[This Transcript is Unedited]



June 10, 2009

National Center for Health Statistics
3311 Toledo Road
Hyattsville, MD 20782

Proceedings By:
CASET Associates, Ltd.
Fairfax, Virginia 22030



Agenda Item: Call to Order and Welcome

MR. REYNOLDS: Okay, good morning. Let us go ahead and get started and I would like to call this meeting to order. This is it the first of two days of meeting of the National Committee on Vital and Health Statistics. The National Committee is the main pubic advisory committee to HHS on national health information policy. I am Harry Reynolds and Chair of the committee. I work with Blue Cross and Blue Shield in North Carolina. I want to welcome committee members, HHS staff and others here in person and also welcome those listening in on the Internet.

I would like to remind everyone to speak clearly and into the microphone and as you are talking, if you are looking at anybody in particular and the microphone is not right in front of you, yesterday we had some problems with everybody else hearing it. So make sure that the microphone follows your mouth as you are speaking. It is a real simple procedure.

Now I would like to have introductions around the table and then around the room. For those on a national committee, I would ask if you have any conflicts of interest related to any issues coming before us today, would you please so publicly indicate during your introduction. I have no conflicts of interest. Marjorie, we will go your way for that.

MS. GREENBERG: Good morning and welcome to NCHS. I am Marjorie Greenberg. I work here at NCHS, EDC and I am executive secretary to the Committee.

DR. TANG: I am Paul Tang, Palo Alto Medical Foundation, member of the Camino Complex

DR. SUAREZ: I am Walter Suarez with the HIPAA/HIT Notation on Research. I am a member of the Committee and no conflict.

DR. CARR: Justine Carr, Caritas Christi Health Care, member of the Committee and no conflicts

DR. FITZMAURICE: Michael Fitzmaurice, Agency for Health Care Research and Quality and on loan to the Office of the National Coordinator liaison to the full Committee.

DR. W. SCANLON: Bill Scanlon, Health Policy R&D, member of the Committee, no conflicts

DR. MIDDLETON: Blackford Middleton, Partners HealthCare, member of the Committee, no conflicts

DR. HORNBROOK: Mark Hornbrook, Kaiser Permanente, member of the Committee, no conflicts

MS. McCALL: Carol McCall, Humana, member of the Committee, no conflicts

MS. MILAM: Sallie Milam, West Virginia Health Information Network and West Virginia Healthcare Authority, the only possible conflict is that we are an NHIN contractor.

DR. SONDIK: Ed Sondik, Director of NCHS

MS. BUENNING: Denise Buenning, Centers for Medicare and Medicaid Services, Office of E-Health Standards and Services and I am lead staff to the Standards Subcommittee.

DR. O'GRADY: Jim Lepkowski, no I am Mike O'Grady, I am the liaison for the Board for Scientific Counsel, no conflicts.

MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services, liaison to the Committee

MR. LAND: Garland Land, National Association for Public Health Statistics and Information Systems, member of the Committee, no conflicts

DR. GREEN: Larry Green, University of Colorado, member of the Committee, no conflicts

DR. FRIEDMAN: Charles Friedman, Office of the National Coordinator for Health Information Technology

DR. FRANCIS: Leslie Francis, University of Utah, philosophy and law, member of the Committee and no conflicts

MR. HOUSTON: John Houston, University of Pittsburg Medical Center. I am a member of the Committee and I have no conflicts.

MR. BLAIR: Jeff Blair, Lovelace Clinic Foundation, we also have an NHIN contract, but I do not believe there are any conflicts.

MR. J. SCANLON: Good morning, everyone, Jim Scanlon, Academic Assistant Secretary for Planning and Evaluation at HHS and I am Executive Staff Director for the full Committee.

MR. CONNELLY: I am David Connelly from Capital Associates

MS. JONES: Katherine Jones, staff to the Committee.

MS. SCHEER: Maria Freedman Sheer, Scripps

DR. WATTENBERG: Sarah Wattenberg, SAMHSA

MS. KHAN: Hetty Kahn, National Center for Health Statistics, CDC

MS. JAMISON: Missy Jamison, National Center for Health Statistics, CDC

DR. BURKE: John Burke, College of American Pathologists

MR. WANG: Eric Wang, Social Security Administration

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

MR. REYNOLDS: Yesterday we had a good hearing on privacy and security so that was an excellent effort. A couple of housekeeping things: first I would like to welcome Chuck Friedman. Chuck is our liaison from the Office of International Coordinator will be joining us on a regular basis, has to leave this afternoon but not because of lack of interest, because of the fact that things are moving quite quickly and if he has to be in one place or the other, we would like him to keep it moving. So Chuck, welcome

DR. FRIEDMAN: Thank you very much.

MR. REYNOLDS: Glad to have you with us. The other thing that was interesting was I was looking back through some comments I had made about when I took over the Committee about this so these continue to ring true. This is a time of change and transition for the National Committee, but also for the country as a whole. I would like to thank each of you for your dedication, hard work and leadership, again. Things are moving incredibly quickly in the country. We have to continue to run alongside some of them, help on some as we will talk about in a little bit, and others we are going to need to leave. So we are going to have to play multiple positions as things start to come to fruition and I think that is going to be very important for us and our Subcommittees to make sure that we stand ready to do all three of those; depending upon the subject, depending upon the timing and depending upon the issues is what we need to do. So I ask the Committee to do that, especially during this time of significant transition and incredibly rapid change. So that is exciting to be a part of that.

First update on our agenda today is Jim Scanlon at the Department of Health.

Agenda Item: Department Update, including the American Recovery and Reinvestment Act

MR. J. SCANLON: Thank you, Harry, and welcome everyone. Well, as Harry said, a number of developments have occurred since we met, I think in February and of course with number of Subcommittee meetings, another hearing since then and I want to update the Committee today on the transition and personnel, budget and the Recovery Act and then I will go into a little more detail about the Recovery Act and then I will talk a little bit about the looking forward to legislation and some new projects at HHS.

So let me start in terms of the transition that we are well past the transition beginning by now. As you all know we now have a Secretary, Kathleen Sebelius from Kansas and a Deputy Secretary at HHS. We have agency heads in place for some of our biggest agencies: CDC; FDA; HRSA; and the Indian Health Service. We have nominees for some of the other operating divisions and we have nominees or intends to nominate, I guess, for most of the other staff of offices within the department. In addition we have a senior crew officials heading and directing the other agencies and staff offices where there is not a political person yet. We have also established an HHS Office of Health Reform a couple of months ago. That office will work with the White House Office of Health Reform to coordinate HHS and the administration's positions and work on health reform.

In terms of budget, again we are always looking at three different years for budget as you are all in your organizations. We are now in fiscal year 2009 with a full operating budget for the year. The fiscal year ends in September. The President has sent the fiscal year 2010 budget to Congress. They have already begun having hearings on those and we have also begun working on the 2011 budget. In terms of the 2009 and the 2010 budget, we are very fortunate on the population statistic side. Increases were included for National Center for Health Statistics. I think Ed will talk about this a little later and as well in the President's fiscal year 2010 proposal, a sizable increase was included for National Center for Health Statistics as well. So in terms of statistics agencies and most agencies, NCHS at least for the past two years is probably getting a, well we hope anyway will get a good boost in terms of bringing it up to the area where we thing the operating level should be.

In terms of the HHS budget our total, again this is the 2010, it is a very large budget: 880 billion as you know, but only ten percent of that is discretionary. The rest is Medicare, Medicaid, CAMA, FEM and other that are called mandatory programs and there is less, I do not want to say there is no control over there, but the budget is handled differently in terms of options, flexibility and much of that is determined by Congress and annual appropriations.

In addition to the budget itself, of course, we began talking last time about the Recovery Act, the Stimulus Act and the Stimulus Act provides more or less a one or two year, three year infusion of funds, anti recessionary kinds of funds, anti cyclical kinds of funds that help the economy get back on track and for HHS, it includes well we estimate to be about 167 billion dollars over ten years and again making the mandatory discretionary distinction, that would include about 144 billion for the mandatory side of the budget and much of that is Medicaid. These were grants to assist states during the recessionary period and it included basically the federal government increased our net for state Medicaid and related programs.

We have also received 22 billion on the discretionary side for Recovery Act activities and again, for the most part, these are one or two year funds. In the case of the information technology, though the funding is actually I think it is available to expend it, which is a very unusual and very almost every agency likes to have that arrangement where you can hold the money. It does not disappear at midnight on September 30th.

Now the main parts that I wanted to talk about under the Recovery Act in all three of these are things that the Committee has worked on and provided recommendations relating to and in support of. Two billion dollars of that discretionary amend was for the HITECH and this is being coordinated by - and Chuck will talk more about this later, they are up through the National Coordinator, the Act provides $2 billion for establishing LNC, a variety of activities creating standards and policy committees, standards, outlines a process for standards at option, provides grant assistance for states for health information exchange, grants for health IT workforce training and national and regional technical assistance centers to help with the adopter and implementation of interoperable health IT. A second part of that is the, as my colleagues like to refer to it as the retail side, 19 million dollars or more because again this the mandatory side of the budget, for incentives through Medicare and Medicaid to providers and others who adopt electronic health records and other technology and who meet some threshold criteria of actually meaningful use. As you remember, the Committee held two days of hearings to try to get some definition framework and operational sense of what does meaningful use mean. That is what would qualify Medicare or Medicaid provider for incentives that are quite sizable beginning in 2011 and then continue for a few years and then phase out. So again, these are all activities that the Committee has worked on. A lot of folks at HHS have worked on. In a sense the sale has been made. Now is the time to deliver in the sense of being able to actually adopt and find technology that actually makes a difference and get them to be used.

In addition, there are provisions to strengthen privacy confidentiality and HHS is working on regulations for those as well.

A second part of the Recovery Act deals with a prevention and wellness fund that is about 1.1 billion dollars in HHS. Some of the money went to CDC for vaccine activities and for efforts to prevent hospital acquired infections, but the bulk of the money, probably 600 million dollars is held in a prevention and wellness fund that the Office of the Secretary is working on and there is a fair amount of flexibility in terms of what those dollars would be used for. So there are work groups within HHS now putting together options for what would be a meaningful investment in that area. To some extent I think this was meant to be trying something new even if it is a little riskier, trying something different. Do not just put the money into normal grants, in the states, or communities or other places but you know try a long pass every now and then to use a football analogy. This might be try to use some imagination and see what happens. That is roughly a two-year program so and again, the details are being worked out. A lot of discretion is left to the Secretary.

The third part of this is comparative effectiveness research. The Recovery Act included a billion dollars for comparative effectiveness research. Again there are three parts of this: about a third went to NIH; another third went to ARC; and then the remaining 400 million again remains in the Office of the Secretary as a pool. Again there are work groups thinking of what would be the best way to invest these funds in terms of comparative effectiveness. In fact, a federal coordinating council was established. It is meeting later today. It has a series of listening sessions much like our own public meetings where we try to hear what advice people have about how to spend the money, what the priorities would be. The final one is being held today. Recommendations will hopefully be made. Reports to Congress are required. An IOM study on priorities is also due I think at the end of the month and then a spend plan to Congress from HHS about how would we actually spend this money and what process would we use.

So again, a number of very exciting activities underway. I think most people view the health fee.

DR. HORNBROOK: Do you entertain questions? Sorry. Two questions, in the federal coordinating counseling, is there an awareness or self awareness of the seemingly strange environment that they are working in when any manager worth his salt in the health care system needs costs in order to make a decision among the comparatively effective options as having a simple ranking of comparative effectiveness of the options does not tell you what to do because some of them are much difference in cost. You cannot notice a solution until you get the costs. There is a huge suspension of disbelief by leaving costs out of this and it feels like we are through some sort of fairy tale. The other aspect of the fairy tale is nobody seems to be talking about effectiveness. What does that mean? Affect on the tumor? Affect on a strain of bacteria? Affect on a cell, on a gene? Or, affect on our utility weighted preference weighted way of life? Where does anybody have a discussion about how that comparative effectiveness is supposed to be scaled? Is this going on down there or are they totally leaving you out?

MR. J. SCANLON: Well, cost is a four letter word, as you know. That was not included in the statute and there is great sensitivity on the top as there is always is that cost effectiveness. Remember, this is funding for comparative effectiveness research where cost is not there.

DR. HORNBROOK: No, I understand but I mean how do we go through society and go through this blinder dance knowing that cost is something that we cannot talk about.

MR. J. SCANLON: Well, I will not even speculate, but there is a fear that cost effectiveness research will lead down the path of rationing and I think that is the great fear of some of the folks who passed this bill is that many folks in the industry now how this all plays out. Clearly we are circumscribed in terms of the kind of research we can do. You raised questions that other folks have raised as well. We will be focused on certain

MR. O'GRADY: Would you like someone outside of the government to -

MR. J. SCANLON: Yes, please.

MR. O'GRADY: Yes, because he is putting you on the spot here.

DR. HORNBROOK: Of course and I do not always say.

MR. J. SCANLON: But, you are not, you are not.

MR. O'GRADY: They know the costs involved here, but there are also this is the group when they are dealing with this methodology and it is not clear to the people who need to have a consensus here that this is ready for prime time so are they ready to take the first step and think about comparing these things. Clearly they know costs. Costs is used in the privacy sector. It is the gorilla in the room, but it is also many of the people who you really need buy in to make sure this work have not had the experience that other people have with cost effectiveness and I do not think they are convinced yet. You take on your first step, you do a proof of concept, you show how this develops and then you get to your consensus, but there is no slam dunk here that this is the way to go in national policy. It certainly is very popular among the research community. I do it myself and I like it, but I also as I do that methodology, I see the data I do not have. I see the variables I cannot pick up and you have to convince the many players here that this really is a fair game. This is not just a way to sort of stick it one player or another and so they all know that. Nice guys like Jim cannot just say those sorts of things that he is still in the government. When you retire you can say things. Okay.

DR. HORNBROOK: I am not going to take the bait.

MR. O'GRADY: This is the same process we saw with risk adjustment five or six years ago. We need the method to work then we can talk about it afterwards.

MR. REYNOLDS: So another nice guy, Blackford has a question and then Bill Scanlon and then Garland.

DR. MIDDLETON: Thank you, Mr. Chairman. I guess, Jim the basic question and we had a little brief conversation about it at least this morning over breakfast is where will the NCVHS relate to comparative effectiveness and the new councils and bodies that are forming. I think it is sort of clear that there are relevant issues pertaining to the quality of the data and the data standards, data transmission, and their use with respect to privacy, security, confidentiality that will be underpinning all of the comparative effectiveness including ultimately an assessment of the costs and value. So can I ask can we put this on the docket somewhere sometime that we have a comparative effectiveness day at NCVHS?

MR. J. SCANLON: And in fact, I think that the again the focus now is just sort of making sense of how, what would be the best investment of the 400 million and what mechanisms would be used, what priorities would be set. Again, I think for the money that is in the Office of the Secretary pool, it was not meant to just duplicate what NIA in fact if you crowd around NIH or ARC research, it would really be a great lost opportunity so I think we are trying find ways, very open process, but I think this as much as we all love control randomized clinical trials and I love them as much as everyone does, it is not the only path and I think that there are other methodologies and all of them depend on having other data sources including large longitudinal link claims data and distributed clinical information systems. I would actually like to see down the road maybe where the Committee would think of having looking at some focus on research and methods for comparative effectiveness research, experimental and non-experimental, maybe a hearing, but I think that would help. But the folks are not even at that stage yet in terms of just sorting out the kinds of questions that they are easy to answer.


DR. W. SCANLON: I agree with Mike. This is honestly an evolutionary process that we are going to be witnessing. Although I thought that the Congress provided sort of more latitude; that there was a debate over the issue of clinical versus cost effectiveness and the word clinical was in the Senate bill and was not in the House bill when the conference came out, the word clinical came out. It seems to provide more latitude in terms of what this research may actually investigate. Though the issue of cost effectiveness is very different than clinical effectiveness, in my mind at least, because while physiology may not change as a result of the analysis, the cost may change. If you are interested in maintaining your market and suddenly you are not the cost effective option, you may think it is better to have your market at a lower price than at our current price and so this is part of what we need to be thinking about in terms of how we ever end up using these kinds of analysis.

MR. REYNOLDS: Garland?

DR. LAND: I was wondering the Committee sent a letter to the Acting Secretary on March 1st recommending peer recommendations in terms of the Recovery Act maze: one on e-vitals hit on population base surveys and I did not hear any mention of what happened to that letter. Is it getting passed to one of these committees that you talked about? We went to an Undersecretary I was just wondering if it got stuck in an inbox someplace. How do we make sure that –

MR. J. SCANLON: I realize it had Committee support. I think it is reflected in an increase forensic test. I mean I think the whole idea was to increase the funding for population data both the '09 and 2010.

DR. LAND: Well that certainly helps support the base. It does not address the issues in terms of electronic systems I think was what was intended here in terms of the Recovery Act of one time funding toward electronic systems and so forth. I wonder if that is still.

MR. J. SCANLON: Well, Chuck will talk about a little bit, but there are because it is still somewhat pre-decisional what some of the dollars will be used for but there are public health. There is some of that money will go to public health and there were a number of projects proposed. I do not know that vital statistics, the e-vitals whatever, I am forgetting what exactly what the proposal was, but that was under consideration. I do not know what the decision was.

MR. REYNOLDS: Okay, any other questions for Jim or Jim, did you have any other comments? Okay, well thank you. Yes, Mark?

DR. HORNBROOK: Just to follow up then. For my own personal understanding, the reason why cost is not allowed to be talked about is because people fear that when you bring cost into the equation, effectiveness drops out and people make all of their decisions based on cost without looking at effectiveness, so it is a domino or a slippery slope argument that we are going to go to hell? Is that the paranoid that is motivating the opposition to cost? Do you think?

MR. J. SCANLON: I will take that as an observation. Mark, is that it?

DR. HORNBROOK: Sorry, I am asking the wrong person.

MR. REYNOLDS: Comment so noted. Okay, Karen?

Karen Trudel from CMS is going to update us e-prescribing and the PHR pilot test.

SPEAKER: Karen is not going to take the bait either.

Agenda Item: CMS Update – E Prescribing and PHR Pilot Tests

MS. TRUDEL: Observation so noted. Actually I am going to talk about a little bit about our work in the PHR area and I want to provide the Committee with an update on activities related to the new HIPAA transaction code set standards that became effective on March 17th, which was the 50-10 transaction set at ICD-10 code set for diagnosis and procedures.

In a sense these two initiatives have been upstaged a bit by the Recovery Act and the discussion around initiatives and all of the other supporting activities like the regional extension centers, but 50-10, and ICD-10 remain a significant workload for providers and plans and CMS is continuing to push forward to try to assist the industry in making this transition. I remind you that the 50-10 code sets, which replace the existing HIPAA transactions for claims, eligibility, queries, remits, advices, et cetera, the administrative suite of standards will become effective in 2012 and the ICD-10 diagnosis and procedure codes will be required for use in those transactions effective October of 2013, which seems like a lot of time but in points of fact, it is not and those two processes need to happen in a step-wise manner.

CMS internally has established an ICD-10 steering committee, which is comprised of representatives of all of our operating divisions. This is an activity that will encompass all of the systems and processes within CMS including our claims and payment process, our coverage edits, a lot of our quality measurement activities, our program abuse, coordination of benefits, Medicaid policy, appeals, all of these business lines are affected to one degree or another. What we are doing is to finalize a CMS impact analysis which is in its second generation now. We will be finishing at the end of the year and will have developed not only an impact for each of the lines of businesses at CMS but also a game plan for how to move forward on issues that cross business lines including mapping from one code set to another.

We have been also working very hard to try to get the word out to people in the industry about ICD-10 and 50-10 in providing educational information. In the middle of May we did a national provider education conference call detailing some of the ins and outs of the ICD-10 mapping and we had more than 5,000 people registered. Yesterday we did an educational call, a national call one Medicare fee for services implementation of the 50-10 transaction standards and again had more than 5,000 people participating. So we know that there is a significant need for information out there and we are continuing to try to meet that.

We are probably within a few weeks to a month of awarding a national contract for program management, which we will use to manage our internal processes to make sure that CMS and especially Medicare fee for service and Medicaid wind up where they need to be, on time and available to test and we are also at a about the same time we will be awarding a national contract for outreach, which will allow us to really extend past our normal trading partners and our normal mechanisms in terms of fee for service, reaching providers, reaching plans and we will try to look for hard to reach providers, small providers, software vendors, clearinghouses, and some of the organizations that we traditionally do not have close communication relationships with. So those are some of the things that we are doing with 50-10 and ICD-10.

With respect to PHRs, we are continuing to operate our two pilots and I know there was a discussion in the privacy Subcommittee meeting yesterday about some of those pilots; one in South Carolina and that is the single PHR that Medicare fee for services beneficiaries can elect to use -- it's supply by Health Trio. We have about 4,000 beneficiaries in an eight county area who are actually using it. The general population that we think in that eight county area who could potentially use that is 100,000 so 4,000 out of 100,000 is not a lot, but it is a pilot and we are learning a lot from it. We also have pilot in Arizona and Utah which is called PHR Choice because we give beneficiaries the option of choosing one of four PHRs including Google Health and Health Trio and two others and in all of these cases we do provide Medicare claims information to the PHRs and in the case of South Carolina, Tricare beneficiaries who are also Medicare beneficiaries can receive automatic inputs on their active medications from Tricare.

We are also in the process of doing evaluations of these pilots, both of which will come to an end at the end of this calendar year. There are two major components to this. We are doing beneficiary surveys. We are doing also analysis of the impact on selected quality measures and care utilization for people using PHRs. So we want to know, did the beneficiary like them? But we also want to know, did it actually have a quantifiable, measurable impact on their health? I will not go into how we are doing that because I do not really get the details, but we are also looking at satisfaction, we are looking at which features they think were helpful. What ones they thought were not helpful. What kinds of outreach they felt was compelling that caused them to want to utilize a PHR.? What they think the impact of the use of the PHR was on their health condition in general. Did it facilitate communication with their provider and what factors caused them to either continue to use the PHR or to stop using the PHR.

