TRANSCRIPT – HIT Policy Mtg 7/16/09

I have posted the rough draft transcript of the HIT Policy Committee’s third meeting below the meeting materials.

  • Meeting Materials
  • ROUGH DRAFT TRANSCRIPT:

     

     

    Event Started: 7/16/2009 9:50:16 AM ET


    Good morning, everybody. Welcome to the third meeting of the health information technology policy committee. This is a federal advisory committee which means it is being operated in public. We have an audience in the room, telephone lines are open if you care to listen to the meeting, and it is being webcast. Minutes of the meeting will be put on our website in about a week following the meeting. Members of the committee, please remember to identify yourself when you’re speaking so we have proper attributes in the transcript. Let me go around the room and you can introduce yiewrgs beginning with la ton I can’t.


    I am a professor of computers? Technology and policy and I am also the director of the data privacy web.


    Deb McGraw with the center for democracy and technology.


    Jim bore land, special adviser to the special committee for health IT.


    ( indiscernible ) Cowman institute for family health.


    Adam Clark with Lance Amrstrong foundation.


    Christine Beck tele.


    Paul tang.


    David Blumenthal, national coordinator for health information technology.


    Judy Faulconer with ethic.


    Gail Harrell, former late legislator from Florida.


    Mike claig.


    Charles Kennedy, WellPoint.


    Paul egger man, software entrepreneur.


    Jodi trining he wills, CMS.


    Michael, military health service.


    Connie Delaney, University of Minnesota school of nursing.


    Roger Baker, veterans affairs.


    Jodi Daniel, Office of the national coordinator for health IT.


    Do we have any members on the telephone, please.


    Yes.


    I am sorry?


    Scott White from 1199.


    Okay.


    This is ART Davidson from Denver public health.


    Scott and Art, thank you, and I will turn the meeting over to Dr. Blumen that will.


    Thank you, Judy. Thank you to those of you on the phone, thank you for being here, thank you to those of you looking in over the web. We appreciate your interest. We appreciate your work. I especially want to thank the members of the committee who have worked tirelessly to get us prepared for this meeting and past meetings, and I hope future meetings. We hope not to burn you out. This has been — we’re on a very fast schedule, and there have been countless hours of volunteer team quoted to the work you will be hearing about today. There are also countless hours of staff time from the national coordinator’s office and from the center for Medicare and Medicaid services and from other federal agencies that have made it possible for us to make a great deal of progress on a wide variety of very, very complicated issues, and I hope that as we process this work today and I am confident that as we process this work today that we’ll make substantial progress towards getting the committee to provide the recommendations that will be so helpful to myself and to the department, and ultimately to the American healthcare system.


    Our agenda today is a busy one. There are two new formally seated members today, one is Toni Trinkle from the center for Medicare and Medicaid services. Toni was here as an observer in the past and now he is a member of the committee. The other is Jim boreland representing the Social Security administration and who coordinates the agency’s internal health IT efforts and the Social Security administration is a major utilizer of health information technology and has a great deal of interest in this committee’s work. So we welcome Toniy and Jim. We are going to cover quite a number of tough and complicated issues today. We are going to start in a moment by approving the minutes, but we are then going to go onto get an overview of the public comments that were received in response to the meaningful use discussions that we had during our last meeting. We’re then going to have a presentation on the response of the meaningful use work group to the deliberations of the committee last time and to those public comments. It is my hope that by the end of that discussion the committee will feel ready to adopt or not the recommendations of the work group, and in a moment I will discuss what I would like to do in the way of process of approval or not approveing those recommendations. We’ll then hear from the information exchange working group which has worked very hard on that particular attribute of meaningful use and of the health information technology infrastructure. We’ll then have a break and then we’ll talk here recommendation from the certification adoption working group and then finally we’ll get a briefing from the health information teching in standards committee which will be meeting next week and is waiting breathlessly to see what we do so that they can develop standards that embody our decisions and which can then be embodied in turn in regulations that the Office of the national coordinator has to issue in an interim final forum by the end of this calendar year.


    Let me start now more formally by asking the committee to adopt the minutes from our last meeting. Yes, Gail?


    I had one change I already talked with Judy about and I would like to see it put in the minutes, please.


    All set on that, Judy?


    Yeah.


    Do you think we need to share that with the rest of the group?


    Just including more information on her remarks on CPOE which is fine.


    Okay. So any other comments on the minutes? If not, die hear a motion to — do I hear a motion to adopt? Second? All in favor?


    Aye.


    All opposed? Terrific. Thank you. So let’s just let me say a little bit about how I have thought about the process of accepting recommendations. In a parented organization to this, and we don’t need to be bound by this precedent, but in a parent organization the organization that existed under the previous administration, the American health information community, recommendations were frequently adopted by consensus, and that strikes me as in some ways the optimal way for us to go, hopefully we will be able to achieve consensus on recommendations. That may not always happen, and if a vote is desired, I will entertain a motion for a vote if people would like to see a vote. I don’t want to officially call for votes unless there is a sense from one or more members of the committee that there is sufficient controversy so that a vote is required. That’s not to say we won’t have votes. We certainly will have them if we need them. Rather than do that as a standard process, I would like to continue the tradition that has existed previously and adopt by consensus unless there is a requirement to do otherwise. Anyone have any objections to that or any problems with it? Okay. Terrific.


    In that case what I would like to do is begin the portion of our meeting which pertains to the meaningful use definition, the matrix that Paul and I want to also recognize George Ripssi C who is a member of the work group replacing Fashad. He was disqualified a a member of the working group because much to our pleasure and benefit he joined the office of national coordinator as a senior adviser, so he is transitioned from one form of assistance to another form of assistance. Thank you, George, for your willingness to work with us.


    At this point I would like to turn to Jody Daniel who will talk about it turns out 720 some comments that we received. Those of course were received for over a ten-day period after we last met. We last met on June 16th, the comment period closed on June 26th. Judy will correct me if I am wrong. We received the comments, and with the help of two terrific first year medical students who I think may never want to hear the term meaningful use again, we were able to process those and qualitatively, we think, get the benefit of the comments and the kind of content of the comments. We don’t have a quantitative rendering of those comments. We are looking at ways to splice and dice the data, but I do think this was an enormous amount of work to process these in a very ex pee dishes and I think fair way all kinds of matrices and spreadsheets were blooming up around the ONC office in response to the comments, but we are grateful to the public and to the many professionals and groups that submitted their very thoughtful comments and Jody is going to give us an overview of what we saw in response to our last group meeting.


    Okay. Great. Thank you, David. As David had mentioned we really appreciated the input of the meaningful use work group and the great discussion of this committee last month, and there was a decision to table the conversation, but that was meant far from dropping the conversation, and in fact it meant kind of heating up the conversation on this topic. Since our last meeting there was a lot of activity and input. We did have our public comment period which I will discuss in more detail, and then we had a couple of meetings of the meaningful use work group to discuss the comments and all the input we received on that, discuss the input from this committee and to revise the recommendations which we will hear a presentation on today.


    I want to just before I get into the comments talk about a couple of process issues for today’s meeting and sort of what’s going to happen next to set a context for the deliberations today. So as David mentioned we’re working under incredibly tight deadlines, and we really appreciate all the hard work of everyone in trying to get to us this point. We’re very hopeful there will be some consensus from the group today to help inform our deliberations. I just want to clarify these are recommendations of an advisory committee, not HHS’s opinion. Whenever there is an agreed to consensus on David sits here as the chair, but he is wearing two hats, one is the chair of the committee and one as the national coordinator, and he will receive the recommendations from the committee as the national coordinator. What we see the advice of the committee is extremely important input into our process, but we will then take those recommendations and incorporate them into our regulatory process, so we will work very carefully from all of the work that we have heard from you all, and I expect they will be an important contribution into our work.


    What we will do because David wears two hats is any recommendation that is come out of the committee will be transmitted from Paul, our co-chair, to David as the national coordinator, and then they will be considered by David Blumenthal and others at HHS in our regular agency process. Our next steps once we get recommendations, ONC, NCNS will be developing regulations standards and certification, on certification process and incentives and the definition of meaningful use.


    CMS will come up with a proposed rule on the incentives including the definition of meaningful use and get comments, and then go to a final rule. ONC will be developing an interim final rule as set forth in our statute on the standards and certification criteria which we will also get comment on and come up with a final rule after comment.


    The timeframe for both the interim final rule under statute is December, and as CMS has stated, their proposed rule will also be targeted to come out in December. There is going to be some limitation what is we may be able to say or do after today’s meeting with respect to feedback and input. We’re going to hopefully — we may be able to come back to the committee in August with some additional questions or some thinking from the national coordinator’s office. We’ll see. We’re going to talk to our General Counsel about that. There will be some period of time where we’re going to be heads down writing our regulations and working on our process internally and like I said there will be comments, opportunities again on these topics in December.


    With that, I will go into the comments that we received on meaningful use. David already covered most of this. We had a ten-day comment period. I guess we have some numbers issued. The number that I had was 7892 comments — 792 comments received. It was quite a substantial number for a ten-day comment period. There was a lot of interest in this, a lot of great feedback that we received and incorporated, and provided both comments and summaries to work group members of the meaningful use work group to take into consideration.


    There is some general themes I wanted to bring up. The majority of folks believe that meaningful use really should be focused on measurable improvement in health outcomes and not adoption of technology for its own sake, and commenters really applauded the emphasis on quality and outcomes measurement overall. We had a lot of support for the work of the meaningful use work group, more than a third of the comments expressed general support for the initial guidance that came out of the meaningful use work group, testment to all of the hard work they did, but some people suggested specific changes to objectives or measures, either changes to the measures themselves or the timeline. A lot of folks said it is too aggressive, you need to delay some of these measures to later years, and then we got some folks who also said the opposite. This is something we can do in 2011, please move tup or this is something critical you need to move it earlier. We got comments on both ends of the spectrum, move reasonable doubt things sooner, delayed things, too hard to do now and know this is too important, you need to do it now. We got a lot of pushback in both directions on the timeline.


    We also got some requests for items to be clarified or terms to be clarified. There was a lot of question about what some terminology meant, what is coded format, what are patient preference, so there were a lot of questions about some of the details and the terminology we used which obviously the work group thought about some of those and that’s something that we would flush out through our rule making as well.


    We received a lot of feedback in three particular areas that I wanted to highlight. One was on CPOE, the second on information exchange, and the third is on patient access to their own personal health information. There was a general recognition that CPOE was a critical function for early implementation, but there was also a lot of concerns raised about the workflow and how this could be done in 2011. There were some questions about having other providers other than physicians being able to do CPOE, so those were kind of the flavor of what we heard on that topic. For information exchange there was general support for information exchange, and of course it is something that is required by the statute for meaningful use, but there was some questions about the timeframe for requiring exchange, the amount of information that would be exchanged in early years, and whether or not HIEs or RIOs or similar type of organizations needed to be used for the exchange of those kinds of data.


    With respect to patient access to their own health information, there were differences in what folks thought were the scope of the challenges in doing this. There were a lot of folks who said a lot of commenters who said it was really important to give patients access early on. This was a critical component to meaningful use. Others were talking about some of the challenges of doing that in early years or the ways that we would do that in early years.


    Then there were some who recommended we have more measures in certain areas, particularly efficiency measures, and that was something the work group considered, and you will see some evidence of that. On the measures front, like I said, a lot of folks asked for additional measures, particularly as they relate to specialty providers. We got a lot of comments from specialty groups, specialty providers, who were concerned about how the measures applied to particular specialties. We also had a lot of commenters who said — who encouraged us not to creates measures denovo but use existing measures and here is a sample for some of the sources that folks recommended. I am not going to read all of these off. This was the full array of the sources that folks suggested for that the work group and that HHS looked at for making measures decisions.


    On privacy and security we heard a lot of concerns about the measure for this, and there was concern that the way it was written might make it very difficult for large provider organizations to achieve meaningful use because they may be subject to complaints for HIPAA violations even if they have done nothing wrong based on the volume of patients and activity they have even if those organizations are then cleared of the complaint and if nafts there is no violation found. That’s something the work group addressed.


    There was some concern about unintended consequences that if it was tied to an investigation that entities would be reluctant to report breaches or to try to improve on their processes and make information public because it might affect their ability r ability and provider’s ability to get meaningful use payments.


    There were others who were questioning what was necessary because they thought it was redundant with the HIPAA laws which already providers would be required to comply with and so there was some question about the redundancy and whether or not meaningful use needed to include reference to HIPAA as part of the calculus.


    Finally, although we didn’t ask for comment on certification, we received a lot of comment regarding certification, so since there will be a topic today on the certification process from our certification adoption work group, I just want to highlight a couple of things we heard. There were many that suggested the certification standards should be designed to support meaningful use and not be as broad as they have been in the past. There were some additional suggestions about the ability to have modular systems certified that having criteria that promote interoperability to a greater degree that there be certification of specific functions for EHRs and certification for specialty provider EHRs, something that is being considered now, but there isn’t widespread certification for particular specialty EHRs. That’s some of the flavor of what we heard on certification.


    We have Fed all of our thinking, understanding of the comments, and any summaries that we had as preliminary as they were with the meaningful use work group, and you will see when they present how they addressed many of these issues in their recommendations. I also want to add to David Blumenthal’s thanking of our medical students to say there were a few analyst that is worked tirelessly to go through all of the comments to try to summarize them, to figure out how we can get information to the work group in a way that would be helpful to their process and we really appreciate all of their hard work.


    Thank you, Jody. Any questions for Jody. I think you will see Paul and George will revisit some of these comments in their comments which are just about to come. I also want to mention that it is a priority of the Obama administration to be open and transparent and to collect information from the public in whatever way we can. We did hold in addition to receiving public comments a series of listening sessions, and I think there were a total of 20 or so listening sessions. Is that right? We heard from a wide variety of informants, large and small, big groups, small practices, associations, providers, the public, those comments were extremely useful. We have not tabulated them, but some of them were shared with the working group in the less systematic form than in the formal comments that we received from based on our thrib reconciliations here — deliberations here a month ago.


    Of course many groups and individuals have taken advantage of the opportunity to contact me directly and other members of our group to share their thoughts about the meaningful use work of the committee. With that, let me ask George for a second and Paul to talk about how the meaningful use work group has taken into account the discussion we had last time and the comments to reformulate recommendations for this group. Let me place one thing in context also or a couple of things in context. We have a 2011 statutory sort of milestone in which providers will become eligible for the first round of incentives, and I think it is only natural that given the fact that 2011 is a clot closer than 2013 or 2015 that we tended there was there was a tendency in the working group I think to focus on 2011 and the most detail is associated with the 2011 meaningful use criteria.


    As Paul will say, we’re not nevertheless I certainly he I am not unmindful of the aspirations that we have for future years for 2013 and 2015, and the fact that we will quote a good deal of time to the 2011 discussion I expect because of its specificity, shouldn’t divert us from the fact that our recommendations, directional and even if they’re only directional, are very important for my office to hear and very important for the public to hear, so keep in mind this is a a tricks of recommendations that includes 2011, 2013, and 2015 components even though the 2013 and 2015 components are likely to be somewhat less specific than the 2011 components. With that, Paul.


    Thank you very much, David. I am also appreciative of having George as a co-chair. He is a chair of a department of bioinform mat ichs at Columbia University and has a lot of experience in running the shop there at New York press by New York. I want to acknowledge how flexible and diligent and passionate they have been at tackling this responsibility at the last call we said, you know what, it is going to take us more time so we’re going to talk tomorrow morning and people drop their schedules and just did that, so people are very, very dedicated to this effort. The other thing I have been searching for a long time for how to extend the 24 hour day.


    ( laughter ).


    I have found that having bicoastal co-chairs adds three days to every 24 hours.


    ( laughter ).


    So there is not a time when one of us isn’t working. This is great. I found the answer. Quickly this is what I want to cover in today’s presentation. George gets a buy just for this one meeting because he just joined but we’ll be sharing it in the future. Want to quickly remind ourselves what’s the framework we set out? You have heard a summary of the public comments. You heard last time’s comments from this committee. We’re going to talk about how we digested that and came up with a revised recommendation and talk a little about our future work. First the framework. As you recall, as David mentioned, it is clearly directed, point towards measuring and continuously improving outcomes. We have really totally made sure that the focus is not on software, really is on the health outcomes. We also recognize that we can’t get from our low adoption rate now to the dream, the division of having everybody adopt EHRs by 2014 in one fail swoop. We mapped out three phases.


    One is get it in the system in standardized format and get it to the people who need the information to make decisions. The second is to use that information in different care processes that are going to focus on the patients and finally we’ll be in a position if we have accomplished those stages to be able to measure and continuously improve our outcomes. Now, as you know, even in statute it is both the President’s goal as well as in statute by 2014 we have adoption of widespread adoption of EHRs, and so that sets the timeframe by 2015 you’re no longer eligible, at least eligible provider to get incentive payments, so the 2015 goal is there. The 2011 is the first time when incentive payments would be made, and so that then sets our timeframe. Then as we mentioned last time, working backwards, we then carved out criteria for meaningful use in the three general areas, 2011 focusing more on the capture and share data, 2013 use it, use clinical decision support and advance care processes and finally improve outcomes in 2015.


    These are some of the considerations, and we use these in almost every decision discussion about the revisions. That is our purpose here is to improve the healthcare system, reform it, focus on health outcomes, but balancing that sense of urgency, the 2014 sense of urgency with what it takes to both install and implement and effectively use these systems. We know we’re starting from a low adoption rate. We’re sensitive to the under resourced practices, like small practices where a lot of healthcare is delivered, the community health centers, rural setting, a lot of those issues, but we still have to get a job done. If we’re going to reform this health system, I don’t know that anybody believes you can do it because these tools, these are tools not an end, so we still have to work towards that goal of getting it out there as quickly and safely as possible. The recovery act provisions do set the timeline, the 2015 is there, the end of the incentive program, at least for the provider’s side, and the beginning is 2011 and 2012 when we have to make our first contribution. The funding rule is being front loaded. The most money subpoena front. Those are stet in the — the most money is up front. We talk about that every time when we talk about changes to the criteria. This is not for reading, but just to remind you we came out with an initial proposed matrix last time, the group saw this, we reviewedt got comments back, and you heard we also have public comments.


    Let me review for you how we approached the comments and what we suggest or recommend as our draft recommendations to this committee for further discussion. They’re sort of buckets, let me talk about them in the framework, timing, specialist care coordination and privacy security, a lot of topics Jody just mentioned. In the framework point of view we’re grail really grad fined I think almost universal adoption and endorsement of the approach, focus on health outcomes and quality measures. So the other major approach that we took beginning with our last set of draft recommendations was to be parsemoney ows in the objectives. We could choose to say we’re going to set 500 criteria and pick and choose which apply to you or go for the few set that if you were to be able to report on and improve on these over time, by gosh, you probably have a comprehensive robust EHR and are making good use of it.


