as a payor, is using their authority to mandate, and many other payors are actually doing the same thing, are using their business, or position, to mandate the use of certain transactions electronically, so they mandate the electronic submission of claims, as you heard from Lorraine, they're mandated the electronic submission of fund transfers, or conduction of electronic fund transfers, so there are ways in which payors can take advantage of really, their position, to move forward with the adoption of these standards.

Readiness for Version 5010. We also mention in this section about transactions and causes of readiness for 5010. We summarized evidence of the state of readiness and talked about some of the things that are happening with 5010. Clearly, we kind of point to the fact that, as I mentioned, with 4010 we had such a great variability. 5010 is the next version, that is truly helping the industry come to a lot less variability in the use of the standard, a lot less number of companion guides, or details --.

That's basically a quick rundown of some of the things that we covered in that section. On the HIPAA Privacy and Security rule, on the Privacy rule, we note a few things. We mentioned, actually, how today HIPAA has been viewed largely as a privacy and security thing. Not a lot of people relate to HIPAA as all the other components of HIPAA, but they all remember and know HIPAA privacy and security along with it.

There is a perception that privacy and security regulations lack strong enforcement. Contrary to the perceptions, the number of privacy complaints filed suggests that HIPAA has actually raised collective consciousness concerning privacy, so some of the interesting statistics that we've been able to gather – OCI has received almost 60 thousand, 58 or 59 thousand, complaints, and issues around privacy, and have been able to resolve over 13 thousand through resolution agreements, and this is between 2003 and 2011.

Some of the other thousands of complaints, many of them were received, but they were resolved without even having to go to a resolution agreement, but they were complaints that were not necessarily truly something that were HIPAA privacy-related.

DR. CARR: Walter, I want to just make sure we have enough time for some discussion, because you've covered in depth, and I'm hoping that everybody has read this, so if there's any -

DR. SUAREZ: All right, I'll just highlight very briefly, then, a couple of other things. The Privacy and Security rule, we mentioned a number of things, highlighted some of the most common five complaint types on security.

DR. CARR: Actually, Walter, let's just, because our time is precious and we're under that time frame -

DR. SUAREZ: Let me just say a final word. The next section of the journey forward is really addressing some of the gaps. We organized that the same way, gaps around the transaction process identified, Privacy and Security, and the most important part, probably, is at the end, really, the fact that we see into the future, increased converging, as I mentioned, standards and interoperability world in quality transactions, and the administrative world, and that's sort of a critical paradigm shift that in the future we'll see.

We do not provide, in this report, recommendations. This is not a report to provide recommendations, it is a report to summarize where we are with things. So the process, the next step, we can take you there, so we're completing this first review now. Members can e-mail to us any detailed comments or work anything or changes.

DR. CARR: Okay. I really do want to get the comments and the feedback; I think everybody is accountable for reading everything that's in there. This is what I want to say. The work that has been done on this is extraordinary, probably doesn't exist anywhere else to have this, all this collation of stuff. I think what we need is an outside group to now take this and pull out an executive summary that punches out the storyline that the Congressional members can read and remember and understand, and my recommendation would be that we begin with what is the ideal state? When this was envisioned, we pictured something like you go, whatever, like your ATM and you go in and your money comes out and a million things happen in the background and it takes about five seconds.

We should say, this is our future state; this is the ideal state. This is where we are today. Here are the key players; providers, payors, clearinghouses, banks or whatever, and here's – the data that you have in there, here are the percent of people using it, here are the percent of people not. To put out there, here is the gap, here's where we want to be, we're more than ten years into it, and this is what lags behind, this is what is in the queue, that we think a year from now we're going to get this much better, and this is what remains.

I think we want Congress to take from this what they could do, how they could think about this. I know we don't want to make recommendations, but we can set the table for here's the gap between where we are today and where we need to be, and we can use some data that's in there of what is the value of the gap, especially in this time of financial distress. We're part way there, but we're not all the way there, and the price that we're paying is enormous.

DR. TANG: I thought it was also a very nice summary and gave a story about how far we've come.

One of the gaps that we haven't acted on was in HIPAA, and you know what I'm referring to. But times have changed a lot, we are interested in populations, we are interested in tracking over time, and we are interested in satisfying the needs of citizens. We have to know who they are. Even if we don't know who they are.

DR. CARR: We have the legislation cited in there specific that says that this work cannot be funded.

DR. TANG: But you might say, what is the newly understood invisible need, and how has the world, how has our society changed in acceptance and understanding, and that it can be voluntary? Because that wasn't part of HIPAA, it was mandatory. There are ways you could at least – because this is going to Congress, and this is a thing that causes errors, harm and interference with communities trying to help themselves. It just has to be said.

DR. WARREN: Maybe we break our mold and we do put a recommendation at the end, and this is it. It's an opportunity statement.

DR. TANG: We're not recommending to go back to where HIPAA has had us go, recognizing that we understand the benefits and have really attenuated the risk, even through actions of Congress, like HITECH. We've done so many more things, and society's changed, and Congress probably just hasn't been updated on those issues.

DR. NICHOLS: Paul – I'm sorry, I'm not sure I understand exactly what you're talking about. The unique health identifier? Just say that, that's what I was going to say, just say it, okay?

DR. NICHOLS: I get the third rail part, I just want to clarify we're thinking exactly the same way.

MS. KLOSS: A couple of points. I think the time is right to say something to Congress, Health IT Week, when HIMMS was up on the Hill last week, this was clearly one of their key messages, to reopen that discussion.

I agree with everything that Justine said. I think one of the ways to create a sense of urgency may be to look at the, to reflect on the lessons learned from this journey, because I think that isn't covered here. And there are so many lessons that seem to pop out relating to this kind of large system change, what worked and what didn't work. And I thought if we – we might position it that way because this is instructive for the kind of change we're embarking on in health reform.

So issues such as enforcement and optional, not having a thousand different guides. So I think unfinished business and lessons learned from a changed management, from a system changed management perspective, might kind of take it out of the sting of getting ourselves too deeply into specific recommendations.

And then one other, just kind of thing that popped out at me was the – going back to our discussion earlier this morning, the semantic interoperability, and how that agenda hasn't, over this tenure, gotten the same level of attention as the administrative simplification, and I thought that we could leave, punch this up by setting some specific goals. I think on administrative simplification, it's such an area where you could say, we need to see ten percent improvement, look at it like gasoline consumption, ten percent reduction by, some kind of goals that are really realistic for everybody to shoot for.

DR. GREEN: I am going to be piling on here. But it's line 55 in the Executive Summary, to reflect upon the entire journey. I really think this is our opportunity, and from my perspective, it's okay for the members of this committee to agree that we have some opinions about this. And that the basis of this reflection can be an NCVHS committee reflection. It doesn't have to have citations in it. If Paul wants to call that out, why can't we call that out?

So again, to pile on administrative simplification, tenth report. Boy, it's really a lot simpler to navigate health care information transfer in the United States now. We have gone so far. I'm being totally facetious – I mean, one of the reflections is that after all this time, all this work, a ton of work and a lot of expenditures, it's amazing how little we've actually gotten done. And the people are waiting.

DR. NICHOLS: I just want to make sure what we're doing here. Did I hear that we are not supposed to make recommendations?

DR. NICHOLS: Of this report? Now it is to me. So surely it's time to break the mold. I mean, I just feel like – piling on, I'm ready to pile on. There's no way you could be sensible about this proposition without using this opportunity now, especially now, and if not now, when, to make this point? I just think if we don't do that, we're embarrassing ourselves.

DR. SUAREZ: You have to be clear, you're talking about making a recommendation -

MR. NICHOLS: Then you figure out how to do a unique identifier, that's right, and you'll have one year.

DR. WARREN: Let me be clear. We are talking about rewriting the Executive Summary, which has always been one page, and which we've drafted, and we're talking about adding recommendations and some things like that, and so what I'm getting concerned about is it's already taken us a year and a half to write a letter that's supposed to go out annually; we're now talking about adding a significant amount of time that maybe a strategy would be let's have the report in the format that we've been told to submit it, but maybe in the letter that forwards it, we could add recommendations and stuff like that.