So essentially, we are going to be able to find out toward the end of this year we think, a lot more information than we knew before about what Medicare beneficiaries really think about PHRs, who they use them or do not use them. Is this something that they find compelling and useful and what does it actually mean in terms of their health care, which will lead us to a number of additional questions and some additional policy deliberations after that.

I will take questions if you have any.

DR. CARR: Thanks, Karen for the update. You mentioned that you are already learning a lot. Can you say a bit more about what you have learned so far?

MS. TRUDEL: I think what we are learning, I have the best sense in terms of South Carolina, but there we are finding that one thing that works best in terms of outreach is actual person to person. The contractor has been doing a lot of health fairs and things like that. They actually take a computer with them. They will sit down and show the person what the PHR does, help them get them going. That seems to help a great deal. I think what we are learning most about right now is what works and does not work in terms of outreach. I do on not have a good sense yet of the outcomes and what I was especially interested in learning and I do not have a good sense of that yet either is once the people sign up, how many of them continue to use it on an ongoing basis as opposed to I signed up, I checked it out, I did not like it or I tried it for a little while and I stopped. That is really going to me the big factor.

MR. REYNOLDS: We have Leslie, Larry, Jim and Karen.

DR. FRANCIS: We did not hear yesterday how many people are participating in the Utah Arizona, so that is just a quick question, but maybe a longer question is that there is a real difference between the Utah Arizona pilot and the pilot in South Carolina in that in the Utah Arizona one, it looks a whole lot more like the market. You know, what is out there in the real kind of rough and tumble world. It is not just one that is being offered seniors. It is different and it is some of the very high profile vendors like Google and I wonder if you could comment at all on what you are planning to try to figure out about the differences between those two; whether you have any preliminary sense about just even maybe reflected in people signing up and people using about the difference between those two pilots and what you are planning to try to learn about that.

MS. TRUDEL: That is going to be a little bit tricky because there is an apples and oranges sense about this. While I agree with you it does look more like the rough and tumble world, the main distinction between the fact there is choice is that in South Carolina, our contractor actually did the extensive outreach as part of the contract. In the PHR choice pilot, most of the outreach is being done by the PHR vendors themselves. So we will have to factor in the variations in how they approach that. We have about 800 signed up so far I believe in Arizona and Utah and again that has only been operating since I believe January or February and it also does reflect the fact that CMS is not, at this point doing outreach ourselves. We had a kickoff event and our regions are planning to do some outreach in the future, but at this point we are relying on the vendors themselves to sign beneficiaries up. That is one issue and the other that will be very interesting to see is the considerations across the different products. What did people like more than in product A more than in product B.


DR. GREEN: Thank you, Karen, very much. I want to build off of both Justine and Leslie's questions. They reveal what I presume is a shared interest in basically the entire Committees. I think we are eager to learn from the PHR, PCMH trials that are, how are we going to do that? How can this Committee rather efficiently learn from these Medicare trials what we need to know to do our job? These are very promising, very important events it seems to me and do we have a strategy about how we are going do that?

MR. REYNOLDS: We will take up -

MS. TRUDEL: We have been working with Jim's office and a number of other HHS operating divisions to collaborate on the evaluations and we would be happy to get a group together to come and actually do a formal briefing when they are completed.

MR. REYNOLDS: Yes right. The other thing is we had an excellent John and Leslie invited that group from both sets of pilots to the privacy and security meeting yesterday and they gave an excellent discussion. Again, that particular discussion was focused on privacy and security and I think added a lot to it and the other thing to remember is these are claims-based PHRs so if we are gong to take up the subject as a Committee, I think it would also be good to probably include some that are not claims-based, that have more others so I think maybe holistically as a team if we take it on. They are coming up with real data and that is great, but the other thing you always hear when you take the whole subject as we have all dealt with on our Subcommittees and so on, then where is the clinical and so if we could add that to it, then I think we would have a real good look at the whole thing.

DR. GREEN: I just want to express one view. I think this is really important and there is a lot of time, effort and money going into these things and from my perspective, this ties directly to the reason we exist and that we really need to drain out of these things what we can so a systematic approach to doing that would be welcome from my perspective.

MR. REYNOLDS: All right, so you are going to comment on that?

DR. J. SCANLON: I guess friendly amendment there as well, I think as Karen said we, again when we do pilots, we like to learn from them and we do not like to leave a pilot without learning something from them. So we have three of them, I guess. The other one is the plan, one where the evaluation that is plans, but I think we could share certainly. We are in the process of putting together the evaluation design for the western states, but we can share that the Committee and maybe once have a special session on the varieties and the effectiveness of PHRs, we would be happy to do that.

MR. REYNOLDS: Okay, we have two follow ups and then we have Blackford, Carol and Mike, so will get it done so Marjorie, do you want to follow up on this?

MS. GREENBERG: Yes, I was just going to say and follow up to what you said. From what we heard yesterday, although they are claims-based, they have lab data; they have got pharmacy data, so it is more than just the claim from the clinician. Also, there was mention of like the CDA and so it was not quite clear to me the extent to which it went beyond. Some of them potentially could get information beyond what was just being obtained from the Medicare records.

MS. TRUDEL: Could I answer that, Harry?


MS. TRUDEL: Just to clarify, we are providing, pre-loading claims data because that is all we have. Until there are more providers using EHRs, that is a main source of data and from my personal perspective, I think that claims data will always have some kind of a use in PHRs as beneficiaries try to get information to figure out how to manage their care from a financial perspective. So, I think what we are seeing is we looked at PHRs at the various candidates that we were going to use both in South Carolina and in the western states and all of those products can bring in data from a number of different sources including labs, including meds and in fact in the western states demo, we are using the CDA as the way that we communicate the claims data to the four PHRs, although we are populating only a very small part of it. We are also trying to step along and show that you can build on this and we are using the transmission mechanism that you could use for clinical data. We are just pulling it from a claims source and sending forth what we have.

MS. GREENBERG: If I could just add one thing and I really commend everybody who was not at the hearing yesterday because you know look at some of the testimony and particularly you all remember E. Dave (?) who gave claims data a bad name we thought, but his testimony is very thoughtful about the value to him and to what he felt of a beneficiary or consumer patient getting that claims data whether you find problems in it or not. I mean that is part of it. So his testimony was much more nuanced than I think the newspaper articles, but anyway.

MR. REYNOLDS: Paul, follow up comment then

DR. TANG: Yes, just to pick up on what Larry said, is there an opportunity to get involved with the evaluation in terms of its design or is that too late?

DR. J. SCANLON: Well the only difficulty is the contracts part of this. Let me think of a way we could do this, but I think it could be done. There should be a way we can do this.

MR. REYNOLDS: Okay, Blackford?

DR. MIDDLETON: Actually it is on the same thread following Paul's comment that I think this is obviously going to be very critical in understanding not only how patients interact with health care information technologies, but eventually how patients and technology interact with their clinicians in health care delivery systems and each other. In my observation actually based on some work we have done and Paul participated in is that the value proposition may actually vary a lot with the different architectural approaches. What I mean by that is to what degree data standards are being abided by? In fact what are the information exchange patterns? What are the communication patterns and what not? I realize this may be beyond what is happening today, but I would hope we could do with this evaluation and even then follow on evaluations is think not only about the clinical impact and satisfaction, kind of our usual clinical effectiveness kinds of things, but to actually add to the evaluation informatics or architectural considerations to see what makes the most sense and provides the most value. I think looking at IT in general, we do not know what are those response curves. We do not have a good idea for how much PHR actually causes a positive response like we do with drug studies. I think that is the way we need to go ultimately.

MR. REYNOLDS: John has a comment on Blackford's statement.

DR. J. SCANLON: Well, yes.

MR. REYNOLDS: If it is not then you do not get to talk because Paul has one on Blackford's and if it is not then you do not get to talk and Carol, you are next and you will get your time.

MR. J. SCANLON: I just want to make one piece of insight. We heard from somebody from the Pew yesterday about some of the work that they have done generally and I think there will be some values and general overlap some of the survey type of work that they are doing on these PHRs with what some of the type of work that Pew does because they have sort of a, I do not want to say, different perspective, but they add a different dimension to try to explain why things are what they are and why people's habits are what they are. I think it was interesting to listen to her speak yesterday just because of the way they sort of go about doing studies and how they infer information and it might be helpful in trying to understand PHR adoption and use and things like that.


DR. TANG: The reason for picking up on what Blackford said and it relates to my previous question is both the contracts and the evaluation were pre-Recovery Act. With the Recovery Act in meaningful use, there may be other dimensions that were considered initially and that might be a reason why you might amend a contract for the evaluation before you get more of it.

MR. J. SCANLON: The contract is for, I cannot say too much about it, but it basically will be a design evaluation and get some very baseline data so there will be an opportunity as soon as that is public. Maybe we could even use the Committee as a technical advisory at helm for some of that.

MR. REYNOLDS: Leslie, did you have comment based on yesterday?

DR. FRANCIS: Yes, what I wanted to say two things. First of all, everybody on the Committee knows the Google and other products that were negotiated by CMS with Google Health and others are not exactly the same thing you would get if you signed up with Google. There are more protections in them. That is just an information statement.

MR. REYNOLDS: Make sure you are speaking into the mike.

DR. FRANCIS: Just an information point, but also we are planning to produce and you will hear more about this later in the full Committee agenda both some informational materials from the testimony as well as some recommendations on a pretty fast track for the full Committee to be discussing so those should be available to CMS in timely fashion before you have to do your evaluation.


MS. McCALL: I would like to link some of this conversation back to actually to Jim and it is going to end in money, but for a different reason. I think everybody is very excited about the pilots that are going on and so Larry expressed that very well, very enthusiastic to know what is going on. I think that in addition to being explicit about what we are trying to learn from these particular pilots and we do need to be explicit about what it is that we hope to get out, I would like to see us do a lot more experiments and I mean a lot more. We are entering a brand new field of information products that at their absolute extreme begin and end in data and we just do not know what we do not know yet. Everything from standards and the things we are comfortable with all the way to the extremes of new forms of knowledge representation and semantics; things that if we go out and ask this end consumer, they do not even know to articulate, but they will know when they see it. And so I too am very enthusiastic and I am enthusiastic not just for what you are learning, Karen, but for all of the things that I am hoping, Jim, that are part of the funding so that we are much more intentional and much more aggressive about the types of discovery work that we do. Any money there for that?

MR. J. SCANLON: Some of that is evaluation and some of it is prospective in the sense of looking at these new ways of displaying and presenting information and looking at what the affect is. We have a number of mechanisms that HSS test, that kind of test those. To be honest, they come from the old, the older communications world and I think we have to extend it to some of the newer social media, but from my office evaluation is our middle name and we generally like to learn. If we do a pilot or we do a program, we generally like to at least learn what they did and what worked and what did not work and why so we can use it for the next time. For example, if a bill appeared on the hill that Medicare has to do PHRs for everybody at least offer them, well if we did not learn anything from these pilots and that may or may not be a good idea. It may be a good idea now or later or not, but we would at least like to know what we benefited from these pilots about what people. We are clearly seeing dynamics that are not anticipated and maybe it is the demographics of the Medicare population, you know, people might register and then use it once and then never here again. It depends on whether there is a health issue or a health problem. There are a lot of dynamics underway there that we are beginning to understand them now that we are monitoring it closely. I agree completely. We should base this on some sort of evidence.

MS. MCCALL: Just to add on a little bit, I am not at all surprised that you are being surprised. I think my point is that we should both anticipate that and invite it and see if there are ways that we can do a lot more in terms of funding it, but also speed them up. There is an insight and a feedback loop that I think if could learn to accelerate, a lot of this would come much more quickly. So there could be a role there.

MR. REYNOLDS: Okay, Karen, follow-up and then we have Mike, Walter and Mark.

SPEAKER: You faked me out by putting me in.


DR. FITZMAURICE: Two things, one is that express some appreciation for what the Chairman has invented that is a system of comments and here is a chain of follow-ups. You can comment on the follow-up, but then we get to the main chain of comments.

MR. REYNOLDS: Yes, but when we run out of time and somebody is left out, it does not work so good. Parliamentary procedure.

DR. FITZMAURICE: Secondly, Karen you mentioned that CMS is doing an impact analysis for each line of business for a 50-10 and ICD-10 and they are both coming on line in 2012 and 2013. ARA and incentive payments come on line in 2011, maybe even October of 2010. I am wondering if the same analysis team is also looking at the impact of meaningful use, although we do not know what it is yet, but maybe quality measures. Certainly they have to make payments to providers. Are they looking at the impact of that also on Medicare's line of business because that might even be more immediate and more, I will not say threatening, but of greater concern at this point?

MS. TRUDEL: We have a completely different team and a completely different executive board that is overseeing the Recovery Act, but it is doing it in the same way; looking at all of the lines of business, all of the policy decisions that need to be made before we can develop regulations and bring up our program and at this point, we are looking at it from a policy perspective, but we are also starting to look at the architecture aspects of it as well.

DR. FITZMAURICE: Thank you, Karen.

MR. REYNOLDS: Mike, it is all that in the same ecosystem regardless who is looking at it. The same doctor's office gets it. Walter?

DR. SUAREZ: Thank you, well I am going to go back to the PHR, this is very, very exciting certainly to see all of this; experiments happening and I wanted to link something that was mentioned earlier, Jim, and that is comparative effectiveness research. I have been pushing at every meeting I have a chance to, to expand the vision of comparative effectiveness to include not just clinical outcomes, but include comparative effectiveness of health information technology such as the PHRs and try to look at innovative research that can lead us to see how different technologies and in the field of PHRs different approaches can lead to different effectiveness and outcomes ultimately. So, I wanted to bring that up and I really like the idea that Blackford mentioned earlier about having a whole day about comparative effectiveness and include in that day not just comparative effectiveness on clinical outcomes, but again comparative effectiveness of health information technology, comparing different health IT approaches. I mean the PHR is specifically exploring the possibility of doing a research around different approaches and how they ultimately lead to different outcomes. So that is one comment I wanted to make.

The other one, I think is very important. There is a population dependency certainly on the experimenting done by Medicare. The Medicare population has a unique demographic altruistic and I wanted to suggest the importance of looking at similar experiments, similar experiences in another population and that is Medicaid and see how, if there is a possibility to support the implementation of personal health records in Medicaid programs and explore and understand better the expectations and the experiences and the learning lessons that can be extracted from having a Medicaid population experience electronic of personal health records and I do not know if there is a possibility of that. I know the Medicaid transformation grants that CMS has provided, has funded the adoption of health IT of Medicaid agencies and they have been using it to implement electronic health record claim base, electronic health records and some other aspects but very few, if any, of the Medicaid agencies are exploring personal health records. I think there is an opportunity to lead that so I do not know that there is something that could be done about that.

MR. REYNOLDS: That is a good idea as we do our evaluation planning.

MR. J. SCANLON: I might just add on the comparative effectiveness research, you will see on the HSS Recovery Act dot gov website a framework for approaching and I think comparative effectiveness research is seen as a continuum from the clinical to the community and it is not just head to head clinical necessarily, but a definition is there to comment and then look at as well as the framework and it is a very open process. It should be a somewhat broader definition.


DR. HORNBROOK: I just do not want us to lose sight as we talk about PHRs that there is an electronic health record up there that is much more functional. On an anecdotal basis, I just had my eyes examine. I have glaucoma risk in my family and so my ophthalmologist was able to pull up all of the eye pressure readings over the course of time and technologies. They zigzag around, but then all of a sudden they pop up and so now they are going to put me onto a digital photography regimen to take a picture at the back of my eye. That also becomes part of the electronic record. What I need is if I ever happen to leave Kaiser, I want all those data to go to my next ophthalmologist. I do not want to be locked into Kaiser because that is the only system that has electronic data. They same goes for PSAs, glucose and hemoglobins, BMI, all of these clinical measures are really where it is getting at the continuity of care. It is not just utilization, although that is a good first step, but we have to take the next giant leap to get real differences in effectiveness of our care.

DR. TANG: We are just down the street.

MR. REYNOLDS: Now that we have gotten personal on somebody else's marketing, we will move on to the next. Karen, would you? So the two things that we listed you have not touched base on yet. Did you have anything to say on e-prescribing or oh you did pilots. Do you want to say anything else on e-prescribing? I am not requiring you to, I am just asking a question.

MS. TRUDEL: The reason that I decided to talk about 50-10 and ICD-10 was that I thought that the work that is going on there was more prepared and compelling and really and really there is not that much going on in e-prescribing at this point.

MR. REYNOLDS: No, no that is great. I just want to make sure that you realize that you have additional time. Okay, we have got Chuck and then Walter.

DR. FRIEDMAN: Just a quick comment because several of the folks who spoke in the preceding discussion made reference to issues related to research on health IT and to a future of perhaps higher functioning technology that the general public thinks, I love what Carol said, the general public may not be able to describe it, but they will know it when they see it. In that light I would like to call attention to one aspect of the Hi-Tech Act that I do not think has been mentioned yet today and this is the enterprise integration centers. They have a somewhat interesting name. If you juxtapose it with the mission for them that is described in HITECH, and we really cannot go beyond at this point of what the statute says about them, but these enterprise integration centers are a potentially important vocation for some of the work to be done that was discussed by the committee in the past few minutes and I would just people who are interested I suggest you go to those few nice paragraphs in the statute and take a look at what they say.

DR. MIDDLETON: Chuck, I think this is extremely interesting to investigators in the field obviously and is extraordinarily relevant to actually making also the extension centers work well because we need more implementation science as well as some of the other research that we have addressed. Can you provide any more detail thought because everyone is kind of waiting with baited breath what kind of announcements will be made, what kind of RFAs, RFPs and when will they happen?

DR. FRIEDMAN: No I really cannot, Blackburn. Obviously I certainly can say a large number of us are working very, very hard on it, but I do not want to say anything that might be premature or misleading about dates. I just to be sure everybody was aware of the enterprise integration centers as an element of HITECH.

MR. REYNOLDS: Okay, Walter then Larry.

DR. SUAREZ: This is question for Karen. It is about the security guidance and the efforts of your office regarding the recall react security regulations. If you could talk a little bit about what the status of that is and what are some of the next steps.

MS. TRUDEL: Actually, the Hi-Tech Act appropriately in my opinion very closely links security and privacy and breach reporting and education and all of the issues that relate to security and privacy are very closely intertwined. So essentially to work that section of the Hi-Tech Act, the department has put together a group of folks, for instance OCR, the Office of National Coordinators, CMS who are all collaborating on different aspects of that process.


DR. GREEN: Another question, Karen, totally new subject area here. Can you alert us to whether or not the Medicare pilots or demonstrations are evaluating anything to do with mental health? Or said differently, maybe to you too, Jim, there may be questions, where in this discussion lies mental health?

MS. TRUDEL: I have to say that I do not know that we are evaluating it specifically in terms of, I am assuming you mean usage and outcomes and whether that as the principle diagnosis would affect the usage of a PHR? I am not sure.

DR. GREEN: Yes, my underlying, I should be explicit when I, my underlying assumption is that this is inseparable from the care people. It is inseparable from improving health care. It is inseparable from improving health and as I read what I can get my hands on and listen to reports, it strikes me that there is a relative neglect of the issues of mental health. Privacy and security aspects of this, quickly often migrate towards stigma with impediments to reporting and collection of relevant data. I am just wondering if these demonstration projects are going to be a source of information about how emotional behavioral problems are monitored, identified, aligned as co-morbid conditions, that sort of stuff. If we are going to learn these things from the more, should we be looking elsewhere?

MS. TRUDEL: I would venture a thought that we probably do not have a robust enough sample size to learn an awful lot from either of these pilots. I do know, and I believe this was discussed yesterday in the privacy hearing that for the South Carolina pilot, we have actually tried to address some of the concerns about release of that kind of information by using SNOMED to collect what we have called informational sensitive topics and that when users of the PHR make a determination whether they want someone else to have access to it; whether it is caregiver or a healthcare provider or whatever, they can opt out of having some of that sensitive information shared to that person. So, the construct of the tool itself is trying to be sensitive to that, but I do not know that we will actually learn anything specific about that group of diagnosis.

MR. REYNOLDS: I also think that I would concur with Karen. There was an awful lot of discussion about that in the hearing we had yesterday and that is an environment where the committee should be able to weigh in quite heavily with the testimony that we have been getting. So through the efforts of the John and Leslie are leading, I think that came up not only in the panel from the CMS group, but some of the other panels and that we had talked about that significantly. So we should be able to not only deal with mental health, but other sensitive situations that came up quite significantly in the discussion. So, make sure you stay tuned with us on that and follow up to make sure that that does occur.

Karen, I would also like to thank you as somebody on the ground that is using 50-10 and ICD-10, I think CMS has done a magnificent job stepping up and has I would say to all of you has learned quite significantly from the other HIPAA implementations as to where they can play and how they can play and how they can get out in front and really help the industries. So, I do see a significant change in that and thank you to you, Tony and Denise and others so thank you very much for that. That is much appreciated.

With that, we will get back together at 10:35 and see you then.


Agenda Item: NCVHS Summary Following Public Meeting on “Meaningful Use”

MR. REYNOLDS: Let's go ahead and get started. The next item on the agenda is our discussion of the kind of effort we put in on meaningful use.

First before we get started, I would like to say some kind of special thank you's to Margaret A., Marietta, Debbie, Karen, Denise, Jeannine, Cynthia, and so on. If I left anybody out, I am sorry. That is maybe the fastest hearing put together with the most oomph to it in the history of the United States. It was put together well. We worked closely with Chuck at ONC. Outstanding job putting that together through the process. Tony Trinkle and David Blumenthal, and so on.

One thing – just a level set for some of the committee that maybe has not been around a long time, this assignment was taken on by the Executive Subcommittee and the reason it did not come back here before the documents went through is there were no recommendations. All we did was basically have the hearing, listen to the input in the hearing, and then we grouped it up into some observations. We did not make any recommendations. No recommendations can come out of this committee without it being through the committee and without the Full Committee's involvement.

I wanted you to understand that. We were asked to complete an assignment to be an environment for a hearing, listen to the hearing, put a read out of the hearing, and then we grouped that up into some observations and I will go through some of those briefly. But I did want some of you that – well, I had not seen it happen at that level before quite the way it did, so we were all kind of making it up as we went. But that is exactly why the documents are already complete. We did not send forward any recommendations to this committee.

