Health IT and Healthcare Reform Information

August 19, 2009

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Medical Uses of Wolfram|Alpha

August 14, 2009

There have been increasing medical uses and capabilities of WolframAlpha, and I am very interested in its potential in medical and health areas. WolframAlpha is like a type of search engine capable of finding and cross referencing relevant data from multiple sources. Unlike other types of search engines, it actually provides real answers to queries rather than only links to possible answers. It returns not only the data, but the relationships between the data. It not only searches data it computes data. Kinda like Google on steroids…

Bertalan Meskó is a medical student at the University of Debrecen, Medical School and Health Science Center. Berci writes a very nice blog at Science Roll. He will graduate from medical school this summer and he has found WolframAlpha very useful. He said “I use WolframAlpha because sometimes (if I know exactly what I want to find) it saves me plenty of time and clicks. If I want to calculate BMI, Google lists me several calculator. WolframAlpha calculates it itself.”
He continued, “If I want to find information very fast about a clinical marker, Google gives me resources, WA gives me the best answer in one click. I also use it for ICD classification, as it’s more easily accessible than Wikipedia; for epidemiological data and other calculations.
To sum it up, I think WA is for those who perfectly know what they want to find and want to save time and clicks. For other search queries, Google still is the best.”

Developers at WolframAlpha have made improvements to the engine’s capabilities and scope of knowledge, particularly in medicine and health. They have published an overview and some examples of the types of searches both patients and clinicians will find useful on the Understanding Medical Tests at their blog.

WolframAlpha is a helpful reference for understanding what the tests measure and how to interpret the results. WolframAlpha allows you to query information on a specific medical test or a panel of tests, compare tests and results for patients with specific characteristics, compute your estimated risk for heart disease, and find the diagnosis corresponding to an ICD-9 code. WolframAlpha can take into account specific patient characteristics like gender, age, smoker, non-smoker, pregnant, diabetic, obese, and underweight. WolframAlpha can give you a snapshot of available data that might help you understand how your results compare to others’.

WolframAlpha can provide a number of interesting medical statistics including body measurements, physical exercise, diseases, mortality, medical tests, and medical computations. You can see other examples of Health & Medicine uses here. For example to determine the benefits of running 20 minutes for a 28-year-old 5’11” 185lb male, then type: running 20min, 6min/mi, 28yo male, 5’11”, 185lb into the search box. Results would look something like this:

If someone is interested in calculating their daily food intake, WolframAlpha can help. Here is more from Understanding Medical Tests.

We have heard from many people who are interested in learning more about calculating their daily food intake in WolframAlpha. If you have been following our posts on how to use WolframAlpha to help achieve your nutritional and wellness goals, this will be easy as apple pie. Our data curators have been busy working on over 7,000 food entities that are listed in the USDA National Nutrient Database for Standard Reference and other food databases. Currently, they’re adding additional brand-name and specialty food items. Once a food entity is placed into WolframAlpha’s nutrition bank, rules and algorithms are applied to help categorize it by typical attributes (e.g. raw, boiled), units (e.g. cups, tablespoons), and unique serving forms (e.g. slices, pieces). As a result of these categorizations, when you enter a food item such as “strawberries” into the site’s computation bar, WolframAlpha computes a breakdown of total calories, fat, cholesterol, sodium, carbohydrates, protein, and other particular nutrients based on standard serving sizes (units) and attributes.

Or, how about cholesterol information for a 45-year-old male. Type: cholesterol 45yo man into the search box. As you can see there are already many uses for health and wellness that people can use to find and calculate information on nutrition and fitness. But the thing most exciting to me is the possibilities for clinicians that have barely scratched the surface. The widespread adoption of tools like Epocrates and UpToDate show that providers are hungry for mobile, web based services. I believe that as WolframAlpha continues to expand its abilities in medicine and health we will eventually see it used for Clinical Decision Support. When that happens it could cause a pardigm shift in web enabled technologies supporting medical care.

Rough Draft Transcript – HIT Policy Mtg – 8/14

August 14, 2009
#HITpol meeting to discuss meaningful use and certification of #EHR. The Health IT Policy Committee will make recommendations to the ONC on a policy framework for the development and adoption of a nationwide health information infrastructure, including standards for the exchange of patient medical information.
Committee Membership:

Chair

  • David Blumenthal    
    HHS/Office of the National Coordinator for Health Information Technology

Vice Chair

  • Paul Tang    
    Palo Alto Medical Foundation

Members

  • David Bates, Brigham and Women’s Hospital
  • Christine Bechtel, National Partnership for Women & Families
  • Neil Calman, The Institute for Family Health 
  • Richard Chapman, Kindred Healthcare
  • Adam Clark, Lance Armstrong Foundation
  • Arthur Davidson, Denver Public Health Department
  • Connie White Delaney, University of Minnesota/School of Nursing
  • Paul Egerman, Businessman/Entrepreneur
  • Judith Faulkner, Epic Systems Corporation
  • Gayle Harrell, Former Florida State Legislator
  • Charles Kennedy, WellPoint, Inc.
  • Michael Klag, Johns Hopkins University, Bloomberg School of Public Health
  • David Lansky, Pacific Business Group on Health
  • Deven McGraw, Center for Democracy & Technology
  • Frank Nemec, Gastroenterology Associates, Inc.
  • Marc Probst, Intermountain Healthcare
  • Latanya Sweeney, Carnegie Mellon University
  • Scott White, 1199 SEIU Training and Employment Fund
  • Roger Baker, Department of Veterans Affairs
  • CDR Michael S. Weiner, United States Navy
  • Tony Trenkle, Centers for Medicare and Medicaid
  • James C. Borland, Social Security Administration
Meeting Materials:

Rough Draft Transcript below:

 

Top of Form


Okay, the first action item would be to approve the minutes from July the 16th, are there any amendments? Christine?


I have one on page five, tasked to clarify under action item two, it says that that committee adoption meeting [indiscernible] by consensus, noting for inclusion in the final version of the number of specific at objections, and it used to say, about an aggressive timeframe and I don’t think that reflects the entire [indiscernible] so if that could change to a few members, depending on what folks would like, I would appreciate it. And delicate that to Judy.


Any other amendments?


I will entertain a motion to approve them.


And its second.


Okay. Our first point of business is to get an update from that meaningful use workgroup, and George [indiscernible] is going to present. I and the other party that I will sit over here out by substitute job well George presents.


Pour all right, thank you Paul. Thank-you to the committee to the opportunity to present our progress since the last meeting. And I will do the presentation [indiscernible] three slides long.


So the work group before I joined it did a great job creating the 2011 majors, and a consistent set in the very short timeframe. Working [indiscernible] one your time frame and therefore we have a more bigger timeframe to adopt a pays part — so what we have done in our last to fall meetings is mainly worked through the process and the timeline. Our draft timeline as shown here on slide and I will go through it briefly.


In this quarter, the first quarter 2009, [indiscernible] measures. Let me go on and I will come back to that.


The first thing we need to do is gather more information. So in the fourth quarter we plan to conduct international meetings to form the 2015 and 2013 development and I have a slide on that and I will come back to that. And the first quarter next year will reworking hard on those objectives and measures and around the second quarter will be ready to start working with the HIT Standards Committee to ascertain the availability of a relevant standards for meaningful use.


By the third quarter we will be refining the 2013 Emmy for his criteria to hand over to ONC.


– initial 2013 Bentleys criteria. Placing back on the fourth quarter doesn’t mean we are one to ignore industry for the next year, it just means we think that will be a good time to collect a lot of the data.


I will be covering this of little bit in the next slide, but ran at our last Policy Committee meeting, how we deal with specialties and how many police relates to them [speaker/audio faint and unclear] specialty and that is why that is on a timely and bear. But we will do other things.


For one thing, our choice of the national priorities partnership framework which over Jerry well we think with the public, and we want to continue to use the framework for Army fleas criteria however, the one thing that we discussed on the found is that we are the meaningful use grouping not the United States policy group so there are people working hard on setting the national priorities with health care and we want to work hard for those people rather than reinventing the wheel.


So the N PP is a good source and the others [indiscernible] objectives. Many of them are quantitative measures.


We have invited presentations from both groups of our last phone call and we’re looking forward to working with both of them to identify HIT sensitive objectives that are appropriate for the meaningful use criteria and 2013 and 2015 so we see it as a collaboration.


As I said, we need more information to we want to identify public input on caps and measures. And I will have a slide on this to follow, so quickly, specialist and smaller hospitals, smaller practices, safety net providers and patients — areas are areas we need more information.


We want to be able to assess financial industry response to the 2011 program and of course refiner meaningfully as criteria that was published. In other words, the part that was published in the matrix are not are filed answers, and over time we will address barriers to e our adoption and address mitigation strategies.


We are hoping to have an informational hearing on the people use criteria in October of this year, said the beginning of the fourth quarter to address those gaps. And we’re looking for two dividing the meeting into two parts. The first part to cover the criteria per specialist, and the uses of majors relevant two specialist, whether we can use national registries as a way to gauge meaningful use for specialists, and assessing what needs to be developed in terms of new measures. So perhaps a half day on that.


The other half day, there are several topics, some I mentioned on the previous slide — and I thought the first meeting we would go broadly and look specifically for feedback and — from New provider organizations. So the spectrum of practices and hospitals and the safety net providers to inform us on not just how we are doing but what we’re not doing that needs to be done.


Now I will take any questions.


Any questions from the committee.


Thank-you, Paul, I would like to first commend you for listening to some of the comments and I am delighted that you’ll be meeting with the specialties and understanding the impact of the meaningful your secretary on them.


I wanted to clarify something. On that meaningful use definition and measures that are put in place for 2011, there are measures that are going to be required. Two questions, number-one, as a 10 percent that is was relative two hospitals also apply to positions on CP 0E, and also, is CMS going to be able to accept those measures in the documentation? Are they in a position to be able to do that? And so we have established majors and being evaluated on it, are we going to be — able to do anything with it?


Purse let me say that all of my answers are about our intention because it is now and see him as a ‘s hands. CBOT is that hospitals would achieve — 10% to apply to them because our feeling was, if you are going to install a EHR in your practice, or are you doing except documentation and orders, that is the work flow. In hospitals is different. CMS cannot judge the feasibility as far as doctors accomplishing that, but that was our intention.


Whether CMS can accept that, they have a range of options from anything from attestation to actual data that things were being done correctly, so CMS should decide how two best prove it.


I think I will defer to Tony, a member of the committee.


[speaker/audio faint and unclear] CMS, cell … are you talking in terms of acceptance or terms of the regulation or terms of receiving the measures?


I am just quite familiar with the difficulty many practices are having with PQRI, and I am wondering if the system is able to accept data on things such as structured and what we’re seeing with meaningful use. What will your system be? A lot of the question is, that were not ready to do that?


Well, we will not propose in the rule or accept in the final rule anything that our systems can’t accept. So if you have something in there that are — we don’t feel our systems can accept in 2011, will propose it as part of the final rule.


Ball up?


So what you’re saying basically at this point, attestation might be adequate if you are not there?


We will propose in the NPR M — we are looking at our systems now and possibilities, and we have regulations and Clarence that will discuss that issue but I don’t want to discuss it at this point because we are in a clearance process. But it will be discussed in the rule how we intend to do that. And then of course we have the public comment period where we can receive those comments. But we’re looking at a variety of ways of power systems will currently and in the future be able to accept data, so whether we can do it in 2011 or later is something not we will propose in the NPR M which will be out in December.


Thank you.


Any other questions?


Passed by the debt the matrix, and I am kind of going back rates and we may not — as I looked at the matrix, and I am kind of going backwards, but I am looking at the documentation and the ability to associate that with some kind of LOINK code, but there seems to be a missing piece. And it might be too late. Did I miss that, or maybe someone could clarify?


Image and documentation and dimension LOINK coats — go ahead.


There will be scanned documents in any medical record that people are going to keep, and whether you associate back two ’86 code so that you can bring it up in the context — I don’t suppose that matter is that you need the ability to store documents. I didn’t see that in the matrix.


From the matrix point of view, we took the approach, do we do that 500 criteria from what a certified EHR might have or do we look at the Excel blowers that a comprehensive [indiscernible] chart is being used and being used meaningfully? So it didn’t come to the forefront as far as being one of the exemplars that we may need to do. We are looking at examining that in the 2013-2015 majors.


David?


Thank-you, Paul. I have a couple of questions also which may come to Tony. We do the meaningful use work and we talked a little bit last time about the challenge of beginning to encompass all of the different dimensions of American medicine. And two in particular, I am interested in what CMS can tell us. One is that the statute says that there are Hospital based physicians who are not subject to the meaningful use incentive program at least in this category for the Medicare funds. Do we want to address specialists.


Is there any clarification yet as to what the boundary is between a specialist who we should be developing measures for as part of the agenda that George described versus those that will be treated separately at because of the statutory plan which.


That is one question, and the second question, at the state level we have been discussing whether the Medicare meaningful use provisions are determined by CMS, or they are determined that the state level, or is there a relationship between federal requirements for the Medicaid [indiscernible]


The first one will be addressed in the regulation, the first one we have been meaningful [indiscernible] hospital based professional and we have some language in a regulation and as I said, it is in Clarence now so I don’t feel comfortable about speaking about that. And the second one [indiscernible] and one option would be to have the Medicare program meaningful use objectives as a floor and then the state, if it wanted to add additional to that, they could go beyond that. But we don’t want the majors to be below what the federal is, so we can think about it that way, but as much as possible, we want to harmonized and recognize and of course there are some differences between the federal and Medicare and Medicaid programs as well as who is eligible for both programs.


The other issue for the Medicaid is that the first year, the eligible professional is not prepared to meet okay, I have a continuing concern about the majors pipeline and I think the meaningful use subcommittee should give some attention to 2015 early, in order to provide direction to NQF or other major development bodies so we have the measures available to as as an as possible to implement the directions we are going in. There are several categories, like The patient engagement categoric an outcome area where the pipeline is not very robust yet, and I think by as declaring ourselves on those directions, we can attempt measurements [indiscernible] now. We don’t need handicapped by using fisherman’s that the cult 15 years ago. And the last thing is, does the community has talked about having also a hearing on a patient supplied data services as part of the strategy, and I continue to hope we do that soon because I think that is part of the longer-term pipeline.


Let me just comment on both of those. One, the importance of signaling early what kind of measure we are looking for so that both the industry and any QF who endorses majors early can have that advanced warning.


You will hear later in today’s proceedings that N QF is already looking on the 2011 majors and that is the direction, so those are good things but notwithstanding should be working on a 2013 as well.


And the is a thing is as George mentioned, that patients applied or patient advised data is on the agenda to get — as an as we can. We have other priorities that we need to act on as everything — everything we have to act on as quickly as possible. But it is definitely in the queue.


And sorry, I’ve got buried, but it didn’t go into the public record on that slide and that was the purpose, to make sure people didn’t know that.


One more question, I would like to follow up on Medicaid because as you know, every state, their Medicaid program is unique to that state. Are you anticipating that CMS will allow states to set meaningful use criteria that, perhaps dealing with children, per instance, in Florida, 75 percent of our Medicaid recipients are children that address specific needs to Florida rather than are specific Medicaid program, or do you anticipate collectibles being set for Medicaid across the board?


I think it is premature at this point. Certainly what we’re doing now is communicating with the states to find out what some of their needs and requirements are and we will taken into account as we develop the rules for the incentive program. That is about all I can say. I know that we are actively working with the states and also ONC and looking at some of the issues that are related to the state programs, particularly in the Medicaid, as you mentioned, the children’s and pediatric requirements are things that we’re looking at very closely.


One more follow-up on that. I believe the statute requires that you do 20 percent of Medicaid in order to be eligible. Is that accurate? And is there a way that that can be interpreted to include S Chip? Because we have any providers that do not reach the threshold of the 20%, especially pediatricians, and are not eligible under Medicare, but they certainly need to be part of EHR and it is important that we incentivize them to do that. For as SCHIP, bus practitioners take that.


As you said, they have specific percentages, so we will basically go by what the law says in terms of qualifying for the program.


Is there any committee members on the phone that would like to make a comment?


Okay, and any final comments from members of the committee here?


Okay, Mr. Chair, we have finished up with the first item which is the update from the meaningful use workgroup.


And thank you. I am sorry I am late. I think we will move on to the certification adoption of work group. I guess I should first say hello and welcome. I don’t want you to think that we live here at the Holiday Inn, but sometimes it feels that way.


Could I ask Paul and Mark to share their thoughts with us?


Paul has all of the thoughts today. But I get to tee it out.


But you have the jokes.


I don’t even have any good jokes. You have seen this before but I just want to reiterate how much work these guys are putting in. Every call and every meeting, they are very well engaged. And also, Paul, his leadership has been tremendous. Over the last month it has been busy for me personally and he has taken a lot of the load.


Nothing on this definition has changed. This is still what we believe certification is and it is focused very much on meaningful use, and that this is not intended to be the seal of approval process.


So as we go to the recommendations that are very similar to the last ones, although we did hear the comments from last time, we’re still basing it on the same definition. So these are the recommendations and as I said, Paul will go through each of these. Our hope is to go through them quickly, we have fairly high level bullets on this and then we can get into discussion around certification.


I am appalled Ackerman, and I and the co-host with Mark probes on this. And I will take you through each of the five recommendations. I wanted to make sure that I explain why we are here at all this morning. Basically it is to — two refresh everyone’s memory, we presented last month at the meeting and the five recommendations that Mark Just went through or approved in general but we were sent back to say, provide some detail and make more recommendations on the detailed recommendations and also consider the feedback that you and other people have given us. So we’re back today to say that we have done all those things and refined and change recommendation based on comments that we received.


So I will take you through the five recommendations. So now what you see on the screen is like a summary of each of the five recommendations but we have put down three major headlines or bullets on each of the recommendations. If you look at the appendix in your materials, there’s a lot more details on each one of these and so that is also aware if you haven’t already done so, you read through all of that detail in terms of how that all works.


The first recommendation is to focus on meaningful years. Basically what we’re saying with the certification process is it needs to be driven by the meaningful use objectives that fundamentally we want to have what we want to call an outcomes oriented system of certification. And so this is a new certification process. A focus on meaningful use objectives, we are talking about the objectives and the measurements, and to do it at a high level with last specificity. — less specificity. We’re not trying to say how these will work, we’re not saying if you have an alert, this is how you do feel there if you have an abnormal value, where just saying you have to have an alert. And we also want you to focus on the objectives. Poor example, if you have an objective with drug drug interactions, that is what you have to do. Even though it is at a high level, it doesn’t mean that you don’t have to have software that completes all of the objectives and that is fundamentally the road map of what we’re trying to accomplish. So that is what we’re saying with the first item.


The second item, pre specificity on Interoperability, we will talk about that in a minute, that is almost saying the last — less is more when it comes to Interoperability. And that is if we want more detail and more specificity and more activity.


The third concept here which is very important is that the current kinds of certifications Tucker should continue to occur as what we call optional certifications that the marketplace might C place value on, and it something that has happened at the last meeting [indiscernible] opportunity to speak with and communicate with Mark Let’s, who is the ICCO of HIT, he says he continues to offer the same kind of comprehensive certification processes that he does offer. And so the extent, the marketplace values that and that is terrific and can still be offered, and it even gets the sense that the process is starting to work, because they seem to indicate a lot of ideas as to who is innovative and how he might be able to do that to respond to various elements of our community.


So that is our first recommendation. The second recommendation really calls out the idea that, fundamentally, certification is like a really powerful tool that we have. It is a really powerful public policy tool and since we have this powerful tool, we should use it to address important public policy issues. That two issues womens’ out here, the first one of course is privacy. And this is an area compared to the meeting last month that we did, provide a little bit more detail and described as a little bit more broadly, but basically what we’re saying, when it comes to privacy issues, privacy relates a lot to policy as to how you do things and how different people interact with each other, but there are also things that the software itself has to do to enable a hospital or physician to implement a policy. And the HHS certified system must have the capability so that a physician or hospital can fulfil all of the requirements of the statute. So everything in HIPPA and everything in ARRA which includes everything like audit trails and consent, and that is like stating the obvious, if the patients don’t have trust in the system, nothing else matters. So this is strong statement and should be a priority for certification. The second issue we will hear more about this afternoon as it relates to changes, but basically we are saying, to aggressively address for Interoperability and data exchange.


Fundamentally I think we all know that the exchange currently doesn’t exist where we want it to be. And it has been some significant work that has gone on in HITSP and the target teams, but it is time to take that into second gear. Fundamentally there needs to be more work done in this area, and we need to go beyond just harmonizing standards. So there is more information in that in the detail.


The third concept is to create these things called test harnesses, which is basically a way for users to test the systems themselves to make sure the systems comply with the standards and perhaps indicate that something did not it accidently broken.


The third recommendation is where there has been I would say it the most interesting feedback in terms of discussion, but what will Racine that we wanted to do was make sure that we create — it is better to say a more objective and transparent process. And basically, there are three comments here, but this should not in any way be viewed as any kind of criticism of CCHIT, but the recommendation that there is a lot of money and people involved and we are raising things to a higher level, so the entire process of monitoring and oversight also has to be raised.


The three concepts here are, the first one is two separate that definition of the certification criteria protesting cockpit criteria and testing process. There should not be one organization that it autonomously can handle both. This is not a shocking recommendation and it actually repeats something to the effect of what is in the legislation of A RRA, and the national coordinator Bill does determine the criteria.


The other concept is to permit and out multiple certification organizations, have some competition. The third is to work with the National Institute of Standards and Technology to establish a national accreditation organization and process.


But want to also say we did take into consideration the comments that are made last month, especially a comment by Neil cowman who said, there is a lot of change in the marketplace and how does this all gets communicated.


That is a very important issue and when you go through the detail on the recommendations, he will see that we did address that by recommending that there be a communications and our rich plan because there is a lot of information here, it is not only a change but information and people need to understand in terms of what it means to be HHS certified, and there has been some suggestions as to how to change that to avoid confusion. Perhaps call it HHS qualified, so that people understand that this is just qualification Corps the incentive payment, but a government seal of approval for the product, to make sure that is very clear.


The fourth recommendation relates to the flexible software resources. Basically right now, purchasers, physicians and hospitals sort of have like a menu of things they can choose from. From a single vendor, or do what is best of breed, get things from multiple vendors were developed concepts themselves, and our concept here was to make sure that the certification process did not alter that Joyce and they still have the same acidification to assist. — same certification choices.