    So underlying assumption for the approach to the criteria is if an organization can demonstrate they have the capability of reporting on these MU meaningful use measures and continuously improving them, then we’re really assuming that you are making — you have a good EHR system and are making meaningful use of it.


    The first piece you heard from Jody is the comment you want it when and the recognition is that there is only 18 months between now and at least the beginning of 2011, and this is good time to mention that to remind people the incentives starts 2011 or 2012 with either of those years you will get the full five-year payments that equal 44,000 at least for the majority of providers in the Medicare system.


    CMS will decide — that gives you up to, and that’s admittedly towards the end of 2012, but you get the point. It is probably another three years. CMS will determine what’s the measurement period to qualify for the incentives, et cetera, and that’s to come, but just to remind people it is probably more than eighteen months when they have that they have to do this job. The second point is we found a double jeopardy. If you can’t make the 2011 and the 2012 criteria and you’re coming in at 2013, gosh, in 2013 the bar has been raised higher, it is a bit of double jeopardy, almost as if you can’t get into the game at all. Although you might think of a rising tide floats all boats, if you’re not in the water, it just doesn’t help. We’re trying to find a way to get people to be able to participate even if it is a little bit delayed.


    The approach we would like to recommend has to do with the concept of an adoption year. Right now it is written as 2011, 2013, 2015, but what if we considered 2011 as your first adoption year, no matter when you come in. I will explain in the next slide. 2013 would apply to your third adoption year. Let me go into that and actually — this is a table from the statute of how you qualify for the incentives. As you see, if you come in and qualify in 2011 or 2012 you get the full 44,000 dollars. Again, this is just a Medicare side.


    Our initial matrix and the matrix we’re presenting today spells out the 2011 objectives and measures, 2013 and 2015. What we would like to propose in the new method of adoption year is substitute instead of 2011 criteria call it adoption year 1 criteria and measures. So these are the first year and how that would map out into the incentive program what we’re suggesting is we would apply adoption year one criteria to the first year no matter when you start. There is no change in the money. You still if you start in 2014 are only going to get 12,000 compared to the 18,000 in 2012, but you have a consistent set of criteria. I think we think that this sort of relaxes that and gives people a fair shake and doesn’t have the double jeopardy built into it. This is a recommendation from the work group and for the committee to consider CMS has its considerations in terms of the system’s ability to administer such things. They will determine the final rule.


    The other feedback you heard, the second most popular feedback or the most common was CPOE is being asked for it too fast. We heard that primarily from the hospitals. The unintended consequence of its not just a software system, you have to build the order sets, for example in a hospital environment. Have you a lot of training to do, so it takes calendar time to get this work done. When we initially set up the objectives and the measures in the first round last month, we actually didn’t necessarily say you had to have 100% adoption of CPOE in the first round. The difference between the objective which is sort of the signal or the timeline, the road map that the goal is to achieve full CPOE use, but the measure was actually a reporting measure so what’s the percent of your physician let’s say in the hospital that are using CPOE directlyt didn’t set a threshold purposefully. Now, understand that it may have been interpreted to be 100% CPOE, but that wasn’t necessarily the initial intent. We have come back and said let’s put a number, it is nowhere close to 100%, it is 10% is our suggestion, that allows people to get started, to have a pilot up and running, maybe certain subset of physicians or certain units in the hospital, some way of making sure that you are on that road to CPOE, but not 100% by 2011.


    Turns out in the interim there was a survey by chime with healthcare COIs and admittedly that’s a selected group, but 70%, over 70% of them said they could accomplish 100%. They were going in the 100% measure within three years.


    I was going to ask if you could clarify who the respondent population is for that.


    Chime is a group of healthcare CIOs. That is one group, one input where they actually did a survey of their members.


    Small and large hospitals, tend to be larger hospitals?


    It is a mix but probably the folks further along are members of this organization. It is not a data point that we use, but it is just a confirmed data point that says it is actually humanly possible. The next point, and it came from this group as well is, gosh, why don’t we move clinical decision support up from we originally had it in 2013. Why? Because that’s the pay off. That’s how you influence the orders written. That’s how you’re going to influence care or one of the main ways you influence carat least using the systems. On the other side it is sort of a sequential act when you implement these systems have you to get it in, have you to get it collecting datea and you have to get people to use it before you start firing off these alerts and putting things in front of them. That’s the normal pattern, so that would be the argument for delaying it, keeping the sequence in place as we had it last time.


    Our compromise is let’s start with one rule and make it really important. We put in that we recommend that you implement one clinical decision rule that’s relevant to your local priorities, each hospital or health organization or region has priority that is are local to them, and that’s the way we constructed that. The other people in the patient and family engagement as you heard from Jody, there was a lot of requests for earlier access. We had a copy of your information provided to you electronically, and the request was to have access by 2011. We responded to that and moved and included not only the copy of but also the access to in electronic format your health information, so these are from organizations that do have an EHR in place. We moved up the realtime access, that is as information becomes available, if lab test results, those would automatically be available to the patient and that originally was in 2015 and we moved that to 2013. We’re trying to be very responsive on saying that the consumer patients are really part of this deal. We want to recognize that they have not only their right but in all of our best interests they have access to the information.


    Efficiency measures. It was point out that we have a dearth of efficiency measures in our last matrix. The reason is because there are a dearth of efficiency measures that are out there to use. NQF has been asking for those for a long time but just haven’t been that quick in coming forward. That clearly is one of the priorities for the country. It is a priority enumerated in the national priorities partnership goals, and so we’re proposing an initial starter set, and those are the following. One is we do know that choices are made between generic medications and brand name ones and that there is a huge cost difference, so our measure is what is the percent of medications that are generic when those options exist, not in every drug class is there a generic option, but when they exist let’s have a measure what percent are prescribed as generics.


    Second piece is high cost imaging services, and we would like to inform the provider who is ordering those on the most appropriate imaging test. If any for that particular indication. Although we don’t have the evidence at hand that says, well, how do we write that decision rule, we want to start putting ourselves on the road map to going there, and so our first proposal for 2011 is to have at least record the indication for ordering a particular test in a structured way so that we can analyze it and provide feedback to providers.


    The third and fourth examples are really having to do with efficiency surrounding the payment system, that the claims be submitted electronically to both public and private payers and that we have eligibility checks performed electronically.


    Specialists. Turns out the majority of EHRs in current use and current products address primarily primary care. We have to do a better job of getting those products developed as well as being able to certify them. Once again we’re faced with a couple of options. One is the 500 criteria model which is let’s make sure we have a measure for everyone, but yet there is very few to choose from at least NQF endorsed. The other model is take what are the critical few that we can build upon and if you were to satisfy those criteria again you approve that you probably do have a robust EHR and are using it effectively. That was the approach that the work group took. That is the excel plar measures that if you fulfilled these we have a good indication you’re a meaningful user of this tool. In 2013, again, since there are not very many measures that are in current use, by 2013 that we would start with specialist participating in electronic registries. There are certain organizations that already have these up and running and have a lot of data in those, and that’s a good way for the country to both start measuring and getting the advantage of this data collection and using it.


    Care coordination. One of the top goals is improving care coordination yet we have a policy of measure that is can measure whether that is happening. NQF has a call formers in this area — for measures because it is a priority. We’re proposing we measure something, we know that 30 day readmission rate, maybe a third of patients are readmitted within 30 days of being discharged from the hospital. That has to improve. We’re putting out there for your comment a 10% reduction in the 30-day readmission rate compared to the year prior as a 2013 measure. To continuously improve on whatever NQF endorsed measures are thereby 2013.


    Now we have the problem of the health information exchange. Clearly in 2015 it is the goal, and I fully expect in 2015 we’re going to require for the incentive payments that people do participate in health information exchange, in interoperable ways with data standards. That world doesn’t exist today at least and we need to do something between now and 2011, so our thought, and it is for further discussion that we talk about requiring the capability in your EHR to exchange following the standards that evolve over time. They aren’t mature at this point point.


    CCHIT does have interoperability standards in their certification criteria. We’re deferring to the work group for the specific requirements and the road map, but what we would like to put on the table is that they use the EHRs capable of doing that following the standards that are available, and say have some of that built in. Now, I mentioned that CPO was the number 2. The number 1 thing that everybody commented on I think is the thing about investigation and HIPAA. Clearly the issues were as present by Jody, we do have a principle in this country of innocent until proven guilty. That still exists in this world, and the intent of the work group that put the original language together was not necessarily to say, oh, gosh, if you have any complaint that eliminates you from the program. We clarified that. The intent was it seems funny that if you have a proven violation that you should be continuing to get money from the federal government. The revised wording talks about withholding payment until confirmed violations are resolved to HHS’s satisfaction.


    The other comment was we did have — have you to comply with state regulations. One question is how does the federal government enforce state laws? Well, that’s a good question. We took that out of the Medicare program, but Medicaid as you know is administered by the states, so we left it up to the states to make sure that people are following their local laws as they qualify for the incentives. In the future work there was some achievable vision bullets put out in the last presentation. Those were set out as examples. The work group is going to refine those, and get consensus on the set that we can put before you. We need to after we’re done with the 2011 need to March on with 2013, 2015. They still are going to come, and find a process for how do we ongoing way update this. It is required by statute that we have more stringent measures as time marchs on, and we are also asked to review the barriers to broad adoption of meaningful use and make recommendations back to the committee on how to address those.


    With that want to open the floor for comments, questions, from the group and, George is willing and able to participate in that.


    We appreciate the strong industry of the outcomes focus framework. It is a clear stretch. We recognize that, to accomplish this in in short of time. We also know it is more than money that prevent people from getting there. It is the workforce. It is the education. There is other aspects of the recovery act that are meant to address that like re gobble extension centers and other research on how to make these implementations go better. While this is extremely ambitious, if we can get the incentives in the good direction, I think it is a vision that is achievable, and maybe this community’s contribution to health reform agenda. Thank you.


    Grnlg, would you like to add anything? I realize that you’re a new arrival.


    You know, I think it is in some ways a high bar, but a clinically relevant bar, and that’s what we’re here for. I think the measures coming in in the once sense are parse money us. I think they’re comprehensive enough to avoid gaming the system. If you have too few measures you focus on those things. If you can achieve everything on this list you really must have a pretty good use of your EHR. It is a stretch actually, that co-in-sides with the 40th anniversary of the moon walk, so this is our next moon shot in healthcare is achieve this vision, so I am excited about it.


    Thank you, George. I think you can see regardless of whether you agree with everything on this matrix and I think you can see number one that an extraordinary amount of thought and detailed work has gone into this, and I want to again applaud everyone who was involved. I think this is a really breaks new ground in policy development and not just in health information technology but really in setting criteria for improved practice that may be implementable. We are struggling to develop incentives and performance criteria in many elements of our healthcare system. This is I think the first time that any group of this type has tried to be this specific related to particular dates and particular programatic elements and particular statutes in laying out an aspiration for what is not only desirable but achievable. My hat off again, and I hope the comments as we go on will take into account the complexity of this work, the demands of the statutes, and the intention here which is overwhelmingly to use a very promising technology to make the care of patients better and more efficient. With that, I have one hand raised. Tony.


    Paul, thank you, David, Paul, just a couple of clarifying points and a question for you. You say 2011. Actually on the hospital side it is October 2010, and your chart on number 13 is actually Medicare, doesn’t include Medicaid, but I did have a question on your slide where you talked about the bar raising, raising the bar over time, and I guess I just had a couple of maybe a thought and a question, you talk about people joining up in 2013 be held to the 2011 bar for first year, and I assume the 2012 bar for the second year. Won’t the bar in 2013 what’s in the landscape be changed enough in 2013 that, for example, information exchanges in 2013 be much more ubiquitous and developed than they were in 2011, same as quality measures, so should the bar for the first year in 2013 not however reflect 2011 but reflect the changing landscape? I think that’s one point I want to make.


    The second point is you have 2013, 2015 is when the incentives, this incentives actually cut in, so are you saying that someone who joins in 2014 would be held to the lower bar but then in 2015 would have to jump up to the higher bar, so I guess what you’re saying by this meaningful use year, you’re delaying the pain but you’re not getting rid of the pain.


    That’s correct. Outstanding points, Tony, of course. Let me answer your second question first which is absolutely true. In other words, everyone has the motivation to adopted this and effectively use this as early as possible. I think the scenario was right saying you got in, but you know what, the pain side is still there, and we’re not making any recommendations to change that. Your first point was the changing landscape, and that’s a really good point. If CMS were to adopt the adoption year approach, then I think it could very easily ask us to come back and say how do we accommodate those, that approach, when measures change just with the change in time, so like you said, there is now a different measure in this area. Can you change that, and I think that would be something we would be very willing to work on if that approach is adopted, that is the adoption year approach. Thank you very much for the questions.


    Neil and then Mark.


    This is Neil Cowman. I just wanted to respond maybe with a little bit of a different take on why the delay is important because if you think about the actual implementation that goes on, the day you start implementing your electronic health record for most people that means they’re seeing patients for the first time with their electronic health record, and there is really no way to import all the history and everything that goes on, so until you have a year’s worth of data or a year-and-a-half or two years worth of data, the reporting out of quality things becomes almost impossible. You’re reporting out on the people who you saw in the first month of your implementation. Second of all, the whole process is one in which the first year of implementation is really focused on ex tense sigh training and teaching people how to optimized the use of the systems and expecting them to also be thinking about how patients are going to have access through a portal to information that is just being put in for the first time. It is just I am practical, and I think when I first brought this up two meetings ago, I think it just reflects the practicality of the implementation process and how you can begin to use systems, so although the landscape is going to change, I don’t think it is going to change much what my original concern was which is that there is a process of implementation that actually takes a year or two until people can truly use all of the functionalities in the system that we’re expecting them to do.


    I am not disagreeing with your point, I am just pointing out the way the incentive system is structured with the disincentives kicking in, it is still going to create a problem beginning 2015 given the law unless we get the law changed.


    It will, and that was I think the committee’s understanding was there is still plenty of incentive for people to get in there early.


    Right.


    It is just that we don’t want to create such a high bar after 2011 that people can’t get in at all, and in a practical fashion.


    Mark?


    One clarification question, and then just kind of a broader question. The first one was 10% of all orders, any type, does that say that if we did 10% of all of our drug orders that would be meeting that or is it something different than that?


    Okay. So the clarification is imagine it is 10% of all orders that are submitted, so in your example it would not be just 10% of your medicine order. We tried to say we’re dealing with all orders, that’s qha it meant and 10% of the all orders. The may you might measure this is bills are one-ways that orders get executed. That’s the denominator. What percent got entered by the provider.


    10% of the total of orders, doesn’t matter which type.


    Or you could choose either way. You can do all net orders which may represent 10% of all your orders or you could do a certain number of services which represent 10% of the total.


    Thanks.


    The broader question, and I am not sure if it is significantly similar to Neil’s, but in the broad spectrum we talked about chime, and I mentioned that that is 70% of chime members, but I am a chime member, and I have a lot of technology in place. Likely if you don’t have technology in place, you’re not a member of chime, and if you look at other statistics, and I think Dr. Blumenthal you went through a study about how much adoption is in place in electronic medical records and playing off what you said, George, this does so significant meaningful use of electronic medical record, but if you don’t have a data center or in that work or PC or people that install those or put the security in place or any of those things, the bar is way, way high. I think for a lot of individuals, and I know we have a fixed period of time. By didn’t set the law, right, from 2011 to 2015. I think it is difficult. I don’t think I am even looking for an answer other than putting it on the table this is going to be a very significant bar for a lot of people that may not have the same voice, even the comments that came into us, they may be members of AHA and have gotten their feelings from that, but likely they aren’t a member of this coalition that was put together of people that are meaningful users of EMR. I think it is terrific work by the way. I really any the group did a great job. I am concerned about those people that aren’t yet into technology.


    Connie?


    Paul and George, I want to commend the working group on listening, compromise and still maintaining the significant bar. My comment relates to slide 16 efficiency measures and primarily verbal comments. It builds the discussion that Mark just facilitated. Given that the majority of states have in place prescriptive authority for advanced nurse practitioners and given the significant role of advanced nurse practitioners and particularly addressing the primary care health needs of U.S. citizens, I would like to request that the discussion of CPOE, particularly referenced provider such that the advanced nurse practitioner can be encompassed in these measures related to efficiency and percent of orders.


    Okay.Gail.


    I have several questions and also a comment. You may have received 720 comments through ONC. I can tell you I have received not quite that many but a significant number of comments locally from con sit wents around the state of Florida. I can tell you that 720 is minor compared to what probably all of us have received. In the way of clarification I do have questions. We’re talking about the measures, in order to receive payment are you going to have to meet all the measures. For instance, would an op that will meteorologist have to verify whether or not I had a mammogram? Would they have to take know what my body mass index is? I am glad that you’re going to go down the road of specific measures for specialists. I think that’s important. Is there a percentage of these measures that you have to meet to prove meaningful use or can you simply meet one of them that is appropriate to your specialty?


    Our thought was that we would have a set that in fact all providers would have to meet, that is admittedly not in this matrix as it stands now but many of the ones would apply to all specialties would be a thought even, for example, vital signs. The other way to look at it is the BMI is an example you mentioned. If you practice in a group where there are other physician that is do cover and record the BMI, that is in the record, and so we want to make sure that BMI is in the record, that’s just one example, so I think the first answer to your question is not all of these may apply to all specialties, and we need to be clear as it goes through the rule making process how do we determine which ones must be satisfied by all providers.


    And a way of follow-up on that. If you, for instance, a percentage of smokers offered smoking cessation, does that create a liability for a physician to offer that and are you going to be penalized if you don’t offer that? Is it going to be a checkup process that if you do not checkup on the mammogram, are you setting up a liability?


    I don’t think there is any intebt for the proposed cry tear to to incur medical liability for example. These are innings specifically designed for the HIT incentive program, program, this HIT accelerating adoption program, and doesn’t have any reflexes on care and liability.


    So if I am receiving a record and if someone sent me if I am an op that will meteorologist and I import a record from OBG Y N and not follow-up area on the mammogram, I have no liability to do that?


    I think it is totally out of the scope of these criteria.


    I have many question from physicians on liability and whether this opens the door for them to when they receive the information if they don’t act on it, are they then liable?


    The question of what causes liability or doesn’t is an enormously complex one I don’t think we have the confidence here to comment on, and I think we have to stay focused on what we think appropriate and good care should be, and we can’t unfortunately sort out our medical liability system here.