Now, if we are asked to do so as a next step, by ONC, whether we do or don't, that would come back through the Full Committee for full jurisdiction by the Full Committee and would go forward in our consensus manner as usual. I just wanted to make sure that you were aware of that.

So we went through all the structures and everything that we needed to, to do that and that is why we took it in that way. I wanted you to be aware of that so that nobody felt that we had gone outside process – we went outside process, but we stayed within the right process to be out there, as you look at it.


DR. FITZMAURICE: John Lumpkin, in his daily blog, has announced that on June 16th, David Blumenthal will announce the “meaningful use criteria” - the first draft of it. I was wondering if given this expertise by NCVHS, that we would plan to make comments on that draft of meaningful use?

MR. REYNOLDS: A lot of time we do – when new things come out, we do as a group, decide whether or not we would want to comment on it.

DR. FITZMAURICE: So we will just wait and see until we see what it looks like?


MR. J. SCANLON: I believe what they are doing on the 16th, Mike, is the Health IT Policy Committee will be – one of its workgroups will be releasing what they think is the meaningful use. So it is basically a FACA product, as I understand it.

DR. FITZMAURICE: So it will be the workgroup according to the FACA?

MR. J. SCANLON: It is the work of another advisory committee. Again, the committee could react or not. It is not an HHS adoption of what they say.

DR. FITZMAURICE: So the question really is is there a policy that we don't comment on what another FACA says or we just wait and see what the importance is and see if we have anything to contribute to it.

MR. J. SCANLON: My only point was it is not an HHS document, it is a FACA document.

MR. REYNOLDS: But it is being put out there for public comment, I believe.

Chuck, help us through what the process is here so we know whether to jump in or jump out.

DR. FRIEDMAN: This discussion is just a bit premature. The matters discussed in the past three minutes are not completely settled. But there is a subcommittee, as John Glaser and Jodi Daniel will describe at 11:30. There is a subcommittee of the Policy FACA, dealing with this topic. There is a meeting of the FACA on June 16th.

DR. FITZMAURICE: I am only reporting rumor that John Lumpkin had in his daily blog, so it is public knowledge.

DR. FRIEDMAN: Right. So I am just stating the facts as I know them to be fact. I think if John or Jodi are more comfortable saying anything beyond that, they will.

MR. REYNOLDS: The other thing, let me say for the discussion between now and noon, let me try and put a little box around it. Everybody knows that there are two new FACA committees. Those FACA committees are playing in some cases in the same space as us, in some case in other spaces – different spaces than us. We are, myself, Jim, Marjorie, we will be continuing our communications with Dr. Blumenthal. You can rest completely assured that when they know more about exactly what they are going to do and what space they are in, we are continuing and we set up an excellent relationship I think, through the Meaningful Use that we just did, to continue to show what we do and how we do it. You will be made aware of how this all plays together instantly upon it becoming clear.

I think the one thing that all of us do since we are so anxious to make a difference, I think it is important right now while the structure of how a difference might be made is under construction, which is exactly what is going on right now, in this whole space with as fast as it is moving and with new players on the block, that you just understand that we are saying to you clearly, we understand that is an issue. We understand it is an elephant in this room. We understand it is an elephant in a lot of discussions and we are excited about elephants.


We are absolutely – we are ready to ride the elephant, we are ready to feed the elephant, we are ready to do whatever, but the main thing is we also realize that we have things we can do ourselves. So for example, in the earlier discussion on PHRs, we are the main FACA committee in the country that is right now focusing on PHRs and everything related to it. Don't stop. Don't slow down. Keep going.

On comparative effectiveness, since it is new and since it is in its infant stages, if were to want to be thought leaders in that environment and think about what ought to be thought about, perfect example. So let's don't paralyze ourselves or our thinking or do we want to chastise somebody else that can't give us the answers to questions that may not even be on the table yet. It is not a lecture, it is a request. I can tell you we have taken this very seriously and we continue to take this seriously – the three of us sitting here along with Dr. Blumenthal and we are in constant contact about that.

We will be sitting down soon. When soon is the right soon. So just please understand that we have got to do that due process because the worst thing that can happen right now is people fighting for turf that is not understood. The worst thing that could happen right now is to slow down what needs to move fast. We will follow, walk beside, and lead, as appropriate in this next period of time and I ask you to continue to remind us what those should be. Those shots that we have that are clear, go and go fast. I think that we showed that we can go fast in helping also, and I think what we did in an excellent way with the Meaningful Use. I just ask your indulgence in that.

Rather than asking Chuck, when he presents, asking him the same question, and then John Glaser and then Jodi. I've said as comfortably as I can, we need to get over that for right now and we need to make sure that we find what we want to do, how we want to do it, and so on, and then we put it through the right filters to make sure that we are not – because it is the same department. It is the same effort. It is the same environment – let us make it happen.

Chuck, you had your hand up.

DR. FRIEDMAN: Yes, Harry, thank you. I just wanted to add because the agenda formally shows me doing the update at 11:30 solo. I wanted to be sure that everyone was aware that at 11:30, John Glaser and Jodi Daniel will be dialing in and we will be giving an informational update on the activities of the two new advisory committees – very much in the spirit of what Harry just said, primarily for the purpose of you all being fully informed of what – or as informed as you can be in the time allowable, of what these committees are doing. And of course, because they are federal advisory committees on the HealthIT.hhs.gov website, there is a full set of materials describing the committee's activities. But Jodi and John will be coming on the phone and giving you an informational update.

MR. REYNOLDS: The other thing we want to make sure we do is there needs to be some courteousy in this clearly, we want make sure that even though our recommendations go directly to the Secretary, we are working in the same space. Let's make sure we don't deter ourselves in what we are able to do but courteousy is a very important thing as you are working in this tight of a box on this big of an issue.


DR. SUAREZ: Just a quick question, the observations document – has it been sent?

MR. REYNOLDS: Yes. It is already posted on the website. Actually, I commend Dr. Blumenthal, as soon as he got it he posted it even before he in fact, evaluated it. That is transparency at its best. Taking our document as we had prepared it and putting it out there for public view before they had even spent anytime scrutinizing it for anything. I take that as a compliment. That is as good as it gets right there. When they take it and put it straight out there and say – I think we have done a good thing there.

Let's turn to, if you would, tab 8. I am sure not in any way going to read this. I just want to kind of go through kind of the structure and have you understand how we organized this. Obviously the first document in here is actually the observations, which is a good place to start because it kind of shows you how we grouped up what we heard.

The five bullets on page one, really kind of got into the overall – it kind of gave us a general theme that we dealt with. We spent a lot of time trying – and actually had a lot of consternation over if we had 17 observations, then we came up with themes – did we need to put those themes under the observation. We had a lot of discussion about that. Hopefully these themes are just really a good way of breaking down what we heard and not necessarily do they apply in anyway one to one, or any other way, with the 17 observations, but were just some of the things that we heard.

We really broke the document from that point on, if you move onto the second page and so on, common directions. I don't know if you know it or not, but we had a 150 testimonies. We had 40 personal right there in the room, that were invited, we had 20 that came to the microphone in the open public mic, and we had 90 written. I can comfortably tell you and it is important that this is clearly stated in public record, we read them all, they all mattered the same. If you went through the documents you can find where there are key premises that were only in written, only on the microphones, or only in testimony. Then we took the common threads across all of them.

Because what I think what is extremely important as we go forward, and each of you in subcommittees or anything, if you ask for written testimony, you must read it, you must include it, and you must consider it, otherwise we would be making that testimony secondary to what else went on. It was a lot of stuff, guys. It was a whole lot of stuff on a subject that is incredibly exciting. It was very rich and I think it was helpful.

I also would like to say to those of you who were not at the original hearing, Dr. Blumenthal, except for the last hour of the second day, remained in the room the entire time, as did Tony Trinkle from CMS. This was something that was played out clearly. We had up to 300 people in the room for the hearing much of the time. It was an interesting event but I think we got a lot of stuff and we did it well.

So the common directions were obviously easy to at least identify, maybe not communicate. Then we had, if you move to page four, we had multiple options. As you can imagine, with 150 testimonies, there was some difference of opinion as to how some of the options can play out.

Then if you go to page five, we actually recognize some gaps. The reason that we did it that way is obviously as the other two FACA committees move forward and ONC takes a look at this, where there were gaps in testimony and maybe gaps in what is going on out that, that would be an excellent opportunity for them to focus and have somebody look at that further, whether it be them or someone else, take a look at those things further if those thing were not in fact, spelled out by the 150. It put us in that position to make sure that we did that. That is kind of what we did.

Leslie, you have a comment.

DR. FRANCIS: I just wanted to describe what John and I did, for example, about Privacy and Security. As chairs of the different subcommittees, we were asked to pay particular attention to our areas of interest and expertise. We actually went through and every time anybody mentioned privacy or security, we did a little compendium and then we worked from that to see what was said or what was simply not treated. That is the methodology that we used.

MR. REYNOLDS: Again, that was done pretty well across the whole group so all the chairs were asked to look at the testimony in its entirety, as well as make sure we did not – since they had an expertise, that we did not oversee something. Then obviously, our summary.

That again, was after the big work, which if you turn to the back of that a little further a long in that section, the whole document itself, which is a substantially larger document that we went through. We tried to put it very much in the categories – on page one, a vision of health care transformed. The reason I am doing it this way is we have people on the internet, and maybe people in the audience, that don't hear this. I know you have your documents in front of you and I know that you can follow pages, so I am not reading to you as fifth graders. I am making sure to the entire that they at least understand what we have put together and where it is.

After our introduction and purpose, really the vision of health and healthcare transformed, we heard, and I would recommend to all of you that you – if you don't spend a lot of time on the document, I think it would be important for you to really, really look at some of this vision stuff because those people were selected mainly to kind of take a look at how all this moves forward. So as we continue to be thought leaders and we continue to move forward on what we are doing, that is a good section to keep an eye on. We are not any way saying, right, wrong, or indifferent, we are saying these are some interesting visions that were out there as we went through it.

Then this whole idea of meaningful use capacity. As was said earlier, I think one thing to be mindful of as Karen was going through 5010, ICD-10, and then you take this meaningful use capacity on top of that, there is an industry out there that is going to, between now and 2015, have a lot of change going on. We, and others, have to be careful not to just take one lane of that highway and focus on it, we have got to deliver the whole highway system of all these changes and all the lanes. I heard a comment the other day that right now, with as much as is going on, there are orange cones in every lane. So you are going to have to do some weaving to get through this whole thing over the next period of time to get this done. We have all got to group up and make sure that we help in every way that we can.

Then the path to meaningful use. I think one of the things we heard clearly, and everybody else did, is this whole idea this is a journey. Some offices may be starting from zero in their electronics, and others may be large medical centers and there may be states that have health information exchanges already. So there is a broad spectrum of who is going on as we deal with it.

The other thing I thought was a key one to point out there is the vendor cycles, which is on page nine. The important thing is when you talk about new functionality and you talk about the other things that are going on out there, if they are delivered through vendor systems then their ability to adjust, change, and react, as they mention in here in a 18-24 month cycle. So if you start thinking about 2015 and you go back to 2009, you don't have a lot of cycles. You don't have a lot of those two-year cycles left between now and the end of the journey. So that is another key element as we think about this. Same thing with providers and so on, as they deal with it. So we have a number of sections on that.

Then the whole thing on certification and meaningful use. The product and the strengths and weaknesses of some of the certification that is going now – what does it mean? What does somebody have to adopt to be certified? So if you get a certified system do you need to do the whole thing to actually do meaningful use? Those are the kinds of filters that are going to be needed – get into measuring meaningful use and so on.

That is kind of how we – that is the way the hearing was set up. That is the way we heard what we heard and that is how we categorized it and tried to turn it into a document, which I believe that ONC has already found valuable, and then the observations take it to a next level as to put it into other categories.

With that, I would like to open it for discussion by the committee or anyone else that has any comments. If there is a question I will open it to all members to answer by the Executive Subcommittee. I will not assume that it is directed at me or anybody individually.

With that, Justine, please.

DR. CARR: Thanks. Thanks to everybody. I echo your thanks to everyone who worked so efficiently and deliberately to make this work so seamlessly. It was really a remarkable effort.

I want to put out the question of with this initiative going on, does this shape what NCVHS – the directions that we take going forward based on this work and this focus of activity within our subcommittees? Would this enter into our plans for hearings or topics to address?

MR. REYNOLDS: I think a couple of things. I think it is one input to it. For example, we talked this morning about comparative effectiveness day – whether we want to go after comparative effectiveness PHRs. I think there is no question – this is my opinion and I will open it to others – the subject is in here, absolutely. There are a lot of subjects that are listed in here. I think as soon as meaningful use comes out, any kind of a definition, this was as we all know, the initial thing was kind of everybody say what you think. Then the observations took it down and then whatever comes out, whether it be June 16th or whatever, comes out as some kind of initial guidance.

I think us looking at where there might – we could either add thought leadership by holding hearings. Whether we have already done work in some of those areas that may be submitted to that. I think that is exactly what I would want each of our co-chairs to be looking at.

Again, as we continue this relationship with ONC, those recommendations can be taken forward so that coordinated with Jim, Dr. Blumenthal, that we take what we have. On the other hand, as I said, some of these items we won't need to ask anybody's permission to be working on. They are part of their charter. They are part of what we do and they are part of how we do it. That is why I would hope that all the efforts that are going on right now, including the discussion earlier this morning where we highlighted a couple of things, would energize people around the room to really – when your subcommittees breakout, really think about how do we make the biggest difference right now. Whether it is thought leadership. Whether it is kind of helping formulate something that is going on or whether it is helping somebody else's ideas. I know that is what I am thinking about and I would hope that that is what every committee thinks about. Period.

DR. CARR: I just want to second that because what I think worked well about this is we did the things that we do well. I think as we look at this and examine maybe the gaps or the things that were not said, these are areas that we can continue to contribute without being redundant or duplicative.

MR. REYNOLDS: Absolutely. I think that was well said.

MR. HOUSTON: I think the challenge is is always trying to figure out where input is meaningful, where it is welcomed, where somebody really is looking for somebody to provide input. Again, I don't like to meddle or make recommendations in areas where I don't think somebody is really wanting us to involve ourselves. I think it is interesting in listening to Karen this morning about some of the forming in order to address the new privacy rules within HHS – the groups that are forming. At least from a privacy and security perspective, maybe than rather than making assumptions or trying to read a crystal ball that may not be reality, I guess I am looking for more guidance. Tell me what do you want?

MR. REYNOLDS: Who is “you”?

MS. GREENBERG: Who is advising whom?

MR. HOUSTON: That is the question. By example, if Karen says they are pulling together a group within I guess, HHS, correct Karen, to look at some of the privacy stuff. Are there gaps? Are there areas where they say you know something, we really could use input through our processes on a privacy and security perspective from NCVHS. Right now we are taking testimony on PHRs and it is obviously an area where the privacy rule requires recommendations over the next four to six months. Are timing for getting something out of lines with the timing in the – where do they want us to be use and where do they want us to be of use and how do we accomplish that?

MR. REYNOLDS: Here is how I would recommend it. We have heard loudly from Marjorie and Jim both, at time. We need to have a customer. Sometimes a subject can be our customer. If there is a subject where we need to be out in front – that can be our customer.

So, for example, - Jeff, I see your hand and I have got you on the list - if you look at standards, and this may be what Jeff was going to say, but I will use how we are doing this along the way. If you notice we took the standards subcommittee to do this hearing. On the other hand, what Jeff and Judy are doing is talking to CMS. Since there is another standards committee, and since right now figuring out exactly how we all play is a question.

So if you took 5010 IC-10 as just an example – I am not recommending that we do or don't do this, but it is a great example, there is a lot of work that needs to go on in this industry over the next three years on 5010 ICD-10 and I promise you none of the new committees have ????

Meet with the people who you tend to deal with. Think about the people that would be your audiences. So that was a great fit for Jeff and Judy to start talking to CMS – okay, fine, all this other is going on – 5010 ICD-10, e-prescribing, dah, dah, dah, some of these other things that are going on, can we go there now, make a difference there now since that is a big change coming, and let the rest of this fall out as it needs to. Oh, by the way, we may find three standards areas we need to go into or we may actually have a couple of things that ONC might want us to do. It doesn't matter. We are working with who are our customers. ONC is a customer. CMS is a customer. The Department is a customer. I am deferring some of that to Jim and others to do it. That is what I want you to do. That is kind of how to look at it.

So I think the PHR – since obviously since they are doing pilots, I think it is great that we do that. Again, for example you referenced to one lady that talked so much about how electronics are changing out there in the general public. That is something that we can bring to the table that working with Medicaid population would not necessarily come out. Walter mentioned Medicaid.

We have got Larry, Bill, Jeff, and Carol – did I see your hand? Larry.

DR. GREEN: Harry, one of the - actually I will prioritize it differently. The thing in the report that leaps out at me – what is the right word – most confusing or most inviting or –

MR. REYNOLDS: We will go with “inviting”.

DR. GREEN: Is the word certification juxtapose to two words, meaningful use. This is on page four, page five, in the summary, it is in the vision statement, it comes out in pages 14, 15 and 16 again. I could use a little help with more elaboration about – I am concerned that I may be just framing this up completely wrong from those of you who were at the hearing. But there seems to be a real tension here in the report about what certification accomplishes and specifically, what is certified. Is it a finished product that is certified or is it a set of standards that are certified? Is it the exchanged standards that are certified? This strikes me as being pretty important and pretty problematic –

MR. REYNOLDS: It is and I will make a comment and then I will open it to my friends around the table who were there to make any comments. Some of them are much better at this but I will give a general statement.

The first general statement is that back to the point of the openness. The whole subject of certification was put on the table by CMS – by ONC and CMS as part of the process. They were asking people to consider, evaluate, and challenge, if necessary, the status quo of what certification is or isn't? What it means and doesn't mean? Who does it and who doesn't do it and what it looks like? I commend them for that panel.

You are absolutely correct because now where certification in the past had a certain meaning on certain things, a lot of that has changed. With that, I will close my mouth.

Jeff, and Walter is into that kind of stuff closely, so I am picking designated hitters here that know their subjects.

MR. BLAIR: I think the fact that you observed – you picked out that there are tensions, inconsistencies, in terms of testimony we received about certification. Well, then that means this report did its job because remember these are observations. We did not try to reconcile them. We are at a stage, and I think ONC is at a stage where a lot of those tensions – it is going to be their role to reconcile those. This was as far as we could go and I think that the report did its job by pointing out that – it communicated well in that you picked up the fact that there were some inconsistencies –

DR. SUAREZ: Of all the things that have been done about health IT in the last six, seven years, the one thing that has been the most of which we have had experience, is certification because the certification commission was created first. Even before any of the standards existed or the harmonized standard that HITSP has done – any of the other pieces that the Office of the National Coordinator established, CCHIT started. I think the question was raised was after four or five years of experience, how much has this been successful? How much as been useful in the meaningful use perspective? Are we certifying the right things of the right tools? Are we using the right process to certify those and measure them and evaluate whether they are being actually used?

To me the bottom line of the message was we have a certification process that is very detailed and specific, but then we have an implementation process that doesn't necessarily match what the certification is. In other words, and I have been saying that several times, what is being certified might not be what is being implemented and that is the bottom line – is it the certification process measuring the right elements that need to be certified or does it need to measure, not necessarily through certification but through other means, the adoption and implementation of those elements that have been certified.

So I think that to me, was sort of the essence of the discussion.

MR. HOUSTON: Could I just add one point to Walter's point, there was a real interesting slide that was put up where they showed a certified product and then it sort of had a scatter gun graph of what actual customers implemented as part of a certified product. It was across – it was nothing to everything and it was a really interesting slide because it really tells the story that certification is not the end all be all - implementation of certification is what has to be really emphasized.


DR. W. SCANLON: This goes back to Justine's question about where we are headed. Since I have been on the committee, and particularly involved with the Population Subcommittee, the focus very much has been on the issue of the adequacy of data to monitor population health since they have an impact on population health. I think partly one of the themes has been the issue of resources and sort of the adequacy of resources and therefore the adequacy of data.

While that may continue to be a theme, I think there is another one that we, as a defensive mechanism were developing, which is how do we get data and use data most efficiently? From that we have had hearings about linkages. We have had discussion of access of information. I feel like we are now at a turning point with this Stimulus Act and sort of the investment in IT because up to this point probably our thinking about health information technology has been as a hypothetical tool, it might improve population sort of health data.

Now we are at the point where maybe it can be an effective tool to do it. But it is not a given that that is going to happen. A major portion of whether it is going to happen is going to depend upon how meaningful use ends up being defined not June 16th, but over the course of the next five years or more.

I think it is very important, since we have probably on this committee sort one of the few groups that has a focus on population health, that we think about meaningful use definitions evolve, what is the impact going to be in terms of how do we change the statistics on health at the population level for the country.

MR. REYNOLDS: One thing good about you being a co-chair, you have that opportunity.

Jeff, Carol and Walter.

MR. BLAIR: I just want to make a couple of comments about the FACA committees and their roles. It wasn't very long ago, it was less than 10 years ago, when NCVHS was in an environment where there was no Office of the National Coordination of Health Information Technology. The role that we played at that time was a little bit different.

Then in 2004, by Executive Order, The Office of National Coordinator was established with limited funding. Progress has been made and now the Office has a great deal of funding and it has a new national coordinator, who has only been in place for a few months. A few months, gosh, it is just barely over one month – isn't it?

The thinking that I had and I am going to echo a little bit what Harry was saying, I put them in a different order. Leading, following, or getting out of the way – each of those roles are appropriate at different times. There will be times in the future when NCVHS will be looked for for leadership. There are other times like with the meaningful use, where it was a short period of time we were asked to help. We were asked to follow some of the lead that was needed in a short period of time. There are other times when we need to get out of the way and not be an impediment because a lot has to be done in a short period of time.