DR. CARR: What I am going to ask for, and think about it, we'll ask later today, is volunteers who will take this, who have been not involved in reading it, and who will then lift out of it the important messages. I think that the fundamentals are all there – it reads well, it's everything you'd ever want to know. But I think our opportunity is in the opening page or two; we could have a two-page, break with tradition, Executive Summary, that really lays out, this is what it was supposed to be, this is where we are today, this is our opportunity statement, in language and in conciseness that is a call to action to achieve these opportunities.

DR. WARREN: I'm hearing two things. One is, beefing up, or whatever, the Executive Summary in the way that you describe. But the other is the idea of putting recommendations, actually developing or agreeing on recommendations, in the report, and I was having the same thought that Judith was, that I think the report provides kind of the fodder for some recommendations, but that they might be included in a cover letter.

DR. CARR: That's fine. But I think that we set the table for when someone reads this, it's so obvious what needs to be done that how we state it is less important, about whether it's recommendation, but more the kind of story Executive Summary that's taken out. Blackford?

DR. MIDDLETON: I support the idea of a more activist recommendation, whether it's in the report or in the letter, about a national health care identifier. I think it's high time. And it's actually not that big a movement away, because we're really disinhibiting what HIPAA said originally 15 years ago. We're almost a generation into this. So that's number one.

Number two, I guess the idea, thinking along the activist lines, you mentioned the idea of a dashboard, Justine, the idea that we might actually more actively monitor what is the impact of our work through, for example, measuring the number of claims submitted one way or the other from the ASC X12 and 5010 or prior 4010 or other. I think that kind of information would be extremely valuable for this group to understand its own efficacy and impact. I'm not suggesting we do something really too fancy, just get maybe annual or some kind of level of periodicity that makes sense, drawn from other sources, and just then use it as a management template.

MS. DOO: Only to ask the Committee to also consider methods by which we might obtain that, because we have done surveys, industry has done surveys, WEDI has done surveys, AMA, AHA and we can't get people to report? So not saying it cannot be done, just it's been attempted many times, so to get some ideas from people about good ways to get quality data would be terrific.

DR. MIDDLETON: If we anointed someone, if this committee asked and anointed someone to do it, it would happen.

DR. HORNBROOK: Just a question – since this is a tenth report, does that mean that you always have to follow the same writing style? I mean, the question I'm asking is, would it be important for us to make this accessible to a lower level reading audience with less jargon and more plain language?

DR. CARR: We have a plan for that, right, HIPAA primer? We have a plan for that. But I agree with your observation, remembering that the members of Congress, so many of these acronyms are unfamiliar to them and what they do. I see you have a picture in the back and it's a start, but I really like this picture of how information flows, or whatever. On to Paul and then Ob.

DR. TANG: I think that was a really nice suggestion, because it's really an opportunity for a lot of things, and to reconcile the stuff in a painting forward way. I don't recall, as I read it, whether you mentioned EHR certification. I go back again to what's changed and what are the new levers they have, and that's so powerful for certification, because not only must the vendors, all the vendors in the country, do such and such in a standard form, we actually have to use it to get paid. It's an incredible opportunity that just really does evaporate with time. A lot of these things -

DR. WARREN: No, we did not mention it. Remember, this is a HIPAA report, so it doesn't have all those others, so that one of the concerns we had in pulling it together was how to scope report, or else we could start writing a Federal Register kind of report, that people would not read because it would be too lengthy, and we did look at companion legislation, because we wanted to get in some of the things from HITECH at ACA that were impacting on this.

So at this point, maybe we should just scope this out as a HIPAA report, but then follow up with some other work that starts linking it to everything else that's going on. Because I do think you're right, and we talked about whether or not to include -

DR. TANG: I guess the theme I'm hearing from everybody is, it's an opportunity, and if we take another year and a half it won't be an opportunity, actually, anymore. But I think it's not that we're reporting on HIPAA; HIPAA actually had a goal, it was actually insurance portability, that some other things got linked to it. That was, in a sense, an end. Now I think HIPAA, in today, in ACA and HITECH, it's an enabler. If we turn it into one. And we're the body that advises the Secretary on this, and how can we turn HIPAA into an enabler of everything from reform, the top agenda, to collecting and using data? It really is a convergence. Clearly administration wants to do that. I also hear it's a lot of work. But I think that's what the lumping comments -

DR. CARR: I want to hear from Ob and then I'm going to take volunteers for the committee that's going to make a draft Executive Summary.

MR. SOONTORNSIMA: Going back to Blackford's point in terms of looking at statistics in terms of adoption, I think that the statistics right here, I think we can call it out pretty quickly. For example, there's a page here that talks about 75 percent of the claims are submitted electronically? Reverse that, 25 percent is not submitted electronically. That's powerful enough already.

So I think we can definitely do that, so now journey forward, and it's going to be about not only the ID for the consumers, but also the adoption, more along the line of compliance, across industry, and that is the call to action, is for the industry to now fully embrace, because health plans and others have done, clearinghouses have done enough in terms of spending the money, and continue to do so, but we really have to realize the effect on -- efficiency, by forcing the adoption. So that could be called out.

DR. FITZMAURICE: I have two comments, one is on the unique health identifier characteristics, it starts at 837. It says that appropriation bill 699 has prohibited spending funds for development until specific legislation calls for such expenditure. I remember initially it was prohibited from spending funds for its final implementation, not the development. So I wonder if more recent language has changed that to expending funds for its development.

I think it may be a non-sequitur to say that without funding to explore the issues, NCVHS cannot advise; does that mean that we're linking funding for the development of a unique identifier with funding for NCVHS? I'm not sure I see the tie-in.

And then I'm not sure I see the tie-in on the last sentence that begins, "NCVHS observes that HHS has standards on metadata." We haven't explained how that ties in with identifying individuals. It does tie in with their expressing preferences.

MS. GREENBERG: Sorry to interrupt, but those who are going to NCHS now need to go.

DR CARR: Before we go, who are the volunteers for the committee? I have Linda and Leslie, Dr. Tang, did I see your hand go up? That's Mark, Ob, am I missing anyone?

Okay. It would be them giving feedback. We're losing much of our committee, yes?

DR. CARR: I am asking them to be editors and advisors on the Executive Summary, so I'm asking them to read what's been written and cull out from that what are –

DR. CARR: - the bullet points. Did you know, Congressman, did you know – boom, boom, boom. This is where we want to be, this is where we are, this is our opportunity. So it will be structured feedback to you, specifically with taking what's in here and making it – and highlighting it in the Executive Summary. That's the charge.

MS. GREENBERG: I don't think they should actually, as a committee or group, try to write it. Just pull out -

DR. CARR: No, just cull out what are the key bullet points for the people who read one, maybe two pages, what's going to grab their attention.

With that we will retire for lunch or travel and then resume at 1:30. Thank you everyone.

A F T E R N O O N S E S S I O N

DR. CARR: The question is, do we have a quorum? Is the action today or tomorrow?

DR. WARREN: The action could be today, but it doesn't have to be today, it could be tomorrow.

DR. SUAREZ: All right. So we're going to do three letters, and you have PowerPoints and you have the letters as well. We thought it would be most productive, instead of reading letter by letter and statement by statement in each letter, to just go very quickly through the information about what's included in the letter and then focus on the recommendations themselves. You know what we want, certainly if you have any wordsmithing to do on any of the letters, you can provide those to us, but we wanted to make sure that conceptually the recommendations were okay.

We're going to start with the acknowledgment letter, so there's – the tab number, acknowledgment is tab number six. And then there's probably a presentation about the acknowledgments.

DR. SUAREZ: The first slide is the background, very quickly, of acknowledgments, so if you can move this one slide. Electronic acknowledgments are really a critical component of the way we conduct business, and it is really an efficient and cost-effective way to execute all these administrative transactions. There is a number of benefits, of course, of acknowledgment; ensuring appropriate communication has been established, allowing the recipient of the information to confirm the receipt of the message, informing the submitter that the message has been received and informing the submitter that the message has either been rejected and why.