    I totally understand that. I am just bringing this up as an issue that I have been many physicians have expressed to me that they are concerned when you have measures in this how many of these measures will they have to meet to qualify, and then does in order because they then have that information, are they — do they have an increased liability?


    This presents a fear out there for many people who may not adopt because of that. I want to bring that out.


    I have a question. Is the fear of liability about measures that are unrelated to a particular specialty like —


    Correct, correct.


    Who is getting information about mammograms.


    Correct.


    It is really about coming from the specialists who wouldn’t normally be following up on that —


    (multiple speakers).


    What standards they will be held to if they have information within a medical record and then they don’t act on it. Also, the concern that they are going to have to measure things and report things that will — that is not within their purview that they normally do not do, that perhaps the family doctor should be doing, will that prevent them from receiving incentives if they don’t have that information in their record? Are they then liable? Do they have to do it if they have not been able to import? So that degree of payment, but also whether or not it opens up a can of worms liability.


    Just to clarify, I heard from Paul the recommendation not necessarily specified here but that the measures be specialty related or specialty appropriate, and that’s a recommendation — that could be the subject of a recommendation by the committee to me taking off my hat as chair of the committee.


    I personally would very much and those I have been speaking with would very much like to have that very well specified within the recommendations that the measures on which you’re going to be evaluated be appropriate so the area of specialty.


    And the second —


    Two sets of measures, those process measures that everyone is measured by —


    (multiple speakers).


    Doing prescriptions you need to do it electronically no matter who you are.


    Exactly.


    And quality measures for reporting say in 2011 where we would need to work on the mechanism to do what’s relevant.


    Exactly. I think that clarification between quality measures and process measures needs to be carefully articulated.


    The other question about liability is one that I don’t think we can address here. There are so many things that are nominally right to do or appropriate to do that create complications in our medical liability system that if we were to have to think through the liability consequences of everything we did, I think we could get tied in knots.


    Exactly. I want that discussion on the table realizing that there is a great deal of concern out there among providers on that issue, and that’s a public discussion that needs to happen in a much broad eraer arena than this committee, but it needs to happen. I am very pleased that we for the hospitals the 10% of all orders clarification is significant. However, I still have a significant concern, and I want to reiterate what I said last time on the process of moving small hospitals, community hospitals who have no expertise, no background, and even if they do have somebody, because these measures, because everything the bar is raised so high, they will be changing systems, the whole decision process to do that, the certification discussion we had yesterday is going to complicate that even more, that these timeframes are very, very short. I am afraid that we are perhaps setting up ourselves up for failure in that we’re not going to get the adoption rates because of that. My goal is to encourage adoption. I want to see every hospital, every provider do this, but I think again we are creating some very significant timing issues.


    I have Charles and then Paul and then Judy.


    Thank you. Thanks for the presentation, Paul. My comments are around the efficiency measures. I agree with you there are a dearth of efficiency measures. However, we might wish to look at the efficiency components of quality. For instance, we looked at several states where we have seen ambulatory adverse drug events representative of 5% of hospitalized charges. That might be a good component to look at the quality measure of economic impact, and the other comment I would make is we’ll have to be very careful with some of these measures, for instance, the percent of all medications entered into an EHR’s generic may not be representative of the value of health IT because that would imply to me the physician already made a decision to prescribe a generic drug. We may need to look at things like therapeutic substitution where health IT provides a unique capability because you need the clinician’s judgment to see if that substitution is appropriate, so I might make some suggestions around tweaks of the measures.


    Okay. Paul?


    First I want to congratulate you and your team. It is really very exciting and very impressive amount of work. On this issue of the specialists, I just had a comment which is there is a lot of discussion about measurements, but there is also these things called meaningful use objectives, and a lot of the solution to some of these issues with the specialists could possibly come by looking at the objectives and asking for specific specialists or certain specialties what’s the best way to measure against those objectives? That might be another way of accomplishing that whole issue and addressing some of the issues that Gail is making. And also I just want to agree with what Charles said. I was very pleased to see the slide on efficiency measures. When you say there is a dearth of measures focused on efficiency, I think you’re being generous in terms of describing how efficiency currently is measured in most healthcare organizations and so this is very exciting. I did actually have a question, though, as I happened to notice in your initial startedder set when it comes to medications in order to measure a percentage ( indiscernible ) claims there is no percentage of claims submitted electronically, and I am just curious why is it sort of like a different metric. Is that oversight in the slides or is there reason for that?


    I think it is probably an oversight in the sense that I am not sure people once they turn on the spying on the I will let specet let landfall half Tcf go through.


    One follow and very key and appreciate the comments about the specialists and looking at the objectives. There are two columns. One are objectives and one are measures. The measures are in a sense part of the recommendations to CMS about what to consider about ways to evaluate whether they are a meaningful user. The objective really is a strong signal about the road map, the direction, and just like Paul mentioned, that would invite people to suggest measure that is might be specific to their domain in this case specialist, and it is a very important request and work group committee would benefit from that, and as you notice the specialists around really addressed significantly until 2013. It is to accommodate that need for more public input.


    Judy.


    A couple things came to mind when I looked at this and heard your talks. First was wisdom of crowd and all the input you got and all the hard work it must have taken to put it altogether, and I think this is a real improvement, and I really like it. Thank you. A couple specific things. In 2013 you have measure of percent of orders entered by physicians through CPOE. In 2011 you have 10%. Is it acceptable 10% includes no physicians? Is it acceptable if the 10% of the orders are orders such as supplies? So I am wondering if you want to specious if I a little bit more in there or not as you do that? Number one. Number two, I see the — let’s a little bit what 20 was asking about earlier. What is the process for moving that to ICD-10 as that becomes the next thing. CMS diabetes, one of the things I know that is of constant struggle is what is the definition of diabetics? Is it in the lab test results? Is it the diagnosis of the problem list? Is it okay if everyone uses their own judgment as to that definition or should will there be set up how to define diabetics. I am not saying medically but in the computerized medical record because there is an awful lot of variation on that, and the last thing I had on this was so the generics folks were talking about, sure scripts and Rx hub have generic substitutions and can be suggested to the physician as the physician does the orders, so that does get people through that, and then the liability, I agree with both David and Gail. I agree with David it is not for this, and I agree with Gail I was speaking to a judge after a trial where the physician was ruled reliable for not seeing something within the medical records, and I know I have spoken to physicians who are very worried about HIE bringing not only their own medical record there but medical records from our sites and their liability as they have to go through all of it. It is an issue that somewhere has to be addressed.


    Okay. Roger.


    Let me add my voice to the chorus of people congratulating on you great work. It is a complex area. I have four or five comments and I will start with the longest first. On health information exchange, to me the key aspects there are how much and how much? How broad and how deep? What I would encourage we think about is at what point do we want to say that meaningful use means having all of the patients that are seen in the facility available for information exchange with other folks, and the other one is implementation of the standard and making a volume of information available. VA and DOD are wrestle be with both of those things or have in the past on the intefer operability piece on that. I think as we drive the standard forward for information exchange, it is going to be port to make certain that we have incentives for organizations to participate with those standards. Another aspect of this and I think we probably all recognize it, but whatever we set here will start to drive the way that EHR vendors market to their customers, the people that they want to sell to. So one of the things, the reason I would like to see us have some fairly stringent things in there about information exchange is that that used to be — needs to be part of the selection criteria. If we see hospitals and providers selecting EHR vendors that don’t have a gad plan for information he is change, that will impact us in our ability to achieve that. I am trying to go in order of length so if I get cut off I get to the shortest ones last.


    I would say on privacy one of the things we found at veterans affairs and I think we can speak with authority on this topic at this point —


    ( laughter ).


    Disclosure is highly driven by the management approach of the organization. We have taken the approach that we want to see the privacy, the unintinded disclosures, things that cause privacy disclosures so that we can deal with them and stop them in the rest of the system rather than persecuting the individual who made the mistake. I am not exactly sure how to factor that into the discussion of whether there is currently an issue going on with a provider because at the same time that you want to make certain that you’re motivating them to deal with privacy issues and disclose them, you also if you put too much money behind are going to dos them to not disclose them. I think maybe whether where I come down on that, it is much more important we get them disclosed and dealt with than we get them hidden from view.


    I would just suggest that we define realtime. Realtime to me has definitions every where from within 50 micro seconds which is a particular thing in simulation to within 24 hours which is what banking seems to think it is.


    ( laughter ).


    So I would just encourage us to do a little bit more on the definition of realtime, probably has to do with episodes of care, how fast does it need to be up in order for the patient to walk out of hospital A and walk into hospital B? On page 14 we talk about folks starting with one rule and making it important. I wouldn’t want to think that we would let people define their own rule and tell us what’s important in their facility, potentially wee would have if you will a pull down list of rules you can select from that we think are meaningful ones, and maybe there are ten, maybe there are 100 different things you can select from and say this is one that matters to me. I can tell you that if I were allowed to select my own meaningful rule it would be one that I already accomplish. Those are just quick comments.


    Thank you, Roger. Christine.


    I just wanted to come back to the measurement issue for a second and say that I think we are all on the same page that specialists and a broader type of clinician need to be able to see themselves in the definition of meaningful use, no doubt, but how we get there I think is a different story. I want to reinforce what Paul said. As CMS goes through and looks at how to translate the objectives into measures, I want to weigh in on the side of those who don’t think that there should be a list of 1R5,000 measures — 15,000 measures that everybody can pick and choose from or just 15,000 period. I think it points me to the importance of what I think we have called the health outcomes policy priorities that are in the matrix, care coordination, patient and family engagement. Those are things that everyone can do patient family engagement and do it well. I think we can arrive as Paul said at a core set of measures that everyone can contribute to whether that is avoiding medication errors or other, but also have the ability for a particular specialty right now we expressed that in reporting to registry, and I think we will be able to evolve that over time, but I just want to be sure we’re careful on that, and then before I give up the mic I just want to say a huge thanks to Paul in particular and to Farzad and John glasser who provided fabulous leadership to this. We had very spirited discussions, and you guys are absolute pros at negotiating and Nav navigating those dynamics, and I am really excited about this definition. I look toward to moving it forward today and hope we can do that.


    Any other — yes, Tonya?


    Being on the committee for the actions for some of the spirited committee meetings, you guys have done a great job, and I wanted to reiterate that. One of the things that I want to make sure got on the record is even though there are categories called privacy and patient implement issues implicitly stated. There is sort of a caveat around fair data share and pros that I think are more cross-cutting, and it really gets to sort of what Roger was bringing up because in that way it is sort of a conflict or a little bit of tension, so sort of like as Gail point out did he piet how much email I got from this committee, I got about three times more in response during the comment period from organizations and even individuals and almost all of them are on this issue of wanting some kind of control, either the provider control or have them have control in the space of opting out, and that is directly intentioned or has attention with having all percentage of the records available as an outcome measure. I think that’s something that we have to fin necessary and work those issues through, and did I want to say there are some reasons some of these things may not be directly put out as measures.


    I think opt out is a pretty important piece of this.


    Adam?


    Againa long with everyone, thank you and the work group for all the hard work you put into this. This is more just a question of clarification, particularly on the matrix is I look at improved population and public health. If calls out specifically I amization registries is one of the objectives. There is then another bullet pont that talks about surveillance data and public health agencies. Is it that include other disease registries clearly from the lax Amrstrong foundation and we’re interested in the cancer registries, bhutd there are other disease registries out dl there and I wonder as a point of clarification because I know some of the groups were concerned about that if that was going to be included.


    Regular sties per se is probably most included in the 2013 state. You need to get the data and share it. In the first adoption year we’re thinking mostly of getting the data in the constructive format and really acknowledge the important role of registries. It applies a lot onto specialists, even the ones that you brought up, and that is clearly in their for 2013. We’ll have to get more spes physician sigh as we get closer to that date we’ll probably actually start working on it right away once we finish up with 2011.


    If although all possible because I don’t see disease registries and wonder if that could be a point of clarification in the verbage, that would be very helpful.


    Okay. Any other comments? We’re just about at our time limits.


    Yes, Neil.


    Just something that I think got dropped that might be important, and that’s in the area of improved care coordination. In the prior draft we said that there was a capability to exchange key information, but we sort of lost the phrase that said an actual exchange when possible, and I wanted to just sort of put that on. I think that’s actually required in the legislation when I read it, the actual exchange of information is one of the things required in the meaningful use definition, and I think we had put that in in a way so it soaredded water touchdown down a little bit, but I didn’t want to drop it completely if the possible of exchanges, that should be in the criteria for 2011.


    Neil, may I clarify? Do you mean electronic where possible, number one.


    Yes.


    And do you mean electronic wherever possible?


    Yes. No, not whenever possible.


    What do you mean by where possible?


    What we had suggested was at least one, at least one electronic exchange of information when possible? The 2011 cry tear A that I think that would be a useful thing to put in here, and it would help us met the legislative intent. The second thing I just wanted to — I do think it is going to be absolutely credited tall and at least from the feedback I have goutsen as a physician I think it will be prit call for us to specify which things we’re requiring for big specialties, and I don’t know we do not want a common list, but I think the comments Gail got are right on target. Are psychiatrists supposed to take blood pressures at every visit? We need to be really clear, and I don’t see a way of doing that with measures September to go specialtily secialt and he be fairly specific.


    The last thing picked up on a liability issue in a different way. When people asked about liability, what I say to them is what’s happening in the country right now is we’re creating a new standard which very shortly will mean since the standard of care in the comiewfnt is sort of the test for a lot of whether somebody is giving good care or p, that we’re creating a new standard in the community that at many point probably very soon, probably within a few years, people who don’t have electronic health records and commit some sort of error that would have been prevented by electronic health record, somebody will turn to them and say why don’t have you a r an electronic healthcare, the liability will be increased by not doing that. I will say the same thing about exchange. Somebody will turn around and say the information was available to you. I think the answer to the physicians is we are actually changing through this. We’re changing the standards of care, and we’re changing them in a way that is getting physicians spob more responsible for broadly for the health of their patient, and that’s what I think we should be doing in terms of getting health technology to support healthcare rye reform.


    I don’t think we want to engage in a debate about that right now.


    ( laughter ).


    Proved unanimously.


    ( laughter ).


    We have had a number of suggestions for changes, and I think what I would like to suggest is that we consider this matrix with the understanding that we will be responding to the suggestions and that you will get a chance to look again of course at the matrix but that we can consider this without all of those specific changes, so let me summarize what I heard and I don’t think I have a full recording of them, but I think I captured some of the bigger ones. One is that it is the sentiments of the committee that measures should be appropriate to specialties, and that going forward the center for Medicare and Medicaid services should adjust the measurement of meaningful use to the specialty — to be plop to the specialty involved and that there could be a number of ways of doing that, and there will be an opportunity for the public to comment on the notice of proposed rule making and to take make its use known and make special specialists make their views known.


    The second is we need to work more on efficiency measures, and Charles Kennedy offered to help us more with that. We discussed the generic, the percent generics, there needs to be a little more thinking about that, but there was I think general support of the direction that we were taking.


    The adoption year framework seemed to meet with general approval. Obviously CMS will need to think through its implications, but again we are in the business as a committee here making recommendations, not rule making, so we can make a recommendation knowing that it will have to be considered for its implications for the actual development of regulations. I think there was a concern expressed about liability. I would prefer that the committee not recommend to me that we change the liability system in the United States.


    ( laughter ).


    But I think the record should note that was a concern that was raised here. There are a number of issues where clarity is needed for when the rule making process goes forward, for example, around the definition of diabetes. I am sure that will be true around the definition of elements in many areas that we are going to be — that CMS will be rule making upon.


    The opt out question we barely got to. It does seem to me an important contextual consideration, mainly that the implementation of records by providers needs to be taken to account the preferences of consumers and patients for whether their information should be recorded in electronic for matted and exchanged. I think rather than discuss that at length right now we might want to come back to that at a future time.


    Then there was an embrace, an ens dorsement of the use of disease registries. That could be used for many purposes. The one that was specifically floated in Paul’s recommendation had to do I think with a solution to the specialty nature or the specialght specific nature of reporting, namely that there might be a way of using reporting to disease registries by specialists as a waif way of recognizing or engaging in ( indiscernible ) use. It would have the advantage of giving specialties a specialty specific set of measures as well as creating incentives for special organizations to work at groping specially specific measures which many have done but not all. Any other points of that nature that people would like to get on the record. Yes, Gail?


    If we could clarify, please, if you must meet all measures tore payment or if there is a percentage of measures you must meet for payment?


    Any comments on that from the working group?


    I think ultimately CMS through their rule making process will decide some of this. I think the work group representses is they would meet all of them, and the comment that there is some at that don’t apply to some specialties. All the one that is are relevant would have to be met as part of the recommendations.


    Any other questions? If not, I would like to ask whether there is any objection to adopting this matrix with those caveats and recommendation for future work, adopting this matrix as a recommendation, and maybe, Jody, I should — I don’t know if I should step aside in making that motion or making that suggestion and Paul should do it. Doesn’t matter?


    Anyway, any objections to adopting this by consensus?


    I would like to make once again is I have a great fear of these timeframe says being very aggressive. As we move forward and I will be part of the consensus, but I still want to know that the dl.POE implementation and time frar for moas providers and hospitals to meet the definition for the 24 hot sets up a high war bar, bar, and I have a greet fear with might not have people a lopt.


    That’s a fear widely shared in comments and one that is period of time nentd and appropriate. By using the adoption year criteria, or cry criteria on, how late could someone adopt or an organization adopt and still be eligible for incentive payments under the meaningful use standards?


    According to the chart would be 2014 could be a Medicare side.


    So that would provide five years.


    By the statute if you started in 2014 you would only have three years left because there is a final year, 2016, that’s the final payment year again for Medicare.


    You would have three years left to get compensatedded.


    July 2014.


    The final year you can adopt to receive full payment.


    Two months maybe.


    2012.


    Can you ask the question again, please?


    The final year you could adopt and get full payment?


    That’s 2012. That remains unchanged.


    It remains to be seen whether you can just make it at the end of the year or not. That would be up to CMS which would give you 42 months instead of 18 months which is a big difference.


    That’s one of the reporting period issues we’re working on now.


    My suggestion, excuse me, my suggestion on that would be that we lengthen that in CMS, use that longest timeframe possible under the law.


    People will have an opportunity to comment on whatever we come out with in the NCRM, and I am sure we’ll get a lot more than 700 comments.


    ( laughter ).


    Yes, Judy.


    The other thing I think that I am hearing health care organizations say the academics of clarifying if they are a certain structures of academics with employ position dues they qualify or not? That’s a big question for some of them.


    That’s fortunately an issue that doesn’t come before this committee.


    Who does it Colt before?


    Cosh come before?


    It is a CMS rule.


    When will that be done?


    The end PRN, the notice of proceed poationd rule making will come out in December of this year.