I think that the role and capabilities of NCVHS – capabilities and limitation of NCVHS are pretty well known. The Health Information Technology Policy Committee and Standards Committee, to be honest with you, I think reflected the fact that the nation needs to do some new things, and NCVHS doesn't have the time, the resources, to do it all. I don't think it was a criticism of what NCVHS has done because essentially it has kind of implemented a lot of the things we have asked to be done. Be careful what you ask for and what you recommend – you just may get it. In a lot of ways we have gotten what we have asked for.

Now things have to be sorted out a little bit because when it was put in place – I think Congress did a very good job in the way they defined the roles of ONC with the additional funding and the roles of those two new additional committees, but there are a few pieces there that don't quite fit yet in the fact that NCVHS still has responsibility HIPAA transactions, e-prescribing, privacy, and for a number of other areas.

I feel as if, just as Harry has said, we need to give the new coordinator a little bit of time to wind up figuring out what they must do under the law, where they have deadlines, and what they can do and where NCVHS can help them. We have been partners in the past. I think we will be partners in the future and we need a little bit of time for our new partner to get their feet on the ground a little bit. Those were my thoughts.

MR. REYNOLDS: Spoken well as the sage of the committee. Carol.

MS. MCCALL: Looking at the documents that you put together, I love first of all, that you added a section on gaps – things that you did not hear. I think right now, it is going to be particularly relevant. Obviously there are a lot of things happening but there is this – the surgical field is small and yet there is a lot going on. Right? Given how small it is and how much there is it is amazing things are missed, but they are.

I think when I was reading through the letter to Madame Secretary, we talked a little bit about the history. I thought the letter was very good. We talked about framing. We talked about bringing together consensus. I would add gaps. I, too, think that the idea of taking testimony, creating observations and given our knowledge, identifying gaps could be a distinct need and role that we could play right now. That is point number one.

Point number two. Where there are gaps I think there could be an opportunity to highlight those and you go, man, this one needs to rise to the top of the list because if you don't address it now it is going to be a mess. That would be something within there.

The other thing that could be needed was to identify connections between where two big themes need to meet each other. For example, we have talked about comparative effectiveness. We also talked about ICD 10. When I think about what happens when we cross those two streams – oh, my god. We sit and we complain about data and look, data happens. It is always going to be messy and dirty and need taxonomies and semantics but data happens. And we think about piling it high and using it for comparative effectiveness, but what happens when how you interpret the future or how you run the future is not how you describe the past. Those have some very specific and painful details in there and I don't know how to cross-walk that. We can barely get all our data together, let along decide giant do-over. Let's just wait until we build mountains off our new vocabularies.

That is a connection between two very important themes, two things coming at about a 1000 miles an hour and I don't know if that would be ours or somebody else's – but it is a gap.

MR. REYNOLDS: Great. Walter.

DR. SUAREZ: I have two comments. First of all I want to echo everybody's acknowledgement of all the people that were involved in this hearing. I think I have not seen anything quite that extensive and complex and comprehensive and successful and well attended as this hearing.

I have two comments. The first one, in going with the theme that in some cases we can lead and in some cases we can collaborate and in some cases we can get out of the way. I think there is also this perspective that in some cases we can get into the nitty-gritty, into the get dirty kind of detail of issues and sort of dive down into the details of them.

In some cases we will need a committee like this one to stay and look at the forest rather than be trapped in the trees. My sense is that both the policy and standards committees that have been created are going to have a very specific focus and attention to details. That is going to be part of their responsibility. I think our committee has the opportunity to keep also looking at sort of the larger issues that cut across not just health IT, but other areas, particularly the things we deal with consistently; population health, for example, is one of the fundamental pieces of our work or quality measurement or quality assessment.

That is I think, one opportunity we have is the ability to try to stay high level in some topics and issues and in other issues sort of take the lead and responsibility to dive in to the details. That is one comment I wanted to make.

The second one is the progression of activities that related to some of the key elements that are interplaying in this whole health IT arena and all healthcare systems. I think in the late nineties, we were moving to evidence-based medicine and started focusing a lot of attention on that and now we are moving into comparative effectiveness. At some point I hope we will be moving to optimization of processes because I think we might actually find in the comparative effectiveness research that there are some things that are better than others. But when you look at those that are better, one can think of making it even better – optimizing those processes. I don't know that there is enough attention being put into that area of optimizing those processes that are comparatively more effective than others.

I think the next edge in this process in my view, my sense, is really looking at optimizing processes. That might be an opportunity that we would have.

MR. REYNOLDS: Judy Warren just joined us. Judy, why don't you introduce yourself.

MS. WARREN: I am Judy Warren, University of Kansas School of Nursing and I have no conflicts that I know of other than with airplane schedules.

MR. REYNOLDS: What I would like to do now is open it to the group for any other comments on this before we – in five minutes we will have ONC calling in.


DR. HORNBROOK: I was not able to attend the meeting for Meaningful Use Panel but you think about the word “meaningful use”. I was sitting in the waiting room one day. This Hispanic lady walks in with a little boy with her and wanders back and forth for a few times. Finally gets the courage to go up to the receptionist and she talks in Spanish to the boy and the boy translates to the receptionist the question. They are looking for a particular medical office.

So the receptionist replies in English that this is a Kaiser office, you need to go up to the third floor. I thought, oh, god, how in the world is this receptionist going to explain to this woman who barely speaks any English, what in the world the concept of a HMO and Kaiser is and why she can't get her care in this office because it is exactly the same as the one on the third floor, it is just a different set of health care arrangements.

It raises the question of course, of whether EMRs are set up to be culturally sensitive? I know there are a number of Kaiser Members who are not English speakers. So when they go in looking at their charts, is it given to them in Spanish? As far as I can tell, one flavor fits all.

Then another thing about meaningful use is – what is it half of the personal bankruptcies in this country are medical bankruptcies. Most people still need care. How in the world do you set up a medical record system to facilitate somebody who has got $300,000 of debt hanging over – they can't afford any more medical care but they are still sick. What is the kind of guidance that you give to both sides for that type of exchange? Do you ignore the fact that they have the debt thing going on?

What about patients who live in abusive environments? Do you keep that secret or does the provider get to know that this patient needs to be protected? You don't just walk into this examine knowing that this patient is just like any other college educated sophomore who happens to have high command of English and a high command of the bureaucratic organization.

There are a whole series of social aspects of meaningful use of medical record systems that we have barely begun to scratch the surface.

MR. REYNOLDS: Better known in today's world as a target rich environment where we ought to be able to come up with some good things. Righ here, and then Dr. Sondik and then Larry?

MR. O'GRADY: Outside of meaningful use, you've also talked about sort of the notion of the role of an advisory panel, and how you fit, so I just want to say a few things having been a policy maker who used this advisory panel and other ones.

Just a few things to be kind of careful as you proceed. Really what the Secretary is looking for what the department's looking for out of one of these kind of FACA panels is an outside expertise and a second opinion. There's great expertise within the Department there is no doubt about that, but it may not be taken into account all the things you're seeing on the outside. It is that trying to get a second opinion that is the real value added to a Secretary or to an assistant secretary.

So you want to be sure that you're not obstructionist at the same time you don't want to be a rubber stamp either. You want to be sure that you bring that extra to the table, but if the emperor has no clothes you do have a professional responsibility to say something about it.

I would advise you in terms of surviving these somewhat difficult waters, that the way often to do that is to be out in front. That you sort of are a exploring those new things you're afraid that folks inside, who are really busy trying to implement, don't have time to look at, and you can sort of explore those. You have better feel for what's out there, what's going on in California or Colorado or whatever, and that's something where you can kind of raise and do a value added. But it is really, I mean, the whole point of doing this if you could rely on SES and GS15's and the various agencies for everything, this would be a waste of the taxpayers money candidly. So it is that idea of thinking about what you bring to the table, what is unique, and it can be very helpful. It's very reassuring for a Secretary when both there internal advisors and there external advisors both say of the four options on the table, option two is probably the smartest way to go. That just allows them to sleep a little better at night that there getting that they haven't been caught up group think?

So you don't want to be obstructionist, you don't want to be a pain, you want to be helpful to this process, at the same time you don't want to be totally part of the rush.

MR. REYNOLDS: Thank you that was well said. Dr. Sondik.

DR. SONDIK: At the risk of repeating what Bill Scanlon said, I just want to draw everybody's attention to the summary paragraph, first summary paragraph on page seven, that says that the focus must be on the ultimate vision for quality outcomes, health status improvement, and control and cost. I think that's really crucial, because it was, as you pointed out, a tremendous amount of testimony. To me this is the bottom line, and what we all hope is that the technology would in fact do this. It would eventually lead to, maybe even more immediately, but lead to improved outcomes.

I think it's very important that we have in place the means of measuring that in a very objective, Mike O'Grady third party, if you will, kind of way that says this is what is being achieved and even more so this is what is not being achieved. These are the gaps, these are not being filled, and so forth.

New York City has a project of personal health records, I guess, that's being put in place, and the defined focus of that is to improve health status. I think that is something this committee can really bring to this discussion, and I think it's something that's very easy to get lost in all of the technical details of the difficulties of mounting something. But if it isn't happening then I think the decision makers really need to know that.

I think it's a really hard question as to know as to how to judge that and when to judge it. It would be very easy not to judge it and say well we'll look in a decade and we'll see what things look like. I don't think that's really good enough. I think we need to put in place a strategy for evaluating this, and not just in terms of process but really in terms outcome.

MR. REYNOLDS: Okay we got Larry and then, Carol do you have a follow up on that.

Ms. MCCALL: Yes I did, just to follow onto that, and I still use the picture from vision for a health statistics enterprise for the 21st century, and I think about how its like opening the aperture from disease and even functional status and well-being, to communities and other broader contexts, and I think you're right. I think if we talk about it a lot, but the data and the metrics necessary to do that, just to get started we talk about it, but there's important work to be done. So that would be an area where I think we could make a material contribution to actually engage what are the sources of data that are available or could be. What are the measures? Let's move beyond data and get to measures that we could begin to use, so that we can start measuring. They won't be perfect but they're a start, and they're important. And it actually goes back to our roots as well.

MR. REYNOLDS: Larry last comment, and then we got some people calling in that's what I want to make sure that we-.

DR. FITZMAURICE: They just left the clinical quality worker group and are calling in.

MR. REYNOLDS: Okay yes, that's what I mean, I want to be courteous of them, so Larry we'll take your comment, and then-

DR. GREEN: I'll be quick, Harry in the spirit of Mike's comments, I would just like to notice something since we last met. Since we last met I've had the privilege of attending a lot of meetings, like all of you, like the
American Heart Association, just came from New Orleans for the American Diabetes Association, the Association of Health Behavioral Scientists, American Cancer Society, and then a number of residency programs that are revising their training programs for physicians to accommodate the health information age. I had noticed something in the last few months that sort of startled me. The conversation where I am seems to have shifted from the acquisition of an EHR to the acquisition of a module that can solve a problem that needs to be solved in order to help people. And it's gone very public very fast.

Yesterday in New Orleans I heard several illustrations where people just stood at the microphone and blatantly said, if you think you're ever going to get an EHR to do that, at least in my lifetime, I think you're crazy, here's what I think you ought to do.

So this relates back to this discussion about meaningful use-

MR. REYNOLDS: And your certification discussion.

DR. GREEN: And the certification discussion. I think it is possible that events are over taking us. And that people that are going face to face with patients – orthopedic offices, whatever, they are looking for ways to get rid of clicks. They are looking for modularity and interoperability, hyper exchangeability, being able to get the information to where the patient is. It sort of builds off of what Mark was talking about, about how do you build a culturally sensitive HER from the ground up? Is that really what we want or do we just want the mechanisms and the flexibility and the adaptability – the ability to adapt to what we have got to get done in our town, our place, and our system.

Again, Mike, you prompted this in what you said. I think the folks on the committee need to keep our eyes and ears where we are between committee meetings. I just wish to report that because for me, this is like a bucket of cold water. For what it is worth.

MR. REYNOLDS: That is good. And again, we will have more time to discuss all this. Great discussion on what we have done so far.

Chuck, I want to turn it over to you. Are John and Jodi on the phone?

MS. DANIEL: Yes we are.

MR. REYNOLDS: Welcome. Glad to have you with us. So Chuck, if you will lead us through this portion, please.

Agenda Item: Office of the National Coordinator for Health Information Technology (ONC) Update and Current Activities

DR. FRIEDMAN: Thank you, Harry.

MR. REYNOLDS: John and Jodi, just to update you, we have discussed all the interactions amongst the committees and so you should not be receiving any questions about those situations. We look forward to your information and we will take it for information. Thank you very much for being willing to join us. You missed that conversation so I did want to update you.

DR. FRIEDMAN: Thanks, again, Harry. We have under the rubric of the ONC Update, actually three parts to present to you this morning. John Glaser and Jodi Daniel are on the phone to update you from an informational perspective, as I mentioned before, on the recent activities of the two new policy committees.

I will follow that up with a brief presentation and hopefully a illuminating discussion around the regional extension centers – a draft report on which was recently published in the Federal Register. Because I know that John and Jodi's time is limited, let us start with them.

John and Jodi, have you worked out which of you would go first? I believe, Jodi, you are doing the policy committee and John you are doing the standards?

MS. DANIEL: That is correct.

DR. FRIEDMAN: Jodi, do you want to lead off?

MS. DANIEL: I would love to. Thank you so much. Thank you Harry and members of the committee. We are just going to give very brief updates on the federal advisory committees; the policy committee and the standards committee. I am going to be talking about the policy committee, which met for the first time last month and is scheduled again to meet June 16th from 10:00 a.m. to 2:00 p.m. eastern time.

The policy committee has a fairly broad charge. They are charged with recommending a policy framework for the development and adoption of a nationwide health information technology infrastructure that permits electronic exchange of health information, as well as to recommend areas and priorities for standards, implementation, specification and certification criteria. Which will inform the standards committee as far as the priority from a policy perspective that they should be looking at.

Then the statue also goes through and lists some very specific areas that the policy committee should or may, consider these two broad objectives.

As I mentioned, the committee met for the first time last month. We have representatives from a variety of different stakeholder groups and with a variety of expertise representing providers, consumers, vendors, health plans, et cetera. We have got quite a variety of folks. We have got experts in privacy and security as well. Then David Blumenthal is chairing that committee, as well, so I think that is very helpful in sort of helping to shape the work of the policy committee in letting folks know sort of where we are working and what kind of advice would be most helpful and what areas.

We will have a vice-chair named. I suspect that a vice-chair will be named at the next committee meeting. The policy committee established three work groups at its first meeting. One on meaningful use. That work group has been talking about meaningful use and will be making their recommendation on June 16th to the Full Committee about meaningful use in 2011 and beyond.

The second work group is the certification adoption workgroup, which is looking at the certification process in the short term. Making recommendations to the Full Committee on what we should be thinking about for certification process – the certified technology, as well as looking at some other related issues like the health information extension center, work force training, et cetera. So it is quite a broad charge for that group.

The third group is the health information exchange work group, which will be looking at issues related to health information exchange from the perspective of policy, governance, sustainability, et cetera. We have both the privacy and security experts on that work group and we expect that some of those issues will come up as well as some other relevant issues that we need to think about for making sure that health information exchanges is available for those that are documenting this technology to be meaningful users of that technology.

All of the committees will be presented on June 16th. We expect the most thorough discussion from the meaningful use work group. I believe that the other workgroup will be following in short order in the next month or so, with some early recommendations to the Full Committee so that the input can be helpful as we are trying to role out some of these big efforts.

The Full Committee will be meeting about once a month, in the future. The dates to be set later, but the next one after June 16th will be July 16th – so one month later. We expect more progress from some of the other work groups at that time.

I will turn it over to John for an update on the standards committee.

DR. GLASER: Thanks Jodi, and thanks Harry, for the opportunity to spend a little bit of time with you. As Jodi mentioned there is a standards committee that is parallel or sister of the policy committee.

As Jodi mentioned, there is a series of work that the policy committee will carry out, looking at a broader ray of topics, but some of those topics will involve obviously changes that ought to be made to the way certification is handled, perhaps because of new meaningful use criteria and other national health priorities. Similarly, there may be recommendations and priorities surrounding where we need standards and whether those are transaction standards or standards for a particular piece of data that will have recommendations.

Those are to flow through to the standards committee, which has really the broad charge of given the guidance and priority and recommendations of the policy committee, what are the standards, implementation specifications, and certification criteria, recently specific that they would recommend be put in place by the underpinning of the foundation for a lot of the work the policy committee has put forward.

The standards committee is chaired by John Perlin, from HCA and also John Halancuff from Beth Israel Deaconess Medical Center. Just like the policy committee, it has created three work groups – one of which centers on clinical operations. So the standards and the certification criteria that sort of surrounds the on-going activities and clinical care delivery mechanisms that exist in a wide variety of provider settings.

The second committee is dealing with the – it is called the clinical quality work group. This is to look at specific recommendations regarding standards for quality measures and also performance measures that might be coming out of meaningful use as a way this is actually occurring.

The third will deal with privacy and security. So specific standards or certification criteria relevant to privacy and security.

The standards committee has had one meeting. It has another meeting on June 23rd. This week, I'm actually running parallel to the conversation we are having now. We are introducing all three work groups to their charge and asking them if they have core questions about what to do. They do have a very immediate set of activities, and as Jodi mentioned, we will be hearing from the meaningful use work group on the policy committee on Tuesday. They are going to present some recommendations for a definition of meaningful use for 2011, 2013, and 2015. As you may recall, it is sort of an evolving definition of meaningful use.

We have to do a fair amount of work to take the recommendations and obviously, with other input from the public to sort of guide HHS in an eventual decision about meaningful use. But that eventual decision has to make its way into regulation. And in order for us to deliver an interim final rule in December, we essentially have to begin the rule writing apparatus in mid-August. So there is a relatively short period of time to settle in on a definition of meaningful use.

Specifically, the relevance of that to these three work groups is we have done some work to take the meaningful use definition as they will be recommended, and cross-walking those with the relevant CCHIT criteria and also the relevant accepted standards that have gone through the HITSP process – in a sort of three-way walk across the board.

In addition, there are some proposals coming out of the meaningful use work group surrounding measures that can be used to determine whether meaningful use has occurred. And by dent of the legislation, they are also required or meaningful use is required to support some quality measures. So they have some measures along those lines to.

We will take all of that and ask the various work groups that we have here to comment on the work that ONT has done to mask from meaningful use definition to CCHIT criteria to standards work that has been and to see whether our homework has been done correctly because the criteria in the standards has to be folded into the regulations. In order to receive your financial incentive you not only have to engage in meaningful use, but you also have to be using a certified system. So we need to determine or define what that means. And you also have to be using a set of standards – and we have to define those.

The last thing is to review, and in some cases there may be holes – we know there are holes, so there will be some questions of the degree to which we can fill those holes. For example, some interim CCHIT criteria or where the hole filling conversation will take longer than that, and perhaps it is not a 2011 meaningful use statement but rather a 2013.

Those three work groups have some very near term work to do which is to help us frame the content that will be necessary to go into the regulation that surrounds the specifics of meaningful use relevant criteria and also relevant standards.

That is where we are both in their broad intent of formation of three work groups, and an immediate charge that they have, along with a longer term charge and set of responsibilities that have been outlined for interacting with the policy committee.

So Chuck, we will stop and see if there are questions for either myself or for Jodi.

MR. REYNOLDS: We will go ahead and take questions on the first two presentations since they have a time constriction. Any questions from anybody?

You two are the greatest presenters we have ever had because I have never seen this group not ask a question.

DR. GLASER: It is either that or we were incoherent. They are wondering what in the world was that.

MR. REYNOLDS: I got their attention so now they are in. Mike and then Mark and then Walter.

DR. FITZMAURICE: John and Jodi, this is Mike Fitzmaurice. Is there any expiration date on the FACA committees or are they in existence to help provide guidance for the foreseeable future?

MS. DANIEL: There is no expiration date. I think there is an expiration of the charter but the statute provides that they do not expire. There is no expiration date for them.

MR. REYNOLDS: Okay, Mark.

DR. HORNBROOK: In our use of the epic system at Kaiser Northwest, there are 4,000 data tables inside that system. It is possible for a systems programmer on the health plan side to make a new table and leave the old table sitting there, but never tell anybody that it has been obsoleted. So if somebody wants to add a variable to a table, they create a new table. Is the certification process going to deal at all with these kinds of delving inside of these thousands and thousands of tables that make up these complex systems for making sure there isn't a bunch of systematic errors inside?

DR. GLASER: Under the current near term, I think the certification process will largely look like it has in the past, where there is a performance testing capability that you would want to see for e-prescribing or for any discharge summary from the hospital to a receiving care provider.

It might be at this point to go into more of how that product is being managed in situ, so to speak, and whether the particular implementing organization uses it, et cetera. So there will be, as the data are exchanged, there is a indication that that data reported or exchanged conforms to standards that will occur but again will be focused on the inter-organizational movement of data rather than things from the internal management of a set of infrastructure and data tables. Focusing to be internal, and although it is a big deal it is coming through meaningful use, their meaningful use is describing a collection of internal actions on the part of providers, whether they are managing a population of diabetics well or reporting to public health.

One of the things we have done under the certification work group that is part of the policy committee, is asked them to look at the certification process and how that will evolve or how do we improve on it, things we didn't do so well (phone connection interrupted).

DR. HORNBROOK: Hey John, you are going to have to get back up on Jodi's desk again – you are cutting in and out.

DR. GLASER: I think along with a response, I think certification will still look like it does today, which is conformance testing of products rather than management once installed. And that the reporting or exchange criteria will look at the transaction standards and field level standards that are being adopted or not adopted at the exchange. But again unlikely to go within the walls of the organization and see whether you manage one table or multiple tables or whether you keep thing internally consistent or not.

DR. HORNBROOK: There are three things that are very relevant to this committee. One happens to be births and linking moms and babies, and that table is essential inside the EMR system to make sure that moms and babies aren't disconnected or reversed. The other is deaths – linking death certificates. So from a vital health statistics issue it seems like this committee would be very interested in certifying that EMRs can talk to the public health statistics systems.

MR. REYNOLDS: Carol, did you have a follow-up on that?