And in the interest of time, because we have three and we only have what is it, an hour? I'm going to just quickly jump into some of the core concepts. Slide number two just talks about a couple of things. Basically, in the health care industry, we are currently voluntarily using acknowledgments, and we've been doing it for some time, but it's not universally done. Standards are not consistently followed. The business requirements and operating rules are not the same across payors, and so that's the reason why we needed to move forward.

This electronic acknowledgment is not part of HIPAA in the original legislation that called for regulations on standards and a name and number of standards, and it was named and referenced in the Affordable Care Act, and that's where we picked up the requirement, really, of saying we need to recommend standards to the Secretary that provide for the timely acknowledgment, response and status of transactions on the claims processing side. So that's the background of where this requirement for us to write this letter came from.

Currently there are three – if we go to the next slide – there are three types of acknowledgments we use in connection with a health care transaction, and it gets a little technical. One is called a TA-1, which provides for a simple – it's like a certification that you receive in a mail packet, simply like that. It doesn't get inside the packet, it just says yes, I did receive it. The 999 implementation acknowledgment, which is one step more detailed than the TA-1, notifies the submitter of an electronic transaction that a transaction has been accepted, it has been rejected or it has been accepted with errors. So it gives the submitter of the transaction some more detail.

There's one specific acknowledgment that is used with a particular transaction, the health care claims transaction; it's called the 277 CA, the Health Care Claim Acknowledgment transaction, which when I send a claim, if I receive a 277 CA back, it confirms that the claim has been received, it has been accepted for processing or it has been rejected and it tells me a little bit about what the problem was with the transaction.

We held a hearing in April of 2011 to understand the current practices and the recommendations from the industry, and you can see there, just in the interest of time, again, briefly summarizing, there's consistent and very strong acceptance and support for adopting the transaction. There's support for ensuring that in the process of developing the rules, we find ways to accelerate that to make the standard move very quickly and be adopted and implemented very quickly. There was a need to ensure that the conditions for applicability and submission of acknowledgment transactions were well-defined, and there were some special conditions to consider, specifically; how to handle, whether there was a need for acknowledgment in real-time transactions versus the batch transactions, and some of the pharmacy transactions, how much there was a need for those.

So the recommendations to HHS; the first recommendation is to adopt the following three health care electronic transactions as standards, and define the corresponding conditions under which each of those must be used. So we define the ASC X12 TA-1 as the electronic acknowledgment transaction viewed by the receiver of a standard transaction to report, and read the actual definition that we're recommending, and then the condition of use. For the TA-1, it would be required only to be submitted back as an acknowledgment by a receiver of a transaction when the submitter of that transaction has elected to receive it, and this is important because in every single one of the X12 transactions, there is a little marker that says – sort of like when you go to the post office and say yes I want a receipt back – you don't do it; – well if you don't do it then the recipient of that is not going to send you back anything, but if you check yes, I want to receive a TA-1 back, then what we are saying in the rules is that if the submitter says yes, I want one, then the receiver of that transaction must send back a TA-1 and must use the X12 stamp. That's what this means.

The second acknowledgment is the 999, Implementation Acknowledgment, so we define it as the electronic acknowledgment used to report X12 syntactical errors, and then the condition of use is required as a response to all adopted administrative transactions. So it will be required all the time, a 999.

Then the 277-CA, we're recommending the definition to be the electronic transaction used to acknowledge the receipt of a health care claim, and communicate the result of the preprocessing application level validation errors, and then the condition of use is required in response to each submitted claim.

So that's the first, and most critical, recommendation, basically, is that the Secretary adopt these standards and the definitions and conditions of use.

The second recommendation is about adopting the X12 standards and corresponding implementation guides that are current at the time of adoption for each of these transactions. So that's same -- the standard should be the X12 standard.

And then the other recommendations are in the last slide, Adopt the Standard Implementation Specifications using any available expedited proposed rulemaking procedure. For example, shortening the comment period time, so instead of giving 60 days comments, use a 30 day comment period. The reason is, the industry, at least we heard in the hearing, they want to see this happen quickly, and the Secretary does not have interim final rule authority to expedite rules for acknowledgment.

An interim final rule authority was granted to the Secretary under the Affordable Care Act for all these other transactions like health plan ID or the EFT or the operating rules or these others, but acknowledgment wasn't a specific one, so the secretary will probably have to use a regular proposal-making process. What this is saying is the Secretary should consider ways to accelerate that regular proposal-making process.

Encourage the industry to use a transaction, in the meantime, as we wait until the compliance date. Adopt the CAQH core operating rules related to the use of acknowledgment for eligibility and claims status, which were excluded in the interim final rule published July 8^th. What does this mean? Basically, that when the operating rules in the interim final rule were adopted for eligibility and claims status, that interim final rule had a little statement that said except for the operating rules that relate to acknowledgment, because at that point the regulations and the standard had not yet been adopted. So what we're saying is that in these regulations, the Secretary adopt those operating rules related to acknowledgment. So lists of comments and suggestions about additional operating rules that will best support the use of available acknowledgment standards, so this is the concept that operating rules need to be applicable to all the other transactions with respect to acknowledgment. Consider excluding real-time transactions from the requirement of an acknowledgment standard. So when I do real-time transactions like a real-time eligibility or a real-time pharmacy claim, in a real-time exchange there's no even time, there's no reason, there's no need for an acknowledgment of me doing some real-time activity, so the recommendation is to exclude real-time transactions.

And then seek input regarding the need for acknowledgment related to non-real time pharmacy transactions. There was some debate during the hearing about health plans would like to receive an acknowledgment back from the pharmacy when the health plans send a payment to the pharmacy; they want to see a pharmacy acknowledgment back to the health plan. So those were the recommendations and I'm going to stop here and see if there are questions and comments.

DR. CARR: Walter, thank you, that was very, very helpful, and Judy, helpful to help us to frame, to understand what it is that we're talking about. My one question is, were there any, is there anything in here that promoted controversy?

DR. SUAREZ: The only controversy was how quickly can we set this up. I mean, really, honestly, I think this hearing was very consistent in terms of its support for the adoption of acknowledgments. This was recommended to the NCVHS by the members of the Designated Standards Maintenance Organization group, back in February of last year, and we just never really, with all the other responsibilities, we never acted upon it, so this is something that is overdue.

MS. WEIKER: Hi, this is Margaret Weiker, I'm with HP. I'm also Chair of the ASC X12 and Insurance Subcommittee, and I noticed on some of the recommendations there were a few errors. You recommended that the 999, the ASC X12 999, be used for all adopted administrative transactions. The X12 acknowledgment is not used in the pharmacy world. It is not used for the NCPDP transactions, so in that recommendation, I think it should be changed to acknowledge all ASC X12N adopted administrative transactions, because pharmacy does not use that.

DR. SUAREZ: That is actually what the letter says.

MS. WEIKER: That's what the letter says?

DR. SUAREZ: I apologize, but the slide didn't reflect exactly what the letter said, but the letter says, I read: "This type of acknowledgment is applicable to all ASC X12 transactions."

MS. WEIKER: Okay, that's good. Also, you are recommending they're not used in real time at all, and I know you had something in there about excluding pharmacy. But there are circumstances in which, in a real time environment, you could potentially send back a 999 transaction. For example, if I receive a real-time 270, an eligibility enquiry, and it is in such bad shape that I cannot generate a 271, which would be the normal response, back to it because it's missing mandatory data elements that are not supported in a 271 to report back, there are circumstances where you would send back an X12 999, reporting those type of errors, which basically says there's so much wrong with this I cannot even generate a 271. So there are circumstances in which you would want to send back, so to allow for that.