    Okay.


    Question 2.


    Can I exercise the curious perogative to rule that — I don’t know how the Congress would term this but raise a point of order. I think we have so much to do I would like to keep us focused on what we need to do today. I didn’t hear any objection to adopting this by consensus, so I did hear Gail’s request to include in the record her reservations about the timeframe and her suggestion to tone and I his colleagues that the interpretation of the timeframe be as generous as possible. Hearing no objection, I consider these rules adopted by consensus or this matrix adopted by consensus, and I appreciate the committee’s attention and their diligence and especially again both ONC staffer and the working group members and Paul and George and Farsad and John Glasser who may be listening in or may not be. Thank you very much for listening in.


    ( applause ).


    Okay. Let’s move — we’re running 15 minutes late. Our next topic is no less complicated though it is r it go by different name and that the question of health information exchange. The health information exchange working group has been working just as hard as the meaningful use working group. Devan McGraw and Mickey have chaired that group. Looked like Mickey, is Mickey here? Yes, he is here. Great. We don’t want to leave Devan to carryall of this by herself.


    I will kill him if he doesn’t show up.


    ( laughter ).


    So welcome. We know you have a presentation, and we look forward to hearing it.


    We do. Thank you very much. Our lack of a slide calling out our other work group members should want be indicated to be a lack of appreciation for their significant contributions so what we’re going to say today. At the risk of leaving somebody out I will go ahead and do this. Siferl from the policy can I chug Judy Faulconer, Gail Harrell, Charles Kennedy, Connie Delaney, Tonya Sweeney, myself, Mickey, and we also have Todd Goetz from Tennessee, Minnesota, Joan from California. Did I get us all, and the quite able assistance of killly Crone an from the ousts of the national coordinator. I think I got it. Thank you. Hopefully it bodes as well for the presentation. On our agenda today we’re going to talk a bit about health information exchange and really we’re talking about information exchange as a verb and meaningful use. Really the first set of things as I work group is to contribute to the us constitution of what constitutes meaningful use and what pieces of health information exchange are going to be necessary in order for providers to demonstrate meaningful use. After the brief presentation that we gave at our last committee meeting, there was a lot of questions about the general landscape of HIE, wheat going on today Chief Justice quite relevant to what our expectations pb and what our recommendations thereabout for 2011 much less subsequent years and we do have recommendations to go through today for health information exchange with respect to meaningful use. Ncht with that, we’ll get to sort of what is the scope of decisions that have to be addressed? Here we have a set of policy objectives that we need to meet and of course the meaningful use group Keyed up for us and what we approved is a set of meaning of objective measures. Someone thing we did as a work group is provide formal feedback on that approach particularly with respect to the implement taightses for health information he can change. Essentially again we’ll talk about in a little bit in this presentation we identified there are key information exchange function that is are necessarily going to be needed for effective meaningful use and in order consequently there are also need to be policies and requirements that facilitate that exchange in order to make it happen. At the same time you also need to have the EHR functionalities as well as EHR policies and requirements that go along together and at the end of the day what you hope to achieve is in fact meaningful use by these providers, so they can get their payments and more importantly is meaningful use measures, being able to measure and report this through these systems ideally rather than through mere self out of station, so what we have been able to accomplish is a essentially as a work group is really again providing the feedback and starting to identify some of the HIE both functions and policies that will need to be put in place.


    Ideal thri there are a lot — many more questions that need to be answered in subsequent months whether we as a work group will have that depends on the aggressive timeline which I know we don’t have any control. Moving along, again, we have just been through a very good presentation and session on meaningful use. There are objectives and measures that involved HIE and some that do not, so since for the information exchange work group we didn’t focus on the ones that didn’t. Essentially there are some that really require health information ix change to be done and infer that would really be enhanced by HAE to make them truly effective or meaningful.


    That’s really the primary focus of our work group, and maybe even most importantly that the ability to both conduct and really measure meaningful health information exchange is going to strengthen the effectiveness of these objectives and measures. Paul and in your earlier — in the presentation you talked about how the clinical decision support was a key lunch pin of meaningful use. I would put information ex chank up there or the close second cousin. Looking at the previous matrix we had identified again of the 94 objectives that were in the initial definition, which hasn’t changed really peshably that much, 42 of them seem to involve health information exchange without a huge difference between thish patient setting and outpatient setting and more particularly in this slide we broke up the categories of meaningful use and to those that really would specifically invoke HIE, health information exchange and these would be better enabled with each information exchange and since we’re on a tight frame frame, we’ll let the slide speak for itself.


    Really the more important point being for each of those, and again maybe even for hours, than that we got the list exactly right. How much do we really want to specify the way infer this happens via health information exchange, the way we measure that it is happening via health information exchange and whether it happens through participation in some sort of formal exchange organization which we’re going to call an HIO in order to distinguish the noun form of health information exchange organization versus exchange which when we say that we mean the verb form or whether in fact is happens from point to point transactions. We really started with a threshold question of is it really necessary at all to set any particular exchange requirements in order to make the meaningful use we want to see map and all just endorse to see that actually come to fruition, and the reality is that the market just hasn’t responded as quickly and effectively as needed in order to have accident exchange today even among the providers that adopted electronic health records, and our sense as a work group is meaningful use could be significantly strengthened and focused with some level of policy and technical requirements related to exchange.


    We think it could lower the cost of interoperability, lower the difficulty of actually achieving interoperability. Those are obviously closely related and really raise the bar on achieving public policy goals that are identified persuasively and clearly in the meaningful use matrix N trying to decide what the HIE requirements might look like, we sort of start from first principles. Ab I couldn’t saily there many model of of exchange in place today, but there are consistencies across what we have today as a very large installed base of dispersate het genius systems, a fragmented market with significant state and local variation, rapid and unseeing techno logical innovation which of course is good and also challenging, rapid and nonseason market accident changes. We all don’t have control ore but have to take into the nct our recommendations, and essentially we want to create a framework of policies that allow to us meet the goals and the vision of meaningful use through exchange, enable information to follow and benefit the consumer a really across continuums of care, incorporates private sigh and security protections, creates conditions the federal government must take into account, still recognizes and allows for more market variation. That’s not going away and in fact there are a number of us who believe that’s a good thing, does not inhibit valuable techno logical innovation and actually channels it in a way that makes it easier to meet the goals of meaningful use and to the extent possible builds on what’s been done in the past in order to minimize market confusion and not try to reinvent the wheel. With that I am going to turn this over to my partner in crime, Mickey, so he can take us through what does HIE look like today?


    Great. Thank you, Devan. One-way of characterizing what we’re doing here before launching into the description of the current landscape is that the what, the when, the high and the who are essentially given to us in many ways, and what we’re really focused on is the how. It is certainly true, however, that the how can actually affect the what, way, how, why and who.


    Yeah.


    What?


    ( laughter ).


    That to the degree that you can make the how easier, that it raise the bar on some other things and who is on first and what’s on second and I forget what’s his name is on third. First just a short description of the current state of health information exchange. The vast majority Tcf occurs in relatively small number of transactions such as labs and E-prescribing, and even those constitute millions of transactions, the penetration of E-prescribing today is even that as a well developed silo is quite low when you look at the denominator in terms of percent of overall descriptions. The barriers to adoption are complicated. They’re high because of technical transaction costs, the technical costs are, you know, certainly there and they’re real. Determination is indeed happening and progressing rapidly. A lot of the work of HIPSBE, and other organizations are progressing raptdly, and for the market and regulatory enforcement mechanic ni.s are lacking. You can have robust harmonization of standards, but at the end of the day the question is how do we monitor and enforce those standards being used, and that’s very different than billing codes for example because those transactions are monitored every single day. Every single day millions and millions and millions of IC-9 claims are filed with commercial health insurers and Medicare and Medicaid and there is as part of the work stream of getting the work done a built-in enforcement mechanism, a built in monitoring and enforcement mechanism that keeps the system together. It is not true for lab results delivery. It is not true for most clinical transactions. There is no monitoring robust monitoring that’s a part of the workflow which makes it fundamentally different in certain ways.


    The transaction costs are also high because the healthcare delivery system is so highly fragmented. It makes it different than any other part of the economy. While there is a significant number of organized health information organizations as we would call them, I think as we all recognize those are in various states of maturity, and each of them very vary significantly as well. We have a lot of variation out there in the market today. Penetration is low and nonuniform.


    So I think what we’re going to do now is talk a little bit about the models. Really just to educated all of us on if we’re going to characterize and very simple terms what are some of the key parameters or factors affecting the market, and they really affect the policy decision that is we think are in front of the policy committee today, really want to present the models. This is responding to the chair’s request from the last meeting to have a picture, some pictures, and though we were tempted to fly out to Indianapolis and stand with Mark in front of the building, smiling with him, we thought it wasn’t the spirit in which that request was made.


    What we have done here is Mike some illustrative models. I will point out before walking through these are not normative. The work group is not saying this is how the world should be. What we’re saying is here are different representations of how the world is today, and how the world might seem if it follows current trends might head. It is really in that spirit that we would like to offer some of these models just to explain what it is we’re talking about. [ please stand by for transition in captioners. [ captioners ]]


    We can focus a lot of technical standards but there are these threshold issues for better data liquidity. Single interface transaction to a single system A to a system B. Walk through a set of considerations. Every single one of these you have to go through in a single form.


    For the transaction you are talking about, do you have permission to do that transaction. That varies by state and sha by the clinical transaction you are talking about. Some of these are packaged in the transaction today. We don’t think of there being formalized consent and that but for all lab results deliverly there is consent along the chain of events. Referral relationship that’s within a particular episode of care that happens behind the scenes for the most part. Persistent data sitting there readily available outside a particular episode of care, that’s where you get into the permission environments. There are some qualitative differences when we start thinking about where meaningful use is headed and where permission may play a bigger and bigger role there.


    Communication standards. I can communicate a message in a certain way. Is this receiving system going to be able to get it? Authentication. How do I know whoever is knocking on my door who they say they are? That happens at thentity level. I may know that’s a computer that’s within [ Indiscernible: Speaker/Audio faint and unclear] partners health care and that is okay. Next level question would be there on the right, am I okay with the policies and technology within that system that allows users to access the system? Some of this is more art than science. These are very real business questions that every organization faces today. It isn’t just a matter of sending a message to that organization. They open the door and let’s do it. There’s a lot of overhead there. So not to go over all of these — record location as you start to think about this happening more and more across more and more points of exchange, how do I know where those records are? I really don’t know where all of his records are. How does that happened to it? ‘S relatively easy — patient matching. How do I know that that record is from the same physician when we have a lot of variety in the way those are represented. Then finally data use agreements. We tend not to think of these that much when we think about lab results and prescribing. Relatively industrial standard and we all agree to. As you start getting into more and more areas of clinical transaction that are outside of the well defined areas data user agreements become more complicated. They start imposing costs on the individuals transactions.


    So going to walk through four models here. So what we’ve done, for those four models, articulated three levels. National, state and local and care setting level. Layed out the possibility of two regions. Those could be care markets, care coordination zones they call them in New York. A relatively self-contained health care market. We sort of represented EHR systems, which would be either in hospital or ambulatory setting. Local laboratory results. Lab results delivery, for example, a lot of it happens locally even though we have national vendors like quest and lab core the vast majority of lab results are delivered locally. That has got to be a consideration. E prescribing. The source of nationally prescribing, therecould be other models going forward. Point to point, the reality of that is — that those are just as you would think of them, point to point considerations. Now it’s not as many each of those point haves to happen. Trading partner also identify who they find are important and then they will engage in as we were showing before the details of the transaction, with all the complexity of doing that. Where health information exchange happens today, this is how it happens. Now the cost that we bear, I think — either the cost involved in every one of those individual point to point transactions. As noted before, some of those are technical, some are business and legal costs associated with every one of them. I think we would argue that the real cost that the society bears is that we don’t do most of these because that are so hard to figure out. The main advantage, I think is in principle, this kind of approach is open to everyone. This is open to everyone. You don’t need other outside networks. You need access to Broadband. To the degree of your own capability have to figure out all those issues around standards and data agreements. This is an option open to everyone. That the current technology and business constraints there are limits to how much value can be to this. We think about public health reporting or quality measurement with normalization of data. It’s hard to understand how that can happen in this kind of environment. The next model would be hub to hub. This is — start with the same picture. Move to thinking about what is actually happening today in the market, which is EHR vendor hubs that are starting to deal with this question. You have different EHR vendors and other types of vendors that are actually standing up local hubs. As we represented here, I don’t know if this is going to work here. Some hubs can almost be national. A national EHR hub that is connecting all the individual installations. Other vendors have gone for a community or local approach where they stand up a local hub that would connect up the local EHRs underneath. Where the main market players are headed today. We want to be able to alignourselves where what the market is doing. There are many advantages an disadvantages here. I would argue the main disadvantage of this is it starts to hard wire parts of the system behind proprietary walls. Provides some advantage in terms of the agoly vision in the market. You don’t have visibility in the point level. Think about other things we want to do.


    So obviously the clinical exchange starts to happen more and more through these hubs. Getting mediated through the hubs. You can have a lot of variety how a national lab provider like quest provides to the hub or to individually to the EHRs dune at the database level. Right now in the market you see every vary indication out there in terms of the way it’s delivered. The same thing out there. Some of them are delivered in some markets into that community hub created by the EHR vendor. Still very complicated and market specific. I think that’s the point at the end of the day. E prescribing is the very same way. Some vendors do it down to the database level. Again, I think the point is that there’s a lot of variation across the market. This is just to point out this is one way in which the market is moving to aggregate some of the things we’re talking about.


    Third and forth would be [ Indiscernible ] State or local HIO mediated. Trying to make sure we don’t lose anyone along the way here. The idea here is what we think about as Rios to use the old term. To the standard point of view to — local-based. I think that this picture is probably one that’s familiar to most people that the transactions start to go through that hub. There’s a lot of variation in that. There is a lot of variation there. But the idea is it starts to aggregate more of that. Those HIO hubs can then indeed ought to be required to connect all the underlying points via hit by compliance and then media exchange. That would be the idea how you would scale it up to a national level. Let me move quickly to the next model.


    There’s a little bit of variation on the last. The reason we want to raise it is does validate some of our recommendations. One of the advantages is it a more hope approach to network development rather than in a lot of cases with behind proprietary walls. HIOs are not mature. They are highly varied and not widely available. Are not able to access immediately. Present very practical problem. It’s also fair to say and probably an understatement is that sustainability is — not really aligned with where the market is heading in many cases.


    As we think about another vary indication on this kind of approach, one of the things we think about a national — the opportunity for a national health information organization, is that if we were to say that health information exchange as a release to meaningful use ought to happen through organized health department information exchanges or it could be facilitated, you could see the market develop different types of options. A national health organization option. We already see that a little bit. You also have single silo companies like quest, sure scripts — national level via a silo if we were to start to say — has to happen to a set of requirements through an organized network. Any of those could expand to accommodate those types of transactions an offer that as a service. If a requirement was imposed that said clinical summary exchange is a requirement according to a certain set of standards there’s a requirement to provide meaningful use, there’s no reason they couldn’t say we can offer that service. So it allows the opportunity for them to innovate a methodment some of the main advantages of this kind of model silt offers a been fit of mediated exchange to anyone in the country. Even though you may be in a state or rethat doesn’t have one of what we traditionally think of add Rios we have MDon to offer that to you. You would have access to that service nationally. Maybe that’s how you would see those develop with the national target area that don’t have the traditional Rio organizations. The main disadvantages is that it’s not mature yet. It could create considerable market confusion and distraction in the future. [ Indiscernible: Speaker/Audio faint and unclear]


    So some key policy questions that arise from these models that inform our recommendations. What do these models suggest? Some of the key policy questions that came to us? What are the policy questions that make meaningful use real? We started to think about these questions as we thought about these models. What’s the role of formal health exchanges? Should it be required? Should exchange be required to meet certain meaningful use criteria? If so, how should we require that? We’ll get a little bit in to that when we discuss recommendations.


    Let me move it quickly to Devon for the recommendations.


    Now it’s the really interesting part. You had to hear that, I think, for any of this to make sense. I had to give that to Mikey because it’s really highly complicated. But really, the bottom line is that those different models that Mikey presented, they’re not going away. In fact, we need them to be there to facilitate exchange. But at the same time we need core exchange criteria that are going to apply to make sure what we get in 2011 that we don’t have today. Is the ability to have data exchanged within providers that are in different systems and using different models whether an HIO, point to point or hub to hub or a national vendor. What would these core requirements look like? Communication standards or transport standards. Content standards. You could probably loop those under the broader ability. We underscore that’s critical. To choke off our ability to exchange data we’re going be in trouble. Privacy and security we raised — complicated one but clearly, there’s some policies that need to go along with this. It’s not just about the technical aspects of it. Resolving this is critical. How are you going to monitor? Enforce any policies we put in place? This legal business and governance issues. If you try to talk to people who have tried to — complicated than the technology. That leads us to a set of recommendations that are kind of in four broad categories. We’ll go into these in a bit more detail. In general, we think that the meaningful use onlitives and measured that involve health exchange need to be requirements that technology and — regardless of what model it takes place in and that really apply to all the participants. Second bucket, again it’s federal policy needs to facilitate any network approaches that will make it easier for participants to meet meaningful use requirements an that would include the ability to report in a verifiable way that they are actually meeting these requirements in a way that is stronger than mere check to box adherence.


    Third category is the federal government should certify networks and products that meet the meaningful use exchange requirements. To ease the burden on physicians for meeting and demonstrating adds herns for those requirements. The final category is the federal and state government approach to this need to be complementary. We all are aware that while we spend a lot of time talking about the incentives that are driven down to individual providers, there are other pieces of the economic stimulus legislation that involve building of the infrastructure and that in some respects affects marrying those two aspects. Get in to more details on what those requirements would look like.


    Thanks Devon. The requirements are necessary to make it easier and make sure that it’s done in adherence of state an federal laws. Make meeting those requirements easier for individual participants but because they can provide a bundled approach in exchange — participation and for CMS, which is an important consideration here as well. The HIO mediated exchange is they are not widely available. Don’t want to have to deal with whether paying for it or just being part of it. Our recommendation is that health exchange be subject to a set of requirements but allows both the government and individual participants to take advantage of network solutions where they exist. The first set of recommendations I talk about are just that. A little bit of a process point on the second and third bullets. The second two are really about the interconnection between the work of these various work groups. Our work group, meaningful use and the EHR certification group. Because of all the burden of the timelines and the incredibility amount of work that was required up until now, those have operated relatively separately. As the policy committee moves forward that we have more coordination.


    — we need information exchange between — [ Overlapping Speakers ]


    Have to be certified first.