MS. MCCALL: I think it is actually something that could go on our potential list. It is a gap. And it is a gap in the following way – when we talk about certification, a lot of times it has been historically about software. Functionality doesn't do what I think it is going to do. And then you can talk about certifying pipes, interoperability. But we are going to get to a place where we are going to need to certify data itself, the content that actually goes through. We are getting into a world of information products of the likes that we really haven't dealt with before.

So certifying the actual content itself, the data is not – you can pick on birth and death, but for me I am only going to do each one of those once. But there are data streams that move a lot faster and are a lot more dynamic. So data itself becomes a living, breathing thing, metaphorically anyway. But what is its birth date and how is it changing? So data gets smarter. Data changes and will become aware. It is an architectural issue as well as a certification issue. There are contexts to where architecture, as you can imagine, someday data with an RFID tag to tell you where it has been, tell you who is using it, how they used it, did they change it, was it okay, et cetera. Those are fundamentally different. But it is a concept that I think we need to break out and keep in mind.

DR. GLASER: I think that is a fair point. The current trajectory of both the NS(?) committee and the policy committee is exactly as you say, it is conformance tested, can the product do what it says it does or do what it necessary to at least give you the ability to engage in meaningful use, and does the data that is moved between organizations satisfy current standards and criteria? It is silent on what is required to do good data management practices or the evolution of data management practices as a managerial function within the walls of the organization. It doesn't touch that, and I think you would be right in pointing out that that is an area that needs some attention and an area that at least the current policy and standards committees are not tackling.

MR. REYNOLDS: Okay, we have Walter, then Judy and then we need to move onto Chuck's presentation.

DR. SUAREZ: Thanks. This is Walter Suarez. Just a quick question about kind of following up on the certification. One of the fundamental observations that we highlighted is the issue of certification versus implementation, meaning a lot of the current products are being certified through a certification process, but yet in the implementation side there is kind of a lack of activation or use of some of the features that are specific kind of certified characteristics of an EHR that relate to the meaningful use of the ERH.

So in the concept of certification, how is the expectation being built around the verification of the implementation of those criteria that is being used to certify the product?

DR. GLASER: Good point, Walter, the certification criteria, patient process, at least for the near term, is whether the product is or isn't capable. But that doesn't mean is or is not well used or work flow adapted or all kinds of stuff that would need to go on to really take advantage of what the product has to offer.

The intention with the extension centers is that they provide the talent, the horsepower, the experience that will help providers, hospitals or physicians realize how best to apply the technology and really use the features, and whether the training is good or not so good, or whether the workflow, all that kind of stuff, has been done as well as you possibly can. It will have a particular orientation to those kinds of workflow changes, training use, et cetera, that are necessary to support meaningful use. There will still be a need for folks to work with providers, to make sure they are doing all that they can or want to do, frankly, in using the product and the fact that the product is certified – and I thought we had plenty of interesting testimony at the hearings you had a couple of weeks ago, testimony about the fact that the CPOE-certified systems at the level of usage is really quite diverse here. So certification will only carry so far. We'll need the series of extension centers that leverage existing IT and support organizations to help people do all the right things to take full advantage of those systems.

MS. DANIEL: And I can jump in here, I think in order for the incentive payments, again, it is really a two-part task, and this is sort of the way I think of it, which is one, they have to be using certified EHRs. And then the second is that they have to meaningful use. So the certification is not enough. There is sort of a second test. Are they meaningfully using that technology? So to your point, Walter, the certification, as John was saying, doesn't get you all the way there and it is not just buying the products, but then there is a second hurdle to jump through to make sure an NCA is actually a meaningful user before the incentive payments would be available.

MR. REYNOLDS: Judy, you have the last question.

DR. WARREN: Mine has been partially answered by Walter's question. I just wanted to clarify what I heard. Earlier I believe, John, you said that you weren't really looking internally to see what hospitals were doing with their EHRs and then in part of your answer to Walter you said that that would be part of the extension services. The reason I keep asking about that is some of the work that I have done, as I can see different hospitals using the same vendor, the same certified software, and one hospital has a class EHR and the other one has numerous errors occurring because of the implementation and eventually they turn it off or it becomes a hazard. So it is really looking at the talent and skill of the people who are doing the implementation and are they clued into that.

Can you clarify for me again – are we looking at that level or is that the extension centers?

DR. GLASER: Sorry for the confusion. The Standards Committee will be looking to make sure the product is certified and that the transactions either between organizations or reporting measures follow standards that have been there. So in a way it is silent on whether you use bubble gum or an advanced EHR to get the HIE out the door, so to speak, and it doesn't, per se -- we know you have a certified system but whether you implement it well or you don't implement it well, isn't inherently the purview of the Standards Committee. Nonetheless we know that if you are going to do meaningful use well and we help you do that, we have to get in and help you, whoever you work with, processes, work flow and training in a wide variety of things like that. So we have to provide assistance to those organizations so that they are capable of taking advantage of the certified product and know how to effectively use it --

I guess the per se we will not be looking at practices internally. One of the possibilities will be either certifying or guiding data management practices is not on the plate of the Standards Committee at this point – it may not be. But on the other hand we want to make sure that the workflow changes are as good as they can be and training and all that other stuff. I don't know whether that clarified or just further confused my comments to you.

DR. WARREN: I am getting clearer.

MR. REYNOLDS: Good. John and Jodi, thank you. I know you stepped out of another meeting to join us. Thank you very much. We really appreciate what you are doing and updating us.

So Chuck, I will turn it back over to you.

DR. FRIEDMAN: Thank you, Harry. I would like to focus for a few minutes on the regional extension center's program, which has already come up in this discussion. What I have decided to do in lieu of showing you slides is to give you the actual raw data for this discussion, which is a copy of the draft report that was published on May 28th in the Federal Register. I hope everybody has a copy of this to refer to.

I hope we can have a bit of a discussion, but I thought I would call your attention to some of the features of this report. I will mention by way of preface that the regional extension center's program is one of four grants programs that is mandated in the sense that the verb “shall” is used in the statute in HITECH. One of these programs is the extension center's program. Another is grants to states to promote health information technology. The extension center's program is in Section 03012, the grants to states in Section 3013. A third “shall” program is a program in Section 3016 relating to training of the health IT workforce, and then the fourth is the enterprise integration centers which is actually charged to NIST, the National Institute of Standards and Technology to implement.

So with focus on the regional extension centers I will call to your attention the statement in the middle of the first page of the report, which highlights the complex task facing doctors of health information technology, including the need to assess needs, to select a vendor and negotiate with that vendor, and to implement the workflow changes without which just about everybody believes the EHR cannot make a positive difference in health care.

I will also point out that the extension center program actually has two parts to it, a central national center, and a system of regional centers. I have already mentioned that the program is mandated. I will also point out to you, turning to the second page of the report, page 25,551 – you have to love the Federal Register – that it is stipulated that the regional centers will become, upon award, members of a national consortium, so they won't be silos. The anticipation here is that they will function in cooperation with one another in a way that is facilitated by this central national center.

Further down the first column of the second page it is noted that four kinds of customers of these regional extension centers will receive priority, although over and above a requirement that the centers in some way serve all providers. The four prioritized providers are public, not-for-profit, or critical access hospitals, federally qualified health centers, entities in rural and underserved areas, and individual and small group practices. I have abbreviated these descriptions, but in your handout they are obviously in full detail.

The centers must be affiliated – top of the third column of the second page – with non-profit organizations or consortia thereof. That is an important feature of them and then also on the second page of your handout, 25,551, in the third column, are listed a number of required criteria for the centers, including a defined region of service, a catchment, that is defined, if you will, defined levels and approaches for support of prioritized and other providers. A plan to put what we call boots on the ground, a plan that brings something analogous to agricultural extension agents, here referred to as health IT extension agents to the practice sites where the health IT is going to be deployed.

A capacity to facilitate cooperation among various elements of practice in that area, a demonstrated ability to meet the needs of those prioritized sites, and finally what I would call a capability to go broad as well as deep, to both put boots on the ground to support health IT deployment and meeting the challenges thereof, as well as providing deep specialized expertise in such things as organizational development, legal issues, topics related to privacy and security and evaluation and others.

There are tow preference criteria listed in this draft report. One would give preference to regional centers which are organized as multi-stakeholder collaborations.

MR. REYNOLDS: Where is that in the document?

DR. FRIEDMAN: I am on the bottom of the third column of the second page, 25,551. So this first preference criterion refers to those organizations that incorporate multi-stakeholder collaborations that leverage local resources and a range of stakeholder groups that might come together in these regional extension centers are called out here – I would emphasize that in addition to the whole document being a draft, the list here is a partial list and specifically allows for other types of stakeholder groups to participate. And a second preference would be a preference for applicants who can bring to bear some kind of matching funds.

The way the statute is worded, it is worded to actually require matching funds, but there is also a statement in the statute that allows, under certain circumstances, these matching funds to be waived and we are actually proposing in this draft document to waive the absolute requirement for matching funds. So matching funds would move from a requirement under this draft to a priority element.

Finally, to bring this overview to a close, initial awards for these extension centers is anticipated as early as the first quarter of 2010. Blackford, to your question early about timing, this is the one thing I can say now and we are anticipating these will be two-year awards, and we are also anticipating more than one application date for applicants to stand up. We expect that there will be multiple, I wouldn't say quite a rolling, where you could apply at any time, but perhaps multiple discreet dates by which those entities ready to apply will be able to submit applications.

So that is a brief overview and I am happy to entertain questions. By the way, the notice is not only a draft notice and description but it is also a request for comments, which are due on June 11th. I guess that is two days form today and I would encourage in addition to any comments you might make here in the meeting –

SPEAKER: That is tomorrow.

DR. FIREDMAN: It's tomorrow. But I would encourage in addition to any comments that you might make in the meeting hat you would also send those comments in to us.

MR. REYNOLDS: We are starting off with Jeff.

MR. BLAIR: Since the priorities are to be able to serve rural underserved populations, is there any reason why telehealth is not mentioned within either the law or the draft for the extension centers?

DR. FRIEDMAN: Jeff, I will take that as a comment. I think what would be most useful to get from the committee at this point would be your comments and observations. I probably can't go too much further in answering a question than almost repeating what was written here.

MR. BLAIR: The other question that I have is it is clear from the timing of the Health Information Technology Extension Program that you want to get this going as much as possible before 2011, when the incentives will go into place meaningful use of EHRs. Is there anything that you can share with us with respect to the funding of HIE networks, which are probably also a prerequisite before 2011?

DR. FRIEDMAN: No, we cannot share with you at this point, any date related information relating to the other programs that will relate to Health Information Exchange. The statute does call for a minimum of $300 million to be of HITECH money to be put directly in service of sub national health information exchange. So there will be a program. There will be a program in place to do that.

I would also comment, perhaps stating the obvious in response to your question, that the push to get the regional extension centers funded and stood up(?) as quickly as possible, is in the interest of providing as much support service to as many providers as possible to help them qualify as meaningful users sometime in calendar 2011 so they can qualify for the payment incentives. Time- wise, that is the whole plan here.

MR. BLAIR: My last comment is setting up these regional extension centers probably will require quite a bit of structure and analysis during these next couple of years. So I will do a shameless advertisement of there may be areas as you move through this during the rest of this year, where the NCVHS might be able to assist you. Keep us in mind.

DR. FRIEDMAN: I will make a shameless acceptance of that offer.

MR. REYNOLDS: Now that you both have recused yourself from this subject.

I have one clarifying thing and then I will go to Paul and the rest of the people on the list. Is there a definition of matching funds? In other words, there is a couple ways to look at it. Matching funds are new matching funds or if capabilities are added to existing environments, the fact that money is being spent in those environments already – is that matching?

DR. FRIEDMAN: I will take that as a comment also and a very valuable one for us to think about.

MR. REYNOLDS: I think that is very important because the difference is if you force people to build it all new that costs more than people being able to add it to something and take some of that overhead and consider it matching. That is just an input.


DR. TANG: Just a point of clarification. You mentioned funds being released the first quarter of 2010. Is that fiscal year or calendar year? I don't know if this is the same repeat of Jeff's question – the same question about the state grants for HIEs.

DR. FRIEDMAN: It is fiscal year.

MR. BLAIR: Which means it is October of this year –

DR. FRIEDMAN: As early as – and don't take that as a firm date – take that as our appreciation of the need to do this as quickly possible while still doing it well.

MR. REYNOLDS: We have got Sally, Walter, Larry and Mark.

MS. MILAM: Following up on Jeff's question about section 3013 grants to states for health information exchange, which organization will actually issue the grants? Will that be ONC or will it be a sister agency such as HRSA or AHRQ or some other agency? Has that decision been made?

DR. FRIEDMAN: No the decision has not been made. I can say that the relevant planning is going on but those decisions have not been made yet.

DR. SUAREZ: I have to say that this is one of the most exciting areas of HITECH and one of the ones that will have potentially the most meaningful utility of all the provisions. Having been a educator for so many years on standards. I used to be called actually “father Walter” because I was a HIPAA evangelist. And having gone through regional education activities on HIPAA – my question is around the encouragement you might give to form a statewide coalition to receive these funds.

In other words, if we fragment this too much to the level having so many different competing interests – even within states, the ability to reach out will be minimized and the effect will be minimized. I know there is an average value of the one million to two million. What is the number of grants – and probably you won't be able to comment directly on the total, but what is the range of the number of grants that you expect to provide and are you actively encouraging states to form statewide coalitions that could actually leverage better the funds across a state?

DR. FRIEDMAN: Well, first let me tell you what I can't say. I can't give you an exact number that we intend to fund. I can say, and I think it is sort of implicit here, that other than saying that a regional center must have a defined regional catchment. We are silent on what a region would be. We really are hoping that the nation in responding to this, will not only in the organizational arrangements that it uses, but also in the way it approaches regionality be creative and come up with the best possible solutions. This was an area where, at least at the level of writing this draft, we did not want to be prescriptive. We are hoping that the best solutions will come from the folks – very much in keeping with the philosophy of the whole program. We very much hope that the best solutions will come from the folks on the ground in that region, whatever the region is, who knows that that region needs.

DR. TANG: Just a quick follow up. Could you say the size of the total funding to be provided through this program? Is it $300 million or $200 million?

DR. FRIEDMAN: No, we have no number defined at this point. The $300 million, just to be clear, the $300 million figure I mentioned was specifically called out in HITECH as a figure tied to sub-national health information exchange that is not directly related to the regional extension center program.

DR. GREEN: I want to echo Walter's enthusiasm for this. This is actually a game changer. It moves us out of theory and practice and it is very, very exciting. But as I understand it the statue itself refers to the cooperative extension agency. This is really grounded in agriculture. This is a 90 year story or so or something like that.

The material in the Federal Register is close to silent on expecting what is known to have been crucial to the agricultural extension agency. It was credibility based on personal relationships that wee sustained over time. The comment I would like to make officially as a member of the Committee, that might be a crucial criteria in the evaluation of who can get this job done. That might need to be part of the evaluation of the application proposals and that sort of stuff.

Is this extension center capable of establishing and maintaining relationships with the providers they are suppose to serve in a sustained way, for years and years. Because we are not talking about a 90 day consult here or a two-day consults, we are talking – if we are going to model it after the agricultural extension agency – we are talking about boots on the ground month, after month, after month, after month.

DR. FRIEDMAN: Thank you. Excellent comment.

MR. REYNOLDS: And if you added unbiased to that, that would probably really make it complete.

DR. HORNBROOK: Have you done any solicitation of interest in this procurement yet?


DR. HORNBROOK: Second question is, do you have any idea who the respondents might be? Are they going to be beltway bandits? Are they going to be QIOs? Are they going to be universities or what?

DR. FRIEDMAN: I think, just going back to a response to Walter, we are expecting – we are hoping for creative, regionally responsive and grounded multi-stakeholder solutions. We list in the draft a number of the kinds of organizations that might participate as part of a multi-stakeholder regional approach, but the list – just to say it again – the list we have in the draft is not meant to be exhaustive and we see the potential for other types of organizations than those listed there to participate.

DR. HORNBROOK: There is no exclusivity? I can combine almost any set of organizations and come in with a viable proposal?

DR. FRIEDMAN: I think the spirit, without knowing what they would be, it is hard to evaluate.

DR. HORNBROOK: Suppose I wanted my CTSA to get the state of Oregon to get organized. Is that something that is possible or is it illegal under the terms of this program?

DR. FRIEDMAN: There would be no problem, for example, with the CTSA.

DR. HORNBROOK: Just one example of a regional organization that could have interest in this informatics structure.

DR. FRIEDMAN: Absolutely.


DR. TANG: I am sure you have thought about this Chuck, but where will all the people come from?

DR. FRIEDMAN: Well, there is another program to develop the workforce. Suffice it to say that the thinking that is going into the development of that which is ongoing, is characterized by the same sense of do it as quickly as possible while still doing it well – that is going into the extension centers program.

We hope to be able to say something more about that program fairly soon but it is not ready to be released yet.

MR. REYNOLDS: Leslie, Carol, Marjorie, done.

DR. FRANCIS: Just a comment, what about the risk of the land nobody wanted? The question of do you envision the possibility that underserved regions might – or regions that are particularly difficult to serve – if groups define their own catchment area, might get left out.

DR. FRIEDMAN: Yes, thank you. We are aware of and concerned about that issue. We are giving a lot of thought to it. Thank you for bringing it again to our attention.

MR. O'GRADY: Can I make just a real quick on that. When we did Part D, it was real important – this day and age, just take a mid-course correction. You could not get anybody to take the Dakotas that wanted to take the Twin Cities, maybe the state of Minnesota. But that was sort of the government deal is that you have to take the Dakotas if you want the good market in downtown Minneapolis. You just kind of “note for the file”. You may find it in the next round – you have to negotiate a little tougher.

DR. FRIEDMAN: Thanks to both of you. Those are excellent and important comments.

MR. REYNOLDS: For the public record, the committee does like the Dakotas.

MS. MCCALL: I am trying to imagine – I know that you said that you won't be prescriptive – I find myself trying to imagine the different operating models, the different business models even, and who might respond. A couple of questions within that. Specific ones and then one I really want you to answer.

Would private businesses for example, be able to kind of come in and put something like that together? Have you talked about and thought about adjacent issues and needs around – we will call it the re-emergence of MSOs – right, when you start thinking about some of the contractual issues. Did you ever talk about them changing and morphing over time to information management structures – so it is not just about the pipes but stuff is going to come out the back-end and it needs managed and we have talked about that before. Again, I am trying to imagine different operating models – the kind of things over time that you are actually looking to explore and would welcome in terms of submission?

DR. FRIEDMAN: Those are excellent points. I really – I want to emphasize a couple of things – this report is a draft description of the program. The comments – and it is not a request for proposals or applications. It exists for many reasons as a draft report; among them to solicit comments such as the ones that you have offered. The intent of the draft – and I think if it works out as the draft would imply - the intent of the program is to stimulate creative approaches.

MS. MCCALL: Does it expect that all of – you did not opine on how much money would be made available – the size of the total pool – but will it allow or would it prohibit actual business models here?

DR. FRIEDMAN: You mean for profit participation?

MS. MCCALL: Right, otherwise – yes, so that it can become self-funding and self-sustaining, otherwise it has got to live on the funding that is provided, in which case I want to know how much is there because I want to know how big this you anticipate being?

DR. FRIEDMAN: Oh, right, so your are making another point which I will take as a comment and a valid one. What happens after the two-year award? How do these organizations become self-sustaining?

MS. MCCALL: Either that or during that two-year period because the funds available – I saw a boundary of about only as much as $10 million for the two-year period per any center. Depending on how big the regions are that may not be enough. I don't know.

DR. FRIEDMAN: All fair points and important comments.

MS. MCCALL: It is a great idea. Having been in the business of trying to get doctors to adopt electronic health records – this in the trench work is where it all happens or does not. If it is not anticipated that this is going to be big enough to scale enough, the difference between the beauty of the idea and the reality of the practice is going to be pretty big.

MR. REYNOLDS: Marjorie, last question.

MS. GREENBERG: I think we are all really excited about this and really appreciate the work that you have done so far and the work that you are going to be doing in the future. One thing that comes to my mind and I have not had a chance to read the whole thing, and kind of follows up on what Carol said, being the folks with the boots on the ground in the trenches – carry this analogy too much farther, but it seems to me that these groups – and I have to agree with Paul, I am wondering where are all these qualified extension agents going to come from – but leaving that aside. That they will have a better idea of how to really get meaningful use of electronic health records than anybody. They will actually be trying to make this happen on the ground with real people. They won't be here in Washington philosophizing like some of the rest of us – myself included.

I am wondering, and I see there will be a national group, which is very good, that will kind of work with them, but if you have any thoughts about what their relationship will be with these advisory groups, with the FACA groups, on everything from evolving definition of meaningful use to how do you measure meaningful use to evaluation – all of these things.

It seems like they could be such an important element of that, having this real life experience, but in order to effectively serve that role they might need some capacity or functionality that is not just delivering services but having that perspective as well – kind of the lessons learned and all of that. They will report directly, I guess, to the national group or they will each report to ONC. How do you see this working?

DR. FRIEDMAN: We are still working that out, but I think a key feature of the program as we have envisioned it and as is described here, is that these regional centers will function as a consortium and will have the capability of learning from each other and sharing resources of various sorts amongst each other to avoid reinventing the wheel in however many centers there are.

We have not figured out how exactly we are going to make this work, but it would seem that the value of having an inter-cooperating set of centers as they figure out how to do all of this very, very well, is incontrovertible.

MS. GREENBERG: And then have them feed in to the policy process.

MR. REYNOLDS: Chuck, thank you for the whole thing that you have done. I think it shows the speed at which you are doing things. It shows that there is a lot of thoughtfulness but there is a lot of openness, and there is not much more that you can ask in a subject. We are glad to have you as our liaison and we will continue to look forward to that relationship. Thank you.

DR. FRIEDMAN: Thank you, Harry. I want to add my thanks to the committee and the staff for all of the great work you all are doing and particularly for the work everyone did to prepare for and conduct the April hearings – which have been invaluable to us.

MR. REYNOLDS: We will be reading the letter that we were going to do at 12:00 – we will be reading it right when we get back, during the 2:30 discussion portion. So we will move that. With that we are adjourned for lunch until 1:30 p.m.