DR. SUAREZ: It's a good point, and the recommendations, as considered, excluding real-time transactions from the requirement to use the acknowledgment standard, so maybe something around the fact that should not apply to every real-time transaction; let the trading partner decide which ones, and then if they choose to do an electronic acknowledgment on a real-time, that they must use the adopted –

MS. WEIKER: The ones that are made. But if it's a normal transaction, you would get a 271, and you would never receive a TA-1 or a 999. But in the instance of a major type of error, you would send back those acknowledgments.

DR. CARR: Very helpful, thank you. Any other comments? Hearing none, Walter? It's you again.

DR. SUAREZ: Okay. So we will make those changes and bring them back tomorrow for approval.

The second one is, I'm going to go to the letter on the ICD-10 and 5010. So that's tab number five. Actually this executive summary really is an executive summary, it really summarizes the entire presentation. So we, as NCVHS, we periodically, almost annually, not every year but almost annually, or some time around that, review the state of the industry's progress towards compliance with the implementation of HIPAA in general, particularly the transactions and code sets.

We held a hearing in June of this year and heard extensively from providers, the entities subject to this, and we created a letter that describes a series of observations and recommendations. Here are the summarized observations; I'm not going to read them here, I'm just going to highlight in the next few slides some of the areas and then talk about the recommendations in each of them so that we can expedite that.

We divided the letter into five sections. One is a cross-cutting section, where observations or recommendations apply to everything related to 5010 and ICD-10. So here, several things. The overall industry is concerned about the ability to comply with the deadlines, but there was consensus that the deadlines should be maintained. The biggest concerns were the ability by small providers outside the large clinic-hospital systems, like long-term care, some dental, the state Medicaid agencies was another major area of concern. The majority of testifiers support strong reinforcement of the current data, so the recommendation is to have HHS use all communication vehicles to recreate and emphasize the compliance dates for both 5010 and D.0 and 3.0, and for ICD-10.

There were concerns about multiple concurrent priorities; you know, having to deal with all this meaningful use and HIE and health reform along with having to apply with 5010 and ICD-10, were some of the big concerns around that. Education, communication and outreach was another major area. It seems like there is never enough when it comes to education and outreach. In this last part of the year, before January 1, 2012, which is the deadline for starting to comply with 5010, there needs to be sort of a special final push in terms of industry outreach and education. So the recommendations were basically, HHS should create and deploy clear, more direct outreach activities to promote testing, and we'll talk about testing in a minute, leverage outreach technologies and tools used to promote meaningful use to expand the awareness around HIPAA 5010, particularly the first one. Consider creating a National HIPAA Awareness Month. We had a HIPAA Awareness Day; we even talk about HIPAA Awareness Weeks; every week or every other week or some sort of – we even talked about a little button that says Have You Been Tested For HIPAA? – CDC might have something to say.

And dedicate more resources and establish a more formal process to receive, and this is an important aspect, really, having a more formal process to receive and respond to industry inquiries, questions, requests for guidance and FAQ, so that's something we recommended.

The next slide talks about testing; clearly over the next few remaining months of the year, testing is really the order of the day. It has proven to be critical to identify and address implementation issues, as they were reported during the hearings; some entities saying well, we tested and we found we have to do this, we have to modify this. Very few organizations have established a formal testing platform, and this is going to be particularly critical for ICD-10. So many organizations test on the fly, or test on environments that are not truly a formal testing platform, and that's an important concept to promote more.

So the recommendation is HHS should immediately make wide-scale announcements to encourage and foster testing; CMS should make test scenarios and files available to trading partners for them to look and evaluate some of the testing that they do. CMS and industries should also share results of their own testing, the issues they have found and how they were addressed. HHS should consider comprehensive multi-parties(?) for the HIPAA campaign process that we talked about. Those were some of the recommendations around testing.

State Medicaid program readiness; certainly that was one important topic that came time and again. There were lots of concerns about the readiness of state Medicaid agencies to use 5010 coming up, let alone ICD-10. At least four states were identified as not going to be ready by January 1^st to do 5010, and there's bigger concerns about ICD-10. We heard reports that 41 states are at medium to high risk of not being able to meet the deadline for ICD-10.

So we had a couple of recommendations of HHS to establish a deadline for submission of state Medicaid contingency plans to CMS, and HHS to fund CMS to provide additional technical services and assistance to state Medicaid agencies. I think that's going to be really necessary to help push Medicaid agencies into compliance in the coming months.

The next slide talks about recommendations specific to 5010, D.0 and 3.0. So with respect to 5010, concerns about software vendors not ready, or not providing sufficient communication and direction, and some concerns about the limited use of certain transactions like the referral authorization transaction, were some of the highlights – and the recommendation to CMS to release data findings from the June 15 testing event, I think that has been done already. HHS to encourage industry to take advantage of certification programs to validate the transaction - this is something that I think Paul mentioned as one of the areas, and then mentioned in the report, the HIPAA report; it's really this concept that certification could be a vehicle to enhance the ability to comply with this transaction; I mean, certainly it's working in the meaningful use program.

HHS to encourage standards organizations to identify, define, accumulate and address transaction issues as they are being found from testing and implementation. This is really a critical aspect, to identify and address any of these transactions issues as testing happens.

And then with respect to D.0 and 3.0, we heard concerns expressed about the limited, or lack of, testing partners for pharmacy transactions, and the dependency on successful completion of D.0 to be able to functionally execute 3.0 as well. And 3.0, for those that might not be familiar, is a Medicaid subrogation transaction that is connected to pharmacy claims.

Recommendations: HHS to work with the pharmacy industry to do more aggressive outreach and testing, and to increase the amount of education and outreach content in CMS' website, specific to D.0 and 3.0. We tend to always say 5010 and ICD-10, and we forget the other two transactions, D.0 and 3.0, and those are very important, and a lot more messages have to be put out; I know the pharmacy industry is very, very well organized in terms of outreach and education but we did hear some concerns about pharmacy testing and outreach.

Next slide is ICD-10 observations and recommendations. So one area was crosswalks and general equivalency maps, and granted we're 2, 2 and a half years away from compliance – we're only 2 and a half years away from compliance with probably one of the largest transformational events in health care, which is moving from ICD-9 to ICD-10, so there's an ongoing need to, and more importantly, escalating in 2012, educate people about crosswalks and general equivalency maps. Many testifiers said that they will not be using, actually, crosswalks, but they will do a full conversion in their systems to use natively the ICD-10.

So there was some kind of concern, we need to have some education on GEMS and crosswalks, but the other organizations were not going to be able to use crosswalks. But at the end I think there's going to be significant usage of this, and I think it's going to be important to continue educating people about them.

Concerns about the explosion of proprietary and vendor-provided code conversion and crosswalks. A need to consider how to evaluate these vendor tools, the quality of the intelligence of those tools in doing the crosswalking, and the internal rules built inside the tool, because there is a lack of really good understanding of why, when I put this code of an ICD-9, it goes to this code in ICD-10, or vice versa. Understanding the intelligence and the internal rules built into these tools is going to be critical.

Recommendations: HHS to work with associations to highlight educational resource information available already, and we are getting more and more information available on ICD-10. And then associations to solicit feedback from constituents on the content and the quality of these available resources and tools, and make those available.

Resources for ICD-10 – there's some level of uncertainty about – actually some level, there's quite a level of uncertainty about the availability of adequate number of trained resources for coders, under geographic distribution, to deal with ICD-10. So the recommendation is for HHS to work with organizations like AHIMA to assess the current level of coders in the industry, the number of coders needed by 2013, what are the potential gaps and then look at investing and expanding educational opportunities to increase this workforce.

Then the last set of observations were just general other observations. We had the opportunity to hear, during the hearing, from Workers' Compensation and from Property and Casualty. These are two areas that are not covered under HIPAA today, but we wanted to start listening to what their perspectives were with respect to 5010 and ICD-10. In the Workers' Compensation world there is the same type of claim that we send to a payor has to be sent to Workers' Comp. They use different formats in many states, so the question was how much can we move toward using the same standard?