    Create the standards very quickly.


    [ LAUGHTER ]


    So the second point is that really part of certification and be part of a national level and enforce through provider specific reporting in exchange activity. That can be architecture neutral and technology neutral. So you are part of a health organization that that information organization is able to perform those transactions according to the requirements that have been layed out. If you — laid out. That is capable of performing those on a point to point basis. Now as we pointed out there’s a whole bunch of legal and transaction issues to be the burden of the provider who choose that root. From a tech any can — route. The technical perspective the EHR can do that. Could be required to add functionality for reporting, so that we’re not in the world of having a single provider level at a station that they are doing this that goes beyond merely providing them or having them certified that they have the capability to do it, but they should have to demonstrate, it would be our view that they are performing these exchanges and provide robust information for that —


    The — the devil is obviously in the details here. We don’t want to pretend these are easy. We would recommend that this certification be at the product level, as I said, for exchange that happens in information exchange level or the HIO level. That would allow the providers to choose the way they want to demonstrate that. Deck dating the health information exchange — we’re saying that a provider ought to be able to choose how they do it an you don’t change the requirements because they choose to either participate in the health organization or not. But the requirements are the requirements and they can choose the vehicle that they choose to meet those requirements an they can demonstrate that they met those requirements.


    The other issue is states may impose their own state level requirements to satisfy state level meaningful use definitions. In our recommendation would be that to qualify for meaningful use information exchange must meet federal requirements to — medicare meaningful use an they may also be required by a state to meet state level requirements. The idea here is within a given state, that certification for exchange that’s mediated over health organization as long as the state is choosing HIOs that are already on the federal list. If the federal government certifies a cert set of organizations — New York and [ Indiscernible ] Massachusetts and sure scripts at a national level that in Massachusetts they would be able to choose from any one of those as long as they are on the federal list. We don’t want to have a disconnect from the states certifying that would not allow a provider in the state to use — to also qualify for Medicare meaningful use. Recognizing that states have varying needs around what they want with respect to health department information exchange at the state level. Try to strike that balance there.


    Sorry. I keep moving in on my computer and not on the screen. Finally we would recommend the proof be in that certification generated by network or EHR system. Gets us to a point of having more robust system at the provider level rather than having blank [ Indiscernible ] Or having a representation just that they have a system that is capable of doing exchange but may never do exchange even though it may very well be capable. So finally, I think this has benefits for the provider because it allows them the opportunity to choose the way they want to do it, but it allows them to use health information organizations where developed to make it easier for them to do that. It also has benefits for CMS. But have it in a much more efficient way than than would otherwise have.


    In terms of the next steps in the future work they are relatively straightforward. One is approval of HIT policy committee. Then further development of certification. Open question right now about what the next steps are in the process.


    Wow. [ LAUGHTER ] Did we talk fast enough? The ratio of content to speed was very, very high. So these are very, very thought provoking. I think you did very well with the pictures. As much as I like Mark [ Indiscernible ] These are much more informative than he would have been. If you could talk for a moment about two issues. One is, there seems to be a big choice here about how assertive the federal government, in general, we’re talking about the federal government, should be in setting the rules of the road for information exchange. Can you characterize this — are there camps or view months on this? Could you take us back to an overview of the sort of pros an cons of the two views? So one view might be let the market do this. The other view might be, at the other extreme, the federal government should create an exchange capability, organize it, govern it, encourage everyone to participate in it. Then there are many variations in between. What do you see as the trade offs between those? I use those as caricatures that are more for hour reis tick purposes rather than real choices.


    I think on the market side, the big question for me is if we left it completely up to the market, would we ever have a set of circumstances where people could actually exchange data across the country, versus competitive behavior on the part of proprietary vendors to try to grab as much of the market as possible with their particular set of communication standards and not be able to exchange with the group in another part of the country that is more vendor driven by another. Certainly the market — I don’t think has gotten us as far as we’d like to be today. Certainly, one of the common themes is yeah, I’ve got an EHR but I can’t get data into it from the lab that’s down the street. Or I can’t accept data from the hospital down the road where I want to send my [ Indiscernible ] Patients. It really should be unacceptable at this particular stage. We tried that approach in my view an it didn’t work very well. The other extremewould be a federal program saying here are the ways to do it. There’s no wiggle room in that. The danger there is that it stifles innovation and cuts off the forms of mechanisms that people are already doing this. The pockets of success we have in the country. We left them out because they’re not doing it the way we prescribe. What we’re proposing is a middle ground to set some standardses that give the market a direction to flow in but still allow for the innovation at the bottom with respect to how exchange occurs but making sure at least with respect to some core criteria — again, we haven’t had enough chance to flush those out, think we’d be willing to if there was time — that’s how I would respond.


    That’s characterized very nicely. At the extremes, some of that’s represented on the policy committee and also on the work group. We’ll welcome that to ampfully those points. All we need are standards for exchange. A CCHIT or like organization to have very specific standards, tell the vendors to do that and then they connect up. There’s no other overhead for that or minimum or little overhead that’s needed for that. I don’t know if this is the other end of the spectrum. If you move more and more toward more organized of that exchange, is the view that — probably a couple of views that drive it. One is certainly that there is a system perspective that is not taken into account if we just allow that point to point type of exchange. I think that’s made more meaningful in the health care sector than others because it is so fragmented. Because the supply and demand side is so fragmented, which is unlike the economy, there is no system otherwise unless you have these organizations that try to take account to the market frailures to provide a utility service as it were. I thought I was a very good example where he said in Tennessee, we allow people to drive on the roads and they can drive where they want but we don’t let them create a road where they want. Regulation to put roads so it benefits everyone.


    Roger?


    At the risk of going down too many analogies here, I looked at your second slide on the hub to hub, is how much that looks like the way the credit card market evolved. Recognizing that there are central places that are not governmental but eventually how to talk together to further the market. I think kind of going down that path, conversations that I’ve heard you talking about, which is there have to be stand regards relative — standards relative to allowing something to occur but not dictating the market architecture because we don’t know what the right architecture for that will be. I find — government standpoint as a government person I strongly encourage the government not be the organization to build any of the systems involved in here. Just have — I’ve seen that too many times.


    Right.


    Counter to the analogy of the credit card market, several of the internet companies have been very vocal, at least to me anyway, about the fact that they have hundreds of millions of bills of trans– billions of transactions that are enabling. In other words they’re not engaged in the content that’s going past, they just provide an infrastructure for that to pass. Why don’t we do something similar in the space of health care. As a committee we certainly haven’t had a chance to get down to those levels of questions. By you brought up — but you brought up the question. How do you make the system work as robust as the internet? That would enable any of the models that provided there, what is the piece that you need? The answer is that you need some type of master name service. I have to be able to know that I have the [ Indiscernible ] Where is that lab? I want to know information about this patient? Where is that information? It has huge privity implications. If we were able to do that and set that up, then in fact, the rest follows. The market can decide whether hubs are more efficient than point to point.


    I have Adam. Neil. Wait a second. I’ve got to catch up. Larry. Paul. [ Indiscernible ] David.


    I think we’ve got several names now after me. First, thank you. I hope I’m not speaking out of turn. I was trying to capture everything you were saying in the models. I have just two things that I’d like to bring up. One is you mentioned consent in there a couple of times. This is just something that we face particularly in the cancer world. Considerations for consent when somebody is a minor versus after they turn 18 years of age. I don’t know if it’s being discussed. I don’t know if this is the appropriate time to discuss it. One is a point that is going to be very challenging when electronic records are floating around hubs, if someone doesn’t have that one.


    Devon says she’s got that one covered.


    Secondly. This is more of a comment. I’d like to get your comments on when I look at each of the models — I understand the different points of information flow and where you were going — what seemed absent to me is where the patient was particularly when we look at 2013, where personnel health records start to come in to play, I saw things funneling in to an EHR. I didn’t see the back and forth between the patient and doctor or patient and other patients. I was wondering if you can comment on that and what some of the perspectives would be as far as impacting those models?


    I breezed through those earlier slides quickly. Exchange and exchange requirements among meaningful use. The exchange for patients was included in that list. But that was always in our mind that essentially what we’re talking about is getting data out of where it sits an into the hands of if person that needs it, whether it’s a provider who’s taking care of the patient or the patient.


    I guess my statement is in question is similar to that. I think the diagrams Mikey are incredibly helpful. Thank you. I think I’m finally beginning to understand this stuff. I think there’s two stuff that are confusing to me. One place where the payishment plugs in. I don’t understand in the various models. Whether you’re a patient or a provider, what we’re not plugging in to is a decreate pack — meaningful view of what’s in all of the data? How does that get passed around? I can understand from the diagrams how a prescription gets passed around or information about a lab test. Who’s consolidating the information into a meaningful view that I as a provider would look at in any of these diagrams? Who’s creating — what I think would probably be a different meaningful view of that, that a patient would want to access. Because I think there’s some thoughts and processing that goes on there and decision making and the views that might be different. Do we want to say something about what those views should contain so that patients have sort of a common expectation about that and that somebody doesn’t just sort of plug in somewhere and the only thing that’s available to them is a lab test or summary? I think we need minimum standards about what should be accessible to people. I know in the provider community there’s push back about what they want people to see of their on. We’ve come out before people should have access to everything. So how does everything view get passed around here? I really think that the diagram should include those two things, the sort of comprehensive view, whether you call it a CCR or however you want to call it and also a patient view. Figure out part of the diagrams are figuring out how these things get —


    I think that’s — those points are fair Neil. Just a couple of thoughts. Certainly it’s true we can add the patient portal or patient [ Indiscernible ] Technologies in there. Not much of that happens today, although they are available. I think we can do that. It’s also true that those don’t become truly robust and meaningful until you have the provider systems exchanging information otherwise there’s nothing in them. I think it’s a very good point that we should add that. The second is I think — this is my view. Devon can express where she agrees or not. Back to this issue of what are we doing versus other groups. We’re focused on the how. We’re not — I think we didn’t get a chance yet to go into the details of if requirements, so I think in that consideration would be where we are then answering the question of, what is it you want to accomplish at the end of the day and we can think about the various ways of doing that. How requirements would feed into that. We didn’t see that as part of our sort of mandate right now.


    In other words we laid out — we wanted to lay out as a first matter that having some requirements associated with exchange should be part of what gets considered, with respect to meaningful use. Fully recognizing that what would those requirements look like is another very complicated question that would require some time to unravel. That’s why I’m taking notes in case we have to do that next.


    It’s very important. I absolutely agree with that.


    Larry?


    That’s a great segue to my question and comment, what we need to do to make this engage. Will are certainly examples of the early credit card systems that were closed and proprietary. There were a lot of things — companies trying to provide email services or online information services to people. Suddenly in the mid-90s we had the internet happen and we had [ Indiscernible ] Affects. There were a huge explosion in the presence and value that everybody could get out of this. My question is, what do you think is missing? So we have meaningful use that hopefully includes leveraging the network capabilities, but do you feel like they are missing things from the current matrix that would in fact move forward the value of the information. The technology solutions are there. They have been there for a while. There are maybe some key things around standards and services. I didn’t want to minimize those. I feel like if we had a strong value proposition we would solve those problems. Meaningful use is our value proposition. That’s where we’re going to provide leverage.


    I would agree with that. I think that when you ask what’s missing up until now, it’s not about the technology, it’s frankly that not enough users want to exchange information. I think that’s what we talk about the credit card industry. In almost every other industry, the standards were formed in a way that wasn’t that the standards got diaphoned and everyone exchanged. — defined. They had an overwhelming interest in wanting to exchange. In some cases I think we talk about that in the opposite way in health care. Then even want to exchange. I think that there’s a combination of incentive and — aspects of why we don’t have more exchange in raising Standard of Care, but I think — 45 bel dollars given incentives gets more and more users to want exchange, which will move all of this forward.


    I guess I also think that maybe there’s something missing in the model and that’s something we need to consider. People using internet today to end email. We all had a means to communicate ten years ago. Some things have happened in between to shift the value of proposition so now we send text messages that we never imagined possible five years ago maybe even. Southwest airlines demonstrated that people want to fly from Louisville to Chicago but not for $300. They suddenly created a huge market where none existed before. I think there may be some things missing in our formula, if you will, that we’ll suddenly discover that there’s a demand to share information but we haven’t found the button yet that’s going to enable that. We have homework to do otherwise we’ll say we have all these great standards and make everyone use the standards but we’re not going to get exchange.


    We have to do a time check here. It’s a quarter of. We’re 15 minutes over and 15 minutes into our break. What I’m going to propose is that we have a couple of other quick questions but what I think we really need to think about is what the committee should do next. My sense is I welcome other thoughts about it — my sense is this is an incredibly vaultable first — valuablestairs step toward the exchange issue, but what we need at this point is to adopt a direction rather than a set of recommendations. So while we finish up the questions, I would encourage us to think about what that direction might be.


    The next person on my list is Paul.


    I’ll try to go as fast as you did Mikey but I don’t think I can do it. I have a couple quick observations in the question. The observations when you went through the point to point structure, I do believe in point to point system, you can still get aggregate public health data. There are mechanisms to do that. I think all the architecture systems are all the same. They are all able to accomplish that. The national exchanges, one was — a company through grew through acquisitions. Acquired a lot of local organizations that simply didn’t abide by standards, so they set up an exchange nationally to deal with that. That’s a vendor exchange. I think that’s a good model for anything. A vast aspects in my opinion that are troubling. As I think about that model, the question I have for you, whether or not there’s a hiding assumption in what you’re doing. The middle assumption is that the — hidden assurance is that the current state of lack of compliance of standards that exists throughout the health department care system is that will continue. If that’s — that’s something I’d like you to think about.


    So well in the last point, I guess I don’t really understand that point.


    Well, at some level the existence of exchanges that have a lot of content in them, sometimes represent failure to abide by is interoperability standards.


    I think we pointed out earlier the problem in our view is not that the standards don’t exist the market is structured in a way that there’s no coherent ability to enforce and monitor that in the sector of the economy that we would argue that is fundamentally different than every other part of the — lab standards right now? When the fast majority of them are delivered by community hospitals. No one is in that transaction to monitor the standards, which is very different than credit cards.


    Thank you.


    I have Charles next.


    I’ll make this quick. When I look at HIEs, I try to keep the perspective of what is the clinical utility of the health information exchange? How does it influence what a doctor or patient does? When you bring that perspective to the diagrams you quickly realize that that data is transactional in nature largely to automated function. A lab, radiology whatever it is. What we want to do, I think is to something that supports better decision making. What’s missing for me is if we connect system A to B and give a pile of transactional data the data is going be duplicated. It’s not going — I don’t think create a compelling foundation for improved decision-making. Some data architecture that takes the transactional data and converts to a foundation for decision support and physician use.


    David


    I think the key thing for me is the policy committee what is the compelling reason for federal action on behalf of certification and so on. I think to get to that decision at some point, I would like us to think about a way to present, if it’s what we believe, a compelling case, that justifies federal action in this particular market space. I’m not myself convinced of it yet. It may be worth drafting or commissioning a white paper that addresses some of the things that have surfaced here. Particularly how some industries have required exchange of capabilities and would be distinctive in our case that would justify a federal action around standards. The second thing we might do very specifically, our premise has been the meaningful use criteria will create the pull for driving exchange of information, but that means we have to look at our criteria and test them against this question. One place having — whether the 2013 criteria that we’re going to continue to talk about is pulling data across the network. If every end user of 300,000 face significant financial incentives by successfully pulling information across the networks, there’s a chance that that would create the response we’re talking about. That’s a test we have to ask ourselves and really amplify that incentive.


    I guess I would say on the last point that now that the meaningful use matrix has been approved, as a work group we’re happy to engage in that level of detail. We’re unable to do that up until now.


    Judy?


    Two things. One, on the standards, I think that HTTP for the network [ Indiscernible ] SMT for email have helped a lot for standards. The VHR vendors are doing it separately is a lot of standards are needed so they can exchange among them. My experience has been that the barrier isn’t really the incentives of meaningful use. The CEOs and the physicians really seem to want interoperability. Where the problem has been almost universally that I have seen is with the compliance officers and the attorneys to allow their organizations to move forward. That’s the barrier that it needs to get through.


    Kristine?


    On the market questions, I think what strikes me is — a lot’s been written about the market and health care not being too functional. Clinicians today can provide care without data exchange whatsoever with no real economic consequences. I don’t know that my care is good or bad. It’s hard for me to go somewhere else without any objective data on performance. I think the market hasn’t done a good job — I am inclined toward this approach that I think you’re recommending. I want to make sure I understand. What I’m hearing you say is HIE/information organization should be part of validating meaningful use specifically. That’s going to require some kind of certification that they’re doing that based on the right criteria and in an objective way. That those requirements should be set at the national level but the technology neutral and architecture neutral. So I just think — I want to make sure I’m understanding what your recommendations is. If I’ve got it right, I think that’s very interesting and I like the fact that it could be potentially less burr don’t? On providers and very robust for meaningful use criteria. I’m not sure whether this pleads in– bleeds into the larger issues around certifying networks broadly and whether that’s a good case or not. I guess I’m thinking of what your recommendations are in the specific context of meaningful use. If you can tell me I’ve got it, that would be helpful.


    I think you basically have it. We went off what the meaningful use work group was doing, which requires exchange. Thinking through how, again, how is that going to happen because it’s largely not happening today. Essentially what we’re saying is we’re proposing that in order for that to happen we have to set out some minimum sets of requirements to facilitate that, while also allowing for innovation underneath. Not being so rigid that there’s not room to do it in the various models.


    I’m not sure exactly that I agree with how you would characterize this. Try it another way. The first off, with meaningful use, we were focused on health information exchange as it relates to meaningful use. I think that’s part of what you would remember. It wasn’t about health information exchange. What are all the great things that HILs can do? It’s about exchange — meaningful use working group from the last meeting. That’s what we were focused on. That if we have a situation in which the government is putting a lot of compulsion behind exchange set of requirements that set the guardrails of how that exchange ought to happen. We’re basically as a society and government telling physicians you are required to exchange data and in effect which don’t want to have that to happen irresponsibly. I’ll put that in quotes. No one is trying to be irresponsible. It’s a very complicated area. Requiring exchange. So aren’t there some guardrails that we want to put around it? We move to saying we want to have a set of requirements that are completely neutral about how you do it. That it’s not saying that you have to do it through an organized health organization you have just to meet the requirements. That leaves it open to the individual choice and the technology vendors to provide various means for doing that. So that’s the second point. The requirements apply across the board to health information exchange, not to organizations but to any organization that wants to do this. To allow the possibility of taking advantage of health information organizations as they exist today or as they could exist which would be a benefit both to the government and to providers. What we mean by that to the extent that we laid out requirements if you have health offices that are — organizations that are able to certify exchange as it relates to meaningful use can be accomplished through the rule that we set up in our own network here and corresponds to those requirements that the government ought to be willing to say any physician who conducts their exchange through that health information organization, will sort of get credit. In effect the burden of proof won’t be on them anymore to show they met the requirements. They still have to conduct the exchange obviously. It’s not just that they’re a member of this but now I don’t send a clinical summary through it. That would facilitate sort of more efficient, more effective participation because it lowers the barrier for individuals physicians. The benefit to CMS by allowing more of that to be aggregated. Some level of certification you need forthose health organizations. It’s not requiring that someone do it through a — saying that if you want to get credit for doing it and if you want to have robust reporting through that organization on your behalf that would need to be a certified one.