And the common response we heard last month, and particularly that comment from Judy Faulkner to clarify how this will all work, so you have seen this first comment that said, and share all systems are certified against technical criteria, regardless of source. That is basically an argument of level playing field. There can be multiple sources and at vendor and non vendor resources but they all have to be certified against the same criteria. This is a very American statement of the quality.


The second concept, whether it’s this same concept of criteria, there can be flexibility to the actual process is themselves. So again, when you go through the detail, you can see that there are things to make things easier in the open source community, and something called the walk down, which sounds exciting but does not quite live up to its name, to make it easier for the open source people and these are people that are unbelievably enthusiastic about their work. We’re fortunate to have people like that in our community. They love their work and are building on the good work that has been done in that the Virginia, so we want to make sure they can participate in this process.


The third process is the process we call the component of the system. The idea here is that it should be possible for a purchaser to obtain systems and not have to buy it all from one source. So if you have a vendor or hospital or someone that has a special emergency department system that you really like, you can buy that or buy everything else or develop one section yourself and advise things from someplace else, the schedule a way to do that, as long as you still follow the principle that everything has to be — you have to meet all the criteria and get the different components from various sources.


So that is the fourth recommendation.


The fifth issue relates to the short-term transition, and this is probably the area that is most different, and we have the most amount of additional information from last month, and this is responding to questions that you had, Gail, and Neil, and in of number of other people, and how is this all going to work in schedules of time? You are pulling forward a new process and putting forward the information, and we have a lot to do, how will this all filtered out and how long will it take? And we have a lot more information to address that.


Purse I will take you through the major concepts of what we have here. There are three major concepts that — the first one is a very simple concept which says, to leverage the existing certification work whenever possible. The issue here is, you look at all the meaningful use objectives and a fair percentage of that, there is already certification criteria written for that. So if there is already certification written for that, the concept is, why not use it? White reinvented when there is something you can use?


The second concept is in a little more tricky to explain because first you have to understand what is the HHS certification.


That just qualifies you for the incentive payments. So now we are introducing the concept that we call preliminary HHS certification. Well, the way to explain this is, fundamentally, you can’t be certified, software can be certified until we know for sure what meaningful use is. But we don’t know for sure what meaningful use is until it passes through this whole regulatory process, and we don’t know how long that will take, but taking a guess, it will be early 2010 before that gets done.


So rather than just wait until that happens, the suggestion is to establish something called preliminary certification. It is based on the assumption of vendors willing to take a gamble and take a reasonable risk that has been proposed to the regulatory process is probably pretty close to what will come out the other side. It is hard to know if it is 90% or 95% or 98%, but presumably or hopefully it is pretty close, and the suggestion is Penders should prepare their software — vendors should prepare their software and we should begin certifying against those and recall that preliminary certification, which does not have any standing in the statute. But the process of doing that — the purpose is, hopefully there will only be small adjustments needed, there will be some adjustment but that will just be a small additional piece that we can attack on. So as rapidly as the regulatory process is done, we are in a position to have HHS certified or qualified products in the marketplace. So that is the preliminary certification, the second concept.


The third concept, and if you have two in Hale to make sure you understand this, we’re talking about the 2,008 certification Jack criteria.


The best way I could describe that is, there are a lot of vendors that it all lot of work and get them certified against the 2008 criteria from CCHIT. So those vendors will say, I did all this work and I already got certified and I don’t want to have to do that all over again. It is not fair.


Our answer to that is, we will not make you do that. So the concept is, to the extent that the 2008 stratification applied to say, half or three-quarters or some percentage of meaningful use, that part doesn’t have to be repeated and it just has to certify to the parts they haven’t done yet, kind of like the Gap certification.


So those are the three basic concepts. If you go through the appendix, there is much more detail. And if you read it through the appendix, you have to understand that to do this, we have to get the actual criteria from the CCHIT. We have to go through a whole process with the standards committee reviews the criteria and in the detail, our work group is adjusted to see if we could get CCHIT to submit a proposal by September, and I have to tell you that were extremely pleased by the way that marked Levitt and CCHIT responded to this. But could not have been more diligent and helpful and they have actually completed that work.


In the emails that you all received it yesterday afternoon, there is a complete detailed analysis of all of the meaningful use objectives and measurements mapped back to the 2008 CCHIT certification process indication where there are gaps. And so we now have proposals on how to fill those gaps, he and a rating of the intensity of the cap, so we now have all of the details we need to put this preliminary plan in place. That detail then, the hope is, that can be submitted to the standards committee next week, I understand at a meeting on August 20th, and through the month of August and September we can go to the comments and public reaction as we need to finalize that criteria so that starting in October, we can be any place starting to do testing for preliminary HHS certification, which is very exciting.


So to try to summarize this, because this was a lot of detail and a lot of words, we’re looking at a news certification process. I could describe it as outcomes oriented, it is into meaningful use, it has a lot of focus on privacy and Interoperability, and we have a detailed plan and what we are asking for from the IT policy committee is for your approval today from these detailed recommendations, because if we could have these detailed recommendations approved and started on the process, I think — meaningful use is going clarity on how the software products could be certified.


So that is our presentation. Do we have comments or questions?


I would like to thank Paul and Mike and other members of the certification adoption group, and this goes for all of our members and all of our working groups. There is no way that wicked by the kind of incredible effort and clarity of thought and commitment that all of these working group members have shown. And the wisdom the have brought. So it has been remarkable 4V has a new public servant to see how much public service is provided by the public and it is very gratifying. So thank you, on behalf of the committee.


Any thoughts or comments? And I am sure that you were reminded that this committee is a body that provides advice to the national coordinator, but not to the policy committee.


That was a great presentation. I have a couple of questions. One, I wanted to make sure that I understand — I wouldn’t call in a [indiscernible] qualification for privacy and security. It sounded like you said you’re not looking presents to the policy-making but instead of looking to certify but I would refer two as the function of this necessary for the technology to be able to implement some of these legal changes. It is just that sometimes people talk about what they will survive for privacy and security and for many folks that have been much more extended [indiscernible] possible to do that when you are looking at functionality and technology, and that is what I thought I heard but I am looking to be validated.


That is what I intended. You said it much better than I could have. But that is what I intended.


Okay. By second question, with respect to — I haven’t had a chance to look at the work that Doctor Leavitt’s said in or he listed the criteria that CCHIT has already developed in the nucleus, but I am wondering if they meet this sort of overarching recommendations that you all set forth which was a high level with respect to the standards so they’re not dictating our particular way that something gets undressed except more specificity with respect to Interoperability, so we know we have criteria that will facilitate the exchange of data.


I am not a technologist, saw the cat these criteria and some of them look fairly general and some look for the specific and so I am wondering if that is something that will need to be assessed, because personally I agree, you don’t want to have the criteria be so specific that they are hardwiring in a particular approach to addressing an issue unless it needs to happen to facilitate the Interoperability and the ability to exchange data, it wasn’t necessarily a specific set of instructions that went to CCHIT under the old regime, so I am just curious if this criteria has been evaluated under that new standard.


I think CCHIT had what they had which was the it meaningful use Beatrix and at their current process, and trying to understand how the two align to.


As I went through it, I thought some of them are kind of detailed more so to the extent [indiscernible] and I think they have been doing an excellent job.


Great. It wasn’t meant to be a normative comment about the work in the past but how the list of criteria that they have that has been identified as meaningful yes, to what extent do they meet this additional recommendation you are making today with a higher level with respect to some criteria and more specificity with respect to others.


Gail?


In looking at HH S specification, will that be done specifically by them and do they have the manpower to do it or set the specific criteria, and if you have to be HHS certified, all that be the definition of HHS certification.


To meet certification requirements, if you are already CCHIT and you get a gaps and dedication, do you need an HHS certification? Also, is N IS T going to be the accrediting body for the other survivors?


I think that was more than one question but I will do my best with it. If I leave something out, I suspect he will remind me.


First, on the issue of N IS T, they will not be the accreditation, because they do not do that. They will be working with ONC to identify and accreditation organization, and to also establish what a good process is for monitoring and surveillance, and that is how that should work.


The other one, to go back to what this means to the HHS certified, but probably will happen is, we — someone will come up with a different name for that or a better way to name it, but if you look at the definition, that is simply limited to what a hospital or physician needs to do in order to receive the incentive payments. In other words, they have to have a certified System test have to demonstrate meaningful use, so they have two either purchase out or get certified that they have it. That is the purpose for this certification.


And he asked about the CCHIT certification, that is one of those, one of those is the start exception. And that is one of those things that is too complicated to understand how it all works. But if you read through it, one of the things we talked about which is set in consultation with the ONC staff, is to be possible and will be possible that there is one of process that does both the age age as certification and also creates a stark exception if that is necessary.


Does that answer most of your questions?


I specifically wanted clarification as to what the process would be.


He would have to meet HHS certification if CCHIT continues to be the certifying body. You still have to have a certified product. You have to have a test certification, so you have to have two levels.


You only have to have one. You don’t have to have anything if you don’t want to. But if you want to sell a product or you want to attain the incentive payments, you have to have one. The idea of the optional CCHIT acidification is, if the vendors to stew, they can continue to do that. It is optional, almost like having a merit badge or a ribbon or a credential that is added to that vendors marketing campaign, this is something that they have achieved. But this is an optional thing, but to get the incentive you only need to do this one thing.


So the HHS certification would basically take the place of the CCHIT certification?


I don’t want to say takes the place, but the CCHIT will continue to offer what they call comprehensive certifications, and that is there choice to do that, and that will continue to happen. The HHS certification is something that is required to get the incentive payments, so it doesn’t necessarily replace it, and certainly no intention to replace it in terms of the marketplace and the value of it.


And is HHS going to delegate that out or are they going to accredit bodies to do that or how do you envision the process happening, and does HHS have the ability to do that at this point? Do they have the money and the allocation to make that happen?


Well, okay, I will try to do my best at some of these questions.


With all of the ONC people in the audience please stand up to ensure it them that we have the staff?


For those of you listening and there are about 400 people standing up behind me. [laughter]


It basically, what we envision happening during the transition period is that, once the criteria is approved by the standards committee, and the very issue that you raised as to be addressed to make sure [indiscernible] CCHIT offering this preliminary certification in October, and once the regulatory process is completed, but in addition, happening is, the national coordinator, we will do whatever the national coordinator does to say that preliminary certifications are now final, that that is how it all works.


On the issue of until we get the accreditation certification in place, we are hoping that will happen. Once the organization is in place, the accreditation organization will monitor the process and the criteria will probably go through some evolution, but there will be one or more acidification and organizations like CCHIT that will continue to do all of the work, and the national coordinator will somehow do whatever paperwork or processed — I have this picture that you have some giant stamp and a stamp it down really hard and it says approved on it or something, that is the process. You ask questions about having the money or the people power to do that, and I have to defer to them. I don’t know that, it doesn’t seem like they have a ton of people over there but I then know.


Judy and then Neil.


This is a quick question. Sometimes when I [indiscernible] — actual topics of meaningful use for much broader and deeper than the measurements. Are we talking about essentially study protest?


That is a good question. The certification process can’t just be on the measurements, it has to be on the measurement. And we can’t have a system where someone just as a spreadsheet and it tells you the percentage of of people that do that CBOT and the reason that measurement exist so that the objectives are a current.


So could there be a their mission of storm in that say, let’s look for this as well?


That is not our issue. I mean, we put together a framework for doing this and if the measurements changed, and we did the right job and found the objectives, it should be possible to change the objectives without a huge amount of effort, but that is an issue for the prior work group.


Or any grouping tested that has a few [indiscernible] just check the depth and breadth rather than just the specific report or other issue being examined?


That is not our work group but I think it is a good suggestion. The second question is can a worker panel that, there is some complex complexity in there as to how they handle the mission of process.


[indiscernible] considerations. That is a good answer.


Purse I wanted to say thanks for focusing on the privacy and security issues and also the educational issue which I think it’s incredible.


And then I wanted to ask whether or not you have considered the idea of the accrediting agencies that will allow to [indiscernible] this marketplace. Because I still feel enormous confusion about what will be created by this process.


Imagine that in have the CCHIT group that will have a gap process in place, but meanwhile we will have new organizations coming up, and will get into the accreditation business.


So they create processes used to certify the HHS certified process, and there could be five or seven or 10 of these, if we could say if any of these could show that there were able to certify and electronics [indiscernible] and up with a lot of these and a lot of them could develop HHS plus products. So just like a feature that will have basic HHS model and that they have the wraparound and all these other organizations could have multiple levels of certifications, organization A could come out with the five levels certification program or like an Nancy QA did with medical Holmes, three levels of certification. We just have to be careful because we are dealing with a market place and we’re trying to drive adoption and trying to get people to get this to an understandable process as possible, and making sure that we simplify this will be an important.


So one thought would be to limit the number is, it not just CCHIT but no more than three. And I don’t even know what the process would be to make that happen. There would only be three and they would be contacted to do this process or it could be completely open marketplace and there could be 10 or 12 different accrediting agencies popping up all over and all of them being accredited to satisfy EHR that they meet the HHS criteria.


We actually did not talk about limiting the number of accrediting organizations and that is something that ONC took the cat as they go through the process.


We saw that NIST as the organization that would follow this through and determine who could be the CCHIT type organizations or the accrediting were acidifying organizations.


It might be a bad analogy, but you could get your car, and inspection done at any number of crashes if they have defined what that car has to pass. Whether it is emissions or breaks or what it might be. The secretary is well defined, it seems to me that it could be a broader range of people and that is specifically what we focused on the criteria, it needs to be identical and very specific. But we did not talk about limiting it at this point.


Just a quick follow-up. I think the car analogy is a good one but it probably oversimplifies. I think what the process is for this other stuff, people will understand whether or not their headlight is out at better than the understand whether EHR meets criteria.


I think the other thing we need to be careful of is that there is a good flows through this process so it does become a roadblock for people, and as this process gets rolled up into organizations are gearing up, we need to make sure that we balance that. Those are my comments.


Actually, those comments are excellent. I just wanted to tell you, as we did this work, the certification thing is not easy to do. I understand your fear and concern the your racing, but I have a concern that maybe no one else will really want to do it when they realize how hard it is to do. So it is very hard to do to how that — two know how that happens. And whether it is one, or two or 10, that they do their jobs right. That is the role of the accreditation organizations based on guidance that they get from ONC and also from NIST. There’s certainly some risks and it is hard to know how they will work out.


David, can I ask a question? Is the office of the national coordinator point to be the one responsible for organizing the educational process around this and outreach or does that go somewhere else?


Everything is in process but yes, we take it as responsibility to educate our partners in this and we are thinking actively about how to do that right now.


By way of perspective, there is another fairly complicated product that gets certified and that is called the medical education. So we have a single accreditation for medical schools and it is run by the W. AMC like the medical organization and it is not clear, and maybe this body could give us more thought, on how the national coordinator would set a limit and at what the optimal limit would be and how it that will rule — A federal rule would justify it one number as opposed to another number. It is to the right number for it is 20 or 50?


That is like with medical schools, the answer was one, that was the right number. So maybe one is the right number.


The difference between that accrediting organization [speaker/audio faint and unclear].


So thank you for the presentation. As I’ve looked through the criteria, the of this is you can see in privacy and security, and there are about 35 of those listed, there are only about five in Interoperability. And as the meaningful work group gets back together two look at 2015 and 2013, we might have [indiscernible] in the group to make it more clear for you because you say here, aggressively established new and very specific requirements. Have we given you enough detail in the meaningful use Interoperability?


It depends on — is as it relates to the current candidates for criteria, those items are just for that. Candidates and given to you for informational purposes. Those committees do not make any decisions or recommendations on that, it goes to the standards committee. It could very well be that there should be more Interoperability required and put into that certification. And I do think that is it viable observation.


Christine?


My question is about Interoperability and I am wondering if he could talk more about what you mean by Interoperability standards, if we are really focusing on how the that moves and their court standards around the move data purses that content, versus what you put in that moves. I am more concerned about the latter because I think that is how we got down this hole in the first place, but if you could tell me more about what you Edition with Interoperability?


I am talking about standards themselves in the data exchange.


Does that mean the movement or the content? To connect the best way to describe it is the detail, the sick with the data needs to be put in, and where you need to put a piece of information in a stream of data. And the problem right now is that existing standards have too much flexibility and wiggle room and different vendors but different data in different places. And so when you go through two exchange data from one place to another, you have to ask the vendor, where is this piece of information and where can I find it. And the other problem we have is that there is not uniform acceptance, so some just don’t follow what the current standards [indiscernible] and to prepare the Second Company description, [indiscernible] did they do interfaces’ according to the standard because the standard existed? If they use a standard, to they adhere to the standard? And this was like an obstacle to get people to use the system, and this is mechanical process in terms of how it all works. And if I explained it correctly –


Well, our recommendation really stem from the fact that there is such a lack of Interoperability out there in the market, and I don’t think we focus so much on the content of the message or the format of the message, but the fact that we need more focus on whether that be through meaningful use or whatever to improve Interoperability between systems, and I don’t think we really delve into what the actual criteria would be to do that, but just that we would like to see a greater focus in that area.


What we are talking about face on your answers is in the same vein that we have said, sort of a principal for certification needs to be a simple tied two meaningful use, and at the principal level, we need to think about certainly most immediately from a patient perspective, if we could facilitate the movement of data regardless of sort of what the data is at a basic level, but getting that data to follow it. , whether it is at a PDF level, that is enormous. I am worried that people will think about Interoperability but dive down to describing what is on the piece of paper so to speak as opposed two just get the piece of paper to go with me everywhere.


I also think standards will look at the real content that is there and I think we will spend this afternoon talking about the overall HIOs and what they’re doing. That is a great point.


[indiscernible] definition and this may be overly semantic but there is a line that says the system is able to produce a meaningful your results [indiscernible] I think that it is about the interaction between the patient and the clinician producing the results. It might be want to say something that the system is able to support the meaningful use care goals and objectives.


When the talk about the need for years, to talk about pensions and outcomes. And so we say the system will be able to do it and we will say this offer has the ability to do it. It is similar to Devons comment about privacy. If the system has the capability to implement the privacy policy, it doesn’t mean you have the privacy, it just means you have the ability to do it.


And what we’re acidifying, it doesn’t mean? By the product, it automatically get meaningful years, it just means that have a system that would let you do it or whatever it is you do, like CPOE for example. So that is a good point.


Roger, that David and Judy.


Let me die in here for a second, and pardon me for being late. If anything I said it doesn’t go with something you said earlier, just ignore it.


DOD and Virginia at this point have a tremendous amount of experience with the issue of defining what Interoperability means.


We are under a law that requires us to have Interoperability of in our systems by September, and we’re spending an inordinate amount of time trying to figure out [indiscernible]Interoperability. And to have conditions defined that, [indiscernible] provides the conditions within the at the point of service. So I would say, a lesson learned number one, as we define Interoperability, it goes back to what is useful.


And going down the path a little bit, we found on the medical side, for the most part, this ability into what is in the other medical record system it is what is needed. PDF ‘s work pretty good with the exception of certain things like that data and pharmacy information and things that we have demonstrated, if you have a computer perform, you can save lives.


So from that standpoint, I would encourage it, and certainly, we can then call the help and expertise we have learned over the last 10 years and doing [indiscernible] with things need to be compatible and what things need to be compatible, and we go back to having declensions commuting [indiscernible] that we have made along the path.


[indiscernible] we would concur complete the going down that road and it is the end of September, not the beginning of September. [laughter]


We will just note, that is September 30 second.


Are we back in the year of Y2K?


I think we should be sober that this is a policy that we are undertaking and your IT advising that we put in place durable long-term mechanisms that will effectively affect the market. So the effect of the private rule in certification [indiscernible] atoll slippers that support your taking, but the questions that others have raised about where the level of specificity should be that comes out of it federal process as opposed to the specificity that may be generated through market behavior of different functions is a very sensitive Maystadt, measure, and Christine’s added to the committee is the same as what I edited myself. And a suggestion of what we want to do police in his callboy back to the beginning and write some kind of a short document out of the ONC process that lays out, what is the policy structure that we are advocating, now that we have of auditor as best we can, and in terms of whether it is supportive, the word here is produced. I think the minute please mechanism is a good way to address outcomes, but certification probably isn’t a lot comes oriented process, and I think whenever the right answer is, we have to be more precise as we finish or the states of our sitting [indiscernible] and I appreciate that subcommittees’ conservatism. In saying the privacy and security Interoperability are the domain of the roll, but an outcomes oriented approach says, [indiscernible] that the growth public process level. The market will continue to innovate ways to achieve the desired outcome, so I would assess all the caution in terms of our process but also a request that we come full circle their lease in and write down the policy profession that has evolved from his profession.


And David, do you feel that the policies as they happen now formulated are reasonable place to start from that discussion?


I appreciate them very much. I do have some interest in what we in that meeting by aggressive specifications of Interoperability. So that three times I think we have seen enough package [indiscernible] appropriate and important but very unspecified as to what that means, so I think that is one reaction is. [indiscernible] Interoperability is the place to have to give a lot of attention in a crosscutting way. It is not actually silo in these different subcommittee, is a crosscutting challenge that we have to.


Judy? [speaker/audio faint and unclear]


Suggestion will be taken under consideration. [laughter]


When we are certifying and we look at what the system will let you do, but we look at different software, a different reading bodies look at software, some of them look at what the software will do and some of them will look at whether anyone can use it that way. Those are two different levels, and just to throw out that all those the certification may show that the software can do it, you might find that that particular piece of software is never used that way because it is really not able to do it well enough. So I am just throwing that out as a thought that a higher level sometimes, we should look back on, not only can we do it, but it is it being used?


That is an excellent comment. Within that comment, I would make two observations. What is that when we go through the detail and recommendations number one, there is a recommendation that ONC possibly evaluate the use of these systems. It is not something we felt we could address right now, that [indiscernible] an issue, but it also makes the observation [indiscernible] presumably the it measurement indicates whether or not the soccer Billy is able to do whatever it does. Or whatever it is supposed to do. And [indiscernible] that could be the effect that someone has already been able to.


We have Charles Kennedy on the phone would like to ask a question.


This is just a follow-up comment on I think it was it David Plante’s? ‘S comment regarding Interoperability. We are talking about this notion of modular certification which by definition increases our dependency on Interoperability as well as older ability also.


During the said community we received testimony that to CCHIT certified applications from leading vendors were not able to be made to enter operate despite a significant amount of resources and motivation, etc. So just to kind of follow-up on David’s comment, I think that we need to kind of address Interoperability in a bit more of a broader way. I don’t think PDF are a good technical foundation for us moving forward. And I think this notion of data liquidity or being able to separate the data from the application from the algorithms is something we need to take a closer and more focused look at.