They basically said, we face very similar challenges, in other areas of the industry, but we do have some unique circumstances that are associated with our own business, whether it's Workers' Comp or Property and Casualty, that affect how we use and comply with 5010 and ICD-10. So we're going to be doing significantly more analysis. We'll talk about, later tomorrow, the coming hearing in November on Section 10109 from the Affordable Care Act, which actually calls for looking at ways to incorporate Workers' Comp and Property and Casualty into the use of these standards. So this was our first attempt, actually, and a lot of very interesting information came out of that.

So in the meantime, we're recommending that HHS encourage Workers' Comp and Property and Casualty to move to implement these same standards and separate transaction codes and identifiers, while we complete our process of learning from the industry and making more specific recommendations on how to bring Workers' Comp and Property and Casualty under the HIPAA standard.

DR. WARREN: I did want to bring up one concern. Bill Scanlon was not able to be here today, but e-mailed Walter and I. We used the word "enforce" the deadline in two of the recommendations. Bill is fairly sensitive to how the community will react to the word "enforce", so I'd like for you to think about that. The only other word that I can come up with that indicates the same level of concern we have would be to adhere to the deadline, instead of using the word enforce. So if you could think about that, if you think that's a good substitution, we could go with that.

DR. CARR: I have one question – you're reminding me of the number of groups that say they're not ready for 5010, and we've made recommendations about accelerating activities to get ready, but my question is, if say Medicaid is not ready or some groups are not ready, what happens? What is the consequence, and is there a contingency plan for what we do, given the downstream effects of this?

DR. SUAREZ: Yes – this was discussed during the hearing. We tried to stay away from the word "contingency" plan because it gets confused with the 2003 contingency plan that gave the industry another year to comply with. We talk about business continuity planning, meaning, basically, what's going to happen on January 2 when someone sends me a 4010 transaction and it's supposed to be a 5010?

I think everybody in the industry, providers and payors, are going to have to deal with that. Everybody is going to be receiving 4010 transactions on January 15, on March 1 – it's going to take several months before 5010 catches up, particularly knowing that the level of testing today is so low. It was reported, in some cases, only 4 percent of their trading partners have tested by now, and we're talking about June, so it's six months ahead.

So what's going to happen? Two things we mentioned, and we didn't highlight in this presentation, but we mentioned in the letter. Number one was, the recommendation that the industry should not be absolutely strict with every single rule in the transaction; that there is going to be situations where minor errors could happen with 5010, and that they should not be rejecting outbound any transaction that had minor errors, that they should work as part of their business continuation plan to process those transactions and then work with the submitters to try to fix those minor errors.

So that's one aspect. But there is going to be 4010 messages and certainly, there's two possibilities – one, the health plan that receives a claim on 4010 processes the claim and not complain; that's one possibility that will probably happen. The other one is the claim gets rejected and the provider will have to work with someone that can take that 4010 and convert it into 5010, and that's a clearinghouse, and then send the 5010 back to the health plan.

So the idea was to ensure that the compliance with 5010 would not, in any way at all, affect access to care, affect the delivery of care services, and affect the quality of care, but that the industry needed to be flexible to doing this, initial months of the transition, to accommodate for some minor situations.

But there's no definition of what that contingency plan means; again, we don't call it that way, the business continuation plan, but every organization will need to develop a business continuation plan that deals with if I get a 5010 clean, fine; if I get a 5010 with some errors what am I going to do; if I get a 5010 with some fatal errors what am I going to do, and if I get a 4010, what am I going to do?

DR. CARR: But what if you submit a 5010 and your partner can't accept it? Because that's – let's say, for providers, if they –

DR. SUAREZ: We asked that question to the representatives from the Medicaid agencies. Basically, they have a step up, step down kind of concept, where if they are going to receive a 5010, then someone, a vendor, will have to step it down to 4010 to give it to the health plan that cannot receive 5010, but 4010. So they will need to do that translation service, basically, as part of their services. But the provider is complying by sending a 5010 and the clearinghouse can take the 5010 and move it down to a 4010 and send it to the payor.

DR. CARR: But the protection for the, let's say small, providers that can't get paid, I don't see any requirements to do that, that you process – in other words, if somebody submits a 5010 and they can't accept it, we're saying that they ought to do something about it –

MS. REED: Hi, I'm Elizabeth Reed, and I work for CMS, Division of State Systems, and I'm responsible for the oversight for the 5010, D.0 and 3.0, and ICD-10 implementation. There are a handful of states who are having trouble being compliant by the deadline, and we are working on the risk mitigation plans. As Walter mentioned, there is a step up-step down approach that we are recommending. We have several meetings coming up with those states, where we're trying to come up with a practical solution for that. Bottom line is that they have to be compliant from the payor perspective.

But I also want to mention that there is a huge concern for the states who are ready, about provider readiness, and there are discussions about accepting both versions of transactions, so that the payments to providers won't be interrupted, and they're looking at thresholds – they're saying it's greater than 10 percent of their providers who are not ready. Then there's a possibility of them accepting both transactions until they are. So there's a lot of discussion going on right now.

DR. WARREN: I would like to add just one comment. All of the testifiers told us to adhere to the deadlines. And if you go back and look in our history, those deadlines were set at a hearing that NCVHS held, and we asked the community, what is the timeline? Because one of the problems we had in implementing HIPAA in the first place was that the timelines were always pushed back. So people wouldn't start working on them until the timeline was there, so we would push them back, and CMS would push them back again, and so people quit worrying about the timelines, and they said this time, you must set reasonable timelines and you must adhere to them. If everybody knows that you're going to push them back, then nobody's going to do anything, testing or otherwise. I think that's why you're seeing a lot of late testers; they were waiting for CMS to say oh, okay, we'll push the timeline back. What we're trying to say is don't do that; it ruins the credibility for any other legislation that's coming out.

DR. CARR: In no way did I intend to imply that we should change that, but just to say that given the testimony that we heard, there is a very steep hill to get everybody compliant, and should there be one or two programs, perhaps, that don't make it, do they go under because they couldn't submit their claims, or whatever.

MS. KLOSS: Thank you for this excellent distillation of an important hearing. I wondered what the subcommittee's plans were for the next event of tracking this, and if you were planning another hearing, or planning any data collection, with what the discussion has been around, that and if there is a next, kind of, milestone, might that be addressed in the close to this letter?

DR. SUAREZ: Yes. We do have plans, and we will be discussing them tomorrow during the subcommittee meeting. We do have plans to continue to monitor progression on at least an annual basis. We don't have a date set for the next hearing on 5010 and ICD-10, could be June of next year as well, or it could be sooner, but the next one will be next year, and will be about how we are doing with implementation of 5010, and then how we are preparing to deal with ICD-10, or continue to do, as well as how we're doing with beginning to implement health plan ID, beginning to implement the operating rules that are coming up. So it's going to be a lot more interesting and dynamic.

DR. WARREN: As to your recommendation to put it in the letter, I'm very reluctant to do that, mainly because the subcommittee has done that in the past and then had to back away from it. We've had to completely redo our plans because events have overtaken us, and so what I'd rather do is just see that in a work plan, that we keep going, instead of actually putting it in a letter to the Secretary.

MS. KLOSS: Thank you. I just thought perhaps that underscored the need for everyone to keep their eye on the ball, but I understand why you might not want to lay it out.

DR. HORNBROOK: I think that for us, as the committee, the incentive here, think about it, is the payors who will switch immediately and enforce it rigorously, because they can deny a lot of claims and get quite a bit of float; even though interest rates are low, at least they get a cash flow advantage from this, and course the physicians will delay until it's absolutely mandated that they do it, because they're not getting any money on it. So that suggests that we should be looking at this transition period for evidence of huge amounts of denied claims and for evidence of any changes in practice, because physicians can't keep seeing patients, so there's access problems because they aren't getting any money.

DR. SUAREZ: Great point; we do emphasize that a critical aspect of the transition, is to ensure, and this is a message to the industry as well as to HHS, to communicate that message to industry, to ensure that nothing in the transition will affect, basically, the delivery of care, and monitor data, particularly the first month. There is fear, of course, among providers and among payors of thousands of claims being received on 4010 and having to be rejected, or people even reverting back to the dreaded paper world, because they say well, if you don't take 4010 I'll send you paper, how's that? And then right now we, in the health plan world, basically transition out from the thousands of processors on paper to electronic transactions. That's a very important – I think the first two or three months of the year are going to be – I mean the first few days, of course, but the first three months of the year are going to be very critical, monitoring data. It's an important point.