    Are you talking about meaningful use criteria or just the —


    Exchange. Exchange.


    See I was intrigued by criteria rate large you making your organization you get quality data. You know what’s happening when a drug alert fires. You know that stuff. That was interesting. I think a larger issue.


    Variation. Some HIOs could offer — do my eprescribe — I do clinical summary exchange through the [ Indiscernible ] Exchange. So now I’m doing it through three.


    I think we have to draw this to a close. I suspect that all of us are learning a lot from this discussion. That we’re not ready yet to make recommendations or consider them. In terms of what might get us further along, I had a couple of questions that I thought you might address for us. I think they mostly have to do with reconfiguring your recommendations and packaging them with some argumentation or at least assessment. One is, I think it’s pretty clear that there’s a school of thought that believes if there’s a market that the exchange will come. Regard less of whether you — regardless — stronger the market the more likely the exchange will happen effectively. One question would be in 2013, have we — has this committee done everything it could to make sure there will be an effective market using the meaningful use criteria? I think for 2011, we don’t have a lot of flexn’t but for 20 — flexibility, but for 2013 we should have more. The demand to pull criterion. The second, it seems to me that the committee might benefit from three packages of recommendations. One might be a minimal, second, a more robust set of federal interventions specified. With some commentary on their pros an cons. What you have done is given us a wonderful compromise between opposing months of view but it doesn’t give us a chance to consider the views that were rejected or that you didn’t accept. What the dangers might be of those views and a chance for us to consider how comfortable we are with accepting those risks and benefits. One risk completely unregulated or unstructured market is that it just doesn’t happen. We keep waiting and waiting an it doesn’t happen. We have to decide whether we would accept that risk. How much it would be mitigated by the first level of federal standards. I think if we could — we might then be able to get to a recommendation about the federal government’s posture, what it should seek, what level of intervention we’re looking for. Might be where you left us. But we get there in a more considered form with a set of arguments about where —


    With more time to think about it.


    Does anybody have any suggestions for the working group? I took the chairman’s per rocktive that people who want lunch can get it eventually.


    Would — I like very much — there was a theme that was happening that was very good. It said look, you view this operation from the pond of the exchange of — point of the exchange of the information what is the comprehensive view of the — I think that’s a really important point because all of the diagram and the emphasis has been on facilitating the transaction, not on what’s required to coordinate and pull back. That’s a task that goes well beyond what the market is currently considering, for example.


    One of the criteria for evaluating the options, they’re all [ Indiscernible ] Options. It might be the affect on the availability of the — in tact personally associated record that either a physician or hospital or patient might want.


    David, this is Art.


    Yes.


    Just to kind of bring together your comments about creating a market in 2015 or 2013, maybe the group that worked on the matrix of meaningful use just revisit and make sure we explicitly stated the value of that view in some of the metrics that we have stated so far.


    Okay.


    That’s part of the meaningful use group, maybe a task we can take on as well.


    Um-hmm.


    I think hunger has got the better of us. I think that’s — first of all, this has moved us a long way. The work we’ve done. We now know what ballpark we’re playing in. Now we just have to do a little more work on the rules of the game. Thank you very much.


    Thank you.


    When do we return?


    Not tomorrow.


    Why don’t we take 20 minutes.


    [ Break taken for 20 minutes, 1:03 p.m. eastern timetime — break time. ] .


    Can we begin the meeting please?


     


    Could we ask you to take your seats please?


    We are understandably losing time in terms of trying to stay on schedule. We’ll have to try somehow to make it up. I want to give Paul and Mark and the working group on certification and adoption a chance to discuss their report and recommendations. So if Mark and Paul could go to the front of the room and share with us their work. It gets repty shoes to talk about how hard they are working for us. Ditto. So I hate to keep repeating myself. But thank you both for your dedication and your work on this.


    [ Captioner transitioning. ]


    Again, this is our committee. They have worked extremely hard Speaker we have had lots and lots of phone calls the in between the meetings we have had. Reset a couple of days, altogether, that was very useful. This is not the work group that we have going. This is the agenda for the. I will not go through it in detail in light that we are trying to go through this quickly. We want to go through the progress we have made and the initial recommendations we have made. This is the broad charge that we were given-up was given to us was to make recommendations around adoption certification HIE, and the work force state and dance because physically weaker as to look at certification and given them four months to do this. I told John Glasser I would bring this up. We were given six weeks to do this. I know all the work groups are familiar with that. We are a little light on time, but it reminds me of a story–


    [ LAUGHING ].


    I come from Utah. I was over and the Capitol yesterday and have a statute. They have a statute of the Brigham Young. He a Catholic priest came to Salt Lake City and went up on the bench looking over the whole city and said that this Catholic priest, and Brigham Young had been there about three years and said what you guys and the board have done to this area is just fantastic. Brigham Young looked Maxxam and said, you should see when does the lord had it. That is how we feel about certification Speaker use it has seen it before our group got it.


    [ LAUGHING ].


    The process we went through was to understand was certification was. We are more familiar than others and some on the committee are very experienced and have some up CCHIT and was great to have their knowledge. We went questions that we went through and I was abuzz with you and to be brief we will not go through them, you have them in your packets, but we set up a series of questions that we wanted to answer relative to certification. A lot of good input, you have mentioned the emails you have been getting. I can assure you we got females around certification and there are different interests and directions and then lot of organizations with opinion. Will setup a 2-day series with testimony that happened on Tuesday and Wednesday of this week. I really think the work group members thank the group members that were there and the people coming to speak to us and the presentation to help us to get our ideas focused. Now, we are going to share some recommendations in as a Minutes. That is the process. We brought them into two areas, the criteria for execution and what should that criteria look like? The criteria as primarily defined by CCHIT and is a fairly broad set of criteria and was created for a purpose. We think they have done them pretty good job with that. How does this really focus relative to ARRA and the high-tech Act and the things we are dealing with? We consider these questions around criteria and also look at the process itself for certification and how it was being done today and how did that apply, really, to the process as we look forward, that we should be doing in support of the act? There wasn’t lot of focus on CCHIT, because it is the organization that has been doing it and how they play in the overall scheme. We looked my criteria and the certification process. These are some of the initial learning as we came up with an. Relative to CCHIT, there is no the broad spectrum of thinking and not lot of opinion around the organization itself. It is important to note that CCHIT was organized or set up prior to the passage of ARRA, well in advance of that for a cynically different purpose than certification around ARRA is. They have done them good job within the spectrum of certification for get what they have been asked to do at this point. There is not lot of confusion around CHHIT, what is their role, how did they set up their criteria and apply that criteria, even amongst the members that are involved in being certified. Significant discussion around how detailed CCHIT is and what they focus on, a lot of the question around how CCHIT was formed by vendors would be the remark that we got more than any, as it roots go back to reap several vendor organizations and, is CHHIT too closely aligned with these individuals? They have been criticized for accepting of the criteria and testing it. It has been one organization that has done those things. There has been coming from organizations regarding a modular approach. Right now CCHIT has a system, a EHR an no lot of systems are composed of multiple pieces and those modules should be able to be certified and brought together to create a certified electronic medical record. We talked about non-vendor systems, those that have self develop systems or use open sores or those that might bring them lot of components together to create their EHR. There was significant interest in this because those of developed wonder what is the certification to for me? If certification is for the acquisition of an electronic medical record, you have acquired it and built it, what is the purpose of certification? On the flip side, some organizations were believing that certification is a bar one should pass to be eligible to receive these funds. Everyone should have to pass that in equal manner. We have discussed that quite a bit. The open source community was really interesting and some of their comments, they really believe they have a great product. Primarily, we talked to Vista. They wondered a lot and wondered how this would be impacting them speak for you have a look with system, fluid system is probably a better term that change is quite often because you have some many people modifying that code. There was concern about curtailing research, people pushing the envelope our research institutions developing their own systems, and how do you get certification in place and not stop innovation out their back and, the cost associated with certification were very-discussed and could be a barrier for Some organizations moving forward. We discussed whether or not certification is a Steel of approval or something different. There were a lot of different responses relative to whether it should be a seal of approval or not and should be broad based or specific, should it focus simply on what meaningful use the fines or a broader range of requirements? Should we look that things like vendor my ability to in moving forward? Is that the purpose of the certification? Certification and privacy, privacy came up, as did security and all the conversations that we had. There were a lot of suggestions that there was not enough focus on things like privacy and security in the current certification processes. There was not discussion about feeder systems, systems that the Intuit the EHR and what kind of probability requirements should they have and security and privacy and should they all be lumped together and should cert include better fitness or provide vendor readiness. We talked about that. Is that an appropriate thing for the certification process?


    As we look at certification, we really wanted to get clear as to what we were trying to define. I will just build this light out. We broke into three categories, that of validation, certification and assurance. Whether those are the right terms, those are what we used. Validation is, is your system redoing on site, which is supposed to do so you can receive these funds? That is determined by a variety of ways. That was the idea of validation. Assurance was more of the seal of approval. Is this something that is good? Is it not make good product? Does it have good usability? As you compare it to each other products, is it better than those products? We’ve at it as something outside of what ARRA was suggesting and not the scope of what certification is because the certification is, will the product to what ARRA and meaningful use are suggesting it should do? If you purchase the product or bill that product or whatever you put together with that product, when it was there, it needs to be certified that it will do what the meaningful use criteria suggests that it should do. We suggested there should be done by a third party or the government. We will talk about our recommendations in a Minutes. That was the focus of certification. We were not dealing with allegations, although it needs to be dealt with to give clarity to the purchasers of the system’s. We were not dealing with assurance. That led us to the following definition of HHS certification. We are using HHS certification very specifically. HHS certification means no system is able to achieve government requirements for Security, and probability and the system would enable the meaningful use results that the government expects. HHS certification is not intended to be viewed as a seal of approval or an indication of the benefits of one system over another. As Paul goes through the recommendations, it is important to keep in mind that this has been our working definition to come up with those recommendations. Paul?


    Thank you, very much. I am Paul. I am going to take you through a series of recommendations that the certification adoption work group has. This is as a result of all of the work we have done. Earlier this morning no, was made about meaningful use and is an opportunity to check opportunity to talk about Kahane patient outcome’s the coat is is an opportunity to talk about technology, although we allow to be meaningful use the definition to drive what we have done. We are driven by meaningful use, which is also one of the comments that were in the public comments about meaningful use. That is what we tried to do this because we have these five recommendations Speaker where I will do is tell you, quickly, an executive summary of these five recommendations and on each of the 5I will take you through a slide and tell you more about it. The first recommendation is to focus certification on meaningful use. That might not sound all that impressive to you, at first, but, basically, this is no focus on meaningful use at a higher level. This is a change on the certification process that I would describe as comprehensive and oriented around features and functions because that is the first recommendation. The second restaurant and recommendation is to leverage the certification process to improve progress and security, privacy and interoperability. Privacy is, of course, besides a basic goal of the legislation, it it is an issue that is very, clearly, on the minds of consumers because we see it a like in public comments and interoperability is an issue where we receive a lot of information and a lot of criticism about the low level of existing probability. The third recommendation was the certification process itself. We had a terrific presentation from Dr. [ indiscernible ] from the National Institute of Standards and Testing Speaker she told us a lot about international certification standards. We have recommendations that ONC should work with NIST to improve the object to the tee and transparency of the certification process. The fourth recommendation is to expand certification to include a range of software sources and enclose the open source community, itself developed systems and also systems that in the public comments are called modules, components. We have recommendations on that. Finally, we have a transition plan because we realize the first four items will not be done overnight and something has to be done to tell what the transition is because those are the five recommendations because to give you more information about them, basically, to look that the focus on meaningful use, if you read the very first bullet, one of the things that you will notice is we are saying that we want this to be a minimal set of criteria, not a comprehensive description, complete medical records system, and it says achieve meaningful use objective, consistent with the discussion we had this morning, we see them as the roadmap. Our view of HHS certification is if someone buys a HHS-certified system, they will have the necessary tools to meet those objectives. Behalf to do the work but have the tools to meet the objectives. To call your attention to the third bullet, is as criteria on function and feature should be at a High level. The first part is a High level and I will give you an example of what that means. If your certify a system, you might say that you want an older given to the physician if there is an abnormal laboratory test or abnormal results because you want an alert but would not say, explicitly, how that would work or how it would look like. The idea is having less is more. By having less specificity in the requirements, there will be opportunities for back more innovation. By doing it that way, we will have a certification process that is less expensive, less time-consuming and less expensive to achieve. While it is saying less is more, if you look that the second part of that sentence, interoperability to be more explicit. We are taking pass-also on privacy you will see, we are saying that more is more and what we are looking for get is more explicit criteria and more criteria, in general. On meaningful use and functionality, we are saying that less is more. As we say that, there might be some vendors that might be upset who have done them lot of work to get certification from CCHIT and. They might be very proud of the work they have done, and rightfully so. If you look the next week the last bullet, but we are saying is the extent that vendors have done as have gotten comprehensive certification and to the extent that that is valuable, that the marketplace and CIOs find that comprehensive certification important, it should continue to exist and existing the marketplace as advisory services because we think that is a good thing but is not required to get an incentive payment under the system. That is a positive thing that should continue to exist if the market thinks is positive and wants it to exist. If you look through the recommendations, we touched on this issue that was discussed this morning and raised at the last meeting by Gail, the whole issue of specialists. What we said about that is the focus on meaningful use to reduce the barriers currently faced by vendors that focus on specialists, the very concept of there is the meaningful use objectives should be used to figure out how to provide incentives for specialists that we are not going to provide certification for each individual specialty. We are certifying the base level of meaningful use objectives. That is recommendation one. Recommendation two on security, privacy and interoperability, went to leverage the power of certification. Marc Probst did not make good job. Certification has been powerful influence on vendor. Whenever you have to say you have to do for certification, people do get. Since people do it, we need to address these issues, privacy, security and interoperability that are stated goals of the legislation. What we are asking for is that the criteria has to be more explicit, more detailed. There has to be, basically, more of it and came across various issues relating to the standardization process and on the standardization process, basically, what you will see here is there needs to be tight integration between standards and certification, issues where standards and certification seem not to be synchronized. There needs to be tight integration and if necessary, ONC should Commission and not just harmonize the development of standards. If we run out of patience, we are recommending that ONC should commission the development of the standards. Another thing that is interesting on this recommendation is the next week the last bullet is the concept of creation of test harnesses. This is a great idea that came out of the recommendations by [ indiscernible ] corporation. The idea is that there should be a process for the user, for the physicians, for writers and hospitals to test their own systems easily to determine if they meet the interoperability specifications. The last bullet you see under this recommendation, it says prioritize focusing on core your criteria. The reason we are saying that is one of our roles as the policy committee is to establish priorities. We are saying, very clearly, there should be a priority is interoperability and the standards committee that we are saying that to them and any vendors, we would encourage you, instead of creating functions and features, look at interoperability, privacy and security. That is our second recommendation. Our third recommendation deals with the actual certification process. There are a number of headlines peacoat the first headline is that we are recommending that the process of defining the certification criteria should be separated from the process of testing. The organization that tests or certified vendors or products should not be the same as the organization that defines the criteria. That is the very first headline here. If you read through it, the other have Plan is, later on, we are saying that ONC should work with NIST on the whole concept of performance assessment that includes testing certification, accreditation or surveillance because surveillance, by itself is interesting. On the issue of accreditation, we are recommending that ONC identify and established less one body that would accredit the certifying organization, the testing organizations and monitor them. The other have Plan here is towards the bottom. We are recommending that multiple organizations be allowed to perform HHS certification testing and provide that certification. That recommendation is probably a recommendation that we will get a lot of comment about. A number of vendors, including the EHR organization recommend the opposite, only one. After giving the issue number lot of thought, we thought, basically, competition is good and, fundamentally, this would be a Good thing for the Industry. We are sympathetic to the concerns the vendors have and did say that vendors will only need to get HHS certification from one certifying organization. You only have to go to one place, but there could be more than one to go to. We think is important because we are concerned that there might be a bottleneck, that there might be a lot of organizations that need to be certified. This can create competition. This is one way to respond to that. That is the third recommendation. The fourth recommendation is flexible software sources. It corresponds to some of the recommendations or comments from the public comments. First is the general statements that we want to provide certification support to a wide range of EHR sources and steps through a few. That one is the concept of what we call certification of components. The idea being, and I think this is in the comments, people call this modules, but the idea of components certification is it should be possible for a physician, provider, healthcare organization to get a certified system by buying different components from different sources. They do not, necessarily, have to buy a single electronic medical record from a single vendor, they can get it from the multiple components. We did spend, as Mark said, a lot of time considering various issues relating to the open source community that are really wonderful people. They are unbelievably enthusiastic for what they do. There is great people. Basically, to try to assist and encourage open source back to the entire open source community, we have a recommendation into the lock down requirements to give more flexibility to be able to make changes. We think that was the idea of the test [ indiscernible ], you can provide for a more dynamic software development environment. We also have a recommendation for self develop software so that people who have software they develop themselves, the recommendation is to provide an optional alternative certification process in which there would be some sort of site inspection and the site inspection could be a virtual site inspection or be done with remote access to the computer terminals but a site inspection of the basic meaningful use objectives as another vehicle for the self develop software organizations. That is our fourth recommendation on flexible software services. We have the that the one that is the short-term transition. The idea with the transition is to realize that everything we just said is all very interesting but will take several months to get it all together. I do not know the number of months. People want clarity on what will happen right away, especially since this whole thing is part of the economic stimulus bill and we have heard them lot of concerns that decisions to purchase are being delayed because of the absence of clarity and. On certification. We wanted to provide decertification on the short-term transition. Beepers two Bullitts are basically that ONC would evaluate the existing CHHIT certification process and look for what we call gaps. The first would be issues that are missing from the current criteria like public health and the second is the gaps might exist for example, an example is ePrescribing. Exiting the trend is good but we need to expand it. We created a MU which stands for meaningful years ago we felt we could use our own MU, gap certification.


    [ LAUGHING ].