I think that we are discussing issues that we will probably be getting to this afternoon in more detail.


I would also recall for everyone that we are not recommending a process that will be fixed in time, or one that can presumably be change over time. Something that we might consider Interoperability in 2011 might not be considered Interoperability in 2013.


I would like to say that if we do that, with concrete blockages in getting to that involved stayed.


Yes, thank you, David. And thank you for your report. A lot like to follow up on the comment that was just made an originally introduced by Roger. That view commutable options, and encourage us to keep in addition, the science of Health and Benson, etc., and our ability to lead to measure criteria and that will be capable of moving target and that as indications for what we will then consider acceptable and fuel and of course, we are then in power to accommodate more computable data.


That is a good point.


David?


I just wanted to go back on the Thoughts on the certification piece. I think this also falls upon David’s point about the policy issues.


What we have really been talking about are the policies that are with people wanting to get incentive payments, but I am wondering what protections there are for a consumer that would go to the health-care provider that has chosen not to [indiscernible]. And no privacy and security. And I think that there is an educational piece, as long as we are only talking about incentive payments, we have two problems. One is we are only talking about policies that apply to people, but one is an incentive payments and the second is that our incentive payment system is going to expire in four years, and then absent any new legislation that comes on the road that fills this gap, we end up in sort of a free-for-all where people aren’t really protected in any way from being engaged in some sort of inoperable systems that don’t meet that requirement.


So we have a no problem a future problem, and I am wondering what our thoughts are about those, or if we have had any yet. Maybe we need to have some.


Just a matter of fact, there is a penalty clause that goes into effect in 2015. Two the extent of financial effects actually extends until 2018.


Gail?


As kind of a closing comment, I know we have kind of beaten this hoarse of little bit but the closing comments are likely to make is, what are the realistic time frame is to achieve all of that? Can we realistically expect HHS to come up with a HHS certification? Do we have the dollars to implement that? Are the rules and regulations going to be written so that the vendor can be out there in 2010 or 2010.5 at have a product that people will be able to buy an opponent into their facilities and practices for their incentive payments in 2011, is this attainable?


Well, there is a group that enables vendors to be certified. But hold us back right now is waiting for the regulatory process to get completed.


However, there are specialties that don’t have certified software out there specific to them, and that presents a real problem for a lot a specialties who want to get into this, and there is not a product to by even with cap certification, will there be a product for them to buy?


The answer is yes. The product to by will be the basic capabilities for things like drug-drug in interaction and CPOE, but whether or not their thing specific to their specialty, I can’t answer that. That is things drawn by that many fleas criteria, and then say, that is what we need to do. This morning I got the impression that the meaningful use group will start to address issues related to specialties and I think how the people his group addresses that Will Drive the specification process — certification process and that is how I live in this in that occurring.


Gail, I think with the preliminary certification we put out there, it gives you a lot of good material. And being from an organization where we develop our own software and we are certified and we have to get there, it is not that big of a talent to take what we understand today and align it and understand what we have to do to be certified. I think the plan is doable, now I cannot answer whether those types of answers but I think the process we are recommending is doable.


Rick?


As a member of the Committee, the only thing I wanted to keep reminding our group of is, our intent is not to endorse any specific criteria that CCHIT has in place today, but rather two talk policy wide about how we might go about this about how we have made the criteria and how we have recommended that ONC be the final authority via the it –


To determine if Secretary was appropriate, and for TLS and this process to be — for ONC and this process to be specifically on Interoperability, we are saying that once we understand more about what health information exchange [indiscernible] is, that more of the standards committee — we are recommending that the standards committee be more specific in the area of the durability of both on how the technical interconnectivity and the content, but once they have been more informed by this discussion. And what we are more over asking is, something we could oversee with NIST assistance seeking a net creditor of desert fires that would ensure a level playing field and a consistent application of the criteria.


Now the criticism that we received that is spent a lot of time talking about was, it will take awhile before we can get to that point, so can we get those that have participated in the process may be a make up to get started towards what will eventually be bought only one certification regardless of the transition certification. Only the HHS certification when it is available to be applied.


Meanwhile we will get as close to is is as we can — if people that do have systems available to cover their [indiscernible] to get the aggressive timeframe, realizing that some people and hopefully the marketplace will respond to that opportunity to the specialties that do not have systems to choose from. I hoped adds some clarification.


Christine?


I have a couple things building of that, and one of thing is an influence and Policy at large at all is recognized [indiscernible] [indiscernible] taking greats the rights. I think it is not okay to hold up the entire process because we can’t get there right now for every single specialty. I think you’re right that the market is evolving and will keep evolving, but I also wanted to note that I will probably have 10,000 emails after I say that, but this is okay. I think that specialists and primary-care practitioners operate in a different payment inverted. They’re is a broader pemmican permit in play here that does tend to report specialists in a different way than primary care physicians and that is why the high-tech legislation prioritize precarious Eighty Matt providers and those who serve the underserved and technical assistance element of a lot. So I think we have to keep accelerating the progress that we’re making to drive a market and support adoption by those particularly those provider operations we have, we have to — have the hearing and I think we’re getting there that I’ve wanted to caution that I don’t think we should slow down just because we can’t get two every population was a population.


Paul?


Maybe two build in some of the previous messages, everyone has recognized it has been an extremely fast time line. And also like to observe just as this work has done that all the workers have been very responsive and I think two both public comment and comments within this committee. And to address some of the comments you made, Gail, I think some of the things that came out of the meaningful use recommendations is to use and adoption year to try to help with the time pressures that all of the industry will freeze.


Another point is to reiterate what George said this morning which is, that many police criteria is under abolition. So for example 2013 and 2015 are being discussed now and built into the process is after the final rule comes out to sort of finally reassess with that industry is, in other words, the program is not baked in concrete, it is something that will responded not only to the comments but what happens to the industry, because we’re trying to get things out and use meaningfully and we will try to adjust the program to achieve those overriding objectives.


If I could just draw people’s attention back to the comments that deal made about the transitional period, I think that is where you focused a lot of your attention. Make sure this market continues to function while we are waiting for the federal government to go through a rule making process?


I would like to know, and I think the working group has given as a very thoughtful potential solution. I can’t tell you whether it is workable or not, because I am not a lawyer, but I would go through the scrutiny of the Federal Council P.C. if the federal government could do what it to us to do what was suggested. But that is — let’s leave that aside for the moment.


Do you see, Gail, and in particular problems with the suggestions that have been made as far as the Gap or enter certification approach? And does this meet the short-term needs that you have identified?


I think that is absolutely necessary to have a short-term solution. I think that solution has got to address just a minute please criteria, whether you call it an HHS certification or whatever come so that individuals out there that have a stand-alone home grown system wherever can become part of this estimate that very specific criteria.


My very deep concern is, we are not going to be able to do that given the regulatory process.


First of all, who will HHS ONC going to certify to the credit to fortuity that? They will have to stop what they’re doing and focus on that because every system out there and lots of other systems who want to get on board are going to have to go through that process. So there is a whole process that Purse of all, the regulations have to be written to do, and then you have to have the body to do it, and there will be a huge up surge in the market, and I think that is great. And then there is the whole decision making process that people have to see what the market has for sale, gather the resources to buy it, and then implemented. Is the tenable to do this and have those products in place in 2011? So those regulations and it back gap certification needs to be as specific and simple which is contradictory perhaps but the process of getting their needs to happen very rapidly. And if HHS is the a creditor at that point to CCHIT or whoever, that needs to be established, that they are doing that and they have two realize that the rest of the market will stop until that happens.


And vendors out there, smaller vendors in particular will have deep concerns about that I would think.


Any other comments?


Are there any particular aspects of these recommendations that people would like to change or amend or qualify? We hear several general comments, the need for a definition of Interoperability, the need for a policy context. And details concern, is not ill advised about the transitional process — the ability to execute on the transitional process. We can note all of this, but perhaps Daniels suggestion to limit to the number of the creditors, I haven’t heard any specific suggestions about changes in the recommendations that were presented to us.


There was the one suggested change for the definition of certification by Christine and David, there was change that I heard.


Could we repeat that just so we are all aware of what it is?


[speaker/audio faint and unclear] able to support the meaningful used supports [indiscernible].


But I thought I heard this system would have the capability to achieve — [indiscernible] interaction.


To support.


So you would change the word system?


No, produce.


So it would like it to agreed, HHS certification means that a system — he is able to support the minimum.


I have an issue with support. Support does not — it isn’t the correct word. It doesn’t give the impact ad achieve meaningful use. Do you want the achievement of meaningful use? Support Team is very different than achieving.


Just to be clear, I think my point Gale is, it is not the system that achieves it, it is the provider clinician patient, and that is all I am reacting two, to say that the system might support the results but the result should come from the clinician and patient working together with the system. To get to the results.


I’m sorry two word Smith and subjective compromise but what we’re saying is the system should be able to stop support the achievement of the monopoly is that the government expects.


In very simple terms what we were trying to imply is that the system could do it.


Whether or not you did it is up to you, but the system can do it. So whatever you want to do that –


Yes, he made a comment to answer, the first activity in the public’s and federal government and also my first one, and I do understand that these documents have been portents and people read them very carefully, but picking up on what Mark says, our intention was to say that the software was capable and that it was capable of producing [indiscernible] capable of achieving.


Capable of achieving. [indiscernible] [indiscernible] government security and Interoperability. And the second produces meaningful results, that doesn’t limit that to the first three categories, or subsets if you like, of meaningful use. My concern here is that I doubt that the subcommittee has recommended that we address the certification of the sub functional capacities to address all of the meaningful his criteria. That is, we’re not recommending the government certify the ability to report in [indiscernible] one C 80% as a particular use criteria. So without doing the wordsmith in here –


Everything but the present we would want to certify.


Well what is different on this statement about security Interoperability is, what I would like to clarify here is that the charge to the certification of [indiscernible] marks point does address all of the meaningful use the objectives — and [indiscernible] Interoperability is one pot, and meaningful use is the second thought and those are the two things that the system has to be capable of doing.


So did we have agreement on language at set of system?


Jody, did the write-down [indiscernible] — the second phrase, the system is capable of achieving the meaningful his results.


I think Roger’s language was, support the achievement.


Okay. I have both written down.


Without amendment, and being able to support the achievement, without other comments, and like to move that the committee to accept the recommendations of the working group specifications.


I apologize, but the best phrase it, the — the systems don’t achieve, but the people do, it is the same kind of point.


I think the language is, is it able to support the achievement.


[indiscernible] cell without objection, the committee will adopt those recommendations.


Very good work.


We are actually running a little ahead of schedule, and what I would suggest is that we start our break early, and come back earlier, because I am sure that everyone but like to work late into the Friday afternoon, but, I am not going to let us fall prey to that desire. [laughter]


So assuming that lunches 30 minutes? So we will be back here at 12:15.


(The HIT Committee Meeting is now on a 30 minute break, and will resume at approximately 12:15 p.m.)


Ladies and gentlemen, can we reconvene? Sorry we are running a little late.


So we have another in our group of work groups. And this is — every one of these issues is really hard. Every one of them takes us to the edge of what we know and sets up and lets us peer into the future, and requires that people leave their comfort zones and think about a future state that is full of uncertainty. All that we can expect in that context is that people think hard and carefully and give us their best device. There is no question that all of the working groups have been doing that, and the federal government and the American people are deeply indebted to them. So Devon and Micki you reported to us last time and we are looking forward to your report.


Thank you to the committee. Let me begin by thanking the work group who have been working very hard and I want to give a special thanks to my co-chair, Devon, who managed a difficult process. Some tight time constraints while I was traipsing around, Montana on two weeks’ vacation. So let me give a special thanks to Devon for managing that.


I am going next week [ laughter ]


So this is the work group and as I said I would like to thank all of the members who have been hard at work helping us go through some of these issues. Let me begin by telling us what our recommendations are going to be and I will do it quickly to orient us. Then what I would do is walk through some considerations that we made and then handed over to Devon who will go into detail. We have four recommendations. Number one is that there ought to be helped exchange requirements related to meaningful use that require health exchange. So that is number one. The Number two, we believe that there is a core set of requirements that they need to meet in the areas of interoperability, privacy and security which is consistent with what you heard from Paul and Mark’s Group. We believe that that would be the case. We believe that there ought to be a certification of interoperability components to demonstrate that the air meeting those requirements. So that would be EHRs as well as introducing the possibility of other products that can meet the interoperability requirements. Fourth we believe very strongly that we need to have alignment from the federal and state requirements. Generally this would be true around meaningful use and specifically are around Health Information Exchange and on the federal level and have state Medicaid requirements that are not in conflict with that. So those are the four recommendations. Let me walk through some of the background and considerations that we made all along the way and then I will turn it over to Devon to elaborate on those.


First, thinking about the state of health information Exchange today, health information exchange occurs in the market today. But penetration is extremely low and not uniform. I think we covered that last time so unless there are any questions I will not be labor the point except to reiterate that it does, indeed, happen today and that we are making slow progress but it is slow progress. And even where it happens the most like e-prescribing, the penetration nationally is 4% of prescriptions, 4% of eligible prescriptions from roughly 12% of for scribers, potential subscribers as.


Just to make one exception that is outside the federal marketplace.


Absolutely.


They are vastly different between the federal organizations at this point.


Yeah. I would not disagree with that. So what are the barriers preventing the market moving to work with health Exchange? The main barriers, and these are not in any priority here. There are certainly uncertainties under legal and liability issues there are a lot of things to figure out with respect to privacy, security and things like that that makes a significant barrier. And too little business in clinical. To exchange more information. There does not seem to be enough at the point of purchase for those that have to conduct health exchange to go through the pain and doing it and on the benefit side, too much difficulty of setting it up and maintaining the electronic exchange related to standards, certification, and a wide Friday of things that we talked about — a wide Friday of things that we talked about so it will be some combination of incentives and penalties and a set of action will standards which is a somewhat aligned with what we talked about earlier with standards on interoperability and one entry in the mechanisms. We have not talked that much today about because I think that is probably something we need to give further consideration to. But I think an ongoing concern that I would have is that standards are not enough around things like — you can have standards and certification that the end of the day to be able to monitor the those transactions are happening according to the standards in a routine way is fundamental to that happening being able to in this Chamber of the workflow on a date today basis — in the stream of the work flow on a day-to-day basis is fundamental could I would point to administrative actions and forced by Medicare they get millions and millions of these transactions and they will report any code in violation of the standard qualification. Take a look at lab results delivery which most happen to from community hospitals. There is no entity in the stream from a community hospital to a physician. How would we know that that is something that a HL7 transaction was modified in some way to accommodate some unique local need and to monitor and enforce something going forward. That is a big concern. As I said, we will not cover that here [ laughter ] a huge, important concern [ laughter ]


So this leads us to the point if implemented judiciously we at the work group believe our funding can health create a proposition for health exchange. And how do we get a value proposition that is the only about the requirements and some comments earlier are fundamental here as well that we do not want to have a system where people are doing things just for the time period that they are getting an incentive and only the ones with a particular incentive are doing it. We want to create something that is more fundamental and foundational that will have the entire market move towards the types of things that we’re talking about here. So some combination of Laureen the technical organization or legal costs or leave in the clinical and business imperatives for more exchange is what we would see as the orchestration of some of the things that we could provide to the federal government to be able to accomplish here. And in looking at that cost an average, source of the right now, we would argue that there are too many institutions that see the cost out and the benefits there which is why we have not moved forward for many of those institutions. When you think about the levels available to the federal government and things like certification and funding and in government are all examples that can lower health exchange and lower the cost of being able to exchange grid and the other hand the incentive payments for meaningful use and ARRA are the opportunities to raise the Business imperative. Because it’s a business need or also because of the opportunity of the real incentive coming from someone who has been paid a substantial amount of money to do what we’re talking about here.


So of these tools that we just talked about, it’s certainly our sense that the meaningful use are the most powerful lever of change certainly in part because of the proportion in the amount of money that we’re talking about here. The incentive category is $45 billion that we are estimated to be a part of HIT spending and the other point is that it directly affects the value proposition at the point of purpose to the extent that they are applied at the position level and you are talking about decision-making at the point of purchase which is the strongest level that you can get.


Obviously ONC does not have the ultimate decisionmaking on incentive criteria but it can create enablers that would allow CMS to create more incentive rules and some of the things that ONC does have discretion over and a strong% of incentives — a strong per cent of incentives in rulemaking.


April look at the speed of great year and decided where the levers are going to be — and if we look at the meaningful use criteria and decided where the levers are going to be. We may have missed one or two here predict and try to, which are those requirements that have helped informational exchange as something that could be fulfilled. As you see when you think about what will happen in 2011, 2013, starting in 2011 there is inappropriate ramp up — an appropriate ramp up and the 2011 requirements are increasing the volume of transactions of the most commonly happen today. The incentives around trying to put more through those pipes that are already essentially there. And once you get to 2013 there is a substantial step up. That is where we talk about a fundamental change in the way that we talk about health care delivery because it seemed that we need to have not only lab to provider but provider to lab and clinical entity to clinical entity and make sure that their records are falling them all the way through. And you could imagine that if we were able to accomplish even subset of that by 2013, we would really change the complexion of health-care delivery. If we were able to accomplish a lot of that from a patient’s perspective they would really see a difference. Finally, 2015 is getting to anyone to anyone. Maybe we have a platform or to the point where you can start to assume that exchange is happening and we want to make it more and more rich. Women think about the work and the Mets ahead for the work — when we think about the work ahead for the work group, the consensus is that the work ahead is about providing policy direction around the requirement for each of these transactions. That is the work ahead. We are dependent on the meaningful use work group to define what those are. And so now for the work ahead is to provide a detailed policy direction and what Christine was alluding to when do we get to those details and how to define the steep hills. That is the work ahead. Obviously we will start with 2011. And you saw Paul and George’s timeline and we will be filing that did so in the third quarter 2011, we will start to focusing in and in addition to privacy and security because those are fundamental and there is a lot of conversation around other aspects of privacy as well as security. So those will start. And then in 2013, the 2015 we will be following the path of the meaningful use for croup and you saw in the fourth quarter of this year and the first quarter of next year is when they will be digging in to provide more specificity among those in be talking on that in that committee.


The final slide before it turned this over to Devon is we kind of walk through what is the state of health information exchange today and what are the barriers and levers available to the government to try to increase demand for health exchange? We will walk through a little bit appalled been sentencing to be the most powerful ones and — a little bit about how these incentives are the most powerful ones and then finally the consideration of how deep do you go? How do we think about the government’s role in the market? You see here is spectrum. We have, of course, we have to make sure its savvy enough to define the extremes so that the recommendation is in the middle there. But there is a spectrum of government intervention. On the left-hand side you would imagine that meaningful use right now does set the floor and that is kind of requiring specific transactions. It is seen by 2013, what you need to exchange among entities and from whom to whom. That hospitals have to send information to physicians and physicians have to send him permission to hospitals and the next point of care. And how far do you want to get into how best to happen? That is what our work group is about to forbid the next step up would be for each of those transactions that are — would be for each of the transactions that are already defined what would be for each of the standard for communication, content, privacy, and security and those are the category of the core requirements. That is will be defined as the categories. You could take another step that they will be about specific technologies or architecture is an organizational forms. For example saying that these transactions, have to have been through a specific HIO or in node would be an example of taking that one step further. There is a sense that the balance that we won two straight here is not to have too little structure because we believe — that we want to strike here is not to have too little structure. On the other hand, the work group feels very strongly that too much structure will absolutely Channel product development and that is exactly what we don’t want to do in the area of technology. So with that as backdrop and sort of thinking of the work group let me turn it over to Devon to elaborate on the recommendations.


Thanks, Micky. I appreciate it.


Micky went over these quickly before and now they are actually in front of you. You will recognize many of them. We started to introduce these when we were before you last month but there were a lot of questions raised at the time. There was a need to go back, continue to think about those, answer the question about how much federal intervention is needed and why and to provide a that a bit more detail to the extent that we could in the time allotted. So here is where we are in here is what we hope the policy committee will endorse today. That is that there need to be core information exchange requirements that are Technology and architecture neutral that will apply to all participants wanting to have at meaningful use with CMS. The core requirements should be focused on the capability to achieve the meaningful use subject to whatever word smithing that we came up with. Capability to achieve meaningful use and include interoperability, privacy, and security. Because we are the exchange workgroup we focused in a little bit more on those but to achieve capability for meaningful use there will have to be other requirements in place, too.


Federal government should certify the electronic health record and held informational exchange component on these core requirements to ease burdens on eligible professionals and hospitals for meeting in demonstrating at hearings with meaningful use requirements. And the last point is that federal and state government approaches should be complementary and any grants to states that come through the grant program and we will get into details about Medicaid they should require alignment with federal meaningful use use and measures and nothing is official until its official click okay. You got it.