MR. SOONTHORNSIMA: To Mark's point, I wonder if we should include any sort of a window with which we would monitor the progress of adoption, because it can be very expensive to the system overall, not only from an access standpoint, where the provider stops seeing patients because they can't afford to, and health plans can't continue to have dual systems, per se, to accept – it's very, very costly. So I wonder if there's some way for us to measure the gaps. Include it in the letter.

DR. SUAREZ: We can bring this up tomorrow morning at the subcommittee to see if there is something we can say about more specific –

DR. HORNBROOK: Just a quick followup. Is it possible for us to think strategically, Walter, about the things that the staff support could do for this committee during this process? Just to put it in your head, to think about what we could ask from Marjorie for intelligence-gathering from the Department for us.

MS. DOO: One of the benefits of being on this committee is that I actually get to know what we're going to put in the letters and can provide guidance to CMS, so we, as you can imagine, have not been sitting on our hands about this issue for any amount of time. So there has been quite a lot of discussion before the hearings and after the hearings about what our strategy would be in terms of communication, education, and there has been a lot of communication with industry to find out are you going to be compliant, if there are going to be issues, how are the plans reaching out to providers, how are providers reaching out to their software vendors, how are the software vendors reaching out to their providers, and making sure that communication is just going on.

We were just in three different meetings last week, talking about this issue, making sure people understood that the date was not changing, asking what peoples' risk mitigation strategies were going to be, making sure they were thinking through them, so there has been a tremendous amount of work already, not publicly on the website yet, that's underway in terms of that, it's obviously not the only way, but this direct communication with our colleagues, some of whom are here but many who may be listening, on this very issue of we can't afford to let this slip, we can't afford to let patient care slip, and certainly not provider payments slip.

So please do be somewhat assured that to the extent we're capable, we can't go in and fix everybody's system, but Elizabeth Reed is here; she's spoken, she's working really closely with the states, and we are working really closely with all of our commercial colleagues. So just at least be assured that we're hearing and we are making efforts to do that outreach and to really look at what's happening from a testing standpoint.

DR. FOLDY: Particularly for the higher risk providers, has there been any thought given to trying to use the new infrastructure made available through the regional extension centers for HIT? They are ONC's, of course, but they are specifically targeted at critical access hospitals, smaller practices and lower income practices.

DR. SUAREZ: I think that's a great idea; I think we should consider including that as a recommendation to HHS, to the Secretary, to consider using the recently set up regional extension centers to provide education, particularly for small --

DR. FOLDY: I'll just add an aside – my understanding is that these organizations, I'm not sure I understand the details, are expected to become more and more self-supporting, or at least are not expected to be supported to the same level by meaningful use dollars over time. So there may be some interest.

DR. SUAREZ: Moving right along – the last letter is a letter related to the standards and operating rules development and maintenance process, under HIPAA. So just a very quick – this should take a few minutes only – just a quick set of background points.

There are certainly a number, a variety of issues with the current process for developing and maintaining and implementing standards and implementation specifications. And the Affordable Care Act, that requires operating rules, so adds to that complexity of the process. So some of the main issues, and this particular slide is a good summary of all of the largest issues – the time it takes to develop, modify standards, so from the standard development process, then time it takes to review and adopt standard from the regulatory process, the process for considering and adopting changes, not chances but changes, while standards are in place, lack of predictability in the process, limited pilot testing of some of the transactions prior to their modification process and the implementation of the new standard, lack of coordination in the sequential and concurrent adoption and implementation of standards and operating rules, limited participation from selected stakeholders, limited cross-coordination between SDO's and authoring entities of operating rules, misconceptions or lack of understanding of the process, difficulty of navigating requirements for submission of change request – there's a variety of issues that have been mentioned and identified in the current process, and the next slide just highlights the fact that we wanted to get into that process and see what can be improved and that needs to be changed.

So we held a hearing in April to gain some industry input and stakeholder insight on the review and update process, and we really heard a lot of this concept of the issues and some ideas of how we can try to improve the process.

One of the core elements of the process was created back in regulation. In August 2000 the Secretary named three standard development organizations, SDOs, and three data content committees to be the so-called designated standard maintenance organizations, DSMOs, and formed a DMSO group to begin to review and process any changes, and then report annually to NCVHS on the maintenance process.

The next slide just shows the regulation that established the creation of those.

The next slide basically highlights the issues that I just mentioned of the current process, and so the next slide talks about the observations that we made. Now just another background – we started this process in April. We are providing this first letter of observations, but we are really looking at trying to do the changes and trying to identify concrete changes, so we're going to hold another hearing later in November with the industry to define exactly what are the kinds of changes and improvements in the process that we can put in place?

You know, some of the general observations that you see here in the slide, I mentioned before, we have a complex process of standard development organizations, of data content committees, now operating rule authoring organizations. All of us have to be members of all of them. It takes time to develop any of these standards and then test them and then make sure that they work, and then the regulatory process becomes also another long step. So that's why we implemented 4010 seven or eight years after the 4010 was actually adopted, and we are implementing 5010 even though 5010 had been already – for three or four years.

There needs to be some clear stated difference between the standards, the implementation specifications and the operating rules, and the regulations that we have just published in July help define that, and I think we are going to find ways to even further clarify the differences and distinguish clearly what is the standard, what is an implementation specification, what are operating rules?

A few more observations – this is probably to me the most important one, the first one, that we need to establish – we use all these terms – dependable, orderly, coordinated, predictable, time-defined process for adopting new standards, new implementation specs and operating rules. This was one of the biggest concerns expressed during the testimony, the fact that we don't know when the next standard is going to come. We are talking about 5010 starts in January of next year; when is the next standard going to be expected? It shouldn't be a guess, or it shouldn't be that someone sent a memo to someone that said we should recommend this – and then start the process. It should be something that should be scheduled, and it should be organized, and the transitions well-defined.

And the coordination between the various transactions that are going to be adopting this new standard, and the operating rules associated with those transactions, need to be also well-coordinated.

Standards, implementation, investigation, and operating rules need to be tested before adoption. This is another important aspect. We're already talking about the next version of 5010, 6020; whether we're going to recommend that or hear from the DMSO they recommend that as the next version after 5010, or whether it will be 6050, who knows? But in any event, those have to be tested and evaluated and made sure that they do work.

A lot of testing is done with specific elements during the development of the standard itself, but they become Draft Standards for Trial Use, the DSTUs, and they need to be tested before they get adopted, that's the point, I guess.

So funding for this effort needs to be available. We need to formalize the emergency errata process, so yes, we have 5010 started January first. What if, in a few months after that, we find some significant errors, or in six months or a year, there are some changes in the health care reform that's going to do changes in how we do business; what if we need to change the standard, do we need to go through a new standard process, or how to handle emergency situations, and so we need to define that, technical flaws that need to be fixed. We have very limited avenue for that.

Next slide talks about the observations specific to the standard maintenance process, so the current structure of DSMOs and members, plus the authoring entities – we need to look at that and see whether we need to create a different structure, what kind of structure we need, what kind of process improvement we need to make in order to coordinate the maintenance activities across the standard development organizations and authoring entities of operating rules.

So we have a number of observations that need to ensure that the work of one organization receives active input from the other organizations, and needs to ensure that the changes that have been requested by one organization are reviewed by all of the other organizations. Some of those are already being done.

It was interesting that we heard, every year we hear a report from the DSMO, and they initially reported a lot of; I mean, there were thousands of change requests over the years. Over the years they have started to kind of significantly slow down, or be reduced, and a lot of the change requests are coming directly now to the standards and development organizations rather than to the DSMO, which is okay. It's another way to do it. But all those need to be, then, addressed to whatever new process for maintenance we work and define.