    The idea is that there would be this gap analysis, gap certification process that, hopefully, if this would happen at a fairly high level would not be hard to do or expensive to do and say that anybody who is currently certified, CHHIT certified, that in effect, we would grant-grandfather them into certification, HHS certified according to the statutes through 2011, when they complete the MU Gap certification. That is how it was grandfathered with the existing certification. What happens if new vendors want to get certified? We do not have our act together with the new process because the idea is that CCHIT would be encouraged to do their current process plus the certification so that they could continue to certify new products and new vendors until we are able to completely rule out the process that we have determined. These are our five recommendations because they represent a very significant change. It is a significant change in certification and healthcare IT Software. For next steps we have comments here. We have the idea that this was open for public comment and based on that public comment, we will be serving recommendations to this committee next meeting.


    Thank you, Paul and Mark. I am continually impressed with the wisdom of Congress in creating this committee and empowering it to give the Austin national coordinator it advice. That advice has been of such high quality. What I am going to suggest, given the shortness of the time is bent we not focus on all of the very interesting and useful sub recommendations in one to 5, that attend but that we focus on the overall recommendations to see how the committee feels about the headlines. By that, I mean that the slides are not numbered on my copy, but the first buyback dealing with recommendations, which is bogus certification on meaningful use, leverage the process to improve progress on security, privacy and interoperability, improve objectivity and transparency, expansive vacation and develop the short-term transition plan. It would be helpful to know if those were directions in which the committee felt comfortable going. If possible, and I have not thought this through completely, but to focus on the short-term transition questions. So, given the shortness of time, those two segments of this very, very full and provocative and interesting set of recommendations, it seems to me where we should start, knowing that we can come back to deal with the more specific recommendations later on-with that-yes, Tony?


    Does not make comment. Due date out some pretty interesting ideas in your proposal. I guess the question I have is that I see a Real-if we get to this desired state, to get there, there is a tremendous need for education and outreach. I can see as we move from today’s state to this more involved state, both for the vendor community and for the provider community in selecting EHRs, there is going to be a tremendous amount of potential confusion and [ indiscernible ] in some ways. I can see the advantages but wonder if you could address that.


    Excellent question, Tony. The title of our work was certification and adoptions because those are the issues you raise our adoption and training issues that we aren’t supposed to be addressing as a workgroup, but is not addressing them today. We thought we needed to address the certification issue as it relates to read the statute and what needs to happen. Remember to get the incentive payments, the provider has to do two things. They have to have them certified System and meaningful you. These are equally important and we felt it important to establish a priority on that right away Speaker you are absolutely right. We have much more work ahead of us in terms of adoption is to.


    They cannot be treated separately. You have to look that it overall as you are going down this road.


    That is helpful.


    Gail?


    I want to commend the group. I was part of that discussion yesterday and appreciate the hard work you have done. I have some concerns, however, and again I go back to this whole time frame. We are talking about gap certification for existing products that people have bought that were certified. They have spent huge resources whether hospitals or providers, spending huge resources and our in-either in the recent past or in the very near future, is there going to be time to implement gap certification to set the rules for gap certification, which is a process itself to establish what those elements are, said the rules to do it, have the entities certified to do and have a product on the market that is going to be available for purchasers in 200011? I just have, again, this huge fear that we are setting up an a system that simply will not work and that we are not going to be able to have the products, have the education component out there for all of our providers that need to buy these products to make that decision, decision making on a Major $5 million investment does not happen in a week. That is a long-term process in an institution to do that. Again, another roadblock, another problem in moving this whole process of long and creating that need to really address time frames.


    It is a Good question. This robot is not as difficult as the others. Through the transition period, the concept of the gaps certification, unfortunately, there is already a fair amount of information known. We know now make their amount of meaningful use and the existing specifications are and has already been some discussions with CCHIT about this because it is my understanding that there is a belief that we can have the certification, the gap certification process completed and announced by Labor Day. If you have that announced by Labor Day, there would be an opportunity to start certifying people later this calendar year. I do think that-I do think that the vendors will be ready. I have talked to a couple of vendors. They are comfortable with the meaningful use criteria to get started this because it is an issue of the mechanics to do this because I think this can be done.


    To follow up on that, we also have the HIE component that the recommendations today were tabled to move forward and you are going to have to include that in that gap certification as well, because in order to meet the meaningful use criteria, if you have to be able to exchange records.


    It is not a problem as it relates to reap the gap criteria. This is certification for products that we purchase for hospitals and physicians. As part of the criteria, standards are already published and the vendors know the standard. We are not certifying the HIE organizations, only certifying-we are certifying the EHRs.


    Correct. One of the components of meaningful use, statutory is that you must have exchange of data.


    We can certify that the providers can exchange according to what the specifications are for that.


    I do not see the issue being as much as the certification process the wait is defined, there are steps that need to be gone through with NIST to follow that process, it is more the meaningful use criteria that is being certified against. I think you mentioned it will earlier, Gail, the challenges of that. The process, if we leave it at that, that is not that big of a hurtle out there for organizations to come over.


    Yes, Neil?


    The recommendation that the certification standard setting organization has to be different than the certifying organization, the testing organization and the fact that there be multiple testing organizations, you can book at [ indiscernible ], joint commission, the purpose of this seems to be-of doing this, seems to be twofold, to give guidance to people that are purchasing systems, but those standards in those organizations seem to drive the industry forward. In other words, they sent new benchmarks each year for what people should expect. I am wondering what the rationale was for both of those decisions, to separate the organizations and have multiple organizations? If there are multiple organizations, what they will compete on is the word on the street of what is the earliest organization to get certified through, rather than competing on some kind of other mechanism. What are they going to compete on?


    There are a number of questions and also to be clear, what we are doing is saying that we want to separate the definition of certification criteria from the process of testing against the criteria. That concept came from advise that we got from NIST, who is very good that setting up the certification processes but also came from a sense that we needed to make sure that the entire certification process and the certification organization was objective and we had a objective process for determining this and there was a concern that the current environment we had one organization that sets the criteria, does the testing and has very little monitoring of what is going on and that is not form of for a problems because we did not see that there were problems, but that is not correct from the control standpoint. Since we are setting up an environment where we want to do things right now, this is the advice as to what it takes to do right, relative to the idea of having multiple certification ideas, I do not know if that will occur, but part of the benefits that we perceive for that is a fear, some of the very issues that Gail is talking about, several hundred bandits and products already certified, but what will happen going forward? Will one organization be able to handle it, or will it be a bottleneck? There is also concerned about the pricing of that. If you have competition, that is the way to address both of those issues. There were specific reasons why we did this because I agree that your comment is a good one. I suspect the competition will be something we get them lot of Commons and vendors will not be happy about that decision.


    Christine and then David.


    First of all, you have done an inordinate amount of work. Two days of hearings, the [ indiscernible ] did not approach the speed we would not have slept, or maybe fall.


    [ LAUGHING ].


    My question is this, coming back to what I remember as the original-part of the original impetus for certification was the concept that we needed to moderate the rest on behalf of the clinician buyer, and that they would buy a products that would not really work for them or, all of the things that we sort of know, was not going to work well, the vendor was going to go away, whatever the case might be. What I am hearing is an interesting approach that would inject a lot more flexibility into the. Have you thought about how you would continue to make sure that what now is a taxpayer investment is protected and the tools that we will use to help physicians and clinician’s make sure what they are buying is workable and good?


    Well, I think that drives more towards the seal of approval process that we discussed and we really did not see it in the context of what we were looking at to do that seal of approval or to raise that to say that there is much variability between when you buy and how you installed it. We can take this and make it successful, which is the open source product. This assures that you have an excellent system in play. But we were driving more is that this assures that the pieces or system that you buy will achieve meaningful use per the definition that we are given and how you implement it. That is another discussion and something we need to go through. I do not think we gave it much more conversation and that.


    Did you envision in your group that there would be something else that would be a seal of approval? For better or worse that is what CHHIT function. If we are taking that out of the market for a host of reasons–


    We did not envision that that would go out of the market. In fact, we thought that would continue-if you think about it today, that is a very useful tool for get people purchasing systems binding it is CCHIT-certified. We believe in the future there will be a purpose for that seal of approval. For CCHIT approval intensification we did not think it needed to be that broad.


    There are other organizations that are doing some level of seal of approval, class reports [ indiscernible ] that the reports on benders. Some people tell us that that is more useful in terms of the seal of approval concept. We will let the marketplace do that function.


    David?


    I primarily want to commend you for doing this because you have been fairly brave in setting out some directions on how this process needs to evolve and is not service to all of us did you have done that and taken on some pretty tough issues. In broad strokes I support and endorse the path you are laid out for of. The mechanical question I have is the timing question that Gail asked about and the transitional period that you imagine pending the HHS certification process being enabled, and it is my question for David or Tony, how long or difficult will it be for HHS to establish a process by which it certifies the body that will do the evaluation, is that three months or two years? How long will HHS the the it certified?


    I will refer that to my colleague, John Glasser.


    [ LAUGHING ].


    Basically, I should say that John has been excellent. I need to make sure I it do that. He has been very, very hopeful. We have that same question with John. I did not understand the entire HHS regulatory process in terms of how long it takes. Hopefully, it is something Mr. In Months. I would not know that such “which is something that is measured in months.


    We are asking the Austin general council to give us some advice about it. I would not-I could not answer it. It is very much on our minds. I think David has put his finger on a critical question. You have been thinking about it, I know. We have to see how our lawyers interpret the statute in terms of the flexibility that we have for some transitional plan. Alternately, we have to go through a rulemaking process, I believe, do you not agree with that, Jody, to specify a certification process. Whether there is any flexibility around that in the short term, I do not know.


    Yes, Judy?


    From a patient point of you, if a software system is self develop and if the criteria is sufficient to establish that, indeed, it meets the certification goals, then shouldn’t that criteria be equally good on the non-self developed? In other words, are we lower our standards or that the Celts developed, and is that the right and for the patient, number one. Number two, some of these cells develop systems, let’s look Marshfield and vendor build that sells software, it is so developed, but sold.


    I will do number two, first, it sold, it should follow the same rules. It is a commercial product. The first question about the site, that is being put forward as an optional, alternate path. should not lower the BART in any way and, when we get all done with the process, I am not necessarily convinced that we need that. The reason for doing that is when we did our information gathering, we found them lot that self develop systems, they have good systems in please, but they were not vendors and not prepared to do the kind of things that weren’t necessary in the entire adjudging and evaluation process. We are not offering our product for sale, why do we have to do all of this stuff.


    to some extent it depends on the number of providers and the number of patients they see and I agree on the three doctor clinic that has their own software and a thousand Dr. Facility, the standard should be different.


    I do not think we made it explicitly clear, but we think the criteria is the same for everyone, whether it is open source [ indiscernible ]. The suggestion is what might be the most effective way to apply the testing. As Paul said, we do not suggest we know enough to give the approach, [ indiscernible ]. That is all.


    Let’s get an expensed on track explicit example, Judy. And other for and abnormal results [ indiscernible ] to have an inspector come in and make sure that the alerts occur as opposed to having some other software demonstration process. To the same criteria but not different way to demonstrate that you have got it.


    I think the key word might be that you are trying to look for a certification process that would scale.


    [CAPTIONERS TRANSITIONING].


    How we might be able to scale it.


    There is, I noticed the last bullet in recommendation one is a recommendation in the office of national coordinators for certification material may not exist today for system and data architecture. I think the usability is in some ways what we’re talking act when we try to think of things that are more along the line Kristine was talking about. The end point that everyone wants to be assured about. We are talking with NIST about usability models and the feasibility with that. We’ll see what we can learn. There is — there should ideally be a market for information about the usability of alternative software products that is part of any market. Should be part of any market.


    In the interest of time, I’d like to bring us back to the high level recommendations you made and to the transition recommendations. First of all, how much comfort there is within the group with the five overall recommendations that you’ve laid before us.


    Silence would be comfort or discomfort.


    Anybody have any objections to these particular recommendations? Obviously, there is some — the details matter, but they do have content. The focus on meaningful use is an important assertion. The commitment to security an privity and interoperability — and privacy and interoperability. Community might find reassuring to know that we’re concerned about. The expansion of certification is also something that would be a change in past practice and the need for short term transition plan is also an observation about the kinds of issues that Gail was raising about the need for timeliness. Even though there’s not a lot of detail, there’s content to those recommendations.


    Yes Neil.


    I’m just very concerned act how this is going to play in the public at a time when we’re really trying to say here is the road. We know where we’re going. Here is where we’re headed. Get in right now. 2011 is the time to get in. It’s a short timeframe and at the same time we’re redoing the certification process. The people who currently certify you are not going be the same people certifying you going forward. We’re send sending people — certification is the one thing that people who know very little about electronic health records depend upon to at least think they’re getting a product that neats certain standards. — meet certain standards. Is going to be critical. My concrete recommendation is that we define dates immediately upon which the things are going to get laid out. Etch with that, I think you — even with that, I think you run the chance of people freezing in place the minute that they hear the current certifications they’ve relied upon and are going to fall by the wayside. I’m concerned about that. The other thing we didn’t talk about an we talked about before is the question that people have when they’re boying — so what does it mean when the certification is going to change year by year? That’s another education message that I kept hearing back from people? What does it mean now? Everyone before people heard that there was a new certification process. So what does it mean right now that certification is only certification for this year and what happens if the vendor that I’m buying a certified product this year does not keep up with the certification so I’m a meaningful user this year but not two years from now? There’s already enough concern out there. We need to be careful how we put this message out on the street.


    I don’t disagree that certainty is desirable here. But I don’t think we did anything today to make this marketplace any more certain. Even with the progress we made on what we want to recommend with the meaningful use criteria, those don’t get settled until the rule making process goes through. We’re several months away from certainty. We’re going to be frozen and we’re going to need to know that the products that have certification are going to enable providers to meet the meaningful use requirements. That is more critical than anything and it’s one of the reasons I think this is a good set of requirements. Getting more data on what criteria do we have in place right now through the CCHIT process that match up well with meaningful use so we have a better idea of where the gaps are. I think you have more information on this than the rest of us do. The sense is that I don’t know how you at least tweak the existing process to make it work — knowing that we got what we paid for.


    Gail?


    Thank you. I agree with you deb. The market is in such a state right now. This is supposed to be part of a stimulus bill. What I see happening in the market is that the whole health care AMR market is dead. Nobody is buying anything. Everybody is frozen in fear because they are extremely concerned that —


    Judy is in deep trouble.


    All the providers I know are frozen. They want to know what is going to happen. Nobody wants to put down a penny until they find out what’s going to happen. So I think this needs to be expedited. If we can — this is a priority issue if we go down that road. Is there any way to expedite this particular element. The rule making section of it, get some concrete dates so that people can move forward with some confidence and that we can open the whole market, get things moving and help move the process along?


    Paul and then Judy.


    I’m going to make an attempt to thaw some of this. I think — this is an advisory group yet it has been a very open and thoughtful process by a lot of people who have a lot of experience. I think what the consensus is around the thoughts that have been presented do signal the market in a very important way. If you look at whether it’s the objectives in the meaningful use criteria that’s proposed by HIE and certification, those are very strong signals. I don’t think people would be lost on the goal that has been set out or even the road map to get there. So I think with that information, there’s certainly intelligent, reasonable steps that anyone can take even beginning today. What I’ve heard — correct me if I’m wrong with this last group — there is a gap and we make sure we match up the certification with if objectives that have been laid out in the meaningful use matrix. You said CCHIT could have it don’t by labor day and that your initial proposal that the existing certified folks with the gap, the additional gap certification would be deemed certified for the purpose of if statute. I think — the statute. I think those are concrete things that would allow the thawing of the frozen actions. So while that’s no guarantee because this is an advisory group and with have the NPR in process, it’s not certainly a reason — not a reason to stop and wait because the direction has been set. That would be a —


    [ Indiscernible: Speaker/Audio faint and unclear]


    Basically makes it sound like CCHIT is temporary. I think that’s where my concern comes from in that message.


    It’s not at all what’s intended by that. Fundamentally —


    Until another process is established CCHIT should continue to perform this with the messages that it’s [ Overlapping Speakers ]


    Could you — rewrite the current process — I would be very surprised how this all turned out, CCHIT isn’t deeply involved with this thing going forward. They’re the ones who know how to do it. They’ll be doing it — plus the whole advisory service. There’s a lot of demand for that. They’ll continue to do that also. CCHIT, people have done tick work. I don’t want anyone to get any impression that there’s an intention to criticize the people at CCHIT. They’ve done terrific work. We have to remember they were formlated under a totally different sort of legal administrative process than what we have here with a meaningful use. Totally different concept. That’s why there has to be a change.


    My sense is that we probably need more discussion before we adopt these recommendations, even high level ones. I wanted specifically to separate the high level recommendation from the specifics so the transition — not to adopt the transition plan per se, but just as the first high level recommendations. If you’re comfortable with that, I think it would be a useful statement to the community that we are moving forward. If you are not comfortable with that, I think we’ll need to revisit this in the — I would think that if we get that on paper, it at least gives our working group some for direction that they are taking us in the way we want to go but we want to revisit the details.


    I see Neil nodding.


    If I’m hearing you correctly, we are not going to adopt at this point the high level recommendations.


    We are.


    We are.


    In the middle of is sentence I looked around the table and the body language changed. I reversed the sentence. So being pessimistic about the high level recommendations to — I’m waiting your comment Gail.


    I believe that we need to move forward and accept the high level recommendations, the tweaking of the specifics that needs to happen. We need to get the message out there that we have got to move forward. We need to expedite the movement of this whole process as soon as possible and really move the thing along. We are under such timeframes. I keep happening on time, I know it. You don’t want to hear me again, I’m sure. I think it’s very, very important that we let this happen. Let the community know that these are the high level recommendations that we are moving forward as rapidly as possible.


    So the connecting I hear all the time — ticking I hear all the time is a bomb Gail? [ LAUGHTER ] So without objection, I will suggest that we adopt the high level recommendations by consensus and ask the committee, the work group to make any changes that they may think were useful in light of this conservation. They may, for example, want to make more specific recommendations around the timing of the transition. That we bring those up at the next meeting of the policy committee.


    We also want to publish in the Federal Register and encourage public comment so we can respond to that also.


    That requires some preparation. We’ll have to get back to you on how that would happen. In order to do the meaningful use, we had to notify the public in the Federal Register two weeks before the meeting that we were going to take comments. So we haven’t done that for this. We need to talk to — primary care doctor. I don’t know about this lawyer stuff. We need to talk to our council about how we would get public comment. I do want to make the point — never mind. I just have to get back to you on that.


    Okay. So thank you very much. We’re going to now — we have another couple of panels. I think we’re going to run over. I apologize to the members of the committee about that. Because we also have to have public comment period.