Fair enough. So this is a little bit more detail on these recommendations and why we think they make sense. If you are going to set criteria that all systems and components have to meet, and then your doctors and other eligible professionals would have a choice about what Medal of exchange they want to use — what’s motive exchange the want to use so if they want to rely on some form of direct exchange or participate with their local organized exchange, RIO, HIO, HIE or some sort of national network, again, if there are a consistent set of standards that all of the component parts and systems need to meet then that choice will be there and we will not be locking in specific architectures. These would be the same standards applied throughout with respect to some courts Exchange criterium — court exchange criteria. Systems that don’t need to be certified would still have a tremendous market incentive to adopt those standards because they will want to be able to facilitate and exchange data with entities that do have to meet certification as well as — you know, there is a certain limit to where these powerful tools go, the rest of it will follow because they will need to do that. And consistent with the certification work group recommendations came out, it really needs to be tied to the capability to exchange or a cheap or support meaningful use criteria in 2011 — to achieve or support meaningful use criteria and 2011 p when the actual exchange requirement by be minimal in 2011 we talking about granting them up specifically in the near future. The systems will need to have the capability to support that over that period of time. And the core requirements really need to be focused on what is the exchange required to meet many police and that includes privacy and security — to meet meaningful use and that includes privacy and security. And what is really required to make sure that the data can be exchanged? So what do we mean when we say interoperability? People probably have different definitions as to how expansive that definition is. But certainly what we agree on at least at this particular phase is that it’s a basic level of you can call them Transport standards are communications and the package that has to go around the did anyone ever content standards are necessary to ensure that exchange can occur to be capable for meaningful use. Certainly a top priority ought to be the transport piece of this because the idea is if you are going to create technological and architecturally data between point of the care it has actually got to be a priority. Similarly taking a look at the measure definitions and would ever semantics’ standards are going to need to be required for the clinical data that has to go with the reporting required in 2011. Biscuits to the point that Micky made in a much more particular — this gets to the point that Micky made in a much more articulate point, if you set the criteria you have to have the out come and work backwards. What is consistent with transport, this has to be able to move from point A to point B and what circumstances do you needed to be structured is an additional set of issues that the policy committee ought to weigh in on and give guidance so that those can be developed. Before I leave this line, meeting the requirements with respect to privacy and security, those should definitely be a priority and as well as — we did not say this on the slide but I will take the time to say this now and what Dixie refers to as the “ARRA 8″ that have policy implications imbedded within them before we can move toward freer and on the issue of the federal and state interplay, but it’s our feeling that they can enforce state level requirements to establish any state level meaningful use definitions. But any such requirements should be complementary. To qualify for meaningful use, again, information exchange that occurs to me to meet the federal requirements. They should not be allowed to fall below that with respect to their own requirements but with respect to whatever discretion there given by CMS with the Medicaid criteria that is not — that is a discretion that we would support. That is a decision that CMS would make. Our concern is that what ever the states to promulgate that it be consistent at the federal level and that it not be conflicting P we actually made this before you actually suggested that perhaps the federal definitions would create a floor that the state could go above with respect to whatever additional requirements that they will put on the state Medicaid incentive recipients. But certainly not fall below. I forgot about this part. This is very important because we got a lot of feedback from folks who had some confusion about some things that we said about certification and HIOs, and this organized Health Information Network. We wanted to take this opportunity to clarify what our recommendations are with that. We are not recommending a separate certification path away for HIOS with a separate standard. We are recommending as we said and as the certification work group that helped information exchange component be certified — that health information exchange components be certified whether its a component or a collection of components brought together by the provider. So one role that HIOS have paid in the past and may continue to play in the future along with other technologies and other technologies that we cannot imagine but there are probably some folks that are making them up as we speak. That is the ability to provide the components that will actually enable this heterogeneous system that we have that is like a — like the federal government to exchange data.


It might be harder Jen is but it looks awfully homogenous — heterogeneous but it looks awfully homogeneous.


Thank you.


And like all of our presentations this is a model of clarity of thought and expression so thank you very much. Questions or comments?


Once again, a great presentation by your work group and lot of good work on a very challenging area. One point of clarification that I would like to have is given the fact that you have combined the verb and noun definition of health information exchange and stated one set of standards for information exchange to exist and the deliberation between a government role and to a structured versus not, and is it your assumption that every access are triggered to authorize exchange of an individual patient’s records that is given by the patient via HIPAA regulations? What triggers and tells an institution to exchange data? Might implication is that it is from HIPAA, is that your understanding?


The next thing that we will take up are details around privacy and security. I will answer you what is the state of the lot today with patient authorization bill with respect to what HIPAA requires it does not require a patient consent before the data can be disclosed for treatment, payment, and a list of activities called healthcare operations and that is regardless of the format. It is not limited to paper and was promulgated to enable electronic exchange of data for claims payment purposes. Having said that, there are state laws that are not preempted by HIPAA and they require some form of patient consent before the data can be accessed, used, disclosed. Sometimes it’s based on the type of data, sensitive data tends to merit some special treatment. And Of course, at the federal level with respect to federally funded substance of abuse facilities there are specific requirements with that data. It underscores the challenges that we need to consider. Another thing is in addition to the law there are voluntary policies that institutions and some of these networks have established that have to do with building the trust of the patients in their communities. So in number of them, for example, have adopted policies where the patient has to opt in to having their data exchange for the patient has the ability to opt out. There is not a set federal policy along those lines although there was some work done on this in respect to the NHIN grantees. So a long winded answer to say there is a place where the law is today except for the state law requires said petrol law does not require patient consent for each and every movement of data. — federal law does not require patient consent for each and every movement of data critic and as we are increasingly interconnecting these systems in a really robust way. I don’t know if you want to add anything?


I think Deven did a fabulous job. This is an area where I think Deven articulated in this is an area that we have recommended that HHS look at the policies regarding opt in and opt out. It is something that we are planning to take a look at and what hope to talk with the work group about in thinking through some policies.


As a matter of process we are also talking about, starting it after this, privacy will be one of these things that we will dig in Holon and bringing in the lead this state of the work — did –dig in on and we will have public hearings about this that are very spirited.


Also the aspect of your presentation, and how much they can require interoperability and I guess just want to know from the work group standpoint if our work group or your work group will take that on and recommend some how implicit in that will be what triggers and what authorizes an institution or provider to share data with another one?


To recommend federal pre-emption?


You said you were deliberating that and that will have to be harmonized with these privacy laws. The only thing I wanted to make sure is that as we go forward we see what we can address and what has to be in the realm of the other groups to deal with. We do not want to be in conflict with them.


Adam was weeding and then Gayle — was waiting and then Gayle.


Kind of what stuck out to me and first, thank you all for putting this together. This work group out of the three is probably the closest to the patient. It did kind of stick out that patient control — it is in here is a little bit but I don’t think it’s brought out as a unique point spread and when I say patient control I look at that as different from privacy and security. As a look at 2013 and 2015 when we get exchanges with the patient and it may be patient to patient, at least in my opinion we need to start in 2011 in the core requirements getting some recommendations from the work group to the policy committee about what patient control is going to be for their own electronic medical records outside of position to physician — physician to physician and encourage the work group to really think about this one.


Thank you.


Is that a comment about this meaningful use criteria not addressing that or about whether we are dressed how we are going to address the meaningful use criteria?


I think probably the latter.


As I see its, HIE and patient control should go into what meaningful use is. Part of meaningful use should be patient control over this information and I look to the work group to try to develop the policies or recommendations under some of the score requirement.


I am curious but you have actually put your finger on some hot button issues and ones that we will deal with and we would welcome your input.


To you want me to answer that?


Let’s leave it — yeah.


Gayle, trying to get to use.


Yes. I want to go back to the basic issue going back to privacy and security in the patient’s concerns about privacy. I think that is probably the core issue here that we have not talked that much about. I really believe that in the long run in order for us to be successful in what we have here is important that every patient has an electronic health record you have got to in — engage patients and we must hold some public hearings to get down to this core issued and how secure is a patient going to be in that interchange, that exchange of their private information. I think it’s essential that we listen to the public and the patience on this and I have made that recommendation. I hope that you will follow through on this.


Would you go back to the cost and benefit slide? I want to make a specific recommendation about that.


To me, we are always worrying cost and benefits. The opposite side of the privacy security concern is the extent to which consumers see a benefit in the exchange of information. I think in the green bar we ought to have in there the consumer comparative where there is a piece to the exchange that is part of the benefit. I think that is the piece of the benefit that balances the privacy and security. People are worried about privacy and security because we have not told them what the benefits are of this exchange to them and a huge piece of this that I mentioned before is their ability to see everything that is being exchanged and that that information to make sure it’s accurate. I think that the sum of the stuff that Adam was talking about. Is it accurate? Is it relevant to the care? Is it relevant to this individual provider? Can they see everything? There is a lot of complexity around this but I think we should add that into the green part because that is a big part of what we should be pushing in order to move this forward.


Just so you don’t think we are ignoring or neglecting that, this was particularly about what it looked like from the perspective of an individual or practice that is making the determination tomorrow, how much do I want to address in exchange and not about the societal benefits or costs.


When these the value proposition that has a much broader extend. The value proposition of exchange goes beyond that. That is why I think that is relevant. I don’t need to edit the slide, it’s just a point that we do not paid enough attention to one of the things that could beneficially drive this. For example in the database model one of the things that I have been reading about the extent to which the consumer is valued this. They actually provide some of the ongoing business value and contribute to the cost of the continuing exchange. So if we are just looking for the business model of it, one of them would be to sell it to consumers and make it so valuable that people would give a couple dollars a month to have their data securely stored somewhere and have access to it and other pieces. I think this is part of the discussion.


Deven and Micky I want to congratulate you for what I think is a good prioritization of these issues in terms of interoperability, security, and privacy. Because the fact is until we can interoperate, the concerns of around security and privacy are minimized. We are dealing with a one-to-one rather than a one too many situation. And in terms of identifying standards as the key to interoperability in terms of the transport and content. Because until we have meaningful data to share, we have not achieved meaningful use. Again, I think there’s a lot of work that needs to be done and I will point TO roger’s comment earlier this morning in terms of allowing the commission to determine what data is meaningful to them in terms of core needing care and the standards committee as well as the panel to identify specifically what data. As a final comment I will say that your point that one ever interoperability standards are established that they should be architecture neutral and Technology neutral is one that will facilitate adoption and interoperability. It will also complicate governance.


The question that this kind of a concern, a couple of times today we have talked about certified and uncertified Systems. In this we are talking about HIOS and certification including security and privacy cert. My worry in the Information Exchange Network World is right now when we exchange information we have an information exchange agreements. We know what we will exchange and how they will protect it. Now we are wrestling with a lot of our partners issues with getting them to agree to the security constraints that VA must have about our patients. And if you were going to provide information on that night that they will protect it in such a way that you are conveying their responsibilities in that world print so when we talk about uncertified Systems in the health information exchange environment IB, were read to the extent of what can I let go of and what can I not — to the extent of what I can let go of and what I cannot let go of. And if I don’t know everybody is approved to protect the information to the extent that I am required to protect it, I cannot participate.


Here is the thing. We have policy levers that we can apply but we do not have the magic wands that says everybody must be certified. We just don’t spit at a minimum everybody has to comply with the law — but at a minimum everybody has to comply with the law with respect to security requirements in some areas and you all have a certificate security requirements. There is a limit to how far we can get with some about we are recommending because these policy tools to not apply and labs is something that has come up in our discussion. You want the labs to be able to accept the same standards but we are not certified labs. However, all of the providers that want the financial incentives and want to be able to exchange and reseed the Lab Data and move it to another provider when that is appropriate will want them to do it. So someone that will have to be resolved with the piece agreement — some of that will have to be resolved with the debt used agreements and some we can resolve with the law. That is what we were a listing there. We were not suggesting that that is an ideal set of circumstances but a recommendation of limitations.


And maybe as a look at the broader information exchange networks we should make certain that we have standards about what the neb protections have to be agreed to before the network can join.


There are other tools beyond certification.


David and then Judy.


I appreciate the direction that we’re going and pick I took to lessons from what you said today. I think the recognition that no matter what you said, did it will not move until the users want it. And that goes back to the question of the structure that click and stimulate — that we can stimulate which will make things like cert more easier because there is a demand to set standards and achieve goals. And this may not be visible enough to create that goal at the moment. So part of what I think we should take back to our subcommittee is — I like this likely to account the 2011, 2013, 2015 measures that create that draw across the network. Looking at that and perhaps we have not done as much work that we need to in 2013 and 2015 to amplify the signal to the market on the interoperability and the debt exchange issue — and data exchange issue which really call for data sharing across parties. I hope that we can take your report back to our subgroup and think hard about the opportunities there to increase the incentives. And the second thaw along those lines is one opportunity do we have or what does ONC have to communicate to the private paper market a set of signals to amplify that message again. So in California where there is a paper performance system that has — And how do we married the signals on a chart like this to other paper performance systems so that we really get the value out there to everybody to start sharing information with each other for the patients benefit otherwise everything may just washout. The third thing that I want to mention is it’s really just a question to you. How have you thought about the role of your subgroup and us as a whole in communicating to states HIE is strategic direction? I am thinking of it because Paul and I both work in California on the structure of the HIE and the support of the ARRA funding. And a lot of issues that we are wresting with without guidance coming from outside. I don’t know if there’s an opportunity to take some discussions that you have been and propagate them to the state so that they can build whatever they will build in a way which facilitates the fact of the adoption of this overtime.


When you say HIE, do you mean HIOS?


I will not answer that the.


We have adopted our own terminology.


I mean HIE facilitated by HIO.


Since this is an the advisory committee we will be administering state grants and we will be having a couple mechanisms by providing that to states with respect to the grants. So we can take some input and suggestions from you, David since there are some issues that you think we need to bring to the states. We currently have the state alliance e-health and that’s something that we could use as a lever if there is some input from the committee that we think would be valuable to the states to have a forum to bring that issue up.


And two microphones away is Tony from CMS and CMS will be with respect to meaningful use and Medicaid so there are a lot of ears perking up.


Judy?


I have three topics. The first is the incentive money what we’re finding around the country is that it does not matter what the incentive money is. The real barrier is the legal concerns. Our customers are not — who are not jumping on our because the lawyers and other advisers are much more worried about legal. I do not think the money matters as much. I think first we have to get those privacy loss figured out. Because then as long as they know them and can follow them we will be in much better legal sheet. Along with that in the incentives we have to look at what is sustainable over time. If we start up now, they need to be sustainable or we will lose people in the lurch or have huge government funding to sustain thinks things could there are a lot of different technologies out there. It’s not sustainable we have a problem down the road. That was one. Number two is on the states. If what we — if we say what we’re doing now is the floor and states are welcome to add things to the floor if they have contradictory state laws they will have a huge problem with interstate interoperability and we have to be careful about that. The third thing goes to what you were saying, Neil. That the patient’s ability to see the information and decide what is relevant. I know somebody who fiddled with his PHR that he could send and he changed some of his lab values. What does that mean to the position? Will they make bad decisions because that was done? What does withholding and misleading to do that and what does it do to the patient who wants to say, please hide the fact that I have diabetes or MS or congestive heart failure. You have the diagnosis and you can see by the tests what they’re looking for and the results, the men, what do we do with an allergy? And we know that there would be a drug-drug interaction. What do we say? Do we not follow the privacy and let the patient be hurt? So those are in deep questions that go into the patient’s ability to do things and you may jeopardize your care and number two, we may not be able to do it anyway. There is so much that is threaded through out the record. That is a huge issue.


I will say that I am looking for it to the hearing because I think it does touch those things can I also want to come back to what Neil said and reinforced what he said. And also ask that as we go full word with these recommendations, which our trip back that we bring in the perspective of patients and families. which are terrific that we bring in the perspective of patients and families. Having standards apply to all participants, and Barry provider eccentric which is inappropriate. — which is appropriate and we often talk about their pain points in the health-care system and everything is about information and coordination did it was things like I have trouble remembering all of the prescriptions and how do I make sure one doctor knows and we threw at them a number of solutions. And HIT was the one that they most clearly grasp and understood. I think that this was the most interesting for me and when they talk about the information and coronation challenges that they experienced, these patients did not see it as a failure of the system they saw it as a failure of themselves. That is enormous. So when we think about Information Exchange and the patient to be part of the solution, I want to make sure that we are always coming with that perspective. Of course, with all of the privacy and security protections that make it meaningful but that is an important perspective so I just want to be on the soap box here for a minute and remind folks.


We really definitely had that in mind they look more provider centric in the slides because the incentives to not go to the patients, they go to the providers. That is why we were clear that the meaningful use criteria and to the extent that we’re pushing very hard to have its also include that patients loop and prospective. That drives how the criteria can happen because the provider is such big part of that and is the one being paid.


We have done a good job overall to make sure that the patients’ families are centers and that we use the incentives that are dear to our providers as the mechanism to drive patient families engagement and that is critical here.


Selecting Neil and then Rick.


I wanted to mention the pope did one of the things that I have been concerned about is the clinical — the pull and one of the things that I have been concerned about is the clinical data and making use of clinical data and a large portfolio of what could be PDFs and all kinds of fears of rekindling — years of stuff and that view is different than the German pilot is looking at a brash and the cardiologists who is doing — dermatologist looking at a rash in the mechanics of the exchange and how that happens will we have not been caged in the discussion of whose response ability it will be to make useful information. And when I spoke to Judy she said not to put words in your now that the EHR vendors have some irresponsibility to keep — have some responsibility to create intelligence around that. While I think we have been worrying about passing this stuff back and forth I am worried that we will pass this back-and-forth and people will not use it because the extent to which that information, the amount of that information that will be relevant in any given clinical encounter will be small. Somewhere the intelligence has to be built to go through that extreme library of information and make something useful audit. That is one point did I guess the question around that it is who are we contemplating is going to encage in that activity and how much — and how might that have been? Because with clinical and clinical utility and how closely we can get representation of that data for a particular provider. The second point that I want to make is around that state and national model. If we are saying that one of our values that we are subscribing to add a national level is that we are not being technology specific, then I would put into our requirements or I would suggest that CMS put in the requirement that that be brought to the state level. I think to the extent that the state adopts a single model, they are violating our federal guidelines that basically say that we believe multiple models should flourish. So if patients in a particular neighborhood do not think that the exchange in their neighborhood is providing value to them they ought to be able to go outside of that and do whatever they want to do to some health enter into a national exchange of the information that not — to somehow entered into a national exchange of informations. So are we subscribing to that not being prescriptive about the technology as a national policy recommendation and if so I think we need to drive that down to the state couple so we do not end of scene at a national level that we believe that there should be lots of trees is but it’s okay if the state subscribes to only one particular – a lot of choices but it’s okay if the still subscribes to only one particular model and everybody has to be in that model.


I don’t think anything that we recommended would preclude a state from deciding for example, for California deciding that meaningful use around interoperability has to be conducted through this network in our state because that is our state network as long as they met the interoperability requirements that we are talking about.


For Medicaid.


Exactly.


Nothing that we said would preclude that. I think it’s a fair .2 days but we did not specifically preclude that.


I am suggesting that we might want to consider precluding that because it does go against both on the provider side inpatient side a possible trace of wanting that information exchanged three different technology that they feel might be more secure or patient friendly. That is why I brought it up for your consideration.


I want to respond to what you said earlier about what I call the gobbley-gook of information and we will not be able to dictate it down to the extreme level. As it is, far too — we had too few instances of the data moving. So certainly we wanted to make sure some of the possibilities was to allow the data to move. And we ought to be progressing to a system as it evolves and integrates with the positions are getting the data that the need to make the decisions. But the content standard aspect of this is one that I have heard described as holy war. Lots of people have strong opinions about and I think there are some different decisions that will have to be made about when to we need specific content because it can differ and where space are we not ready for that because that would violate our principles to allow for innovation. We did not spend a lot of time talking about standards content because in terms of where the work group was able to get was presented in our presentation today but acknowledging a lot more work has to be done in this area. There is a role for the policy committee to play and a high interest among the members of our workgroup because we had a robust discussion in trying to be more helpful on this issue but I suspect we’re not the only ones.


Okay, Rick?


I would like for a minute to maemac visit the decision — two revisit the decision and the health information exchange in the verb and noun definition and it seems like we have it interchangeably talked about a state health information organization and providers and a mixed the discussion. It seems to me that it is somewhat confusing.


I want to make sure I understand, are you saying that it’s your interpretation that we have combined those? Because we have not been we have broken them be part.


When we say health information exchange, we mean the verb and when we mean a structure we say HIO.


And they do not have a separate certification criteria, is that Ray?


That was to — from our last presentation when people thought that that was what we are suggesting.


I did spot –


You are not the only one don’t worry.


I guess I would just endorse that concept and validate it for you. And my suggestion as we go forth and seek more public comments and segregate the discretion, it might health to clarify some of these questions that we’re hearing. That would be my observation.


I started using “the little v” and “the little n.”


By breaking apart that the recommendation applies to the verb and not the noun, we are not recommending that the Government do that.


Okay Paul and then Roger.


Thank you for the articulate presentation. We have been talking a lot about the technical data exchange standard and certifying the technical exchange components. My question is should we also be considering interoperable policies and be more descriptive? Because you said we will allow direct exchange and Fender — and allow vendor hubs, etc., and if I’m going to join or share my patient stayed out on this exchange, don’t we need to in addition — my patient’s data in this exchange don’t we need to protect the data as it flows around? How can we say, should we join as a provider group? And how safe is it to join if we do not have interoperable policies? Should that be part of the mix? Should we be more descriptive on the policies as part of HIE?


That is certainly worthy of more conversation and we had a conversation in the committee where we started to step to the line is where those came into specific architecture considerations and if you look at that spectrum there was a sense as you start moving there to start to dictate architecture’s so we backed off a little bit. That may warrant a further conversation and we would love your input and others on that.


The other that we talked about is whether certification which looks at technical functionality is the right vehicle for enforcing policy requirements and we came to the conclusion that certification is not a great vehicle for enforcing what should be good policies before networks as a noun to use much less exchange that occurs in a direct way. We do know that there are some other tools that the ONC has to set up some over arching policy and one could be to the grant program and any criteria that they want to establish.


You mean setting policies that are required to be licensed or whenever?


Yes, the analogy would be what Tony said about federal being the floor and if you think about how NHIN would go out and they might be the floor for any HIE.


I think its HIT semantic imperialism we start talking about the reconciliation of policy and making them interoperable we will leave Political science behind.


It may be as they considered the other levers, governance would be when the work group take that up as the area of recommendation.


Did you want to say something else, Paul?


Okay, Roger?


Back to Neil’s comment, I would like to reinforce, Deven, what you were saying with that simple phrase. The scanned image is flowing today between users would be wonderful. I have seen this team doctor for a long time and he has something like this. And one of the things that I think is interesting is that we need to remember that it’s important to separate the data from the presentation. If we do that we need a lot of room for innovation for what they could do exactly to Neil’s point to make that a very useful. So one of the things that we need to remember is what we do will have tremendous impact on a lot of things we have no concept on relative to innovation and mixture in the Mexican that we do not preclude in addition. And from that standpoint to separate the data exchange from the presentation that is there and let innovation flourish from that standpoint.


[ Captioners Transitioning ] Dale?


I wanted to follow that thread and say, that is how that exchange happens and being architectural is very very important whether it is through the Mauna HIOs, we want to make sure whether it is a state entity or individual Rio or hub. Vendor or something like that, I think we want to keep everything as neutral and as open as possible to facilitate as much of that. And as much of that within the system to take place. We don’t want to have a whole bunch of rules set or have the federal government set those rules and be prescriptive, we want to allow open an ovation.


Arthur?


I wanted to follow on to what Paul was mentioning before about these policies that need to exist to ensure an environment of trust for exchange. And you mentioned earlier in the presentation about the work Upper [indiscernible] and I wondered if comment on that. And also, I wondered about certification of Interoperability components, we might say that somewhere along the certification, we have policies that are — maybe the meaningful use group needs to go back and figure out how to ensure that level of trust in one of the measurements they look at, and ensure that the partners within NHK are adhering to that over time.