Overall, there needs to be established a transparent and understandable coordinated process, eliminating duplicative efforts, identifying and resolving conflicts between the standards and the operating rules, et cetera. So the next steps – we are going to be working, and will continue to work, with the DSMO group members, the operating rule authoring entities and industry stakeholders to: Number one, establish this predicable time-defined process for adopting new versions of the standard. Number two, develop modification changes to the current process for processing and resolving change requests to the existing standards.

Identify opportunities to improve coordination between SDOs and authoring entities of the operating rules. Help clearly define and delineate the difference between standards and operating rules, and identify strategies to improve representation and participation from certain stakeholders across the board.

So we will be holding a hearing, coming up November 18^th, with SDOs, operating rule entities and other stakeholders, to advance this process and to come back with recommendations on how to improve them.

This time, this was a letter primarily of observations from that hearing. Again, in November we'll have the second hearing, and after that we expect to have formal recommendations.

MS. KLOSS: As I read that, I assumed that this discussion applied to code sets and vocabularies as well as other kinds of standards, is that correct?

MS. LOHSE: Hi, Gwen Lohse from CAQH CORE. One quick comment – as we think about, and I know we're far from finalizing this, but as we think about the cycle with the operating rules and the standards, I just want to figure out, as we're moving forward, how to recognize right now, with 4010 and 5010, for example, in 2006, the operating rules were able to take advantage of some of the things that weren't mandated in the standards, like in and out of network variances, co-pays, year-to-date deductibles. Back to your comment about how do we get the cost out of the system, get the providers what they need.

So as we're thinking of these cycles, it doesn't mean that the rules and the standards need to necessarily be concurrent; but they can be at different cycles that are expected cycles, but potentially not at the same time, so they roll out at different times to take advantage of the different pieces that are bringing value to administrative simplification.

I just want us to be thoughtful of that, as to what is the end goal, and do we need to continue to roll out at the same time, or is there a value to roll out at different times, so we're looking at what has the biggest impact, and then tracking it and then updating, so we're very much supportive of contributing to this going on, but I want to just make that quick comment. Thank you.

DR. GREEN: I'm not sure it's a very helpful one, but I wanted to ask a question – when I read this report, and I hear Blackford and Paul's comments about measurement development, it seems to me that there's a lot of parallel issues here, about how you establish a standard or a measure, the process of development, how you get it implemented – am I not paying attention here, or are we not basically trying to manage change here? Blackford, help me out here. Tell me to quit thinking about this.

DR. MIDDLETON: No, keep thinking please. I guess – I apologize, I had to slip out of the room for a moment – but obviously, following along the administrative simplification and HIPAA sort of provisions and extending and enhancing standards used for transactions obviously – critical, the measurement issue, I think, applies across the board, whether it's in a transaction framework or a quality assessment framework, there certainly will be common themes across both. But Larry, I'm missing, sort of, maybe the core of your question. Is there quality assessment to be done in transactions?

DR. WARREN: Some of your work, Larry, there's some work going on right now within the ANA, to begin to look at the issue of where do evidence-based protocols march up with quality indicators, and how do we generate the quality indicator data out of data that has been documented in the patient care. So quality indicator should be a byproduct of care delivery.

What we're beginning to look at is where that fits in the standards. So right now, we have an initiative going on, in fact Walter's part of that at HL7 of creating clinical domain models that will then be referenced back to the REM at HL7, also binding terminology to each of the data elements in that domain model, et cetera, so when we're done, you should have a package that is HL7 compliant, is also compliant with the quality model, because we're also being sure that we meet with that.

So one of the things we're hoping to learn is, what are all the steps that need to happen from at the patient bedside to the end, before you get that quality indicator coming out? So it pushes up against some of the stuff in that some of the claims data is also going to be coming out of patient care interactions, whether it's the admissions, so looking at admissions, transfers and discharge data sets, things like that, and I think that's where Paul was looking at and why I got excited about him is, let's start looking at this for much more than health surveys; let's look at it throughout the whole workflow of health care delivery. So I think that's where the match is.

DR. CARR: I heard something. I was thinking along those same lines, but a little bit differently, going back to what Linda was saying, when we talked about wholesale changes that we've done and things that we've learned, we look at ICD-10 coming up as a wholesale change, that we ought to have a way, at a high level, of understanding change, change management and processes around that measurement and assessment of, are we getting what we thought we were going to get, and are we creating any unintended consequences with that? Linda, then Walter.

MS. KLOSS: Just a follow-up comment to my earlier question about code sets and vocabularies – several years ago, AHIMA and AMIA had a joint task force to look at the issue of maintenance of code sets and vocabularies, given the experience of what it's taken to get us to ICD-10 and the opportunity, going forward, of using web and other kinds of tools to expedite the update of these kinds of very complex, living standards, like vocabularies and classifications.

So I would think that when this hearing in November – we might carve out a piece to talk about that issue, because I think it is slightly different than the dismal, where a new version of a standard is promulgated, but the kind of maintenance rigor over time is perhaps a little different.

The other thing – a couple of years ago I had the opportunity to be part of a hearing, and it was health policy-related, but it was speaking about best practices in the regulatory, modernization of the regulatory process, and I think that there are certainly some names of researchers that have done some good work there, and it might be useful to bring that perspective into the hearing, so that we aren't continuing to roll forward and find a way to tweak things that perhaps are so badly broken that we need to look at a restart.

DR. CHANDERRAJ: I think there's so many things being imposed on the practicing physician and the providers, especially generating this data, old-time physicians are not in the habit of attending to these details. They're practicing medicine in the best interests that they know, that they've been trained. Some of these things, I think should be a core curriculum in the teaching programs of medical students, to become aware of these facts, that the data that's been collected should be generating quality data as well. I think once they become tuned into that, then it will be practical, but I think to impose all this on these existing physicians is a mindset alteration for them and they don't know how to deal with them, and they're dropping Medicare patients and not dealing with this kind of quality issues.

DR. SUAREZ: Just a comment, I guess, thinking of 50 years of HIPAA, I'm now beginning to reflect a lot more about this. I think it will come in time where this concept of a claim will be quite different, and these administrative processes, and these transactions, because at the end, if we're going to be paying for quality on a population base, or paying for not an encounter fee for service kind of approach, we're going to have to deal with a lot more clinical content data than the simple administrative numbers that go on a bill. So I think that is where, in the future, I see the convergence between the clinical world that we're dealing with under meaningful use and maybe that's where Larry was trying to go to, is really that convergence of saying we have to send a referral abstract of the patient record for a referral, we have to send a claim, which is a completely different system. The two sometimes don't talk inside the organization, and if they talk then I have to translate from SNOMED into ICD and back and forth. It's going to come the time where I think we're going to see a convergence of the two large systems, administrative and clinical, and we're going to be able to say, it is now integrated to do clinical care, to do quality measurement and patient safety, to do administrative functions and to fulfill all these requirements. That's my hope at some point, Version 7010.

DR. HORNBROOK: One of the things that I was thinking about was that we have this tripartite data flow, hospital claims, professional claims and drug claims, and they don't intermingle very well. One of the things we should be thinking about, perhaps, is can this committee talk about prescribing by indication, so that every drug claim has a diagnosis on it that a physician puts to that drug as to why they are ordering that drug. Can we talk about how that changes the data flows, how it opens opportunities for better quality and for better clinical management, and also for integration of drugs inside the health care system, because people are using multiple pharmacies and not keeping their drugs all in the same place. It seems to me like that's what the committee ought to be focusing on more and as much as we need to do this detail, it seems like it's slowing us down.

DR. GREEN: Aren't we seeing, again, that we're missing something? Whether it's for a plan identifier or it's for a 5010 transaction, we simply don't have a system in place in the country to execute this type of maneuver. We don't know the state of the – we don't know if people are going to be able to execute this thing on January first; we don't know whether it's going to lead to denials of claims and making money off the flow, we don't know, we don't have a clue, really, about where the system is about this, and the system that's trying to get this done could use a little help. It's one thing to adhere to the deadline and make the recommendations, but – so anyway, what I want to do is I want to connect dots that perhaps should not be connected, but once again, what standards is working on here reveals, again, I believe, a need for a new type of infrastructure, for what quality is working on, and what populations is working on, for sure.