(Whereupon, a luncheon recess was taken at 12:30 p.m.)


MR. REYNOLDS: Looks like we have a few stragglers back from lunch but we will go ahead and get going so that we can honor time commitments. Our next agenda item is Measure and reporting Functional Status and Dr. Lisa Iezzoni and the thing I would like to let all of you be aware of is she was a two time member of NCVHS so one of our own. The positives are she has been a member of NCVHS and has had an outstanding career. She has had her challenges like working with Justine. So moving right along, Dr. Iezzoni thank you so much for coming and we look forward to your comments.

Agenda Item: Measuring and Reporting Functional Status

DR. IEZZONI: Thank you. My title is a tiny bit more creative and metaphorical than the title that was listed in the program: Are the Stars Aligning for ICF in the United States? Anything intelligent that I say in the next hour I can attribute to John Hough and Marjorie Greenberg.

The US health care system, I do not need to tell this crowd is awash in codes. Coded data do everything for us--diagnoses and procedures, help us figure out how to pay hospitals, how to pay Medicare advantage plans, how to measure quality, how to monitor service use and how to also increasingly monitor public health concerns.

Mostly what we are kind of talking about is this volume, the CPT volumes and ICD, as all of you know, is now 30 years old and finally we're about to in 2013 get moving into ICD-10. But even the diagnoses and procedures, even though they tell us a lot about patients, they don't tell us sometimes the most important information about health and how people just get through the day, how they participate in activities of daily life.

You've all heard about this volume. This is the International Classification of Functioning Disability and Health and this is going to be the focus of today's conversation. The ICF was endorsed by the World Health Organization back in 2001 and in that universal endorsement they endorsed it for research, surveillance, reporting “as appropriate in member states”. I think we're a member state but the ICF has actually never gained traction in the United States. When I was a Chair of the Population Subcommittee I tried to find some physician groups who had even heard of the ICF. I don't know if we could now in 2009, but we really couldn't back then. That is kind of the grounding of my talk.

If you go onto nasa.gov and look for stars, this is a picture. I chose it because it looks like the stars are kind of aligning so it kind of helped with the metaphor that I'm trying to build here. Today my talk is really going to be what are the key leverage points for saying that maybe we can finally get ICF into the code sets.

I'm going to try to talk quickly as I possibly can about five different forces that could be helping this alignment: social forces, demographic forces, the consequences of health care reform, public health focus on determinants of health, and then a growing recognition of the ICF in the United States, finally. The NCVHS report that we put out in 2001 noted that the concept of functional status applies to all persons regardless of age, physical or mental condition, or other characteristic. The kind of slant that I'm going to take on it in my talk this afternoon, as you could imagine that I might, is going to be on a disability side but everybody, even people who don't have to use wheelchairs, have a functional status. It is just maybe different than mine is so just kind of keep that in mind that that will be my bias in my conversation with you this afternoon.

Societal forces. Franklin Delano Roosevelt, arguably the most famous person of the 20th century but nobody was supposed to know this. It was supposed to be a secret from the public. In fact, this is only one of two remaining pictures of FDR sitting in his wheelchair. As a woman said to me a number of years ago when I was interviewing people with disabilities for a book project I was doing, disability is a lonely state. But here we have George Herbert Walker Bush and what he said was the proudest moment of his presidency--this is July 26, 1990, the signing of the American's with Disabilities Act. From that point onward, people with disabilities really were often out front. I'm from Boston, this is the starting line of the elite wheelers at the Boston Marathon. I am always proud to say that the wheelers come in about 25 minutes earlier than the bipeds do but we won't hold that against you. Most of us are not elite wheelers but there are so many of us out there now on the streets. The societal force that I wanted to emphasize is that people with disabilities are no longer hidden behind closed doors as they were in FDR's time. They are out walking around. They are going to the store. They are going to parks. They are going to schools. They are everywhere.

There are still barriers and of course, the New Yorker gives us kind of a social view of some of this. This is the Grim Reaper in a scooter following an old man in a scooter. Then this was the cover of the cartoon issue back in 2004. It is a kind of--I am just going to be biased here and say a grumpy looking older lady about to foot her four-point cane on four banana peels. I view this as a Rorschach test for how people respond to this one. The point that I wanted to make here is that the ADA functions differently than other civil rights law and I'm going to show you a couple of slides to make this point because accommodations require that disability be known and noticed. That is where the codes come in.

Here is my two slide version about how disability civil rights differs from civil rights, for example, for racial minorities and for women. This is the picture of the iconic figure of the civil rights movement, Rosa Parks, who refused to give up her seat on a bus to a white man back in 1955. Rosa Parks knew that she achieved civil rights when the color of her skin, the stigmatizing attribute that made people think she should move to the back of the bus, was no longer relevant to where she sat on the bus. She would get on the bus, the color of her skin was irrelevant, she had achieved civil rights. For somebody like me to even get onto the bus, my stigmatizing trait has to be noticed, somebody has to react to it, the bus has to be made that will allow me on board. So because of that we need to have information about my disability, somebody noticing it, and somebody reacting to it.

Now, you would think that health care systems are completely accessible to people with disabilities--who thinks that in this room? You are wrong. Somebody raised their hand. They are wrong. We need codes and medical records to alert physician staff and other nursing staff to patient's needs because health care settings are not accessible. They are, in many cases, kind of like the bus. People can not literally get onto them.

Here is a three slide set that I am going to show you that is like the Olympic games where somebody is kind of approaching the horse that people jump over. What is that called? The horse thing. This is a woman with spina bifida. The standard examining table in a doctor's office is fixed height at 41 inches. It was set at 41 inches because that is the height for a standing doctor to find it convenient to examine a patient. There are, however, tables that do automatically lower to wheelchair height. It is just that they cost a tiny bit more, not a lot more, but a tiny bit more, people need to think about them. So here is a series of pictures about how Janice, who is very proud of her abilities--she has spina bifida, can get onto the fixed height exam table. She approaches. She twists around. And then she is on the table. This is all well and good but what you may not notice here is that she is 22 weeks pregnant. Are you going to want her doing this later in her pregnancy? I don't think so. Wouldn't it be nice if there was a code in a medical record and if the health care facility happened to have one of these automatically adjustable examining tables that were lowered to wheelchair height so whenever somebody like Janice made the appointment to come in, that code would automatically tell the practice staff that she should be put in the room with the automatically adjustable examining table?

Demographic forces. Across the lifespan, Americans are living with growing numbers of chronic conditions and disabilities. The epidemiology is pretty clear that younger people have lower rates of disability than do older people. 40-54 million Americans, the younger folks maybe six percent, seven percent, once we get to 75 years of age more than half of people will have at least some form of disability.

There are pockets of people with disabilities. This is the cover of the New Yorker magazine with a soldier sitting at the foot of some stairs. I have a feeling that this came out at the time that the Walter Reed scandal came out a year or so ago. Obviously there are pockets of young people coming back with incredible disabilities that people are noticing, but most disability is in the older age group and these are some data from the Census Bureau showing that since the year 1900, we just have many, many more people 65 and older and, incredibly, also 85 years of age and older. Even for older groups, the life expectancy continues to rise even from 1950 on it continued to rise.

Disease and disability are distinct concepts, although they often coexist. The causal links are pretty obvious. Disease frequently contributes to disability. Osteoarthritis is the single most disabling condition among adults in the United States. Obviously osteoarthritis impairs walking. Diabetes can cause vision problems. Disability can cause new diseases. For example, a spinal cord injury can cause urosepsis or contribute to a pressure ulcer. The MMWR, a month ago, released information about rising disability that they then linked back to chronic conditions with arthritis, again, being the number one condition that was disabling, back problems number two. It was kind of cute the word that they used, the said heart troubles was number three.

Aging-related impairments, many of us in this room kind of can relate to this a little bit--vision, presbyopia, glaucoma, macular degeneration, hearing presbycusis, which is aging related hearing loss, cognitive dysfunction with Alzheimer's, organic brain disease and functional impairments, again, arthritis, back problems. These are diseases of aging that then contribute to disability.

These slides show the percent of people aged 65 and older who report having selected chronic conditions that are very associated with disability. The blue bar shows men and the reddish bar shows women. As you can see, sometimes men have more and sometimes women have more. Arthritis, again, is the most common.

Then we have to talk about the functional impairments that people have. About 48 percent of men have some trouble hearing compared to 35 percent of women. About 60 percent of men have some trouble seeing compared to 18 percent of women. Then we have people over 65 who have various functional problems--problems stooping, reaching overheard, writing, walking, lifting. So disabilities are more prevalent in the older age group but that doesn't mean that these people want to go and not participate in the rest of daily life. This woman who I interview when she was about 55 has had multiple sclerosis for probably about 30 years said to me, “the baby boomers are coming, we're not going to warehouse them in nursing homes. These boomers are not going to go quietly into the night”.

As the Future of Disability in America said, the Institute of Medicine committee that reported in 2007, virtually everybody in the United States is going to as some point in their life have a disability or live with somebody who does or love somebody who does. Disability is not a minority issue. It affects, today, everybody or will affect tomorrow the lives of most Americans. The future of disability in America will depend on the country's response to this demographic shift.

Health care reform. There is a lot of heated rhetoric about health care reform. I am using Obama's kind of phrase from his campaign the fierce urgency of now. As the President said, “Our families will never be secure, our businesses will never be strong, and our government will never again be fully solvent until we tackle the health care crisis.” Of course, I'm teasing you a little bit because that president was Bill Clinton and this was a quote from his state of the union address in February of 1993. I raise it just to make the point that we really do not know what is going to happen with health care reform. I mean, we kind of think that the stars are aligning there, too, but we are not entirely sure. Although, Obama, in his now famous letter to Kennedy and Baucus dated June 2nd--I think it was just a week ago--this year we must do more than discuss, we must act. America's future depends on it. Of course, the 2.4 trillion dollars that our nation is spending on health care does tend to focus the mind a little bit on this topic. As he said, without a serious sustained effort to reduce the growth of health care cost, affordable health care coverage will remain out of reach.

Now, I showed you the slides in my last kind of stars aligning segment about the demography and you would think that part of the reason that health care costs are going up so much is because of the aging of the population and the increasing number of people with disabilities. In fact, the CBO, the Congressional Budget Office, the nonpartisan group that looks at costing and budget issues for congress, looked at several studies to try to figure out what is driving differences in cost over time. From 1940 to 1990, the aging of the population only contributed, according to all three studies--they were very consistent in this--about two percent of the increase. If you look at the bottom of this slide, the place where the money really is--I literally mean money--is in technology-related changes. That includes not only imaging but also pharmaceuticals and various different surgical techniques and so on contributing maybe up to 65 percent of the increased growth.

Even in Medicare and Medicaid, you can see here that the thin wedge, which is the dark blue, is the effective aging alone on the incredible increase that is projected through 2082 in the costs of Medicare and Medicaid. Now, health care reform might happen this time because basically what Obama has done is he has taken Clinton's playbook on how to do it as a reverse playbook. So he is kind of taking what Clinton did and done the exact opposite. He basically told Congress you figure this out. He gave Congress broad principles. He has tried to involve all the stakeholders as much as possible. The broad principles--there were eight of them, protect financial health of families, make health insurance affordable, aim for universality -- although, he's a little uneasy and squishy about the mandate thing but we will see how that works itself out -- make coverage portable, guaranteed choice, invest in prevention and wellness care, improve patient safety and quality of health care, and maintain long term financial sustainability.

Quality is where I want to focus now. People recognize this is the cover of the seminal report of the Institute of Medicine in 2001, Crossing the Quality Chasm. We know that we do not give as good quality of care in the United States as we should be. The diagnostic and procedural data that we have to be able to look at health care quality only goes so far. We really need to know more about patients' functional status, number one, to be able to look at the outcomes of care. Ideally, we also would like to know more about patients' preferences for care but that might be asking too much from the coded data system.

In 2007, Medicare started again releasing the mortality report cards for hospitals that they had started actually back in 1986 but had rescinded during the Clinton era because of risk-adjustment problems that were happening back then that actually haven't gone away but we will get to that in a few minutes. It is a program called Medicare Hospital Compare and I suspect that you have probably heard about that at NCVHS. Have you heard about this at your committee meetings? The risk adjustment for this--it is 30-day post-admission mortality and the risk adjustment relies on going back twelve months previously in Medicare claims looking for history of coronary angioplasty, coronary artery bypass graft, heart failure, myocardial infarction, and then using secondary diagnoses from the admission that is the index admission that they are looking at from diabetes, metastatic cancer, other kinds of conditions that they viewed as risk factors.

This is from my hospital, the Massachusetts General Hospital. This is the Medicare Hospital Compare Report, just pulled off the web about a month ago, for heart failure. What this slide shows is that the MGH had 348 people in 2006/2007 that qualified, according to Medicare, to be in this particular population to look at. Our expected mortality rate was 9.3 percent and our confidence intervals overlapped the national average of 11.1 percent. So the Massachusetts General Hospital is just an average hospital in terms of its quality of care for congestive heart failure patients, if you believe that the Medicare Compare data tells you about quality of care.

The risk factors that they used were fine but, frankly, from a clinician's point of view, not the major risk factors that one would want to look at for heart failure. There is something called the New York Heart Association Functional Class that cardiologists are always assigning to their heart failure patients because this basically tells you whether the extent to which the heart failure limits the person's ability to even get up and walk around a room. This is a critical indicator of risk in heart failure. If you have the ICF codes embedded in the discharge abstract, you could just pull right out of the ICF codes to be able to convey that information. You need full information on patient's clinical risk to avoid penalizing hospitals with sicker patients.

Of course, one of the big problems with this is that the discharge abstract--although, in Massachusetts that has changed in 2007. Our discharge abstract now does include do not resuscitate status--that often the patients who died, in fact, were hospice patients. There was a study that was published by Holloway and Quill in JAMA in 2007 where they looked at the heart failure deaths at a hospital in Buffalo, New York, that had been found to be one of the 35 worst hospitals in the United States. They found that 40 percent of the CHF deaths, when they reviewed the medical record, were, in fact, do not resuscitate or hospice cases and the mortality reports did not adjust for that.

Health information technology does not need to wait for Obama's health care reform to take place. I think HIT is lucky because it was kind of enshrined in a way in the ARRA, the American Recovery and Reinvestment Act, that you were talking about greatly this morning so I don't need to review this for all of you guys. The 20 million dollars to the National Institute on Standards and Technology to work on technical standards is already there. You are already talking about what makes a qualified electronic medical record but I am just going to remind you what the words are that come directly from ARRA. Improves health care quality, reduces medical errors, reduces health care disparities, and advances delivery of patient-centered care, requires HIT to “reduce health care costs resulting from inefficiency, medical errors, inappropriate care, duplicative care, and incomplete information”, and provides appropriate information to help guide medical decisions at the time and place of care. If you read these words you know that ARRA requires information on functional status. It just has to be there to be able to achieve these things that the law says that it needs to achieve.

What are the electronic options? Can ICF be integrated within the standard electronic framework? The really excellent 2005-2006 work of the Consolidated Health Informatics Initiative, the CHI, Phase I Disability Work Group tell us that yes. In fact, the ICF codes could be helped to be determined through the LOINC process and the NCVHS report that came out in November of 2006 really talks about this in a very specific way. In fact, what they said was that endorsing ICF as a CHI standard for functioning and disability allows it to be used in all these different and helpful ways such as inclusion in the Unified Medical Language System, mapping between ICF and SNOMED, expanding the coded disability content available for use, and making ICF available for use in standardizing patients' assessments.

Of course, we still have this vexing problem and Marjorie I remember we went out to Baltimore one day when I was on NCVHS and we heard this exact same thing--that there are these silos, right? That the nursing homes have the minimum data set, the home health care system have the OASIS data set, that the in-patient rehabilitation still use the IRF-PAI. We literally did go out to Baltimore to try to hear about how at the time--I can't remember what year it was--they were trying to homogenize and figure out some way to make the kind of coding and data collection for what is basically a continuum of looking at functional status more cohesive but that still hasn't happened and you still have these silos of data collections that, again, could be helped by having an ICF framework in place.

Public health. The Health People 2010 came out before the ICF was mandated but an earlier version of the ICF, the ICIDH--it was a kind of crazy acronym--had the same kind of environmental point of view. One of the chapters in Health People 2010 quoted that as kind of talking about the contribution of the environment to people's health. In fact, I think Health People 2020 is going to go farther than that.

This is the action model to achieve Health People 2020 that was proposed by the Secretary's Advisory Committee last October in their report. I'm going to, actually, on the next slide give you the text of the outermost circle because it is kind of hard to read those words when they go upside down. It basically talks about what the determinants of health are. You start with kind of the biology of the individual and then you go out to the social and family environment and the living and working conditions but you also have to look at the broad social, economic, cultural health and environmental conditions and policies at the global, national, state, and local levels. The ICF can actually help you do that. That is part of the framework of the ICF.

Healthy People 2010 also had chapter six, which talked about health care disparities for people with disabilities. The Surgeon General picked up on this in 2005 and on the 15th anniversary of the signing of the American's with Disabilities Act, July 26, 2005, issued a call to action noting that people with disabilities experience disparities in the health care that they receive compared to other people.

We, ourselves, have done some work on this. I will just show you one slide of our results but we have a series of slides that I could show you. I will just show you one. We looked at the use of breast conserving surgery for women with early stage breast cancer. For the non-clinicians in the room, breast conserving surgery is considered medically equivalent in terms of disease-free survival as mastectomy as long as post-lumpectomy the woman gets radiation therapy. We were able to show that for women with disabilities under age 65, they were 20 percent less likely than other women to get breast conserving surgery. Now, that might not be a disparity. There might be all sorts of reasons why women with disabilities were 20 percent less likely to get breast conserving surgery as other women but if they did get breast conserving surgery, they needed to get the radiation therapy so they could have the same disease-free survival as the women who had a mastectomy. What we found was that they were 17 percent less likely to get radiation therapy and--no surprise--women with disabilities were 45 percent more likely to die from their breast cancer.

What data did we use for this? We used a very, very prominent data source, the SEER data registry--that's the Surveillance, Epidemiology, and End Results cancer registries that are produced by the National Cancer Institute. They now cover about 21 percent of the US population. Quite a few years ago they merged these data with Medicare claims and there has been a lot of work on disparities in cancer using the merged SEER/Medicare data but our group was the first to actually look at the under 65's. Every other paper that used SEER/Medicare data there will be a single phrase in the methods sections: we eliminated the people who are under age 65. There is never any rationale for that but that is what they always do. We did not. We looked at the under 65.

The SEER registry, even though it has all this great detailed information on the tumor type, it does not have any information on the functional status of the patient. For oncologists, they look at functional status. They look at Karnofsky scores. They look at whether the patient can get up from the bed to know if they should give the patient aggressive chemo therapy or what types of therapies that they should give them. What we had to use for our ability to identify women with disabilities was we needed to use the fact that they were on Medicare, which is equivalent to the fact that they have social security disability insurance. The only way that we were able to identify disability was through an administrative definition that the woman was on SSDI. Wouldn't it be an easy thing to have, in the SEER registry, a single code from the ICF or two codes that would indicate what the patient's functional status was.

Back in 1999, the Congress required the Agency for Health Care Research and Quality, AHRQ, to start reporting national health care disparities reports. They use all sorts of information that I think Ed Sondik's group produces and it is really terrific--the MEPS, the NHIS, and all sorts of other kind of surveys. The report is to talk about the prevailing disparities in health care as it relates to racial factors and socio-economic factors in priority populations. The law defines priority populations in a very broad way. Women are a priority population, children are a priority population, old people are a priority population but so are people with disabilities.

If you go to the most recent disparities report, 2007, the content on disabilities is vanishingly small. They talk about exercise counseling in obese adults probably from NHIS merged with the Healthy People supplement. They talk about inappropriate medication use by elderly people, delay in receiving care, and then children with special health care needs, delays in care for illness and injury, and poor communication with health providers reported by the parents. That is probably from MEPS or from NHIS.

MS. GREENBERG: Actually a supplement to HIS.

DR. IEZZONI: Supplement to HIS, okay, yes. The basic point that I am making is that a lot of the other content comes from claims and other data sources that has diagnosis and procedure codes but the only place that you can get the information on disability is from the National Health Interview Survey or some of the other survey sources, which are great and terrific but it does mean that it is limited in terms of looking at some of the disparities, especially in use of services because things like NHIS do not code services the way that the claims files would be able to allow you to do. So limited definitions of disabilities and relatively few reported measures.

Growing recognition, finally, my final star that is aligning. Alright, I have to talk about your reports. The first one is the report that I was involved with back in 2001 where we said that the ICF is the only existing classification system that could be used to code functional status across the age span. Again, we just talked about the Consolidated Health Informatics Standards Adoption Recommendations and ICF being CHI-endorsed standard for the functioning and disability domain--both really excellent reports and a good place to start recognizing ICF.

We also have the National Library of Medicine adding ICF in 2009 to its Unified Medical Language System, which is a terrific thing, in a partnership with the World Health Organization. What this now means is that UMLS users can link ICF terms with other classifications, terminologies, and vocabularies.

There are other examples, the National Institute on Disability and Rehabilitation Research, NIDRR, incorporating ICF into its Logic Model and referencing in defining disability. Endorsements now by about a dozen professional organizations. Then, again, as I noted already, Healthy People 2010 had the ICIDH as part of their conceptual framework in an earlier draft.

Right, finally, the 2007 report, The Future of Disability in America that came out at the Institute of Medicine was also quite clear about this. I was on this committee so I can speak a little bit to it. There really wasn't an alternative. When the committee was talking about what could we use to code and classify functional status, the ICF was really, basically, the only kind of reasonable thing that we could focus on. Recommendation 2.1, out of that IOM committee, was that the National Center for Health Statistics, the Bureau of the Census, the Bureau of Labor Statistics, and others should adopt an ICF framework when you are thinking about functional status and disability in designing your surveys. They also suggested promoting refinements and improvements to the ICF and that the interagency committee on disability research take charge of this. The directions that the IOM committee recommended were, number one, clarifying the activity and participation concepts, number two, incorporating quality of life, number three, delineating personal factors more than they already are, four, extending the classification of functional factors, which are already kind of extensive but they could be extended more, number five, incorporate secondary health conditions, and, number six, add a dynamic model reflecting movement of functional status across different state of functioning.