I hadn’t even thought whether there was room with in a meaningful use to make this happen. But what we did discuss was whether certification which again looks at technical functionality which either exist in the H.R. or components and again their capability to allow for the exchange set is required by and all of the other bucks nowadays that are required for medical use, that that can actually happen to discuss a fair amount today about whether or not it is dependent upon the other variables that can be address but that exchange. And I have given more thought as to whether meaningfully as was the way to do it or another vehicle was available for use. But I think you are just checking off one of many boxes when you say that technical pieces are in place.


Right. I think the components are not really enough here two say that we have an Internet where people are willing to share their information. Maybe you could, to back on the HISPC [indiscernible]?


Our group has been looking peers over state law — and the project has been on going for a long time and maybe we need to get a better look at where their work is, and only to give a nod to that effort and say we need to incorporate it into what they’re doing.


And as the person that has been responsible for that effort in ONC, I think we have had 42 states and territories looking at privacy and security policies and laws and how the variability might affect health information exchange in the states as well as across states.


The last days that at this project was actually pulling states together to come up with some comments and solutions for how to deal with some of these issues, some of which have certain to be a demented and some of which need more work. But there was a lot of discussions and collaborative is that were focused on consent issues, one of them looking at the availability of cross States and reaction will be coming out with a report sand that does the 50 state laws survey on all of the different consent laws across the states and show some commonality and the differences which will have on our web site in the next couple of months probably, and then another group that was looking at how you deal with the fact that there is variation. Congress had not made any decisions to preempt state law so we do have a federal for with state. Dili on top of that how we might be able to bridge that, so that the that a couple of different approaches, modeled laws, compacts, and some discussions about having HIEs and regions working together. Asian, so I think there is some good thinking and some suggestions and some things that may be further along than that that could help in your thinking.


If I could follow up on that comment, in Social Security, obviously we have interactions with each and every state. And health-care facilities in the states and would also mention, not to get two granular, but there are 148 health-care facilities around the country have their own release and Clarence forms process these that go beyond even the state requirements. So that is a challenge that we deal with everyday and so harmonized in the state rules will get us so far. But I think to create an Internet of trust, we must develop guidelines that everyone can live with, even the health-care attorneys. [laughter]


Good luck without one.


The Okay. — Good luck with that one.


Okay. Let me see if anyone would seek to modify these recommendations at this point?


And if not, would there be any objection to accepting them as recommendations to the Health Information Technology Policy Committee?


I think that is a ringing lack of dissent. [laughter]


We will take it.


Thank you very much and we anticipate your continued work on the issues that have been raised here.


When I get back from vacation.


Yes. It isn’t Montana though is it?


No, it is not Montana. [laughter]


Okay. We are ahead of schedule, I don’t know what is wrong. [laughter] I don’t know if we have people here from the standards committee, but –


Jamie is in the room and I think the other three are on the telephone.


Okay. If I can get ahold of my agenda than, Jamie is the first up.


We are now going to get comments from the standards committee, and and obviously we have been adding to your workload here. Or anticipating what you are going to be doing anyway. Maybe that is better.


Exactly. I end Jamie Ferguson. I have a relatively brief presentation here and should serve to further? Ahead of schedule, I think. What I will do is review the standards, and we talked about this last time that we presented a different and probably more easily understandable format of our standards recommendations that we’re making for the standards required for the 2011 measures, both for certification and cell that certification could allow applicants to achieve meaningful use through the use of these capabilities of your systems.


So I will talk about our primary standards and then the framework within which we are making these recommendations.


I will just do a. Brief review. Generally we found that many of the standards that have been harmonized and specified by HITSP are useful for the 2011 any police majors, in particular, the clinical documents architecture at HL7 is very useful or structuring document. Also HL7 2.5.1 is useful for more traditional messaging or that is needed.


But found that the continuity of care document was appropriate for summary records, and the NCPDP script for prescriptions x 12 for the administrative transactions, I don’t think there are any real surprises here.


Moving to the vocabulary recommendations, we find that for clinical problems and procedures, snow, meg CT is our primary recommendation.


Board drugs, are X norm. And that test would be identified by LOINC, and units of measure, and at ministries of terminology, the petition of the hippa standards.


The key concept I wanted to talk about though is that it will take longer than between now and 2011 for many applicants to implement and get to the full use of these standards. Therefore, we are recommending the standards for definitive implementation where the 2011 measures in 2013.


We’re also said recommending a specific number of alternatives that should be allowed for 2011 meaningful use and examples of that are unstructured documents, pretext or PDF as long as they have the appropriate CDA ex em el header. We have also found that there are a number of legacy implementations, and so there are a couple of primary reasons for Really meeting to consider this delay.


First of all we have discussed in the work group that we do not want to place an undue burden on any of the mentor, and in fact there are implement jurors who have implemented some of these legacy standards to have yet to get value from their implementations. So we felt it would pose an undue burden on them to make the switch after they have imposed something else, and if it could meet the intent of the 2011 meaningfully is measures when they meet their current implementations while taking a longer time to transition to the standards. And at the same time, many information technology projects take longer than two years in order to provide and be cost effective, so as not to interrupt or disrupt operations, clinical operations. So for all of these reasons, we felt that the 2013 definitive implementation of the standards set 2011 standards was a recommendation that would not place an undue burden on any applicant.


Recon have a couple of remaining issues, we found that a couple of the standards we wanted to recommend were not quite ready and for one of them we have an alternative that we are recommending proportionate quality of major submissions. If we found that the standards that are being used for? Are I standard reporting through its EMS through registries is a recommendation in the process right now and we are still vetting that and we’re still working on the Public Health Data Exchange recommendation aware that CDC ‘s method called gypsy we found was not quite ready to be recommended.


So our next steps with the standards committee is to move forward with the revised recommendation of the documentation which we think is much clearer. Have a lot of input that it was hard to understand what we are saying, so we think we have written it better patients fundamentally have not changed. We have also gone through with the help of the clinical quality work group, the have identified the individual data elements that are in each of the measures that are in the quality reporting and 2011, and we have recommended standards for those. So those are the basic things which are still working on. I would be happy to take questions.


Roger?


There was one thing I didn’t understand, just to clarify. On slide four, we are talking about. [indiscernible] also pretext image documents. That is as a limitation we have to wrestle around or is that a plan?


The plan is to use structured documents in that seat NCPDP format as the standard, but we found that we thought it would place an undue burden on implementors Board 2011. And we found that there was the [indiscernible] put a CD a — structured documents. But because we found it would place an undue burden on them to get to that standard by 2011, we are recommending that these alternatives be allowed temporarily only.


Do we — are we in general agreement that people can get around away from pretext PDF and other images by 2013.


That is our feeling, yes.


Wow. I would disagree with that. I think that it’s. Very aggressive.


Well, from the gist of our conversations and our consensus in the committee, we say now that this is a 2013 requirement, we feel it is reasonable and does not place an undue burden to get there.


So we don’t have to take a position on these right now? Just for everyone’s information. The standards of committee will make recommendations and that ONC will then have to react to them.


Gail?


On the medications. The units of measure on medications, for you taking into account pediatrics when New York dosages and are handling dosages on a weekly basis of the child? To have that capability with the standard of measure and the ability to do that, because I know that has been a real concern with the pediatric folks. Also, on the summary, when you are talking about that meaningful use Department of and encounter a summary or a patient summary, your recommendation is to use the continuity of care document?


Yes.


This opens the door on the whole meaningful use conversation that we have had many times. When we come two, what is a clinical summary, we have to be very careful about what that definition is because, when a summary — In normal terms when you think of a summary, I think of a complete clinical summary of what has gone on with that patient including history. Whereas for an individual practitioner, event ophthalmologist is seeing a patient, it is a very different summary, so that continuity of care, would that be specific to the specialty as opposed to a general clinical summary?


So is your question asking whether we are going to have different summaries for different specialties?


What is the summary as opposed to how — there’s a real difference in what that summary is depending upon their specialty.


Jamie?


I would say there could be different content, it’s it’s a specification that has sections for example medications, immunizations and allergies, so the content of the sections may be different for the different specialties but the basic structure and its standard for that the Cavaliers would be the same.


The structure would be the same, but how it is applied, Ida bell many podiatrists that make sure if you have had your mammogram, you know, in the clinical summary.


That is true, so the heart of whether that is populated or not it would be out of the heart of our purview.


Paul and then Arthur?


Jeanie, I have a question I guess on slide three were your recommended snow Med. And my question is, for billing purposes, you really have to use ICD nine and 10 and C PT, cell will everything be coded twice?


Oh well there are cross maps you can use and part of our recommendations, I accidentally omitted IC D. Tennant from that slide, sorry, but that is one of our recommendations proportion use in 2010. It is in our use recommendation for documentation that is nomad CT is recommended for clinical documentation. SCHIP nine antenna are recommended for classification purposes and other transactions, so we do anticipate that a standard at mapping for that exact purpose is being provided by the lack National Library of Medicine and on what can and cannot cannot [indiscernible] we do envision and we recommend as its general direction that documentation should move to.


CT.


– every health-care organization is one to have both coding organizations and [indiscernible].


What is going to be required is that for purposes of Interoperability, outside the boundaries of that organization, that you be able to map into the specified standards. It doesn’t say how you have to cut things internally or how you have to store data internally, but it does say that for Interoperability purposes in have to be able to represent more information in terms of the specified standards, and that is true for all of them, not just SNOMED.


Judy?


Isn’t there a lot of argument about SNOMED versus other things such as — the international standard the support by that — disagreement about physicians as to which one they preferred, am I correct on that ore and-remembering?


I don’t think there has been a lot of exposure to this up until now. It is clearly two recognize standard.


I just thought there was disagreement.


Jamie?


I see on slide to there is an and this is on NCPDP 48 peppers grading, and as you know, that is placed in 2011 as one of our key objectives, and you also have prescription Norm on sliding three, but I want to stand a little bit about the third bullet on a fourth slide.


So if I am a provider and by fax and scanned a script to the pharmacy, and I actually structure that in such a way that it has a CD a header that says it is a backs script, does that qualify as E prescribing?


That would not be our recommendation for prescriptions, no.


[laughter]


Right, but what does the third bullet mean if someone did that?


This is a problem of taking a summary statement and applying it to a detailed case. There are particular cases where we are recommending that, for example, images of documents should be allowed for 2011 with a CDA header and prescribing is not one of those if you look at our detailed matrix.


Okay.


And this is additional detail [indiscernible] additionally and that NCPDP script, we’re recommending a HL7 version 2.5.1 prescriptions for indigent, but not for ambulatory. And that is consistent with the rules.


Tony?


This is on page two. Jamie. Of course in 2013, it will be eligibility benefits and referrals will be the ONC.


It has Persian 5010 and version 1210 instead of ICD nine.


I don’t think there is any danger of people confusing the standards experts suggest there with me if I am not getting it over here.


On slide four, is what you’re saying here, I am sort of missing [indiscernible]. In those area, if you are doing lab results delivery, you can’t do it PDF or via image of lab document. But that is not saying that your recommendation is that electronic health records never include PDF or images of Health documents.


What we’re recommending is for the coordination of care purposes [indiscernible] — those kinds of submarines CC A and CCD structured documents.


So if a patient comes from a specialist who is not part of this or doesn’t have a record that meets the criteria, and therefore can’t enter operate, with the specialist does primarily is printout a care summaries of the patient can’t take it to their primary care doctor and the primary care doctor has bought back they can still stand in and store it, it is just a specialist from before cannot get any critical use of his time.


I don’t think they’re would be a prohibition on that, but what I am saying is, for the next encounter, in fact scanned document needed imported, that would not be part of the structured document after 2013 that would be provided to the patient after that.


I think there is no question that you have been interested audience here, and we could keep you here a while longer, but we do appreciate you coming and reporting, and IT were meeting next week I expect, and of these recommendations will be presented and hopefully some or all or adopted, and we can think about how we might want to get our input into those, if the committee wants to do that.


You think?


I second that.


Thank you, Jamie.


Our next presenters are Janet Corrigan and deployed Eisenberg, who are present by phone.


We are here.


Great. We have your slides up.


Wonderful. Let’s go to the first one. And I should say my background, these recommendations have been delivered to the standards committee yet, and there is other recon process and they need to be reconciled across the barriers were Crips and the Standard Committee overall needs to weigh in on these. We need to get the latest intermission for the clinical quality work group. What have been doing is to afford that process and identify the appropriate standardized performance measures that correspond to the policy committee’s 2011 measures. So left second, review the performance measures and develop guidance for a major retooling. Because virtually all of these performance measures have to be leased specified to run off of EHRs.


Third, identify the underlying data tapes and elements that must be captured in the EHR and PHAR2 produce the performance measures, and then head off to the clinical operations group to identify the specific information technology standards. Which you just heard about.


We started with the recommended set of 30 performance measures that the policy committee came forward with and provided to us.


Out of those, there currently exists for 23 of them NQF endorsed measures which are pretty close to what the policy committee requested.


About 18 of those can be produced from EHRs, and then some of the measures can be retooled but by that them must be produced in the near term 32011 through attestation.


One of the key issues we grappled with which affect nearly all of these performance measures has to do with the capture of diagnoses and through a problem list of some sort generally.


As Jeanie indicated, we decided there was used [indiscernible]. And what our work group not would be appropriate is for 2011 to have two versions of the performance measures, one which uses ICD HIE and one which is in SNOMED CT. One goal [indiscernible] CT [indiscernible] in the measure which is in the SNOMED specification. And we thought it was appropriate to probably have multiple versions of the majors during these early years because it for those organizations that already have the ability to use SNOMED CT, the last thing you wanted to do is to ask them [indiscernible] that is ICD nine or 10 in his earlier years.


I wanted to point out and I think this came out in the prior discussion, it is certainly anticipated that for many organizations, they would use their internal coats and obtain some SNOMED CT expertise to map those over to SNOMED.


It is also recommended by aircraft that EHR certifications should immediately begin to require the existence of a problem less.


And the other thing is we need to make sure that the NL and SNOMED CT chorus subset which is what we expect to use in the near term in terms of the problem [indiscernible] [indiscernible] to approve that terminology [indiscernible] 2011 and beyond. I think we will likely need for defined [indiscernible] to be able to map over and make sure that as the performance measures that SNOMED CT continues to evolve in the terminology in the course set set for the populace.


We recommend that a more comprehensive assessment of the inadequacy [indiscernible] the sooner rather than later so we are prepared going further.


The next slide, [indiscernible] that has to do with the exclusion.


[indiscernible] mission is to be perfect [indiscernible] to be accurate and 100 percent, and going forward, [speaker/audio faint and unclear] in the performance measurement community. For 2011, attestation likely be necessary. Exclusions from the EHR by 2011, that would be for 2013. And in 2011, there is currently a sea PT to code that is used right now from many nations that has three levels that indicates right now whether there was an medical reason for excluding … system reason. So that is one of providers could readily adapt two because many were already using it. Now our overall goal and getting these measures retooled is getting it moving towards what we call patients entered measures. So what we would like to see essentially is all of the majors when they apply to acute-care settings were ambulatory or long term settings, that they have similar denominators, denominators that are specified to apply two whatever setting the patient may be in, and also that they use consistent protocols for the various age groups, and in general, we want to strive towards is harmonization is not only with the majors but across all settings.


I should mention — long-term care facilities and members of our crew to come from the long term care community have been working very closely with us to try to make sure that we keep in mind applications, to long-term care settings whether they are nursing homes or home health or assisted living and those kinds of areas because somewhere in the future what all of this to be harmonized across all of the settings.


We also took a look at some of these measures, and in some cases, there is more than one major listed in the grid that you have as a handout. As it applies to a particular policy committee majors. And that is because we need to be sensed — have some staging of majors over here. The first one, body mass index, for 2011, probably what we want as a measure that indicates a patient at that BMI or not. [indiscernible] capable of identifying that BMI percentile, and if that is recommended for this particular patient. You see a similar thing with asthma medication. In 2011, we would recommend use of a major, which is separate meds for patients with asthma, that in 2013, a more refined measure that works whether — but that but that the medication it’s appropriate for that patient’s particular stage of asthma.


And that in 2011, it would probably suffice to have a mission that looked at whether we’re not [indiscernible] to only be able to define some of the ability to look at [indiscernible] across the things the entire committee that the 2015 looking at the ability to recalculate commissions committed wide.


And the last slide here I also wanted to [indiscernible] [indiscernible] Some market needs to be done fairly immediately to begin to generate some issues of whether patients understand their treatment options, and whether we begin to underline HIT [indiscernible] aristocrats measures of capturing, the do not in today orders and things of that nature.


And Ellis, I would make it is, there clearly a lot of myth and parts here. Have to have measures that are ready to go, and that involves the development and the major stories that develop these measures and there has to be inappropriate time table laid out two will making and in have to identify all of those HIT standards. And our work group thinks it would be very helpful and strong the urgent for these standards and Policy Committee to work together to develop tide table and have some very serious thought and discussion with this that reflects the rulemaking process and it covers really the next 527 years, [indiscernible] 2013 will probably be a bit of a compromise and some very tight time frames for both the EHR vendors as low as the [indiscernible] [indiscernible] everything is in sync and there is adequate time table for various organizations and groups that have to participate in this rather complicated effort rather than just getting the work done appropriately.


Now will have this over to Floyd and Floyd has put together in the techs which I believe [indiscernible] the matrix, you have that in front of you that will just get an [indiscernible] of what that shows. A ticket recommended list from a policy committee, and identified the corresponding measures that we currently have this interest NQF measures, and using the free-market that is established by the EHR expert panel [indiscernible] which Paul [indiscernible] helped to chair, we identified all of the individual data elements for each of those measures in the appropriate column. So that we could work with Jamie’s work group to identify those elements. The standards of course that they have looked at, they of course but at the terminology but that the standards for Interoperability. And he will see and some of those fun, specifically, it is a little more complex on [indiscernible] and has more comments and concerns and Things, data such as the anti robotic devices as opposed to medications, the devices themselves may be harder to identify, especially identification that they have been used. In most of them, the data elements except for the exclusions, as Janet already mentioned, are fairly well defined. So that is just a brief overview. I don’t want to take a lot of time on it but I would be happy to answer questions.


Questions for the committee?


I know that 23 had current standards, and 18 it needed retooling and five would be done through a station. And by recalling that correctly?


That is correct.


Can you translate that into 2011, 2013 and 2015 terms in terms of the of availability of standards for majoring the quality metrics that were included in our meaningful use me to expect is that what addressing? And as far as the standards you would recommend it, five of them would be documented throughout a station.


That is correct. So for seven of the 30, there are no existing majors. Unlike could quickly tell you what those are, percentage [indiscernible] enter it through CPOE. Percentage of patients with access to health information electronically. So that is just an example of that but for seven of them http://www.have a major constructed yet, work would have to be done.


Sell for all of them that we have a major, you can specify majors with a [speaker/audio faint and unclear] for 18 of the 23 that we have measures for, yes. We believe that those can be generated from the DHR and Jim is work group is well along the road to identify the HIT standards that they needed to do that.


When they need five, which in 2011 [indiscernible] the goal of that would be to be generated from the EHR directly by 2013.


Okay. One last question. One of the issues we have been discussing is the issue of special pieces specific measures. To go beyond the primary care domain which is most of our measures have been concentrated to specialty specific measures, what is the implication of that for the availability of standards within the 2011 remark?


You identified.


Do you want to speak to those?


The reason you see asthma on the list is to address some specialty and also pediatrics. You will see one towards the end of the grid about — for a stroke and atrial fibrillation and providing an attack like a nation which is, one, two at a hospital measure, but also two address the specialty. So we did address the specialties based on a review of existing measures around specialties, and there are standards to deal with those. And if that is what we’re trying to do as far as addressing his specialty.


One other thing, our report report did a call this week and started to focus on issues for 2013, and we’re trying to identify what is in the pipeline. Many of those our industry specific measures, but it is pretty slim the pickings. We are talking about maybe half a dozen or 10 nations that exist, we so we need to start sooner rather than later to edify the specific types of major so we are needed [indiscernible] the mini pool use Workgroups will go identify some of the existing measures that are in the 2011 set, but some apply … A call out to try to grab some more specialty specific measures.


In answer to that seven majors, the reported measures that do not have NQF endorsed measures, some of these did not have the intended endorsed measures with the percentage of patients [indiscernible] electronically to almost an attestation, to make that available to all of your patients, that have major, it wasn’t intended to be something that you measure out of the EHR system.


Another example is the compliance example with HIPPA, that would be a quality measure that NQF but typically indoors. Even though a hundred percent supportive lab electronically, they have interfaces to certain lab test results systems and not others and what 1 percent would have — so some of those would probably never go to NQF the endorsement.


David?


Janet, I have a question that is sort of a NQF process Development to question I guess. Your assay the pipeline baby than in some areas that may be important to us in 2013, so I guess I see it — and correct me if this is not accurate. I see this process as accurate with a customer have NQF and people that defined need support measures and policy making for a for purposes. And in some sense, NQF and the pipeline that supports NQF is being stimulated by variety of demands from across the country. I am sure that [indiscernible] what can you as far as you go about [indiscernible] the needs we need to anticipate for 2015 given the range of other users of measures that are out there, I really want to avoid the situation of us booking under the lamp post to head for years from now with the things that we can measure ITI effective meaningful use of decisions and care. And I also worry [indiscernible] we are not the of providing for [indiscernible] measures, but there isn’t one. We have these voluntary coalition attended by three groups, all of whom expressed themselves but we don’t really have a mechanism to create national policies around these areas of emphasis. But we are contributing to that ourselves. So in the nucleus discussions we are going to happen next few months, and equates them operative discussion around, Janet, Cure other users to make sure that we can sync up the pipeline of developers and the other directions.


It is a very good point. Phonetically are actually a little closer to having a multi stakeholder national process for identifying the priorities for a major development and endorsement going forward. The me just sort of tell you where we are at with it.


We have a very expensive process in studying the six major national priorities which I know developing it’s 2011 policies and measures and those are the major cost-cutting areas, whether it is care ordination were overuse or palliative care or anything in the major cost-cutting areas. [indiscernible] under development with a contact for HHS which is emphasizing the top 20 conditions using the set of criteria not only about incidents prevalence and the burden and the ability to impact high quality and ability to attack attack and things of that nature, [indiscernible] about eight weeks are now, I thank we are also going to be working, as we have those top 20 conditions, we are not — we also want to make sure that the attics portfolio of measures that covers all of the leading surgical procedures as well and if they don’t get reflected and separate we are covering [indiscernible] surgical procedures asthma are those cost-cutting areas that you have already got. But that a text and work is already over way — underway in [speaker/audio faint and unclear] already have in the portfolio to the cells in the matrix and we will see where there are gaps. And where there are gaps, that then gets translated into a set of priorities for a major development. And that work will be completed by the end of this calendar year. There are already pieces of it that a good deal of progress has been made.