There's just something missing here. There's an empty space that's not occupied to help us accomplish our goals.

DR. WARREN: I'd like to respond to that, because it's been a concern that I've had. One, with the passage of AHQA, our subcommittee has been given a charge by Congress with incredibly fast time lines that we have to meet, and we have been running at full pace. With that, we have not been able to sit back and do the kind of reflection and thinking that you're talking about, about what is the state of standards, operating rules, infrastructure to manage all those that we need to have, and I agree, I think there needs to be a place where we can kind of elevate ourselves and talk about that.

Right now it's not going to be in the standards subcommittee. We are going to be – we have our marching orders straight out because of – we've been given to work on our timelines, but I do think it's really important, Larry, and I don't want us to forget about it, because I think that's where NCVHS can make a difference.

DR. CARR: I think we're all on the same page, which prompted me to continue to resurrect our overarching view, so I handed out yet another version of our work plan that we began last year; was it this time last year, when we had the first part of our retreat, yes, September 2010, and we were going to identify focus and themes for the next 18 to 24 months to align with our charter, the national priorities, emerging issues in health and health care, resources and time frames of committee members and meeting --. And invite feedback from partner agencies.

If you look through the slides, there's a slide – I wanted to hand this out, to look at this today. So maybe the next slide, just our charter, that talks about our scope of activities and our focus, and I think it gets a bit to what Mark was saying too; sometimes we have to be in the weeds with our standards things, but we also need to be remembering that we're advising on strategy on health data, statistics, privacy, et cetera. If you go to the next two slides, again, reminding ourselves how important this shaping a health statistics vision for the 21^st Century is, tying in tremendously with the work that you've been doing on the community data initiative, and actually tying in with some of the things that Jim mentioned today, again – next slide is again, the provider, the personal and the population health dimension, keeping all three of them in mind.

And then the next slide, which it's been a while since I put this out, and it's not quite right, but I think, borrowing that methodology, I think we put this together a year ago June, when we began talking about a learning health system, information on health and health care, and all that feeds into that, and our data stewardship, health data stewardship role, that has gone throughout, where we talk about data integrity, data standards, data analysis, workforce and competency, research, as well as privacy, security, ethical use and education. I just keep coming back to this, because these threads traverse all of our discussions, and I think it's a good – it's important for us to stay at the 15 thousand foot level, which leverages the expertise of this committee. Each of us has some particular unique expertise, but there's one of us, maybe two of us, whereas as a whole, we have the collective overview of a universe of things.

The next slide is one that I took with permission from Chuck Friedman. Again same idea, learning health system for the US and focusing on the outcomes of that IOM committee. We're talking about governance, patient engagement, trust, aggregation, analysis and dissemination, and these themes – Chuck asked us on multiple occasions to think about how we integrate with the themes that came out of that, and I've heard all of these, actually, mentioned today at some point.

Then, next slide, when you wonder why we're in the weeds and you think about all of the mandates that have been given to us from Congress, what choice do we have? It's detailed content, and I think that Walter and Judy have done a fantastic job in educating everyone on the committee so that we're aware of it, and I think it's impressive when you see how much output there's been from standards and we'll continue to have that role.

Then I put together, for purposes of the subcommittee meetings, the detail on the HHS goals. I'll observe that they changed from our last version of goals, but that's okay – and they in fact had changed from the previous version, but that's all right. We have our goals now, and the details. So when we look at the detail, some of these are tied to what we're doing, some maybe not so much. But we ought to be looking at those and lining up – we are doing this and it ties to our Secretary's goals.

And so this is just a little worksheet for you to choose which are these things that we're working on, and what are the actions. I know that there is so much out there that we could be working on, but I think we do our best work when we have a thematic harmonization, very much, again – I think the two things that have predominated here are the community data initiative and standards, and I think that the input on privacy and now what quality is talking about as well.

And then these are the domains Jim provided us this morning – the domains to monitor health reform; these are the domains where they're coming up with measures, and actually, Blackford, I have some detail on that as well, if Quality wants to look at that. But access to care, cost and affordability coverage, quality, vulnerable populations, workforce innovation and population health prevention and HIT.

So I leave you with these just to ensure that as we map out the work that we are doing and where we're headed, that we keep this in mind, keep this charter, this view and altitude in mind, and then tomorrow, we'll meet back and give our report out. Let's think about how these tie out together. Walter.

DR. SUAREZ: Thank you for this – just a comment. I've been hearing all day today how population health and privacy, working on this community health information initiative, or project, and the standards, working on the world that we work, which is very down into the nitty-gritty of things, and trying to balance – I was trying to do a transition between listening to this incredible report on CHIP, the project, and talking about HIPAA's 10th anniversary, and it's hard.

But the reality is, number one, we're not the only show in town. I know you all know. Really, there is a health IT standards committee that is – we are a subcommittee of standards of the National Committee. There's a separate thing called the HIT Standards Committee, and they work on the standards. There is the HIT Policy Committee that defines the overall policy on information technology, pretty much, in this country, and ONC just published the Strategic Plan on Health Information Technology – all this larger amount of work that is being done, and so clearly, we have some space that we filled because of mandates, that we're responsible for, and we do have to deal with those, but we haven't had a chance to step back, necessarily, as a full committee, and now that we have full membership on the committee, maybe it's an opportunity to step back and look at this space that we are in and try to revisit exactly –

So we do know that we have a mandate to do this HIPAA stuff and yes, we'll be able to do it, but really, put the context around all the things that are happening, all the actors that are playing and where we fit. I think it's going to be challenging to try to adjust the HIPAA Report to Congress to meet some of the overarching goals of the other committees, when they're into different spaces.

DR. CARR: I'm not sure I agree because I think we've heard repeatedly the importance of standards, and the data integrity, the utility of the data, all of that depends upon data standards. So you're talking about administrative –

DR. SUAREZ: Yes, but data standards dealing with electronic health record is not our space.

DR. CARR: But we're about a lot more than electronic health records, and I think that's one of the important things, when we think about learning health systems and all that goes into it, all of the contributions that are emerging from the digital world, whether from devices or from surveys or liberating the data, and I think that's a good point, that we need to recognize that ONC has their very clear mandates with regard to electronic health records, but our traditional NCVHS role has been about population health and a much bigger picture. I'm trying to keep us at that level, because we don't want to duplicate work that's already being done.

So going back to this slide, when I did this, I was doing it on quality; when I was the Quality Co-Chair, and trying to say what are the data sources, where does it come from, who are the workgroups, and so on. I think that that's an important activity to understand who else is working in this space. But I think that we have an important role. So we heard today also that governance of NHIN is something ONC is doing, but what about there's more beyond NHIN in governance and thinking about those issues.

I agree with what all have said, but we need to be able to participate in broader conversations, like what Mark was saying too, about in addition to the detail, what about the big picture?

So this is just a starting point; it's just something we can continue to work on, and help us get to the right focus, where we do our best work.

I think with that, we will adjourn the Full Committee, welcome back our travelers from Hyattsville, maybe take a five minute break and move into the Populations and Privacy Committee.

Department of Health and Human Services

National Committee on Vital and Health Statistics

September 21, 2011

Proceedings by:
CASET Associates, Ltd.
Fairfax, Virginia 22030
(703) 266-8402

TABLE OF CONTENTS

P R O C E E D I N G S (9:00 a.m.)

A F T E R N O O N S E S S I O N

Department of Health and Human Services

National Committee on Vital and Health Statistics

September 21, 2011

Proceedings by: CASET Associates, Ltd. Fairfax, Virginia 22030 (703) 266-8402

TABLE OF CONTENTS

P R O C E E D I N G S (9:00 a.m.)

A F T E R N O O N S E S S I O N

Proceedings by:
CASET Associates, Ltd.
Fairfax, Virginia 22030
(703) 266-8402