Back again to ICF, are the stars, in fact, aligned to make this happen? This is, again, off the nasa.gov website. This is the picture of a star being born. There is a lot of hot air, a lot of gas, okay? It might be a little bit of a mess but it is also beautiful, don't you think? So I think that the rationale and impetus are there, it is just really seizing the moment and who is going to make that happen is really what we are waiting for. That is the end of my talk. I hope the stars have aligned for ICF.

MR. REYNOLDS: Thank you. Question? Will?

DR. SCANLON: Thank you very much that was really very interesting and very timely I think, too, because I think this is the part that is essential for health reform if we are going to be thinking about it. We talk about wanting to reform the delivery system and we have ideas like bundling, ideas like paper performance, medical homes, et cetera. One of the things that we are really missing is the ability to define what a patient needs. Your point about risk adjustment is exactly on target. We have had faith that we are improving our risk adjustments but we are not necessarily at the level of adequacy yet. Going beyond diagnosis is a critical part. We have been stuck with diagnosis because that is in the claims so I think one of the things we have to think about is what will cause no harm in this process as we sort of move forward.

My question is because one of the things that has bothered me about sort of all of the talk about delivery reform is the fact that as we think about improving risk adjustment and we say we are going to look at more dimensions of the patient and we are going to focus on the outcomes, we have people that are not going to get better--permanent disabilities maybe sort of on a trajectory to die. What I worry about is the issue of rating a situation where there is an incentive to avoid those people. Right now there is some confidence in terms of SNIF and home health care that--look at all the people who's functional status improved when we look at OASIS or we look at the MDS, okay? Some of that you can say, well, that is because they had their joint replacement and that is the expected outcome but there are other people that I think we don't want to leave behind in the process. How are we going to be able to get the data to tell us that we don't have to worry about them, we can protect them is kind of my question?

DR. IEZZONI: Well, that is such a huge question and thank you for the empathy that was conveyed in the way that you articulated that question. Let me just say that when I started the project that I mentioned earlier where the woman told me disability is such a lonely state I was interviewing people who had mobility problems because of progressive chronic conditions. I asked a gentleman once, tell me about your trouble walking. He said I don't have any trouble walking. I don't walk. I use a wheelchair. We have to get away from the notion that being able to walk is the be all, end all of disability or somebody's value. That is why I think it is really important to look at other functions that people perform. The fact that they serve in their family as kind of a caregiver. The fact that they are still able to go to work even if they use a wheelchair. The fact that they participate in activities of daily living and daily life. That is one of the things that ICF does. It looks at the various other things that people do in life. Yes, it looks at whether they can walk but it also looks at all sorts of other types of functions that other people can do.

The thing that really frustrates me about the quality measures and it frustrates everybody about most of the quality measures that P4P, pay for performance is based on, is it is usually based on processes of care--what is done to patients. There is very limited information about outcomes. That is because the only outcome that we kind of reliably code is lived or died. We have got to get away from that. The only way that I think we are going to get better outcome information is if we start to get more information on functioning and, you know, activity and participation in daily life. Trying to make that case, it is who are the powers that be that are going to have to enshrine that in the data sets that we routinely collect for the P4P type of initiatives where the hospitals are already so burdened by the coding that they are required to do.

DR. SCANLON: One potential bit of hope for you is I think it's CMS actually does have a common instrument now for post-acute care that they are either testing or--

DR. IEZZONI: They have been working on that and, in fact, back in the time when Marjorie and I went out to CMS, they had people working on it back them. This has been something that has been--you know, that goes back maybe a dozen years or so, Marjorie, is that possible? So I know that they are working on it. They have--I think--RTI is working with them on it but it might be nice to actually hear more detail about it.

DR. CARR: Thank you, Lisa. That was great, as always. My question was along the lines of what you were starting to talk about. What are the on the ground operationalizing challenges? For example, who provides that information that then gets coded? Does it come from the person, from the physician, from someone else in the practice and where does it appear so that it can be captured?

DR. IEZZONI: It is a really, really excellent question Justine. Back many, many years ago when I was first starting my research career, we went and reviewed medical records at 15 metropolitan Boston hospitals. We were collecting information on severity of illness in a very medicalized way but we were also collecting information on functional status. We could not find any information on functional status in the physician notes. We simply could not find it. The doctors were not noting it. My colleagues were not noting it. It was in the nursing notes.

However, the first project that I ever did when I moved to the Beth Israel--and it was Beth Israel back then, the BI back in 1990--we did a project where we were looking at predicting mortality based on electronic information that we were able to kind of download into relational database off of the BI system. We were able to take the nursing functional pattern assessments off the IBM mainframe, if you remember that, and then we were able to take the labs off the other system. We couldn't merge five percent of the cases, which is I guess a pretty common thing that even if you have the same hospital, the same patients, you can not merge five percent of the cases but we were trying to predict mortality for people with pneumonia and congestive heart failure. Low and behold the primary predictor--and we had all of this--your creatinines, BUN's--blood urea nitrogens--the most promising and strong predictor was functional pattern assessment--whether the patient could feed or bathe themselves. That was really what was driving--because as you can think of it from a clinician's point of view, that is the overall kind of functioning of the patient. That kind of just summarizes all of the information right there.

One of the problems in collecting functional status information is that there is some research on this, not a lot but some, that shows that doctors--nurses might be a little bit better at it--but doctors are not always as good as the need to be at measuring functional status for their patients. Often times they only see their patients at the sickest possible moment and they do not know what the patient is like when the patient goes home so they tend to over assess how functionally impaired the patient is. One of the questions is whether the patient can help document the medical record themselves. I certainly think that there could be some value for doing that but I think that although I kind of glossed over and was trying to make an advocacy case for adding functional status to routine data collections, it is going to be hard and it is going to require, also, physicians to--it will require physicians, I think nurses can do it but it is going to require physicians to change their mindset a little bit and recognize its importance will take some effort.

DR. FRANCIS: I want to raise a set of devil's advocate questions in a way but I think they are actually very serious as well. I think there are enormous advantages, particularly on the aggregate data front for having measures of functional status in medical records but I think there are enormous risks as well. One is the confusion of disease and disability because it puts disability is a medical context and a lot of people make that confusion. Your breast cancer data may be indicative of that, actually. I think there is a huge risk on the individual patient treatment side of people getting less treatment. There is the old DALY problem. I don't want to get you started but it is an issue.

I also want to think about the question--I don't know how to bend my brain around it--there are many people with disabilities who hide that disability. To get on the bus you need to disclose that you are in a chair. You don't need to disclose that you have MS if you can locomote onto the bus. MS is a particularly interesting example of a hidden disability. Yet, there might be some functional status codes, for example, that somebody can conceal but that would show up in a functional status code. I'm wondering if you have thought about masking possibilities?

DR. IEZZONI: Absolutely, you know, I can talk on either side of these issues, too, as you can well imagine that I probably could. I have MS, myself, so I am often asked by people early in the disease should I tell my employer? My answer to them is no. Try to keep it hidden as long as you possibly can because there will be stigma and you will be discriminated against. I have experienced it personally, myself. That is why I am not a practicing doctor, for example. I graduated from medical school in 1984, six years before the ADA. Enough said on that one.

I think that I also very much respect situations where patients ask for certain information not to be documented in the medical record. You know the BRACA, the breast cancer gene, is a perfect example of that. The genetics people tell me that before Kennedy signed the bill that he signed I guess a year ago about protecting genetic information that they would have a conversation with their patient about not documenting information in the medical record.

I am sensitive, very sensitive to what you say about physicians withholding treatment for people with disabilities because of their prejudice about what that patient's life is like but it troubles me to not have information out there because you expect somebody to discriminate based on it. I think it is better to have it out there and then what you can do is actually try to monitor discriminatory behavior on the part of physicians.

It is interesting, our Boston Globe yesterday had an editorial. It was the second editorial in the Boston Globe about adding disability to the state's effort to look at disparities in health care. It was based on BRFSS data, a state disability consortium has just issued a report using the Behavioral Risk Factor Surveillance System information from Massachusetts and identifying serious disparities in care for people with disabilities. The Boston Globe was out there saying to the state that the state has just passed a law about eliminating disparities for racial minorities but they didn't include people with disabilities in it so The Boston Globe, even though its writer's union had kind of voted against--well, never mind there--whether the Boston Globe will continue to exist--but they had a great editorial about adding this to the disparities report.

I had a conversation later in the day with an attorney at Great Boston Legal Services who does a lot of work with people with disabilities and I said to him look, Dan, where are we going to get the information? People are not going to necessarily want to disclose their disability. It is a conundrum but I really have a lot of trouble--as an information committee, here, thinking about not putting information some place because people will use it to discriminate against other people.

DR. TANG: I just want to thank you, Lisa, for very powerful testimony. I am really struck by your comparison in terms of this is something to be known and noticed, which really rings true. It points out poignantly why it should be these systems and the system should act on it to help us do the right things.

I just want to offer some words of encouragement. I don't know if you keep up with what we have been doing but we did decide to focus in on the patient as an important source of their information, which is where Justine was going and that PHR's might be a source of that. You might also know that Robert Johnson has this PHR activity looking at observations of daily living and it sort of gets to your point about what is It like outside the acute setting and what is it like in real life? In order to track that and provide feedback not only to yourself but to the professional-sided health care team.

You are probably aware that Meaningful Use also has or at least the Recovery Act has disparities recommendation for reducing in it so it seems to me that not only is this a moment of opportunity to work with this committee but also with the relevant FACA's in that world.

DR. IEZZONI: Yes. Thank you.

DR. SONDIK: I had a question related to ICF or the little red book as I call it. There are five different dimensions in it. Could you say a word about using that for coding because it is very complex? One of the efforts that actually Jennifer Maddens has been working on here is a set of questions that could be used internationally to give us a better handle on disabilities and be able to do international comparisons because right now--I won't say impossible, she is the real expert--it is really difficult to do. But just the coding using the ICF is a challenge so if you could speak to that.

DR. IEZZONI: I am not going to argue that the coding is a challenge but what I will say is that there are some really interesting codes in there that get at concepts that are nowhere else, that you can not replicate with ICD. I think that there are some codes that might be better done with ICD, frankly, but there are a lot that you really can not find anything like it in ICD. I think looking at those dimensions where ICD really can not capture it--the environmental factors I think is especially powerful and that is something that you really can not get in ICD. The activity and participation, I am not sure whether that has worked itself out. I know that that has been, historically, a problem that not only US investigators and users have had a problem with but also some of the international users have also had a problem with that.

MR. REYNOLDS: Doctor, thank you so much. I really appreciate the insight and the information so thank you. Judy, if you would now go ahead and read the recommendation letter to the group, please?

Agenda Item: Recommendation letter on NCPDP 10.6

DR. WARREN: First, let me ask, Jeff, do you want to make any comments about why we are bringing this letter forward?

MR. BLAIR: No. I just want to make sure we request Denise and her help on this.

DR. WARREN: We had some hearings I think it was back in November from NCPDP and they were--if you remember our prescribing task on the MMA, we were required to make recommendations used in e-prescribing. In the early versions that we put forward and were later accepted by Medicare, one of the problems with the codes is they didn't really handle to need for long-term care facilities, which handles e-prescribing in a slightly different fashion. One of the wonderful things that happened during our initial set of hearings on e-prescribing was that the industry actually came together and started working to improve the set of standards and to come together to do a set of standards that did the whole process of e-prescribing. In our last letter to the Secretary, we had recommended that they adopt 10.5 of the SCRIPT Standard from NCPDP and they had to have an exemption for long-term care with that standard.

Now NCPDP has come to us again saying we have corrected those problems, we now have SCRIPT Standard 10.6 and you can life the exemption from long-term care facilities and all of the problems that were in using these standards have been alleviated. We heard from both the long-term care community as well as the e-prescribing community and the standard setting bodies so it was a nicely done piece.

This is the letter that we would like to send forward to the Secretary about why we need to now adopt the next version of SCRIPT Standard 10.6. With that, what I would like to do is kind of read each section and then if there are any comments we can take them then. So we gave it a tag line for Paul.

NCPDP SCRIPT Standard Version 10.6 for use in Medicare Part D e-prescribing in long-term care settings. Dear Secretary Sebelius, which by the way makes me very happy coming from Kansas, I just had to recommend that, she is one of our favorite people--

MR. REYNOLDS: Have you stopped reading or what are you doing?

DR. WARREN: No, I'm making comments now.

MR. REYNOLDS: Oh, thank you very much. Just making sure.

DR. WARREN: Now I will start reading again. You know you Boston guys get all this stuff so us Kansas guys--

The National Committee on Vital and Health Statistics, NCVHS, is directed by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) to develop recommendations for uniform standards to enable electronic prescribing, called e-prescribing, in ambulatory care. This letter will specifically address the current exemption for long-term care facilities from use of adopted e-prescribing standards, the progress that has been made in modifying the standards to make the workable in long-term care, and our recommendations regarding adoption of e-prescribing standards for use in long-term care.

Any comments on that?

DR. FRANCIS: It is a little bit long.

DR. WARREN: We tried everything. Denise did a Trojan job on trying to break some of this stuff up and I think part of it are the titles of things--that they make it long as well.

DR. SCANLON: This is coming from someone who has been involved with long-term care and it is the issue of confusion over what long-term care is. Long-term care facilities is a broad term. I had this discussion with Jeff before, I think if we maybe put after long-term care facilities the first time we used it, in parentheses, skilled nursing facilities or nursing facilities. That gets to the things that are actually certified under Medicare and Medicaid.

MS. BUENNING: Bill had mentioned this to me prior to the beginning of today's session. Under Part D, long-term care is defined specifically as skilled nursing facilities. Other entities such as assisted living communities are not called long-term care under Medicare Part D. We can either put in a phrase here or I had actually penciled in something on the third paragraph of the background section--the last line that says therefore, long-term care facilities (defined under Medicare Part D as skilled nursing facilities) were exempted from the requirement. The reason I put it there is because it talks specifically about the exemption under Medicare Part D. So if you would like to entertain that change, I can make that change and have everybody take a look at it.

DR. WARREN: So that gets your--you don't need to have it in that first paragraph?

DR. SCANLON: No, just somewhere we need to warn people.

DR. WARREN: Anybody else on that first paragraph?

DR. FRANCIS: This is a wordsmithing. It will be my only one. I would just say that this letter will specifically address three things, one, the current, two, the progress, three, our recommendations because otherwise it is very hard to follow.

DR. WARREN: Did you get that one, Denise, about address three things? I have got it. It says this letter will specifically address three things--

MS. BUENNING: Three things or three issues? Do we want to say things?

DR. FRANCIS: This is beyond wordsmith as long as we put something--address three issues and just put the number one in front of where it begins the progress--

MR. HOUSTON: That's not an issue, though. Progress is not an issue.

DR. FRANCIS: Okay, three areas.

MR. REYNOLDS: So tomorrow when it comes back up the appropriate word that you would like to use. Continuing on.

DR. WARREN: Background, what I am going to do is read to the bottom of the page and stop there so that we can address this. The MMA established a voluntary prescription drug benefit program for Medicare Part D. Prescription Drug Plan (PDP) sponsors and Medicare Advantage (MA) organizations offering Medicare Advantage-Prescription Drug Plans know as MA-PD are required to establish electronic prescription drug programs to provide for electronic transmittal of certain information to the prescribing provider and dispensing pharmacy and pharmacist.

Second paragraph. There is no requirement that prescribers or dispensers implement e-prescribing. However, prescribers and dispensers who electronically transmit prescription and certain other information for covered drugs prescribed for Medicare Part D eligible beneficiaries, directly or through an intermediary, would be required to comply with any applicable final standards in effect for e-prescribing.

Next paragraph. The November 2005 regulation that adopted foundation standards for e-prescribed contained three exemptions from the requirements to use the standards. One was based on comments from the health care industry that indicated that the proposed standards, while well-accepted in the ambulatory setting, were not proven to sufficiently support the workflows and legal responsibilities in the long-term setting. Therefore, long-term care facilities were exempted from the requirements to use the NCPDP SCRIPT standard.

I think that is the paragraph that you want to add--

MS. BUENNING: Right. If I can direct your attention to the screen, I have inserted the proposed language in the parentheses.

DR. WARREN: So it's the next to the last line of the third paragraph so that it reads therefore long-term care facilities (defined under Medicare Part D as skilled nursing facilities) were exempted from the requirements to use NCPDP SCRIPT standard.

So let's take any other comments about those three paragraphs.

MR. REYNOLDS: Yes, I have a question. Is it still appropriate to say in the first sentence of paragraph two that there is no requirement that prescribers or dispensers implement e-prescribing? Isn't there something out now that by 2011--If you don't implement it by a certain time you are going to get--

MS. BUENNING: There are disincentives. Still it is voluntary.

MR. REYNOLDS: Thank you. I know. I guess as we continue through history at some point when there are disincentives--this is a fact but some of the reasons that we are doing some of these things is so that people won't fall into those disincentives. Is that not correct?

MS. BUENNING: I mean, we certainly encourage them and there are obviously incentives to e-prescribe but it is still voluntary in that you can choose whether to e-prescribe. Now you will, perhaps, experience a disincentive but this is still--

MR. REYNOLDS: As we continue forward, I want to make sure that--I don't want to change it now.

MS. BUENNING: Under the MMA, e-prescribing is still voluntary.

DR. WARREN: It may be what would be better here is to turn that around. Instead of saying that it is not required, make the statement that under MMA e-prescribing is a voluntary process.

MR. REYNOLDS: We don't need to change it. I am just making a point as we go forward. We are going to have incentives, we are going to have disincentives, we are going to have some other things going on--saying it is not a requirement, somebody reading this that is not as close as we are--

MR. BLAIR: Could I make a friendly suggestion saying not a requirement but the clarification Denise just gave us is that it is not a legal mandate. So maybe if we changed it to legal mandate then that would be more specific. Does that help, Harry, or not?

DR. WARREN: I think the issue is it is a voluntary practice with financial incentives attached. Is that it?

MS. BUENNING: But not under MMA.

MS. MCCALL: Can I ask the importance of making the point at all? It is there for a reason. What is it?

MR. REYNOLDS: That is where I am going.

MS. MCCALL: So the people that put this together, you guys put this in for a reason. It was to communicate what?

DR. WARREN: I would like Denise to talk about that because that was something that came out of her office to make the statement. Also, people that testified had talked about it as well. Denise, do you want to?

MS. BUENNING: I guess we always put this language in to clarify that it is voluntary for prescribers. Plans must support e-prescribing under MMA but in terms of prescribers they still can choose whether to e-prescribe. If they do e-prescribe, they must use the standards.

MS. TRUDEL: It is an important point to make in that we want to make sure that people don't read this as once we have removed the exemption, long-term care facilities are required to e-prescribe. They still are not.

MS. MCCALL: Maybe just stating it that way and not withstanding our recommendation it is important to remember that it remains voluntary and that is what I would say.

DR. SCANLON: I think the reason for making some acknowledgement here is to show that Medicare has thought about the importance of doing this. The acknowledgement that I would make because this paragraph is really about the MMA would be to put a footnote in at the end of that sentence saying--I think it's MIPPA, Medicare Improvement for Patients and Provider Act, which created sort of an incentive and ultimately penalties for not e-prescribing. It's incentatory prescribing and you can just say it in a sentence. The notion is that we move forward beyond MMA and not dwell on it.

MS. TRUDEL: That's correct. The MIPPA incentives apply to practitioners apply to practitioners not to long-term care facilities so I think there is a little bit of a disconnect there.

DR. SCANLON: But a prescriber has to be a practitioner, right, because the facility can't prescribe. We are modifying the prescriber here, not the facility. The facility is in charge of overseeing the dispensing but not the prescriber.

MS. TRUDEL: Well, the use of e-prescribing in a long-term care facility is going to be under the control of the facility not the physician. That is the distinction. There is no disincentive to the facility for not e-prescribing. I guess that is closing the loop.

DR. SUAREZ: One way to deal with this is maybe start the sentence with a while there are incentives for adoption, there is no requirement that prescribers or dispensers implement e-prescribing. It addresses the two points. It clarifies that there are incentives for adoption but still there is no requirement for implementation.

DR. SCANLON: There just aren't incentives, though, for the dispensers. There are no incentives for the dispenser. It is up to the physician. The physician receives the reward or the penalty.

MR. REYNOLDS: Let us do this, can you guys take this--since the letter will be finalized tomorrow--can you take this particular issue under advisement. I think you have had more than enough input from a number of us. Please continue.

DR. CARR: I had a question on the November 2005 regulation. E-prescribing changes workflow for everyone so I am not quite following why the change in workflow was a non-starter for long-term care facilities.

DR. WARREN: It is the whole piece of who writes the prescription and how they are managed because long-term care facility patients do not go visit their doctor and get prescriptions. It is the facility that manages the renewal of those prescriptions either through a nurse practitioner or they have a medical director that comes in periodically and signs those. There are different ways of managing prescriptions. It is not like in-patient care. It is not like ambulatory care. It is different. Trying to track the thread of responsibility for that prescription was what was missing before in the standard.

So, healthcare delivery in long-term care (LTC) settings is unique for several reasons. Nurses are frequently the primary caregivers, with physicians (who are often not at the site of the LTC) monitoring care. Specialized long-term care pharmacies are located off-site with drugs being delivered to the facility. Given these unique factors, the calendar year 2006 pilot project tested the use of foundation standards within LTC facilities in a “three-way prescribing communications” between the long-term care facility, physician, and pharmacy. This pilot setting provided a special opportunity for understanding e-prescribing's impact and use of both foundation and initial standards on a patient population, provider type, and prescription delivery system that is quite different from ambulatory or acute care facilities.

I'm going to read the next paragraph then I'm going to stop again.