For example, the fifth major national priorities, the NQF art has projects up and running that are reaching out and try to obtain other potential majors that are out there and the major development fields have been [indiscernible] about seven great aunts with those prayers were released that those are going to beat beat a big area of emphasis on a good manager of development is already underway in those areas. So that is the division of the area Ford dimensional matrix as to having the highest of priorities for major development is what [speaker/audio faint and unclear]. ITI say it will meet your needs to a great extent but if it doesn’t come provided input and will make sure that we no how they reflected as well.


Okay, I think we are one to move along at this point. They’re just getting reports here. Janet and Floyd of terrific work, and with the court to do in the clever to work — that collaborative work they discussed. It seems important that are meaningful use and standards development groups be continually coordinated. So we appreciate your presentation.


I just wanted to say one thing and this is in response to something Paul said because I wanted to clarify that CMS is in the room today and that was about the percentage of patients with access to health information electronically. And we talked to [indiscernible] and knew that would be an attestation process, but what I heard you say was different. This was I think designed it to be at attestation of perhaps 30 percent of patients and not whether you provide access yes or no to think about it being used or not that it with established a minimum or Max% but that with with what the present reported as opposed to a yes or no.


That is noted for the record.


Is Dixie Baker on the phone?


I am.


Terrific. Thank you for being here.


This has been very interesting.


What I am presenting today, as Janet mentioned in her introduction, this is summary of the full Standards Committee meeting and I would encourage the standard committee meeting, but I’ll hopefully give you enough of feel for what your doing that we would feel comfortable with making good progress.


– capabilities that are needed for what Devon referred to a while ago with the eight priority areas of focus that are enumerated in the American recovery and reinvestment act.


And that is the standards that were available for your product certification and then in identifying the issues that could be used for demonstrating that a certified product was being used meaningfully.


Last month, at the July meeting, we completed our certification. And the services that needed to be provided by the products as well as the standards that were available, and we gave them readings and the standards a readiness reading. That work was accepted by the committee last month but since then we have discovered a couple of standards that we wanted to add. It also discovered a couple of that readiness ratings that we wanted to change. Cell– come up with significant changes secondly we have developed privacy and security measures and these are measures demonstrating that the certified EHR product being used meaningfully and being presented to that work next week as well.


Okay, this is kind of a summary of the standards update. Last month when it presented de [indiscernible] in the rank of rating 1 to 4 and this month we have added the 2011 and 2015 readiness.


We have added a bit more detail about the source references and last month we had a fight that this came from a HITSP contract, this month, and we had questions about this, so we had added specific references to constructs.


We identified the International common criteria for tested system in violation as one of the standards, and, we got a question at the meeting about that, and although it was accepted, we concluded that really, the assurance measures themselves should be included in the certification criteria, and that the PAL certification criteria is should be used as a module [indiscernible] this process.


We added to standards to the web services security, and the IET cross document reliable interchange particularly with the reliability exchanges.


We added three HITSP capabilities. We haven’t identified any of these capabilities, at the last meeting, so we have added three. 143 is the managed consumer practices and consents. But all three of these have lots of things to do with consumer — committee structured documents and for both 119 and 120, we passed by this this would be using the system to system possibilities within the capabilities. So this would be used for providing the consumer and electronic copy of their EHR and either an unstructured document which would be acceptable in 2011, and then by 2013 it would be a structured document. Two system topology as well as the portable media, for the case in which a provider might provide the electronic copy through PHAR.


We had quite a bit of discussion about the rest which is a much simpler messaging approach that is used for service oriented architecture solutions, and it is being used more and more. It is not a new standard, it uses traditional http and universal location indicators. And we added a note that will allow the use of breast as an alternative to sell pore service oriented architecture messaging.


And finally we changed to a readiness levels, and when heroism the wrong direction. And in the case of [indiscernible] we changed it from a level of 1 to 2 because it is probably at 1.5. It is certainly immature standard but it is probably not used by 20% or more of the people who have Unix security positions. And then personal White pages which basically uses LDP and domain name services and so we changed it consistent with those standards. And I will present most of these next week but most of next week’s discussion will be focused on defining meaningfully is measures.


And since our objective was runups policy committee, I thought that you should now about the challenges that we found and we discovered and identified with these measures should be.


First of all, every objective that we identified is HIPPA compliant. And I identified the reason behind that and the truth is that already applicants are required by law to operate in compliance with the HIPPA privacy and security rules. And so the question is, can the impose any additional measures without prescribing new laws or new regulations? So that was a challenge for us.


We also had the new ARA provisions and it wasn’t clear handle those so for now we are including the ARRA provision specifically in the majors that we identified.


We also didn’t appear to be set setting HIPPA. We got about, well, maybe there are some standards for its petition specifications in the Security and privacy rules that we could specifically identify and say, well, you have to demonstrate these appalling five. But then you’re coming across as saying, these five are very important from all of the others. But really, you don’t need a full HIPPA compliance come you really need to address these five. So that was out of the questionnaire.


But the bottom line is, there is a strong recognition that I have heard reflected over and over in today’s discussion, that the meaningful use of EHR technology on collectively brings new privacy and security risk to the provider organizations, and to consumers, and that are effectively addressing these lists is absolutely critical to the ultimate objective of furthering adoption and [indiscernible] of interoperable WHR F and interoperable the exchanges.


So our next recommendations that we will be presenting next week include the three basic types of measures.


The first R measures that represent a value EHR adoption is contributing to the organization’s challenge of remaining HIPPA compliant. So if they have to audit access this to the information, and the fact that an EHR product instead of an automated way to do that gives them additional value. It is not a new requirement but the EHR steps up and plays a role in their hippa compliance. The second head of measures that they will be recommending are those that represent a fundamental change in an organization’s approach to maintaining hippa compliance as a result of them having adopted an EHR product. So in other rates, these are like counter measures to a new risk that they didn’t have before. Also, the configuration at Security and privacy capabilities that are inherent in the product, I recall at the last meeting of the meetings that I presented, if in fact I have a product that might have saved and encryption capability, is certified have that capability says nothing about how the organization uses the capabilities of that would be another type of measure that we intended to present.


Finally, measures that can be objectively assessed, and I know that we have been talking about this today as well as the other two work groups from the standards committee. We need to be able to figure out, or somebody needs to be able to figure out how they are going to objectively assessed how they’re going to meet those measures.


So I will not present the details today, because that would steal my thunder for next week, but I encourage you to come to our meeting next week. Are there any questions?


Questions? Devon?


Thank you for that presentation, unfortunately I won’t be here next week so I will miss the meat of your discussion at 42 catching up with you later.


The have said a fair amount today as a policy committee, although certainly not the definitive word on standards, but a couple of things we agreed upon to conclude that the standards be architecturally and technologically pitch well and that there be CCHIT for acidification been that many for years and not necessarily a greater list of criteria that products might be it sort of given a good housekeeping seal of approval by are not necessarily part of the certification for getting your meaningful use incentives.


So part of what has been done today has been looking at existing CCHIT criteria and mapping them, given that they are sort of putting some new shape on what the criteria ought to look at with meaningful use, do you have any plans of how to go back and look at those and assess whether they address some of the overarching discussions we have had today?


I think we are fortunate that we had very good guidance from the TLS early on, and with attacked the HITSP standards. And will ultimately go ended up going to the ARRA eight, and instead of really using the CCHIT criteria as a major input into our analysis, we have used that ARRA eight and HITSP standards as major inputs and the process. So as a result of that, everything that we recommended — we are recommending can be traced back two either, and potentially Bowles, the eight priority areas identified in the ARRA law itself and for to the HITSP standards or constructs that with the port the security and privacy Services required for the ARRA eight priority areas.


I also wanted two just clarify that you want to see in the standards that you recommend, you won’t see any HITSP constructs listed, but we use the HITSP constructs and with it at the standards that does constructs reference, and the standards are the ones where we majored their readiness and ultimately ended up recommending.


So, now, I don’t see any need for us to go back because we went right direction to begin with.


I am not sure I agree that that addresses the question, but we can take that up later, because these are the new criteria we talked about today so it would be unreasonable to expect, but I think it is something that we need to talk about.


Let’s talk about that because I haven’t heard anything to cause me to change what we’re recommending today. But I’d love to follow-up with you on that.


Okay.


I think that we are questioned out, Dixie.


Thank you so much. This is such important work, and we really appreciate you and your work group ‘s activities.


We will now move to the public comment and at this point I usually turn it over two Judy.


[speaker/audio faint and unclear] the public to make public comments to the committee as well as anyone on the telephone. The operator can give you instructions on making a phone line accessible to the committee.


I think we will begin with people in the audience, but remember, we are capping your comments at two minutes. So there is a two minute limit.


[speaker/audio faint and unclear] you interrupted me a previous time. Pilot I sent a letter to Dr. Clement ball, who has — Doctor plum and Paul, who has written my comments, which was interactive, and ask you to put this record on the record.


Number two. As I mentioned, how much time to have?


Please continue.


If you don’t know, I will count.


It is [speaker/audio faint and unclear] illustrated very well. You cannot damage [indiscernible]. I do not know the term how to explain this.


The second point, I didn’t understand why you don’t consider [indiscernible] issue [indiscernible] because it is exactly input information technology for medical needs.


So I have may be used my two minutes, but I need to say to you, I have flash memory with me. Everyone has a computer, I can demonstrate how to solve the problem of verification [indiscernible] efficiently and bought back. Thank-you very much.


Good afternoon. I am Lynn [indiscernible] the vice-president of government affairs with s are as soft.


I have listened to York webcast over the internet but I felt it was important for me to be here today to deliver this book personally. This ask you to provide private — these are the physicians who will have to achieve what they’re EHR [indiscernible] have to be achievable [indiscernible] medical practice as he move forward.


The fact that a relatively small companies like ours would receive such a response in just a few weeks with minimal our reach efforts is an indication of the deep level of concern pervading that community. Two things are clear, as some selected was is not being heard and they perceive that the government’s specifications are overly burdensome from a practical perspective. The signers of petition are not all clients. Other providers have reached out to us and as we stand up for them as well. As our S users are not, they’re passionate about EHR and speak from a positive and negative aspects. Physicians will not adopt technology that compromises their productivity, they wanna become data entry clerk and will not jeopardize the patient physician relationship. No financial incentives or penalties will persuade these positions to take actions the team detrimental or non valuable to their practices.


150 signers of petition or so concerned that they took time to compose their own supplemental Commons to consider, and they are in this book. I hope that you’ll take the time to read through even a portion of them. Baton intensity and content will provide insight in what will be necessary to successfully encourage widespread EHR adaption.


Okay. And we will take the next to the oven.


Mike Koppel. First of all affected Spence appreciation to all the members of the committee. Obviously you have spent a lot of time and our of our is dealing with some really tough issues. It is gratifying to see the level of the Matt you have two both HIT and to provide health outcomes. And certainly the hours expended and the best of intentions [indiscernible] best of intentions and [indiscernible] point out one of them distract from the credibility as a whole.


In your transition strategy for the certification process, I think the current strategy that you laid out and that you approved today has a serious flaw. And I believe this lot to be unintentional. But it is significant because it has market implications and it distorts the market. With the 2008 CCHIT plus gap approach, and I think — in the spirit of the level playing field they talked about in hospital segment, there is only one vendor that has currently achieved HIT certification for 2008. [indiscernible] [indiscernible] so they went to or plan on applying the 2009 criteria which was more stringent. However, I would like to also point out to fascinate certification is no longer available. So as your approval of the 2008 plus gap appears to favor one company only in the hospital space, and the company unfortunately appears to be on the one represented on this panel. And I’d think this is unfortunate, because it reflects inadvertently, I believe, but an unintended consequence that has that potential that, we will say, distorting the market in hospital stays. So I would ask that either the national coordinator for considering the recommendations or Mr. Twinkle in development of the regulations would consider, is there a, we will say, a review process that would prevent such things and the unintended consequences from happening.


Okay and I believe we have a comment from the telephone?


Our first, it comes from Chester frenzy of covenant Health.


Chester Ramsey?


Let’s go to Mr. Perot.


Good afternoon, my name is Ruth Perot [indiscernible] and I want to thank by acknowledging with appreciation three features of the current meaningful used craft. We certainly applaud the lifting up with high priority the addressing of Cyprus Party, and we also want to commend the panel for addressing the upper purchase of — primary lead which data and first year of adoption, we also celebrate and commend you for the focus of the entire document. 70percent of the patients in California said they want the doctors to have it HIT. Second to that I have recommendations to enhance your fine work. Twenty-nine actually, I want to talk about all of them obviously. The first recommendation would be to look at the concept of safety net providers and expanded, and there are nearly as many free clinics as there are federal qualified health centers. And 50% of the ethnic and racial Pratt minorities seek their primary-care from individual physicians. Back to talk about the product safety net. And if you do you have to acknowledge that the safety net providers have to be more than [indiscernible] they need a friend [indiscernible] to acquire the necessary infrastructure and they need a decision report support. So think about the safety net, but broadly.


The second recommendation, you may recall the CMS our rich campaign to get beneficiaries of Medicare to adopt prescription drugs. The whole part D campaign. We think this effort is as important as that in terms of reaching providers and consumers about [indiscernible] the penalties as a seated and the benefits. And you think there needs to be that kind of investment by ONC, CMS, all of you to make certain that word gets out because it doesn’t get out, will have a participation disparity that will aggravate the help disparity we already see.


The first thing we recommend is that back ONC plan to monitor as of 2011 the participation of safety net providers to make certain that they are indeed included. If the be terrible to wake up in 2014 or 2015 and find they aren’t there. It is too late and it would keep them away from the [indiscernible]. And we do see despair disparity is [indiscernible] and me to eliminate disparity.


Mr. E10?


I am with the medical imaging and technology alliance, and that is the largest trade agency representing the industry. I have been have a number of these meetings but at this meetings of stock at how often the issue of Interoperability has. For example high-fat — heard aggressively established remove requirements for Interoperability and the exchange, that was one of the recommendations that was made. Interoperability across challenges — across clinic. And we need to know that death Interoperability is part of this whole system and there is no Interoperability without Interoperability standards. That is where it comes in. Have over 80 plus years of standards [indiscernible] and our members work dicom, and you know what that standard is. [indiscernible] you are the leader and development of the dicom standard and that was over 28 years ago.


You are in crunch time. I have a great deal of sympathy, and for job is very difficult and have a time crunch on top of that.


I am offering our expertise, our services, our knowledge and Interoperability testing and development, if you need us to testify, if you need us to write a white paper, I am very encouraged by about the October meeting we will be dealing with this subject matter. All you have to do is let us know what you need and who will put the boys voiced and power behind it. Keyes is us, we are all in the same boat here and we all support the same goal so I urge you to take it finish of our expertise.


Okay, to have someone on the telephone or a comet?


Yes, I have Christine right. Would you please proceed with your comment?


Okay, let’s go to Robin [indiscernible] please.


Hello, I am [indiscernible] and I volunteer of thought for the tiger team and HITSP. And just have a comment about one that was made about detail and interfaces and Interoperability, and I like two-point out the new work that came out in [indiscernible] 1.7 and if you dig deep in the weeds and the document, there are 79 interfaces and 443 interfaces like to 7,000 pages of documentation. I would hope that is enough, and also, just in the perspective of talking about a shy owl and — IET and HIE, section 453 of ARRA where it talks about the very 2010 with the individual has a right to request, did not disclose if the health insurance company did not pay for this, this an area of bury someone comes in for a routine physical, and they say, by the way, can you check for herpes, and they don’t want that to go out, that sets out the situation with have to make a separate counter so that becomes, I don’t want to disclose this. Because of the situation comes up where it some accounts are taking from a piece of level, to disclose this and this and this, you have an electronic health-care maintenance or need anything going on.


And I just wanted to point out one other thing. I just noticed that because there is one enterprise [indiscernible]. And I wanted to offer on the part of this committee, because there is one [indiscernible]. That CCHIT has Ashley broadened their website that you can actually filter out and say 2007 or 2008, two others are just for the record premarket which means they don’t have a and live section yet.


We have time for two more comments. Dr.Peale?


I thought I would come in person today because I have tried to comment before on the phone, and I know that many of you, but not all of you. I am a practicing to position, and I have found privacy rights and I am still a volunteer and I am unpaid. Patient privacy rights has over 10,000 members in all 50 states, the bipartisan coalition for peace and privacy which represents 10 million Americans, and we have sent you all to detailed letters, very detailed comments about meaningful use, which, I not sure it’s been in police work group has ever seen or heard from, and we are very concerned, because the process is happening, and we’re trying to participate and trying to send you evidence that there are going anywhere, but [indiscernible] there is no place for the consumers to be heard. But the main thing that consumers want for EHR to be meaningfully useful, is the ability to control the disclosure of their information. Anyway, is that a detailed letter recommending both federal policy be used for meaningful use standards — recommended an open source robust consistent management system that has been in use for eight years and it has enabled the exchange of 4 million patient records in eight states. Effectively that complies with the standards and 42 CSR. This was developed by the National Data infrastructure — information infrastructure consortiums. So we think that there are. Robust solutions to health information exchange. — Health Information privacy. We are also really concerned that there were several votes today at have been boats every day on documents that we don’t see to it until we get there.


Again, for public input and for us trying to be a part of the process is, we really can’t come when we get documents the same day as boats, we can’t be involved in the planning process seas, and we have offered our organization have the members of our coalition including the atomic travesty Information Center, ACLU and others will be happy to provide comments of the work group level.


So again, another concern of ours is of course privacy. The word privacy is used in all of these presentations and documents, and we would urge you to adopt a definition of privacy, because to consumers and in a legal sense the term means process of information. But because HHS and ONC have yet to adopt the definition, the proposals are very confusing and the meeting of them is not clear about an actual definition.


The problems of the legal concerns over health information exchange that Judy Augmented could all be solved — we don’t have to do agreements or a legal contracts or business agreements to exchange data, if you simply get informed with robust patient consent. You don’t need all of these agreements from stakeholders, because the person that can that the data immediately where it belongs for care and research really is the consumer, it is the patient, so we would recommend that to you again. And then, listening to the comments about quality, I would expect that the top 20 conditions would certainly include depression, that have the greatest prevalence and targeted the and mortality and costs, the depression would be one of the top 20. Depression is the second bus, a disease in the world. But I would have to caution you that if we had a system of electronic records that does not allow trust and segmentation of electronic information, we will never get that data. We know that from HHS as back on findings that 2 million people a year refuse to get treatment because they know it is not private. 2million refuse treatment and diagnosis for cancer because they know it is not private. If we don’t have the privacy, we don’t have the data to find what is comparatively effective in my field. I would really like to know that. We will never get that data about cycle analysis and psychotherapy, all the kinds of treatment a third at patients are off of the credit because they pay some of privately like me or go to and a court day. And if we designed a system that does not allow segmentation and privacy to look at from the is and missing data and that would be ashamed.


The last thing I would say is the comments that were made before me about how we should have to — a patient should be able to block the transfer of data would have paid out of pocket. That is actually a new right that high tech conferred on American citizens. That is an important new right. If you pay for treatment, you should decide who it goes to for purposes beyond such as health-care operations.


The queue.


And last, a short comment from Tom Leary. [laughter]


I will save you the story of when I presented to the board and the Pope went out. I think Judy Faulkner was there. Discussion today particularly around health-care facilities. Either it is between DOT and [indiscernible] with 50 percent of their care going downtown, whatever. This committee is addressing the policy issues, you’re not shying away from the policy issues that need to be addressed and so continue moving forward. Predecessor organization sometimes backed away from the policy discussion. [indiscernible] September 20 first through 20 fifth. We will have a Senate proclamation, house proclamation, and we are hoping that because it is in September, not in May or June, we are not going to be drowned out by the Thursday we’re fathers stay at this year.


One hundred organizations have signed up including nonprofits or not-for-profit, so please pay attention. These are the folks and this is the activity that this policy committee is a result of, and we are the Can for more and more organizations to be part of it.


Thank you, and I will stop before I lose my voice.


Thank-you and I will turn it back to Doctor tank.


Thank-you to the committee at all the work that has been going on at all the members of the work group and a committee. Thank-you to the public hearing and on the Web for this thing in the and we will see you in September. Thanks.


The Uninsurance Crisis

August 13, 2009

The problem of the uninsured is continuing to grow. The federal government estimates that over 45 million individuals lacked health insurance coverage of any kind during 2008. Millions of American workers have lost their jobs, so the numbers of those losing their health insurance and applying for Medicaid or going naked (without health insurance) are also rising rapidly.

The report 

The Clock Is Ticking: More Americans Losing Health Coverage by FamiliesUSA provides the first ever state-by-state data on the number of people who may lose health coverage between the beginning of 2008 and the end of 2010. Numbers are broken down per week, per month, and per year.

The early release of Selected Estimates Based on Data From the 2008 National Health Interview Survey by the CDC gives the most recent data on health coverage available. Some highlights include:

  • In 2008, 43.8 million persons of all ages (14.7%) were uninsured at the time of the interview, 55.9 million (18.7%) had been uninsured for at least part of the year prior to the interview, and 31.7 million (10.6%) had been uninsured for more than a year at the time of the interview.
    In 2008, the percentage of children under the age of 18 years who were uninsured at the time of the interview was 8.9%.
  • In 2008, 60.2% of unemployed adults aged 18-64 years and 22.2% of employed adults in this age group had been uninsured for at least part of the past year. Also, 33.3% of unemployed adults aged 18-64 years and 13.4% of employed adults in this age group had been uninsured for more than a year.
  • In 2008, 19.2% of persons under age 65 years with private health insurance were enrolled in a high deductible health plan (HDHP) including 5.2% who were enrolled in a consumer-directed health plan (CDHP). In addition, 18.7% were in a family with a flexible spending account (FSA) for medical expenses.
  • In 2008, the percentage of persons uninsured at the time of interview among the 20 largest states ranged from 3.0% in Massachusetts to 22.9% in Texas.

I have created a map on GeoCommons trying to show the distribution of the uninsured around the country. I leave it you to draw your own conclusions how to address this crisis.