     


    I want to thank the members of the standard committee for their patient for sitting through these comments. I think we’re going to start with Jaime fer by son.


    Thank you very much for having us here. Gofers of all why are we here?


    our relationship to this committee is by statute the health IT standards committee is charged with specification — health information exchange in the use of health IT to implement the policies that are developed and determined by the policy committee. So how are we doing that? We have three work groups, I’ll be reporting on the clinical operations work group. We start with meaningful use objectives and measures.


    Of those standards by 2011 or 2013 or beyond. We take a formal step of doing a reality check. We make notes about going away and come back and think about what is it that we didn’t consider in terms of the implementation feasibility for widespread use of these implementations in the EHRs. Now once we specify the standards for each measure in the clinical work group, then the quality work group has responsibility to direct.


    I think Janet will go into that in some additional detail.


    I have two examples of our process. I’m not going to go through the details of this. It is in the materials. I’ll be happy to take questions. But in general, the existing standards for quality measures such as those for NQF or those that are used in CMS are not geared toward EHRs. So they need to be reworked for EHRs. As we look at the standards that have already been adopted — I do want to point out that we identified some gaps in the adepartmented standards that may affect the adopted scope of the measures. As an example here in this measure.


     


    To define standards for calculation of the measure.


    Now many of these same EHR standards are going to be useful for measures other than those for quality assessment and quality improvement. For example, standards for the continuity of care documents may be selected by the standards committy exchange — we will complete the identification of the existing standards and we’ll have cross work group discussion on that as well as the implementation feasibility of using the standards for 2011 versus 2013 and beyond. We then want to take a step toward harmonizing the recommendations across all the different objectives and measures so that if we’re using a standard for one purpose, it might be used for other purposes and the same implementation year. We’ll develop the standard committee’s recommendations for meaningful use.


    To identify the specific standardized measures that currently exist in the most part are in use. That apply to each of those quality measure descriptors. Should have a brief listing. I want to be very clear. This is a work in progress. What our quality measure work group did was to look at each of your quality measure descriptors. So for example, percent diabetics with hemoglobin A1C under control. That is own dorsed by NQF. For those who may not be familiar with the quality form, with the organization that evaluates performance measures an selects the best in class.


    That have been endorsed by NQF. The largest repository of measures and measures of first choice. What we did is we went in to that repository, the database and identified where we had a performance measure that was well specified — exclusionary criteria and as I said for the most part, typically in use. That’s really been our first step in the identify indication of the measures. We then essentially hand those miss off to Jaime’s work group that takes them into identifying what the appropriate HIT standards are. The good news is that for the most part, for the majority of 2011 qualify measures identified by the policy committee, we do have an NQF endorsed measure. Most of them are pretty good matches for the quality measures. A few divert a little bit. There’s a few whole. The challenge though in moving forward, these quality measures, standardized performance measures were developed by many different measure stewards. These measures were not developed for EHRs for the most part. They need to be retooled to actually run off EHRs. As soon as we’ve reached agreement as a community, our various committees on exactly which measures will be selected that retooling process will begin quickly so they’ll be retooled by the end of the calendar year. That is the goal. Now there is a variety of challenges in that process. Since the measures were not developed to run off electronic health records they would probably be specified quite differently. So for example, many of these measures have a denominator population that have been identified ICD9 or 10 codes. Electronic health record, you probably would use other information to didn’tfy that denominator population an you would come up with a more all encompassing accurate estimate of the patients that belong in the denominator population. So for example, that you could identify patients with heart failure using diagnostic code but if you had ejection fraction you’d probably get a better estimate of the patients that belong in that denominator. That’s one of the challenges that we have going forward. There’s also going to be some challenges in terms of certain types of data that need to be captures for these data that could be difficult in 201010. In our — 2011. Probably going to be tough to capture in 2011. So we’re taking a close look for each of these measures what types of data do need to be captured. That builds on — Paul chairs for NQF which has taken each of the measures in the NQF database and traced them down to the types of data that need to be captured to generate the particular performance measure. For some of the measures, we don’t have for some of the policy committee quality measures, we do not currently have an NQF standards endorsed measure and probably have to rely on attestation for 2011. We wouldn’t have that anymore probably a good example there is the percent of laboratory results that were submitted electronically. Some of these measures that we look in greater detail significant cost implications for capturing the data. That would be another consideration. Lipid profiles is another example of one that would be quite costly. Last but not least, the performance measurement community, for those who aren’t familiar with performance measured are developed for quality measurement and reporting purposes, there are many different measure stewards that develop measures. Dozens of them. These measures typically have been developed in silos. For example, we may have a body mass index for the hospital environment. Another one for ambulatory environment and long term care community. Different conventions that have been followed by the measure stewards. We want to use this as a real opportunity to encourage hear monoization and the development of — index should be the same regardless of what environment that patient happens to be in. Regardless of what type of provider is treating that particular patient. This will be a bit of a moving target over time because there’s a huge amount of work to redo and — harmonized across various settings. You’ll also find there’s inconsistency depending on whether pediatric or adult patient. Measure development occurring in silos — then the add adult commune tee developing measures for adults. We will have to kind of work through going forward. Now the quality work group over the next few weeks what we’re going to be doing is start to work on a frame work for classifying the NQF endorsement measures. The degree of readiness for implementation in 2011 and in what form. The second one to begin to take a look at some potential recommendations that we can take to both the standards committee and also to the policy committee at some point about setting thresholds for those various years depends upon the degree of — depending upon the degree of readiness on the years going forward. In terms of timing, we think we’re getting pretty close to a list of performance measures at this point. Will be delivering our recommendations to the standards committee next week for them to weigh in on at that stage the over all frame work for the thresholds and degree of readiness will be in the very early part of August. Be glad to answer any questions you have. I should acknowledge my colleague Floydize enberg who has done such extraordinary work in the mapping of the endorsed performance measures over to the policy committees — which was a huge amount of work.


    Thank you Janet. Any questions for Janet?


    can you give us an indication of when those harmonized measures will be available and when they would become part of the 2011 project that we have to have ready for the venders and the markets?


    It will be a mixed back for 2011 as you can imagine. As a quality work group dives in deeply into the individual measures, I think what we’ll find is that we do identify some aspects of hear monoization that the measure stewards can respond to in their retooling between now and the end of the year. Then there’s going to be a variety of other aspects of hear monoization that frankly, it’s closer to a new measure than it is to the existing measure. We’re making a distinction between modifications to the existing measure that probably have more to do than the underlying data source, maybe more minor tweaking. If that hear monoization really requires a significant change in the measure, then it’s really more of a new measure and you’re looking at 2013.


    I don’t know if this is nor Jaime or Janet. We heard discussions on the certification work group regarding a lot of the specialty practices, particularly from one oncology group tumor classification varies from hospital to hospital. Are there standards in place for some of these specialty practices that can start incorporate or being looked at?


    From the standpoint of our work group, we are identifying a number of gaps in HHS adoptestandards where there may be a virtual of standards that could potentially be used. We haven’t been through the public comment and vetting and selection process so we’re identifying those as gap and we’re going have to figure out how to deal with those. But I also think in some areas partial standards or no standards that would affect the scope to which the measure could potentially apply.


    Let’s move onto Dickcy. Last question.


    Do you know when you might have the required — the list of required fields available? That would be extremely helpful. I realize you are in the middle of changing the measures. But having the notion of the space of the fields would be very helpful as we move forward in trying to understand privacy issues and things like that on the secondary issue with data. Do you have a timeframe?


    I guess not.


    [ LAUGHTER ]


    I don’t think we have firm dates yet.


    Dickcy please.


    I appreciate you letting us report arista does today. The security and privacy and security work group of the standards committee. Basically I credit Jodi for making it clear. Adopting an EHR an eligible provider must meet two separate requirements. They must show that they’ve acquired a certified product or certified service and secondly, they have to demonstrate that they are using that product and service or service meaningfully. The standards committee really needs to recommend two things. Two sets of criteria. One set of criteria to be used in the certification of products and the other to be used in the demonstrating that the applicant is using that acquired product or service meaningfully. In the case of privacy and security, this distinction is particularly relevant and important because certification of a defined function or service has been implemented in the product does not imply that the user is necessarily using it meaningfully or in fact, if they the user is using it at all. I’ll give you two good examples of this. In the case of audit. I’m absolutely sure the capability to audit user actions will be part of our criteria for certifying of an EHR product, by everybody knows that when auditing is implemented in systems, it can be turned off. You can audit different actions. Another example is encryption. You may have the capability to encrypt, but depending on your policy, depending on the use case, the environment, you may or may not use that encryption capability. It’s really important that the privacy and security working group make this distinction and what we’ve done is adopted an approach that addresses both, the certification of products and the demonstration that a user is using the certified product meaningfully. I’m going to somehow you how that coming out. We went back to the ARRA priority areas of focus. In those eight areas of priority, we extracted those areas that have implications for privacy and security. We identified the privacy and security services that are implied or directly required by the ARRA 8 as we affection atly call them. Once we have that list of privacy and security services, we looked at the available sources of standards. Those being the CCHIT certification criteria and the hit by construct. We mapped those available standards into the privacy and security services. Now what really happened is that in the case overhits my uses IHE profiles, then we went to the IT profiles and extracted the technology standards that those profiles depend upon.


    So the next step is to really map that in to the meaningful use demonstration.Fection of all, we — first of all we belief there will be a sub — believe there will be a subset of the criteria that will be part of the meaningful use criteria in particular. Then above and beyond that subset of certification features, are things like the IT infrastructure, things that are derived from the HIPAA requirement from meaningful use. The combination of the required services — this list of services must be configured if your application is deployed on a laptop for example, that’s carried around between hospitals or something like that. That would have a different set of configuration requirements than one that sits in a very secured area. Secure operations in particular, we want a current risk assessment and current contingency plan. Both of those are HIPAA requirements but important to meaningful use. Particularly contingency plan, to show that they have processes and procedures and operational rules that assure that the information and the services that they need will be available when they need them. We haven’t finished that list. I doubt we do by Monday, but there is a list of additional things that meet criteria that will become part of the demonstration of meaningful use.


    In these next two slides I show you the crater yeah that we derive the privacy and security services that we derive from the areas of focus. There are 8 areas of focus. Here you see the first four and on the right you see the services that we identified that the first ARRA priority areas is jam packed full of security requirements. Security criteria. Identify management. Access control. It implies two types of access control. It applies user based identity based as well as label based when it gets into the segmentation category. Consent management and encryption. The second one the [ Indiscernible ] We’ve been told that in all probability, most of the health department exchange requirements are likely to come in in 2011 with some exceptions. My work group would very much like to talk to your work group on the HIE what those are likely to be.


    Pardon?


    Yes.


    What those are likely to be so which of the exchange capabilities we need to include in 2011 versus 2013. Then the fourth one, technologies that are part of the accounting disclosures. That’s in ARRA. These are the kinds of security services auditing. Consistent time, [ Indiscernible ] Trace ability and on the repudiation. This slide shows the priority areas 5 through 8. You can see number 5, some of you may not consider number 5 a security priority area, but in our view and certainly in my opinion, I believe — security is important not only to protect privacy but also to assure the integrity of data and critical services and data are available when needed. The use of certified EHRs to improve the quality of care, those two functions of security, protecting the integrity of data and the assurance of information is available when needed, I believe will make or break EHR adoption because if we have systems that are able to perform the clinical functions that we need at that particular clinic or that particular hospital, but the doctors soon learn they can’t depend on the integrity of the day they and the services and data being available when they need it, they will not continue with that adoption. We believe that is very important.


    Only paying attention to time.


    This is the last slide. These were the concerns that we sent to the policy committee when we reviewed the goals and objectives and measures, our committee did have feedback on that. We were concerned that privacy and security were focused on confidentiality. We believe that the security functions to protect data integrity and service availability are equally important. You already mentioned — I saw in your slides you mentioned HIPAA compliance. Our people felt HIPAA compliance is required by law so it may not make sense for a measure of meaningful use. We felt that public health should be addressed and that the measures that we put in place, the criteria we put in place — integrated networks.


    Thanks to all three of our panelists. We are so pressed for time that I’m going to choose the chair’s per rocktive to ask you to step off the panel. We’re not going take any additional questions, I’m sorry to say. That won’t mean you won’t get questions later. I think we’ve benefited from the opportunity to coordinate and learn about what you are doing. I’m sure this exchange will continue.


    I think that we’ve now reached the point on the agenda where we are going to open the floor for public comment. Judy are you going to manage this part of the process?


    Those in the room want to make a comment, step to the microphone. Make those comments short and non-commercial. We’ll check in on the phone periodically. We have about 10 or 15 minutes for comments.


    For those on the phone that wish to make a comment please press star one that you would like to make a comment. That is star one.


    HL7 and NIT. I would like to — are great for the copy of EHRs. I would like to ask that the committee consider whether those are appropriate for some of the modular come point tech knowledges that are now being looked at for meaningful use for implementation. The IET standards are more for enterprise systems an are not particularly helpful for privacy protection. Thanks.


     


    I represent myself. So I am professional. Behind me, 55 years in information, science, technology application in particular for medical needs. X-ray very chemical analysis, CT and MRI. I am professional. But my remarks will be from professional point of view, but mainly from the common sense point of view because what we don’t see is we don’t see forest among the trees. So [ Indiscernible ] Comments. I am professional in data compression so I will come press as much as I can, my commands.


    So first of all, this numbers to 9 to 15, it’s too long time. From [ Indiscernible: Speaker/Audio faint and unclear] it’s unbelievable if you can tot do anything for six years, we need to wait, maybe don’t do this.


    Second comment about numbers. 10% this and this and this, it remind me very simple anecdote that describes situation very eloquently. Man came to [ Indiscernible ] [Speaker unclear due to accent.] product to buy to and [ Indiscernible ] Said to me. What do you need? So this timeframe to 11 to 13 to 12. It’s nothing behind it.


    Sir. Thank you. We have a line.


    I’m sorry. We have people behind you. If you can make it a lot shorter. Thank you.


    So what? I can speak or no?


    You can, but just please make it shorter.


    As short as I can. I come press tremendously. Commence about meaningful use. Ladies and gentlemen, if you are adult, don’t play with what — with this term. What kind of use can be as meaningful [ Indiscernible ]


    I’m sorry sir. You’ll have to — if you want to submit written comments to me, that will be fine. I’ll put it in the record. We have people waiting. I’m sorry. I appreciate what you said. Okay. If you don’t need me to speak.


    You have been speaking. Thank you very much.


    Good afternoon. I’m Robert — I’m — blood centers. We represent 75 glad centers across the nation that collect half the blood annually. I am one — we are one of the organizations that submitted meaningful use comments. I first want to thank everyone here forallowing us to submit the comments for the transparency that you’ve shown. You’re willingness to include the viewpoints of all stakeholders. I’m not going to reiterate my comments, but I just want to point out a couple of things that blood centers were included in the stimulus act under title 8. We are part of the national response plan, which means we are part of the critical infrastructure of this country, and as such, as long with EMTs, I was at the connect seminar. EMT got up and said where can we fit into this process? He said well basically this is geared toward the Medicare and Medicaid billers. The physicians and hospitals. I submit that blood centers should be part of this process. I ask you where can we fit in? I looked at the meaningful use matrix. By the way, we endorse most of the measures of the meaningful use matrix. We think this process is being done correctly. We believe transfusion should be part of the matrix.


    Let me just put a two minute limit on everybody else so we can get as many people as possible. Sir?


    Rick brake strategic health resources. The GAO released it’s report on DoD and VA, the challenges that they face are harmonizing their clinical data. Since veterans use both VA and non-VA facilities on a community level, wondering if this committee has a goal or objective with the — EHRs?


    Let’s take a caller on the phone now please.


    Our first comment from the phone comes from the line of Jean [ Indiscernible ]


    Hi. Yes. I’m the vice President of operations here in the implementation of the electronic health record in [ Indiscernible ] Wisconsin. One of the comments I wanted to make was and the 10% of all orders entered into CPOE. We’ve just completed a 3 year project or finishing a three year project of implementing 22 applications that will comprise our health record. We’ve implemented 9 hospitals across two states. CPOE is not as, I believe it was Gail — I don’t want to misquote her — said it’s an aggressive timeline and it’s challenging. I think one of our approaches to implementing CPOE is to stratify the implement station where we’re concentrating on the hospital size of implementing it first to all the hospital — intensivist, RN population because we feel trying to apply the 80/20 rule of getting at least 60 to 70% of the orders for the inpatient world is addressed to the clinicians. Something that the panel could look at as they’re looking at the 20% of all orders does that apply to the inpatient world, to all of the hospitals? Maybe you look in 2013 going — start with the impatient world, certain population and expand it to all of the clinks and outpatient areas. That’s my comment. Thank you.


    In the room please?


     


    And to safe costs through reduction in unnecessary or duplicate imaging scans. However, but if a practitioner is unable to access imaging information, this fuels the growth of duplicate imaging so that is something that needs to be remedied. Therefore, I think that both diagnostic images and imaging ultimately must be part of EHR. Thank you.


    Thank you Richard. Let me do one more on the phone. We’re losing our committee here.


    Our next comes through Donna Robinson with caption


    Brian Ahier says: My public comments as follows:


     


    Brian Ahier says: I have not heard much about the patient in all this…


     


    Brian Ahier says: I hope the committee will make sure the development of an electronic health record includes accessibility to the disabled, including sight/hearing impaired…


     


    Brian Ahier says: Also I hope that the committee will consider a patient centered EHR that provides clear Health Data Rights for patients to control their own health data.


     


    Brian Ahier says: thank you very much


     


    Brian Ahier says: thank you for your assistance


    .


    Thank you.


    American physical therapy association. We wanted to comment specifically on meaningful use. As we reiterated in our comments submitted last month, we think that [ Indiscernible ] Severely limited without the inclusion of all health care providers. Physical therapists and other non-physician health care providers play a crucial role — safe and collaborative care cannot be met if they’re excluded from initiatives that are designed to foster the adoption of meaningful use of health information technology. We would encourage you to consider limitations of HIT to physical therapists non-physician health care provider is unable — vice versa. To therefore we would urge you to put together a recommendation that insures the inclusion — [ Indiscernible: Speaker/Audio faint and unclear] work that is taking place. We are prepare today assist you in any way possible — physical therapists and the vital role in quality care.


    Thank you very much.


    We’ve gone over now almost 30 minutes. I think we need to adjourn.


    I appreciate that and appreciate all the folks to boast their comments. They are extraordinarily helpful. They play a role in the work groups of the committee. In this late stage is there any other urgent business on the part of the committee? Hearing none we’ll stand adjourned. Thank you.

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