In long-term care a prescription order typically remains an open order with no end date or with an end date far in the future. A prescriber may need to modify this order and notify the pharmacy. Changes might include dose, form, strength, route, modifications of frequency, or a minor change related to the order. Also, in the long-term care environment, there is a need to send a refill request from a facility to a pharmacy. An example is when a medication supply for a resident is running low (2-3 doses remaining), and a new supply is needed from the pharmacy. The facility needs a way to notify the pharmacy that a refill for the medication is needed. E-prescribing was evaluated within the unique context of long-term care workflow from facility to pharmacy.

Any comments about those two paragraphs? Denise?

MS. BUENNING: I propose that I remove the letters CY. It doesn't add anything and people trip over it.

DR. CARR: This is explaining what I just asked about, is that what this is?


DR. CARR: Is there a reason why we have to give this much detail because it is a long letter.

DR. WARREN: When we put this out to the subcommittee there were quite a few people who wanted to know what were the differences between 10.5 and 10.6 and why we were asking for this update so we felt that it had to be spelled out what the unique differences are because most people think ambulatory or in-patient and not the unique needs of this setting.

MS. TRUDEL: In addition, it would prove to be helpful to HHS on the back end as we develop a regulation and go through the briefing process with the Department principles and OMB to be able to point to the letter and say here is what the background is, here is what the industry told us. It would be helpful for us.

DR. WARREN: Any other concerns about these two paragraphs? Okay, next paragraph.

The long-term care pilot site grantee tested the NCPDP SCRIPT 8.1 standard in the long-term care setting, and, upon demonstrating that the standard was not feasible for use in the long-term care setting, used workarounds (modifications) to test the standard as required to ensure complete prescription data was transmitted and received appropriately. On completion of the LTC pilot, the proposed modifications that were identified and tested by the grantee were formally submitted to NCPDP to modify the standard by adding: bullet one, identification for facility unit, room and bed, for medication delivery; bullet two, census update transactions to notify the pharmacy about census events such as a new resident, a change to a patient's demographic information or a patient discharge; bullet three, a new transaction type of “Resupply Request”; bullet four, a change of prescription status flag for discontinue or cancellations in the request segment; and, final bullet, fields for needed no later than with a date and time.

These requests were fully incorporated in NCPDP SCRIPT 10.2, and approved by the NCPDP Board of Trustees in July 2007, with industry feedback indicating that NCPDP SCRIPT 10.2 meets the basic needs of the long-term care industry relative to e-prescribing.

We are going to go on and talk more about the standards. Walter?

DR. SUAREZ: Just a minor suggestion. In those bullets it might be helpful to put in quotes the few elements like in the last bullet “Needed No Later Than”. In the first bullter “Facility Unit, Room and Bed”. The second bullet, the “Census Update Transactions”. Fourth bullet the “Change of Prescription Status”.

MR. HOUSTON: In the first sentence, second line--it's upon demonstrating that the standard was not feasible--I would simply say upon demonstrating that version 8.1 of the standard was not feasible because what you basically said afterward is that the standard was adapted to be feasible. Just add that.

DR. WARREN: Did you get that Denise?


DR. WARREN: We also had a request from members of the subcommittee to put in the differences between NCPDP SCRIPT 10.5 and 10.6 so that is the next section of our letter.

Since that time, NCPDP SCRIPT 10.5 was approved by the NCPDP Board of Trustees in June 2008. This updated standard version built upon NCPDP SCRIPT 10.2, supporting an XML Implementation section and a Health Information Technology Standards Panel (HITSP) recommendations for Medication Management Use Cases; making changes to the PVD Segment (Pharmacy) prescription fill status notification (making RxFill mandatory), and inserting new PVD Segment fields and additional clarifying notes.

The NCPDP has further advanced its SCRIPT standard in other areas to achieve Version 10.6, preserving all the previous NCPDP SCRIPT standards requirements needed to support e-prescribing in long term care settings. The additional new functionalities offered by NCPDP SCRIPT 10.6 are primarily related to the Medication History functionality, which was adopted in the April 7, 2008 e-prescribing final rule--and then we have the number of the final rule. They include: first bullet, prescriber order number added to Medication History response; bullet two, source and fill number information added to Medication History Response; bullet three, a “Sold Date” value added to the DRU Segment Date/Time Period Qualifier. As an aside, DRU is not an abbreviation. It is what the name of the segment is called. Bullet four is enhancements to the DRU Segment enabling a physician to include prescribing-time drug utilization review alerts and comments to the pharmacist when communicating a prescription. This applies to retail, mail order, and long-term care pharmacy settings. The final bullet is an Allergy Segment and Diagnosis Segment for use in the CENSUS transaction that allow sharing of person's full allergy and diagnosis profiles with the pharmacy at time of admission and/or changes in their allergy or diagnosis statement, to help pharmacists catch additional, potential drug-drug interactions. These additions facilitate better record matching, de-duplication, and rich information being presented to the prescriber at the point of prescribing.

The long-term care industry has expressed its readiness to NCVHS to embrace e-prescribing so that it can enjoy the potential workflow and patient care benefits. I will stop there for any comments.

DR. CARR: What is de-duplication?

DR. WARREN: One of the things that we heard testimony on was there were many duplicate orders written. Is this something that you heard, Denis, and that is why you used the word de-duplication.

MS. BUENNING: I have heard it before, yes. It basically means elimination of duplication.

DR. WARREN: If you want different wording we can do that.

DR. CARR: If everyone is familiar with the term--maybe it is just me, I never heard of it.

MR. REYNOLDS: If the term is not easily translatable, let's change something.

DR. WARREN: Reduction in duplication.

MR. LAND: On the last dot point, shouldn't that be allows and not allow?

DR. WARREN: Yes, thank you.

MR. REYNOLDS: Please continue.

DR. WARREN: Okay. Recommendation one: The NCVHS recommends that NCPDP SCRIPT Version 10.6 be considered for voluntary adoption under the streamlined process for backward compatibility standards. In June 2008, NCVHS recommended that NCPDP SCRIPT Version 10.5 be considered for voluntary adoption under this same process. However, given the availability of the updated NCPDP SCRIPT Version 10.6, this version would provide the expanded functionality needed in long-term care settings to communicate information about prescription drugs and prescription drug-related information. It would also allow for the voluntary use of a more recent, backward compatible version of the NCPDP SCRIPT standard in ambulatory settings. Denise?

MS. BUENNING: I see Walter already has his hand up. Walter has made a recommendation regarding recommendation number one and he would like to see the NCVHS recommends that NCPDP SCRIPT 10.6 be adopted by the Secretary for voluntary adoption. I think it should be adopted by the Secretary for voluntary use under the streamlined process for backward compatible standards.

DR. GREEN: The recommendations both get lost in all the words and we repeat our rationale again in the recommendations. What would you think about streamlining these to where the recommendations state the recommendations? If we want the additional language just have an additional explanation or something but the first sentence of recommendation one and approaching recommendation two is really what the recommendation is, what follows is not a recommendation at all in either case.

DR. WARREN: Anybody else agree with Larry's suggestion?

DR. CARR: Yes. I agree because there is a lot to take in here so either put it--I think it is actually in the background so I don't think we need to repeat it. I would just make it real clear what the two recommendations are.

MR. REYNOLDS: Yes, we have warmed them up.

MR. BLAIR: Can I make a suggestion with a friendly amendment? It is fine with me as we decide to do that but let's make that decision after we have read both recommendations to see if that same practice would apply to both. Is that okay?

DR. WARREN: Any other comments on recommendation one? Okay. Recommendation two: The NCVHS recommends lifting the current exemption from the requirement to use the NCPDP SCRIPT standard for non-prescribing provider in long-term care settings. The exemption currently applies to prescribers when they are required by law to issue a prescription for a patient to a non-prescribing provider (such as a nursing facility) that in turn forwards it to a dispenser. While long-term care facilities would be able to voluntarily use the NCPDP SCRIPT 10.6 standard even while the exemption is in place, we believe lifting the exemption sends a clear message to the industry about the desirability of e-prescribing in long-term care.

MR. REYNOLDS: Before we take up Jeff's amendment, Karen, you are obviously a key customer in this. Style-wise I agree with Larry, I want to know whether removing some of that content is a detriment to this being able to be used by the government when we are not in the room.

MS. TRUDEL: Well, I think if it is repetitive that is not a problem.

MR. REYNOLDS: Well said. I wanted to have you on record.

MS. BUENNING: The only question I would have is is that the only place that we use backward compatible, Karen?

MS. TRUDEL: That is a critical point that needs to be in the letter. It is backward compatible.

MR. REYNOLDS: Yes, and that is a cornerstone for everything we have been doing on NCPDP is backward compatible. So regardless of how we streamline it, those words must remain in that area.

DR. FRANCIS: An easy way to streamline it would be simply to delete the second sentence and then say this version would and then bullet provide and bullet allow for the voluntary use for. That way you haven't looked like a recommendation and you preserve all the functionality and you don't have to figure out where to put it back in somewhere else.

MS. BUENNING: If you look at the screen, I have made that change if you want to take a look at it.

DR. FRANCIS: You want the provide and allow for. This version would and then you bullet provide and then you bullet allow for because you have two different concepts here.

MR. REYNOLDS: Let's do this. I think Larry made a good point, Jeff played off of it, Leslie added to it and so on. Why don't we let that be what the subcommittee does, come back with an abbreviated version tomorrow. Larry?

DR. GREEN: Sounds good. It also seems more logical to me to reverse the recommendations in their order. At least to me, the first recommendation is to lift the current exemption and then the second recommendation I to do something.

DR. WARREN: Actually, you can't lift the exemption until you say that you have the standard. The only reason we can lift the exemption is because we have recommended the standard. That's why we put it in that order.

DR. GREEN: I take your point. Thank you.

MR. HOUSTON: I'm trying to understand and, again, this not being my area of expertise, you are talking about all these different versions. I am assuming that we are not going to come back every six months or a year to write a new letter on a new version of NCPDP for whatever use and whatever setting it is. I understand that what I think you are trying to say is you want to adopt 10.6 for use within long-term care settings, correct?

MR. REYNOLDS: I think we have a couple things going on. Two things. One is you sit and read this letter if you are not as close to the game but this is huge and let me tell you why it is. A lot of the complaint in the industry is standards don't happen fast enough. With this letter, which to some of you may seem like we are trudging through some wording, immediately enhances a standards process dramatically and allows it to be as current as possible. Second, I know there are final rules and other things that are being dealt with so as the industry moves and we can make the right things available for when these things occur, that is a good thing to. Third, we are enhancing an exciting segment of the industry and allowing them to move forward with everyone else.

MR. HOUSTON: I think you may be missing my point.

MR. BLAIR: It's more than long-term care.

DR. WARREN: Let me see if I understand. One of the problems was when we made recommendations on MMA, we were asked to specify a version of the standard and that went into the rule. Any update on the version of that standard has to go through a formal process to be updated. We can't just say the current.

MR. HOUSTON: My point is more basic, though, does NCVHS need--I understand the basic premise of this letter and I think it is appropriate. You really are endorsing a specific standard for use within long-term care facilities and I think it is absolutely vital and viable that it gets--

MR. REYNOLDS: That's one subject, yes.

MR. HOUSTON: I'm almost feeling like the letter is us having to in one sense certify or recommend each version and do we want to get in the game--

MR. REYNOLDS: Yes, because somebody has to recommend it. The second thing is we have taken it up because if we don't do it in a public forum and we don't restate things like backward compatible and everything, you can be leaving a significant portion of the industry out that is shooting towards something.

MR. HOUSTON: Okay, but what happens when version 10.7 comes out?

MR. REYNOLDS: Well, when 10.7 comes out, if it doesn't meet the same criteria and it doesn't allow the industry to move forward and it starts putting undue restrictions, we have the public hearing to help decide.

MR. HOUSTON: Is it NCVHS' responsibility to review each one?

MR. REYNOLDS: Yes it is.

DR. WARREN: Yes, as specified in MMA. NCVHS has that responsibility.

MR. HOUSTON: Okay, because it sounds like this becomes almost an administrative task for NCVHS--

DR. WARREN: Much in the way HIPAA is that we have specifications that we have to do for HIPAA.

MR. REYNOLDS: But compared to the other standards process, it has turned it into light years different. In other words, this is what you would always hope standards might work like and you might be able to do the right things at the right time as they occur and put some value on them.

MR. HOUSTON: I'm just reacting to the fact--

MR. REYNOLDS: No, no, good questions.

MR. HOUSTON: I think NCVHS obviously wants to involve itself in making these seminal decisions about adoption of a technology and adaption of a technology for different areas, such as what this is talking about. If NCVHS wants to stay as a spot leader, my fear is this sounds like it could just become this task that always has to be done by NCVHS and it sounds like in many cases it very well might be something that doesn't require my input. That's just my thought. I understand we have an obligation to do it.

DR. WARREN: You bring up a good point. We had a lot of dialogue within our subcommittee about it, although, it is mandated in the law that we do this. This last version we were able to bring in a panel to provide testimony for why we needed to make this recommendation, do it during a full committee meeting, one of our breakout sessions, put together the letter--I think it is the fastest turnaround we've done so we're getting better at that.

MR. HOUSTON: I understand our need. When there is a need and when there is a value it sounds like it's a great thing to do. My fear is you would get down in version and subversions.

MR. REYNOLDS: Agreed, but I could argue back that we actually are acting as spot leaders as compared to the rest of the normal standards process in doing it so that we are able to literally stay up with the industry and able to allow CMS and others to move as rapidly as they need to, especially on something that is not on the street yet as far as everybody wants it to be on the street.

MS. BUENNING: Under recommendation number one I have made some revisions.

MR. REYNOLDS: Well, we will just bring it back tomorrow. I would rather bring it back tomorrow. Mark, last comment and then we will get off this.

DR. HORNBROOK: Are you going to have any implication by size of SNF? And rural versus urban? Are we, in essence, requiring all SNF's regardless of where they are sitting and how big they are to be electronically compliable?

DR. WARREN: Not required. This is all voluntary but the standard will now have the fields to communicate the appropriate information that they need to do e-prescribing.

MR. REYNOLDS: It's allowing them, if they choose to do it, to have the means to do it. Marjorie and then Karen.

MS. GREENBERG: I wanted to suggest because I think I heard a lot of discussion about people getting kind of bogged down in the letter but on the other hand there is a lot of useful information here to be in the letter and that is fine. I would say, just in response to John, if we had to get into the weeds like this with everything, of course, we couldn't, but I think it's actually good for the Committee to have some things that it's very specifically responsible for and other things that it can be more big picture about. I don't think that the balance is out of whack. There's something to be said for that to increase the Committee's utility and visibility. In any event, I was just wondering if we might, I mean the “Re:” says what we're talking about but it doesn't even say that we're recommending something and then it kind of refers to our recommendations in that first paragraph but we don't get to these recommendations to the bottom of the third page. I think the letter would pack more of a punch if after the first paragraph, we actually stated, generally, what we're recommending and then you can provide all the background you want and repeat the recommendations. They say tell them what you're going to tell them, tell it to them, and then tell them you told them or something. Put the bottom line up front.

DR. WARREN: Let me just clarify, I mean, we followed the format of our letters, which always puts the recommendation at the end.

MS. GREENBERG: Yes, but most aren't this long.

DR. WARREN: Well, the original NCPDP letter was very long.

MR. REYNOLDS: The point is--with two recommendations a lot of times our letters are long and we have series of recommendations and so you have to build it up. Again, I'd like the subcommittee to take that under advisement. Karen, your comment?

MS. TRUDEL: One of my comments was to Mark and to point out that we did hear a lot of input from the long-term care industry and they were very favorable about our moving forward with this because they thought that it paved the way for them when they are at a point that they are interested in adopting EHR e-prescribing technology and also that they felt that it sent a very clear message to the vendors in that space that this is the way you do it.

MR. REYNOLDS: Yes. The exciting thing about the way that e-prescribing is moving forward is the standards development organization comes in and they unanimously agree and then the industry comes in and it unanimously agrees also. So everything you would hope that you saw in a room, that you would want in a process, literally occurs in the room. That's why we're able to move this along and then with backward compatible as the keyword so that you're not leaving somebody out.

DR. HORNBROOK: So are we working towards a model, ideally, where the nurse and a SNF can send the prescription refill request into the pharmacist, the pharmacist contacts the doc electronically, the physician sends back an electronic signature approving it, or even skipping the physician all together? I mean, we're not saying that the physician has to get involved for refills, are we?

MS. TRUDEL: It's as appropriate. Basically, we've taken the flow that is occurring out there now and enabled that to occur electronically with a nurse, a physician, and a pharmacy being in the loop as needed.

DR. HORNBROOK: Right now most of it is by phone, isn't it?


MR. REYNOLDS: Okay, so Judy and Jeff I think you have a letter to take into the committee.

Agenda Item: Committee Direction Discussion and Strategic Planning

So moving on to discussion, there are some breakouts, I noticed. Privacy doesn't have one because we just had one.

As you go into your breakouts,--and I want to hear anything from the co-chairs--we had a lot of discussion this morning about who we are, what we are, what we're doing, what we can effect, so please don't go into your breakouts and just act like we always acted before. There are whatever subjects on the table that we think should be the right subjects on the table. We have some that carry over. Again, two came up this morning, the whole comparative effectiveness and the PHR, which right now is only really being dealt with significantly by the privacy group--whether or not those are subjects. If any committee decides that they would like to take the subject, not just the subcomittee portion of the subject on any of these, then it is a good time to step up and do that. Again, you may have to have some other players in the room help you do that but I think those are some of the things to consider.

Then, as we look at our meetings in September and our meetings in November, if, as we have done a couple other times, if those need to be educational or other kinds of things and if a subcommittee will pick that up and take that as a to do, bring in the right people to educate the full committee and/or make sure that the subject gets discussed, whether that's PHR--I'm just using these as two examples that came up this morning--or any of these other things. Again, I think the most important thing is we're trying to continue to drive this, making sure that we keep the full committee educated on the right subjects so that when the letters come in and the issues come to the table, we're not starting everybody from ground zero and they haven't had a chance to ask their questions along the journey, not all of a sudden when we have a letter of recommendation that appears to have been done by a subcommittee and nobody knows what is going on. I challenge you to take that. I also challenge you that it couldn't be a more exciting time for us and all of us that are trying to make a difference. I really ask you to make a difference. Don't just do what maybe your subcommittee thought before, acted before, did before, or believed before. How do we make a difference? Period. That's what I'm really excited about here. How do we make a difference because there is a lot to do in a lot of ways.

Any comments from any of the subcommittee chairs or anybody else before we break into our breakouts?

DR. FRANCIS: Could I take this opportunity, actually, as an invitation? We've had three days of hearings on PHR's and we have the need to have recommendations be ready by, at the very latest, November to be out the door if they are going to make a difference in the work of both HHS and the FTC with respect to personal health records. We have a work plan over the summer to develop a set of recommendations. They will be primarily on topics such as transparency, the importance of people really understanding what they're doing when they set up a PHR with some attention to how you get that genuine understanding, as well as not having bait and switch--not having the data be put in for one purpose and then, unbeknownst to the person, being used for another. We have a series of conference calls schedule over the course of the summer and we will let everyone know when they are if you would like to join in. We will also send around an informative summary that's just going to be a working document, not a public one as of yet, from the hearings that you are all welcome to have a look at as background.

MS. GREENBERG: There will be minutes, also.

DR. FRANCIS: There will be minutes but I think a couple of us--Paul, actually, came up to me this morning and John suggesting that the analytic summary would be a good idea just as a working document. We're going to send that around to members of the committee. As we get the recommendations put together, we will also make sure that those get circulated around so that we have an opportunity for people because if this is going to make a difference, it has to be signed, sealed, and in a pretty little bow by November. That gives us two committee meetings at max. Just a heads up folks. It's coming.

MS. BERNSTEIN: I thought that we also agreed that we would announce when the phone calls are scheduled so that all the members of the committee who might want to can participate in those.

DR. FRANCIS: We will send that around to everybody, I think. I don't have the list of dates, myself, right now. I don't think we have it yet but we will make sure that all of you have it when we have it. I think the first one will be July 17th.

MR. HOUSTON: I know that Blackford has graciously offered to help. Mr. PHR help--involve himself.

DR. MIDDLETON: I just love that stuff.

MR. HOUSTON: I know you do.

MR. HOUSTON: To expand upon what Leslie said, just very briefly, we had three days of testimony and a lot of really great input. I think, unlike EHR's, PHR's are going to evolve in many, many ways. While we heard a lot of people talk about privacy and concerns over privacy in PHR's, we also recognize that we don't want to stifle innovation and I think PHR's are going to be an area of great innovation over the next foreseeable future. As Leslie said, we think that the way to bridge the gap between privacy and not stifling innovation is really this concept of absolute transparency and trying to do it in a way that engages consumers so that they really do understand and have the ability to make choices when deciding to use PHR's rather than imposing some type of regulatory burdens on PHR's that may cause them to fail in providing services that people really want. There's so many different forms of PHR's, everything from social networks to what we classically think of as a PHR, whether it be claims based or tethered to an EHR. It's a very complex subject area and we do really do encourage people to involve themselves because I think that the more we got involved, the more we recognized how incredibly complex and powerful this is.

MR. REYNOLDS: I would add to that, every time you sit in one more of the days of hearing, it changes your perspective. So please engage because this is one that you are going to really need to take a look at. You're going to really need to have a sense of what you're doing because it's happening quickly and some of the testifiers kind of gave us the same flavor, others have continued to move it forward. It's going to be an interesting challenge as things continue this quickly so that's very important to do.

Judy, you had your hand up? No? Okay. Anything from Quality or Populations? You will be back tomorrow? Good. One last comment before we break into our breakout groups is we have drafted a letter to Rob Kolodner for his service as the National Coordinator and I don't plan to read it. It's well done by a lot of people and it is heartfelt as to the difference that he made and especially his relationship with us and how he was very open to work with us and very inclusive with us and we were the same with him. I just wanted to mention that and get an approval from the group to forward that from the Committee to Rob even though he has moved on to other opportunities.

MR. BLAIR: May I make a motion?

MR. REYNOLDS: So moved, second? All in favor?

MR. REYNOLDS: Opposed? Okay, thank you. So we're adjourned for today. Break out sessions and then we'll start promptly tomorrow morning at nine for the full committee.

(Whereupon, at 4:40 p.m, the meeting was adjourned.)