Can CEOs help fix healthcare?

July 31, 2009

Two of the authors of “The Innovator’s Prescription,” Clayton Christensen and Jason Hwang, wrote a recent article in Wall Street Journal titled “How CEOs Can Help Fix Health Care” they put forth the proposition that American companies can turn high healthcare costs from a weakness into a strength. But they start with an admission that “High health care costs are one reason many of America’s once-venerable corporations – like General Motors and Chrysler — are struggling to compete globally.” They go on to say:

Foreign firms rely on their governments to shoulder the burden of providing health care to employees; in the U.S., tough decisions about funding and managing healthcare has always fallen upon business leaders. However, rather than simply being a historical and cultural burden, this responsibility also creates the opportunity for remarkable innovation.

The idea makes some sense in a theoretical way, but to pursue the innovative opportunities the business would first have to be enabled to handle the current burden of providing health insurance. The article makes three basic recommendations:

We recommend executives make one or more of three innovative changes: 1) encourage employees to use nurse-staffed in-store health clinics for common ailments, 2) partner with integrated health systems like Kaiser Permanente, and 3) set up company-run clinics at corporate offices and plants.

Not all of these options are viable alternatives for most businesses, and some would find it hard to implement any of them. However, those businesses that can move towards these steps would be wise to take their advice or possibly suffer the fate of the auto industry. Healthcare reform is going to take innovation and cooperation from both the public and private sector, and corporations can not wait for Congress to address the crushing costs.

Lawrence H. Stiffman, Ph.D, MPH makes a case for Retail Clinics 2.o and promotes the idea that Retail clinics 2.0 could fulfill Public Health Service disease prevention mandates and guidance, partnering with manufacturers, PHRs like Google Health and Microsoft HealthVault, visiting nurses and local health departments, and schools to establish a new paradigm for a medical home model.

Christensen and Hwang say:

Retail clinics are basic health clinics staffed by nurses and located inside pharmacies and stores such as Wal-Mart, CVS and Walgreens. There are about 1,000 such sites in 37 states, according to a September 2008 article in the journal Health Affairs. Nurses deliver routine medical care for common ailments like a sore throat or ear infection. A typical visit costs one-third less than an urgent care clinic visit and three-quarters less than a visit to an emergency department, according to another article in Health Affairs that analyzed the costs to the insurance carrier.

Ninety percent of retail clinic visits are for 10 common complaints that constitute 18% of all visits to primary care doctors and 12% of visits to emergency rooms. So, the more employees visit retail clinics for these common problems, the more money companies will save.

Plus, retail clinics would help reduce the absenteeism related to the time it normally takes to schedule an appointment, see a doctor and fill a prescription. Retail clinics have made convenience a key part of their sales pitch by offering walk-in, no-wait visits in places where people already shop.

William Hazel, MD, a member of the American Medical Association’s Board of Trustees, said retail-based clinics can “play a positive role if done properly, but they are not a substitute for a regular medical home,” a term which describes the relationship built between a primary health care provider and her or his patients to help ensure all of the medical needs of patients are met.

The hard part is creating and staffing these new retail clinics (as well as the reaction from entrenched interests who might believe that this is an intrusion on their territory). The retail clinic trend is important in a nation with up to 40 million uninsured, any of whom could end up in an emergency room because without insurance or a “medical home,” a simple sore throat turns into a costly hospital visit. Going to the local drugstore or other retail clinic to be diagnosed and treated for a sore throat or aching ear could become a typical healthcare scenario and would certainly be a disruptive innovation.

The article also delves into the thorny issue of fee-for-service reimbursement. Although pay-for-performance is already gaining more widespread use, the effects of this incentive system on physician response and healthcare outcomes are still unclear. What types of financial incentive strategies work best is also still undetermined. But I agree with the authors that the fee-for-service reimbursement system is not sustainable:

Next, employers must take aim at the fee-for-service reimbursement system, which is the most common method by which health insurance companies pay for medical services and which has fueled much of our skyrocketing healthcare costs. Fee-for-service rewards providers who are able to squeeze in more patient visits and perform more procedures. It encourages providers to profit from treating sickness, but not from maintaining the wellness of their patients.

Employers can help fix this flawed incentive structure by moving their employees away from health plans that offer little more than a telephone directory of independent contractors. The alternative is to partner with prepaid, integrated health systems like Kaiser Permanente, which serve as both insurer and care provider. These organizations are much more likely to deliver cost effective care that keeps their members well because these organizations are involved in both delivery and financing of care.

The high cost of healthcare must be addressed and innovations in methods of reimbursement will be key to achieving savings. California physicians given financial incentives to improve the quality of healthcare have made important changes designed to reduce costs, according to the results of a RAND Corporation study reported in the March/April issue of Health Affairs.

“Physician groups are responding to pay-for-performance programs by making practice changes and altering how they compensate physicians to reward quality, but health plans and purchasers say that those investments are not yet translating into substantial gains in quality,” lead author Cheryl L. Damberg, PhD, a senior policy researcher at RAND in Santa Monica, California, said. “The true benefits of these programs may take more time to be realized and it is likely that investments in other quality efforts will be needed in addition to performance-based pay.”

Health IT can help achieve these quality measures and promote further disruptive innovations. Using an Electronic Health Record connected via a Health Information Exchange is a first crucial step to any meaningful reform. Changes in reimbursement structure, quality measures, medical home models and expanding access will only be fully realized if we use all of the technology tools available.

Healthcare Costs and Reform

July 27, 2009

The federal budget is on an unsustainable path, primarily because of the rising cost of healthcare. Healthcare reform is a central issue in Congress this year and a top priority of the Obama administration. One major concern as solutions are being debated is the cost of various reform methods. On July 26, 2009 Doug Elmendorf, Director of the Congressional Budget Office (CBO) published Additional Information Regarding the Effects of Specifications in the America’s Affordable Health Choices Act Pertaining to Health Insurance Coverage as a response to Peter R. Orszag, Director of the Whitehouse Office of Management and Budget (OMB) blog post CBO and IMAC in which he stated that CBO (which he headed until Obama named him to OMB Director) seems to have overstepped. I expect a little back and forth between these two blogs as this issue moves forward.

The issue of the cost of reform will be front and center as Congress heads into its August recess. The Whitehouse has said that healthcare reform must be deficit-neutral. It is unlikely that the plans being debated in the House and the Senate will achieve this goal in their current form. A big part of this issue is controlling costs. Getting costs under control will require making some difficult choices about which procedures and medications will be covered under any new plan. There is some hope that preventive care can save money, but a 2008 study published in the New England Journal of Medicine concluded, “Although some preventive measures do save money, the vast majority reviewed in the health economics literature do not.”

Medicare is going broke. Trustees of the Medicare program released their 2009 report which shows that the fund that pays for hospital care will be exhausted by 2017. Correcting the fiscal imbalance will require “substantial changes” to funds coming in and going out of the fund, “even in the short-range alone,” according to the trustees. Any successful heathcare reform will need to take the current Medicare fiscl crisis into consideration.

Sen. Charles E. Grassley of Iowa, the top Republican on the Senate Finance Committee, said “Kicking the can down the road isn’t an option any more because we’re at the end of the road. Necessary policy reforms to add efficiency and improve Medicare’s fiscal health without cutting benefits will take time to implement. If Congress waits, the savings from those changes won’t materialize until after the program becomes insolvent. At that point, the only options would be cutting provider payments, reducing benefits, or raising payroll taxes.”

Rep. Pete Stark, D-Calif., chairman of the House Ways and Means Health Subcommittee, said “while opponents will use this as another excuse to arbitrarily slash and burn Medicare, our energies are better focused on how to reform our health system and rein in rising health costs.”

There are no easy answers. Healthcare reform is complicated and will be difficult to accomplish. It must be done in a thoughtful manner and with a measured approach. But is is vital for the financial health and economic stability of our nation that we succeed. As anyone that reads here regularly or follows me on Twitter knows, I am certain the Health IT will play an important vital role in providing innovative ways to control costs and increase quality and clinical outcomes.

TRANSCRIPT – 7/21 HIT Standards Mtg

July 21, 2009

I have posted the rough draft transcript of the HIT Standards Committee’s 7/21 meeting below the meeting materials.

Meeting Materials

Rough Draft Transcript:

Event Started: 7/21/2009 8:48:27 AM ET


 

Morning everybody.


We’ll come to the third meeting of the HIT Standards committee. We have members of the audience as a lawless people on the phone as well as listening over — as well as people on the phone and listening on the Internet. The meeting is being transcribed and we want to have proper attribution. Let me go round the room if you could introduce yourselves and I will begin with Doug.


This is Doug it and I am from Arizona St.


John Gina, Judy, [ Indiscernible ] from Blue Cross Blue shield.


Lloyd Isenberg from National Quality Forum.


Steve Finley.


David Blumenthal National coordinator.


John.


Chris Shoot Mayo Clinic.


[ indiscernible ]


Kevin Hutchinson.


Liz Johnson.


David McCauley.


Stan from Intermountain Healtcare.


Jodie Daniels.


We should have a number of people on the telephone.


Martin Harris?


Janet Corrigen and Mark.


Hi, this is Mark.


I will turn it over to Dr. Blumenthal for comment.


Good morning, I want to welcome you all to the Holiday Inn in our neighborhood. We are having, as you know better than I, our third meeting of the standards committee. We are at this piece of monthly meetings. And I know it’s probably not what many of you are used to it you have served on comparable government committees in the past. But I want to assure you that you are providing an invaluable service to us at the office of the national coordinator, Department of Health and Human Services and I think to the American people. To say that I am and all of the quality and amount of work that our committees are doing is probably not overstated. You all have done an extraordinary amount of very high quality thinking, and formulating and writing. I am sure that many of you are thinking that you are asked to do to much and if you have more time you could be more thorough and you could design better plans, find more of the gaps, late a better foundation. I know you all are thinking that. But I’m sure that you hardpan seen our work enormously — You are advancing our work enormously. And we are all living with the deadlines that Congress created for us. Those deadlines are tough but also provide a kind of discipline that perhaps is beneficial in the end. We are working towards an initial, an interim final rule that will include standards and certification criteria to underlying the implementation of meaningful use in the 2011 time frame. And our goal is to make sure that we give physicians and hospitals and patients every chance to have the benefit and the use of electronic health records and other health information technologies that permanent improvement in their care by 2011 to the maximum extent possible. And knowing that this is just the beginning of the process, and not the end of that process. And that we will be continuing to design what we are doing, continuing to fill gaps, continuing to make things better over the next several years. So we appreciate your willingness to stay with this, and continue working at the piece that you were talking. We want to assure you that we are listening carefully, and that your work is helping us to do our work in a very material ways. I will not take more time. I want to apologize in advance that I have to step of the meeting at about 10:00 for a couple meetings that I cannot avoid. But I will be back later in the morning thank you, David. Good morning everybody. This is John. I share Dr. Blumenthal’s awe at the amount we have accomplished. We wondered if it was doable. And those individuals who have not been party to all of the subcommittee work, let me just assure you that daily there has been conference calls. One of the questions that arose with the subgroups was to coordinate with each other and to triangulate. And that has gone on very effectively with much of credit to the office of the national coordinator who helped us with some very complex concepts. We have a tremendous amount left to do, that we are to do in today’s discussion. We wanted in addition to express appreciation to go through our usual process. We have adopted the process of asking if anybody has anything that they know to be in conflict in terms of personal interest with any of the items on the agenda. Let me stop and pause and ask that. If we go on around the room are there any members of the committee would that have any conflicts of interest?


Doug?


No.


No Gina? John? Ann? Wes? Floyd? Dixie? John H.?


I belong to a provider organizations so I am sometimes biased towards doctors.


No conflicts.


F Linda, member of provider organization and a better representative on the board of HITSP.


No conflicts.


No conflicts.


I am a member of the port of HL7 and the cochair of the committee, I do not have any financial interest but I do have a bias.


I have the no conflicts.


Let me just say that Jim Walker has joined by telephone.


Jim, good morning.


Any conflicts to disclose?


And we have a some people on line.


Okay we will continue on.


I trust that you had a moment to review the minutes. Let me just ask if there are any corrections or modifications or Amendments that anybody would wish to offer were.


Let’s declare that we have agreement on those and move forward to the meeting. Let me introduce the first part of the agenda for today. We obviously are going to come together with a division on our insights and standards to support meaningful use. It has been provided to us through the meaningful use workgroup and office of the national coordinator. And our focus was on the 2011 activities, objectives that we would want to support. We appreciate what this group has offered in not only identifying standards, and also assessing the readiness of the standards for adoption. And a great deal of thought which has gone into that and we’ll see convergence of the standards to support what is teed up for meaningful use in 2011. And, of course, there are caps and there is work that will need to be charged. But between that that needs to be charged and that is ready for adoption are two levels of readiness. And those that are essentially in progress and incompletion and those that are, in fact, chartered. And you can see the logic between what is really available in the year term, and what that requires for down the road. We have had some reports from our three work groups, clinical quality and the criteria for quality. How do we represent the data that will provide insight into performance? And they have done tremendous work on criteria work quality. The clinical operations work group has an extraordinary work in terms of providing specifications of the molecular granular data elements that are necessary for the exchange of information that underlies not only meaningful use but real life use of information for the care patients and the care of populations. Privacy and security Workgroups has also had the philosophy that has been tremendously helpful. It has been framed from the outset into how to make meaningful use possible and how to achieve the aspirations of health information for improved health care. Beyond responding to the development of meaningful use they were charged by statute in the high-tech legislation to attend to what we have been referring to as ARRA eight and the privacy and security standards and a great sensitivity towards pursuer perceptive how to understand assurances are created with. And the use of information are protected and usable and accurate and I try to avoid technical terms because this is really at this juncture is a gray from those individuals — — a segue from those individuals to a broader understanding to understand how this is used to improve health care. Let me turn to my co-chair John Halamka and I want to thank you for work that your organization HITSP has provided in terms of mapping the standards in a functionally defined manner to the concepts of around this.


Good morning, John.


Good morning. And a point that you made, we really took Mark’s comments and ask ourselves, what is the deployed ability of the standards that we are doing and all of the elements, and so you will see as we have in Dixie’s matrix and the the pliability for this particular purpose and we actually got quite granular and the committee. Thinking through in what way is the standard used today? Is it used with in an organization? Between an organization? And this sets within an organization is probably ready for a prime time and that is a good way of taking the work that has been done by HITSP, standards development organization, and the industry and putting it into a framework that people are actually going to sit oh, we can do that on the time frame that you have outlined. And Jamie has done similar things and where we want semantic interoperability. Of course, we want that, the ability of computers to exchange information and have data that goes between organizations that is untreatable. Can we have it tomorrow? Me it may be slightly aggressive. But we should not lose sight of the need to do it and say, 2011, you should but there is an account and in 2013 the out goes away. You have to use those vocabulary’s. And there is this wonderful ramping up and I think you used the term escalator we have to set the speed of the escalator so that folks could get on and would not fall off because it was moving so fast. I think you will see that spread throughout Jamie’s work and similar the work that Janet and Floyd have done and the architecture for how one describes quality and I think we can all it meant that when you look at the measures there are some gaps and there are some gaps of around how the measure meaningful use? How do I electronically measure the e prescription I did not write or paper based educational materials being handed to a patient. So if they have fought very clearly about what do you want in 2011 in 2013 and what can be electronically recorded in what has to be at the station. And their work which will continue on over the next several months is to put some scores on each of these measures just as Jamie has done about the deployability. And it’s really remarkable in the coming together of these groups, there has very little dissension. There has been great discussion. I think it was rather amusing that so many stakeholders came together and had such unanimity. So look forward to the day.


Thank you, John.


Thank you for your terrific leadership.


I suspect as many members of the committee were asked, John Glasser will update the status of the recommendations did the health information committee and meaningful use that we have been responding to. And I will amplify one of John’s point that many of us are often asked about this. This does change things. But I think my sense of the direction of activity is that the office of the national coordinator and all of the people involved in and academia and providers are joining together to want to make this work. So I think that really has been really encouraging for me to see each of the work groups respond. Bring together consumer perspectives as patients, users, advocates from the technical perspective what are the necessary prerequisites to actually put this in place, and help to serve health care more effectively. So with that let me ask David if there are any other comments that we wish to offer before we get into meaningful use with Dr. John Glasser.


Thank you paid as you know, meaningful use is at the center. In the June policy committee meeting, Paul and Douglas presented the preliminary recommendations and I have an opportunity to happen over a few of that presentation. And there was a public comment period and approximately 800 comments were received. That went into the work group deliberations as well as the policy discussion itself. Last week Paul and George, the new co-chair who has joined ONC presented a revised definition and put in the wide range of thoughtful and terrific comments that were received and I will give you an overview of what Paul presented at the policy meeting last week. I will move relatively quickly because they want to make sure that there is enough time for the workgroup are in this meeting. Also I doubt I can do these presentations the same justice that Paul did so we will try to hide that fact by moving rapidly and I will not be using any verbs for the next 20 minutes so I challenge you to go along with this –


Okay. Let me grab something here. Okay. It might be my Catholic upbringing — sing along in your hymnals, psalm 43 and we will go from there will. So the core thing and we will look at slide number four is to remind us from the framework that is behind the meaningful use recommendations that the work group came up with. That is the evolution using the escalator analogy, moving an issue from data capturing and cheering from 2019 to infanta and the processes and then dashed into an enhancement of processes and there’s a shift as years go by. If you go over to slide by, you notice the term used internally the North Star and they have transformed the health-care system that is remarkably more safer and of higher quality than the one that we have today, and realizing that there are multiple threads. One of which is the work in the HITECH and the health care reform agenda. So this captures on slide number five the central city of the meaningful use comments by a year, 11, 13, 15. And as we deliberate, we go to slide six, the conclusions and recommendations we have to consider a variety of things. One is the reform agenda that is under way. The other is to remind us that we are looking for outcomes not necessarily for the Software installation, etc., and in the course of moving the industry aggressively we have to consider the adoption rates are not what they are to be in a lot of ways. There are a wide variety of communities that would like to move but they do not have the resources to move. So there’s a balance, a juggling act between aggressive movement and the practical realities it on how far we can move in the state of industry today. And last but not least the fact that the legislation’s particular type prints and we have to be mindful and conform. So all of those had to factor in and be considered in the course of the discussion. If you flip over to slide seven there is a screen shot of one of the pages of the meaningful use definition that was presented in the June policy committee meeting, and given the feedback the workgroup frame their responses according to the categories. So they categorize the comments, and they might have multiple points across these categories and we will walk through these next couple minutes. The first on slide nine on V meaningful use framer, it was a wide lead knowledge that the framework was terrific and the efficiencies that we all aspire to achieve free and that the measures provided a good way of stressing, in other words, if you were able to record a wide variety you had to be using the EHR and you would have been having electronic laboratory results and the problem list, and you would have prescribed medications etc., and they did a nice job of moving us toward that to express those outcomes. And they exercise the broad range of EHR capabilities. And as we evolve Purdy’s a framework represented before — for these framework represented here and how the target is expected to grow as the standards and delivery of care will increase. On slide number ten with specific feedback regarding timing, and that is in the number of cases a concern about the aggressiveness of the schedule. In other words, can we really do all of this or can a large portion of the industry do all of this in the timeframe for 2011 is only some months away and there is some concern on CTOE and some concerns elsewhere. And if you look at these payments schedules, the goals if you receive the maximum amount of incentive possible that the start date was not January 1st 2011 or even the fiscal year 2011. And that is the work it mentioned on the last bullet on slide ten, the adoption. And that is, in fact, that we will illustrate that on the subsequent slide on page 11 here. As you see in that schedule this is a schedule that is part of the legislation that went out if meaningful use begins in 2011 there is a stream of payments that go from 11, 12, all the way up to 15 until the penalties can. But if you start at 2012 and you can start at 2013 and receive less payments. So the suggestion was that meaningful use start on one of these calendar years. In other words, if 2011 is a meaningful use year. So you could start using the 2011 definition in your 2013 and that would be your Year one rather than your 30’s of giving provide for some time. Because if you go out to party began to surrender some incentive but giving them more time to pursue some of this. Because some people might say I’m not getting on the escalator because it is moving too fast or too quickly and things like that. So that was one of the recommendations with this notion of meaningful use here to fundamentally give the industry more time to respond. You also see continuing on that threat in spite of is rather than the initial definition, we have all orders by 2011. So he began to move your way through the House or the inpatient unit. That might be some pilots and a couple units and we would not expect that all be done at that period of time. In regards of decision support we would want that to be moved earlier where there is drug interactions and other decision support here. But also balancing that if we need to actually have a EHR in place and you want to have the implementation done. So with their recommendation was to start with one rule, a fairly wide open on what that might be but make sure it’s relevant to the clinical priority of that organization or group of providers. And flipping over to slide 13, the feedback on patient and family engagement, it was to provide access to electronic health records whether it is a PHR type approach which is distinct to an electronic copy or could be eight thumb drive so they actually moved up those recommendations from 2016 to 2013 From response to that feedback and on slide 13 there were comments and there were measures on efficiency and quality and safety and we are mindful of the Health Care cost and record ability for both governments, businesses, and individuals and we need to be more focused on that. And the National partnership remark that was adopted broadly for the new police also has an emphasis on efficiency. And as we proposed some additional metrics with and associated set of objectives with that and you can see them here, all medications entered as generic when generic options exist for that drug class. Also efforts to reduce the inappropriate use of expensive radiology procedures. Two areas that are not dead center did EHR but should be factored into this is more of the administrative and financial transactions for the termination of eligibility but also the electronic submission of claims. So they brought in those two criteria that are appropriate. Nonetheless the are good recommendations. And going to slide 15, some concern about from the specials community when they looked at these, the are largely primary care measures and some are relevant to was in the specialty practice but most are not paid and by the way the special the measures that we made in our society, we do not see those year. So what about me? That is really the tagline for that. And sort of the recommendation here is that they focus on a couple of exempla measures that would be broadly epochal across a range of providers may be not all but broadly applicable across a range of providers. The other for the specialist’s particularly in the efforts to create a registries which CMS is working on it and that they contribute to their special the registry in the data that those treaties registry is contained in that would be more relevant to their measures of quality and the specifics of having quality reporting as part of the meaningful use recommendation. On slides 16, some feedback that we need better measures for care coordination with. And they point out that NQF is working on that and they also propose a 2013 measure of the readmission that often happens because of the poor coordination of care. In the second bullet that you can see on slide 16 is the concern. On one hand we want to encourage and motivate the use of health information exchange recognize in 2011 we may not have broad capabilities across the country. Some of their recommendation is that in 2016 that we might require an exchange given the exchange time to come to be and grow. But also to require the ability for change and make some additional recommendations to the HIE workgroup. And I expect that we will hear more from them. Moving in on this, the major comment was under investigation and we will hear from Dixie and folks around these lines, that you could become paralyzed or something along those lines and you can see the revised wording that they recommend is that to the degree that there is a complete that there is effectively an option for them to put an something that would resolve or have resolved the particular issue. To both ensure that people conform to the privacy and security regulations but also not to inappropriately keep them strong during the course of the pursuit of a meeting to address something pecans be the maxi and slide 18, of future work, we will give them a break. you can see on-site team, of future work, we will give them a break. And then you can see their future work is to review and revisit the 2015 vision and to redefine the 2013, 2015 measures and criteria. There are other areas, the process used which we have been working at to arrive on this definition. We ought to make sure that in the years that we have a process that is more deliver tip and there will be coming back and how to do the meaningful use definition calibration process and then like all of the stuff that they put out we need to monitor the industry to say, how terrific are the? When the confront the reality and have some feedback mechanism from the field into the meaningful use objectives and measures and refine them as appropriate here. I think in summary you can read, I will not read this for you, and encapsulation of all the work that I just wanted to give you a brief update on both their work and the revisions that the proposed to the policy committee. The policy committee approved these recommendations and has ordered them to David and ONC. So we’re looking at those internally and the want to thank the workgroup and there may be a question or comment on what I decide so we will take it from there.


Thank you, John. Thank you for all of the work that you have done in shepherding this work along with the ONC staff. They have been terrific as well. I want to put in perspective, this is something that Jodie usually does but she will Janet and how will I do on this. And that is too late, clique out the context of the Policy Committee and the workout that you all to — is to lay out the context for you are providing us in valuable recommendations under the law that created this policy committee. Those are recommendations to the office of the national coordinator. And they will be transmitted to the secretary. And they will inform the rulemaking process that will establish the definition of meaningful use. And that rulemaking process will result in a notice of proposed rulemaking. Under the current schedule it will be issued late this year. Probably around December, sometime in December. But that is not a certainty. The standard for Medicare Medicaid services will be part of the Department that issues that role because it will be governing compensation of providers under Medicare and Medicaid. So while they are extremely serious, they are not policy. They are not set in stone as policy. The same is true for your work. What you recommend to was will be taken extremely seriously, but will not be in policy by themselves. Your work will inform an interim final rule that will be issued by statute has to be issued by the end of this calendar year. And that will contain certification criteria and standards necessary to undergird meaningful use. And as you listened to John the talk and his comments on how we modified the meaningful use criteria and objectives as they go for word. I do not want you to misunderstand that there was our policy of the Department of Health and Human services. They are recommendations. And we cannot say for sure whether they will or won’t be in all other aspects adopted. Anything that you would like to add to that?


I think you did great. I think we can go home now [ laughter ]


Thank you, K one and thank you John — David and thank you John very much.


I know there may have been some questions or comments and you can put your name card up so let me see if there are any comments.


We will start with you John Halamka.


This has been a very aggressive process, one concern that we have as multiple iterations of meaningful use are issued, that somehow might not aligned with the work that we are doing. The good news is that you see across the multiple iterations that we have been working on the themes are similar. Pair may be slight adjustments, 10% for this and 30% for that. But there was not a substantial change of direction so there is a very good alignment in the parallel process.


Kevin Hutchinson?


Hey, John, the question on slide 16 that refers to where possible the information exchange which I think is very applicable knowing that not all lab results can be done to avert electronically these days. That is what I assume that is referring to pick where there might be pockets of transmissions that simply might not be able — we may not be able to have on the receiving end.


Yeah, listening to the work group conversation there is for imitations. Either the center is not able to send it ordered the provider might want to be able to send it to a recipient or they are not capable with.


I think the one thing that we should be careful of and what if we require certain functions, but the capability is not on the other end, it will make workload as you well know very difficult. They are still required to enter it in but I will have to print and fax it and send it but I’m still required to enter its even though the exchange is not available on the other end. There may be some workflow challenges with trying to make that functionality to fill the requirement even though the exchange of it is not a requirement.


And I think it’s to David’s point, we look these the route and in December you see similar or exact type of wording. There is a fair amount of work in the industry and how do we ease this transition because we will not have broad interoperability by 2011 and full EHR by 2011. So I think it will take collective, not only people on the committee but policy at large to sort through all of the approaches to minimize the workflow hassles and all of that. So I think we have our work cut out on the multi year transition and the minimizing.


Let’s go over to Stephen.


Of the 800 comments that you have gotten, have been categorized them in any way and are they posted on the Web? Is there any categorization that has been done that is posted on the Web? And if not is there any intention?


We did categories and by type of center, whether its a consumer group or IT industry or hospitals and there is categorization by concern or recommendation. For example, we are clear that a lot of the directors came up with [ Indiscernible ] recommendation that we did. And I am not sure of the posting of those for public review, etc.


They are available for public inspection and we have hard copies of all of them. We are still, I believe going through and redacting any proprietary information and things like that. Our intent is to make them electronically available as well but I don’t think that we have that up on the web site yet but it should be forthcoming.


Thanks.


Wes?


Thanks did I have a question for John. % want to pick up on something that can and said — First I want to pick up on something that Kevin said. He said that requiring the physicians to enter an order was not worth the trouble if it was not being transmitted electronically. My own analysis of what Steve colter gets what value for what part of the e-prescribing process, the prescriptions get a very minimal amount of the value and there is an argument for the efficiency of the overall system. They get the value piscine the medication information and having the opportunity for clinical decision support engagement as opposed to however much money they save and callbacks from a drug store. The reason I mention is not to pick on Kevin, but I think that we continually battle with this distinction between the good of society and the good of the efficiency and the good to the position and a lot of us have concerns. There was an article in the major media yesterday about position resistance to EHRs and I think keeping that talent and mine will be critical as we go forward. John, in the meeting that you reported on there were other topics that were discussed that were not discussed here. I just want to know what is the status on to the vacation, if there will be a comment period associated with that. I am not sure whether that came a recommendation of the committee or not.


Decertification group did had some high level recommendations that were approved by the committee but there was a request that they come back in August regarding the specifics. So the high level recommendations are focusing on meaningful use. And this sort of stopped there have that meeting. And so we are planning to bring them back on August 21st, I believe, to be set for the recommendations regarding how they see the near-term and long-term carrying out the certification process. There was a public hearing that they held on the 14th and 15th of July that had a party of testimony from vendors and purchasers of that was open to the public. And there were summer in comments received here. We have some decision internally were the we open a public comment period. And I doubt that we will do that at this point. We may not have a fully, , and period. And there was the presentation at the policy committee meeting that we may not have the additional comments period.


Obviously waive the fact that public testimony before the recommendations does not constitute comment on the recommendation.


Correct. So there was a hearing of the issues and concerns, etc., but there were not recommendations put on the table on the 14th and 15th. There were at the policy committee but not on the 14th and 15th.


Let me say one thing. The Professional certification process, and the certification process that we develop that — there will be an opportunity for public comment. So there is opportunity for the public to make comments at the work group meetings when we have a public meeting and there will be a formal comment period at some point in time when we go through rulemaking as well.


Soever approaches, we will go through the rulemaking process.


That is our plan, yes.


And I know people asking when, but do you have a sense of when?


That is a good question. We are trying to put it up with the other regulations that we have been talking about. I do not have a specific timetable right now.


Okay.


Next question?


I think this exchange [ Indiscernible ] and need for comments and have been much of my life in Washington the rulemaking process can introduce many opportunities for a commentary which I think the volume of responses to meaningful use Web are aware of and encouraged to take advantage of those opportunities. Any additional comments or questions for John Glasser?


Ann.


Is this final version open for comments?


The public comment period on this as closed and we now have a recommendation that is going to Health and Human services. And as David mentioned this will be part of the CMS portion of the rule so when they came out with that in December there will be a subsequent comment period. Right now it’s close but once it comes out in December there will be a public comment period.


He reported that he would go back and look at June and look at 2015 for more?


I think the work group has been focused on 2011 because of the reg writing and they did not have as much time to look at 2013 and 2015 so after their break we will revisit with them with what they would like to do with that. But I think they will want to go back and whether the change anything, I don’t know. I don’t know if it results in making modifications to that.


My only concern that this is the last chance. The disclosure is in 2013, and the accesses in 2013 to consumers. So I don’t know if that would make consumers be concerned about knowing who is accessing their information.


One thing, when it comes how you all can collectively read it and expressed concerns along those lines would. And let’s look at the work group regarding what they want to do for 13 and 15 and whether they want to take a repine shot at that and when they present initial thinking. So I think there will be opportunities for people to come back and say, I have an issue with that.


Thank you.


Okay.


Just to be clear, what is the timeframe of the CMS proposal and what is the length of the comment period?


The CMS, there are two sets of the deletions of focusing on meaningful use is due out mid December. So there will be a 60, 90 day –


I think that CMS will require to have at least a 60 day time period. That is my understanding. And our internal rule, we have at least 30 days and we have not made a decision about whether it’s 30, 60, 90 and CMS would be at least 60 and ours would be a minimum of 30 but it could be longer.


So after December, two to three months.


Okay. It — got it.


Okay one more question, the HIE debate on the policy committee was not finished. Will there be additional debate around some of the HIE recommendations before rulemaking starts?


I presume that they will be back in August with refinement of that kind of stuff. And obviously if there is a recommendation there we will have to factor that into the rulemaking process.


Thanks.


Okay.


We appreciate that. I should also say that despite [ Indiscernible ] which processes are very — the balance of the opportunities to allow and encourage commentary on David part of this discussion. Jodie do you want to close out?


I want to make one point, in the policy committee as well as this meeting there has been questioned about the process and when there will not be a commentary in what is will making and what is not. And we have heard that loud and clear that there has been some confusion. So we are trying to put together a very high level outline of what our process is that we would pull Center Web site. I do not have a gap anybody who is on the list, we will let folks know — We do not have a gap anybody who is on the list, we will let folks know at a very high level to see what is going on and if we make any changes and we will make sure that that you have seen that data.


Traffic. And just to show that there is responses, and the idea of time lines and this is part of that. And your question about the things that are keyed up 4.11 those of the markers that are helping orient the field — keyed up for 2011 and thank you so much to the entire staff for your incredible work. Our appreciation and George and the meaningful use workgroup as was.


Now to our work and we will get really into the bulk of the efforts of this group. These are decisions all areas in terms of going forth with recommendations. And what we require for the work and Dr. Blumenthal has outlined to was with the time frame is for 2011 and what is deferred to 2013 and beyond. With that said, let’s switch to the first of the workgroup presentations. I am going to invite Dr. John Halamka to moderate this section.


So you see now a series of three presentations that build on each other. We will start with quality that gives us the framework to measure performance and you see from Jamie the standards that would be used to link hobos quality measures and then from Dixie and Steve on how you would ensure privacy in their transmission and other aspects of security. You will see that each of these presentations include two types of presentation material. The report of the committee in PowerPoint format and the matrix that gives you incredible detail on the exact nature of the standard selected. And as mentioned you will see from both Jamie and Dixie the measure of maturity or deployability. And in the case of Jamie he has shown you this. And they are both using the same sort of notions that John introduced us to pretend they are clearly ready to implement now, four is a glimmer in our eye and some between.


Will you be doing the presentation?


I will be doing the presentation.


Okay being thank you.


Thank you for the opportunity to present. If we go to the first slide, just a process to show our meeting. I can do that. I’m sorry. Thank you. That we have had two conference calls with the Workgroups on June 22nd and July 15th as well as consultation with the policy committee where we met with the meaningful use workgroup and presented our findings as to the operations group. And we received feedback from them and also presented to the policy committee on the 16th. So we do have a lot of interactions back and forth. We identified a potential set of existing standardize performance measures corresponding with the quality measures that currently have been approved by the policy committee. And from that sat there are some gaps where there were no measures. We have selected indorsed quality measures because endorsed measures have gone through the process of consensus and assured the of the evidence behind them and the value of the measures. We also identified specific data tapes and I apologize for the new acronym, and you see QDS, Quality data sets which are the key elements to use to calculate the measures of. And we have handed that off to the clinical operations work group to identify standards for use. And the National Quality Forum database has approximately 512 endorsed measures at this time and others are going through endorsement in the pipeline by the end of next week. Others are through 2009. It includes — we includes measures and used by a CMS for hospital and ambulatory reporting and the Alliance measures and position codes — physician consortium and also under AHRQ funding convened a health information technology panel for creating a framework for the types of elements required to measure quality. And this includes a quality data set that indemnifies codes and their related context with used to create the quality data element to identify its use with an electronic help records. And the HITECH draft report was out for public comment in the final is in progress. And it went out last night to the full HITECH panel and we expect publication by the 31st. Except for some minor editing that will occur after that will be out on our website for a full reading. The types of data necessary to calculate and report performance are present in the data said. We also identified data flow attributes. So that they can identify from Houma or what the Vice went in to — what device went into and what setting it occurs and and what health record field or location it would be expected from and there are currently over 56 data types identified and that will health us with the future framework. And we have identified four measures to hand over to operations. And on our hands out of the Grand there are 27 performance measures. Part of our additional work which we will be after this meeting will be to add scoring and thresholds to the measures that currently exists. There will be some additional work on that as well. The recommendations are provisional until we go through the threshold. You’ll see and I will give some explanation of some of the reasons why earlier portions of the — or some versions can be used in 2011 are more robust in 2013. Some of the retooling when we talk about these measures, they are geared for claims, submissions, or manual chart extraction. So there needs to be some retooling rather than creation of a new code that says that hemoglobin is less are greater than nine. It is looking for that there was a hemoglobin A1C for a diabetic and the term it was within a right threshold. So that requires some retooling. I will show for slides that are not in your slides said to explain what that means and we are seeking standards committee approval understanding that there may be some changes. So just to look at a single measure this is a measure published as A description out for public comment now if you go to the HITSP site. This is for stroke for inpatient care and the anti coagulation therapy. It focused on extractions’. So any patients that have a stroke who have this need to be prescribed anti: — anti coagulation therapy and they are identified using an algorithm and also had stayed and definitions and the data dictionary and also three or four of tendencies with all of the data elements. So in order to describe this more clearly knew what we have done in a process that I will put in my HITSP data — I’m sorry, my HITSP quality Tiger Team, what we have done is identified the data elements and definitions and logic. What is new for retooling is would be the organization. Where do I find it in the record? And the code set or values at that represent each of these elements. The measures already identified the logic based on evidence and it’s the code stop that is new. So in the grade in the report that you find on the HITSP site it talks about the elements common definition, and logic that exists. And where would we expect to find that in eight EHR or interoperability format. Where are some comments about buy and where we find the value sets. In that process for this particular measure, it has modified what might be an ICD9 to a Snowmed codeset so there are both for the specific measures. And the next step with the tooling is to put it in a computer readable format. We would not expect the average reader to read an exile document but a computer could so that is a process that is in development now. And five e-measure is coming forward in HL7 for public comments and goes and on the week of September 20 if that will incorporate the performance of this. The.


If we look at Gap’s there are some measures requested four additional resources. And using CPOE. For the current 2118 is likely for collection. There are some structural measures that we have endorsed that request at the time each patient is discharged from — or send home from the office, if the electronic prescribing it is not performed at an additional form and they felt that it was adding additional work for the conditions and they preferred that we do e-prescribing in office rather than adding a code. Although those measures to exist. We do have some clinically enriched measures. But they do not always taken an edge of the clinical data. And one example would be patient with high-risk for cardiac events on aspirin prophylactics and we will need to identify that aspirin is on the medication list. Some measure is required data types that will be challenging to capture. Even though we have endorsed measures as a look at this we have a pediatric measure and a adult measure that is greater. And there are two measures with slightly different criteria. So there is a challenge in trying to align those two instead of collecting one measure. We also would expect some specification differences. And you will hear that more run the operations group where everyone may not be able to use the SnowMed value sets for 2011, we would expect that for 2013. Some measures also required data when there is no standardized means, embolism asks for the use of eight anti for robotic device — of an anti phlambotic device or anti coagulation and there is no standard to identify devices, they are all local codes and to know that it was placed on the leg is another issue. And some may require data that is costly to collect. And the example in the profile is not that the profile is costly, but the measure actually asks for the theory of the profile. In our workgroup we identified that it’s only the LDL that is needed on follow up, and if we ask them to look at profile all the time we may be encouraging overuse so looking in some of those measures, those just came out. Significant harmonization, they should be patient centered and current measures to bury someone across said Deans whether it’s in the hospital, ambulatory — do vary across settings whether its hospital or ambulatory. So these are some of the challenges that we can address. This was part of the talent in selecting the measure on your credit. We are currently in a detailed review process of the detailed measures and a subgroup of the work group will be reviewing all of the details of them to provide guidance for retooling and identifying any changes. Also to identify thresholds’ for performance and also some scoring guidelines. So we will be classifying them for a degree of readiness and scoring and also the thresholds. That is our next step. That is the full report.


Thanks. Just a couple of comments. You highlighted how HITECH looked at the workflow, where do you capture these measures? Because if something is an observation with the time the stamp at the moment that the nurse pushes the fluid versus a diagnosis created three weeks later, that is clearly an important distinction with that level of granting a rarity. Who is the actor, what is the event, and Wendy capture it in the workflow? And understand the types. There are both nouns and verbs. A noun meaning medication or a verb may be administered and they may happen after be like date/time so we will declare an measure that based on the fact that it was Please stand by whilecaptioners are transitioning.


Jamie’s group, said, how would you actually represent the particular event that will transfer to – – metric gathering organization. A quick comment about some of the gaps. We chatted in one of our meetings about that it is challenging the measure some of the methods. How do you figure what you’d – – are you prescribing what you did not E prescribe. It may very well be 2011 which is the best but there could be proxies. This may be controversial and not accurate, but if you imagine that I got the number of E prescriptions that I wrote and a number of encounters with patience that I had and not certainly perfect and normalized across specialist and PCP, those that are young and old and sick and well, but if you throw it 100 prescriptions with 100 encounters versus 4000 patients and 100,000 encounters, it give you a qualitative sense that E is being used. This call was every time an encounter is close, have the physician check the box. Wrote a prescription or did not? That would clearly be a burden for the workflow and require modification of the existing HR system so did not seem a rational approach. Lastly, one of the things that you saw in the presentation, those vocabulary – clear coordination between quality and operations had occurred because we know this is a big moving target. I seen nine very commonly used today, Snowmed being introduced in clinical the day but maybe not ubiquitous by 11 maybe by 13, so it has been in their quality data type work a recognition that multiple a cappelletti might be used and may be passed over time to use the various to vocabulary’s. Let me open it up for questions based on the presentation and the matrix of the 27 items that you see.


Always the same hands. First of all, I want to say that this is a wonderful piece of work. The business of going from the high level concept to the thing that looks wonderful when you first talked about it to what really makes it work. It is such a slogging through the mud and the work that has been done seems to be very positive and potentially doable. I have a couple of the questions that may have been answered and other context. I would be happy to take a reference instead of an answer. The first question is in determining the denominator, these measures to look like queries from a database, all patients were over all patients – there seems to be some conditions missing in the queries. For those environments where patients are not an arbitrary Administrator Lee assign to whoever you are measuring, were there are patients who come in and come out in the community health center, it seems like determining what other patients that have to have a measurement in order to do the denominator is difficult problem. The bigger question and confusion I have had in this process is what we believe is the scope of the EHR? in most organizations that I’m familiar with, if you want to answer these questions, you do not go to the computerized system, you go to the warehouse. There are a lot of reasons for that. Some good some not good, but all real. If in fact we are in a meaningful use measure, determining the eligibility of a hospital or a practice to receive incentive payments for its EHR, can we ask it to do more than the EHR does or not? I hope that we do because this is what it is all about. I just want to understand how we do it.


I will start briefly and turn it over to Floyd. Denominators are challenging. You can imagine that Floyd said in a slight four that diabetes can be defined as an icy nine code. It could be defined as a non – you are on insulin and maybe that people on insulin had never had an diagnosis and 250 URLDOT exe. You want to look at multiple possibility in the fighting that denominator I am sure Floyd can describe the thinking. Regarding the date of house question, they have a query capability built in. I have an abstraction on a nightly basis, the EHR vendor itself provides a duplicate copy of technical data that could be queried. It is becoming more commonplace for his products to allow identification of who in your panel has set a particular condition our issue, that is part of many employee use. What we are spacing the next sitting is if you have a capacity and / or your environment that has a and EHR warehouse of generating some of the numbers. Floyd please comment on those.


For the two questions, the first was pretty much attribution. How do I know who is in my denominator? Most measure developers have determined that perhaps in the ambulatory area asking have you had to this is within one year? Very likely that if you are looking at a specialist and primary-care physician, each of whom have to visits with the patient, you can say that the they each have attribution. That is a master developer decision of how that attribution is determined. The data element becomes an encounter. The date and time and you need to of them. Each element is you need to of the data elements or presentations. In hospitals, it is admitted so that is a little bit easier. On the question about use of the HR, when I mentioned the data flow attributes of IT expert panel looked at, they identified health record fields and it was not down to the exact field, but it’s is suggesting that I finder conditions on a problem list and so if a problem list is used, in the EHR, that makes it more meaningful because the problem list gives you the condition that are going on with the patient at any one time and adds value. The fact that Your medication come from the Midwest, and the fact that you are on over-the-counter aspirin for profit taxes, because you are over 50 and are preventing coronary artery with the system or you have an MRI and presenting and occurrence, since it is over-the-counter there is no prescription for it. The fact that it is in your medication list, it beat it allows you to see all the medication together and potentially do medical interaction checking. To find the allergy, it is not just in the note, but we expect to find it in the allergy less. That is how we suggest that it is applied to EHR. What that means is if it is in the data warehouse, they have to identify where it came from. So the allergy had to come from the allergy list to make it meaningful. Or and intolerance can come from the allergy list or and tolerance less. That is where we see the connection.


Usually there are two reasons to have a data warehouse. One for additional functionality and determining things and the other because my enterprise is badly fractured in terms of how it serves individual conditions. – – clinicians. If I understand, it is a good challenge. You are expecting that enterprise to solve that problem in order to get payments for a EHR. Many of the visits for a patient may not be in that EHR.


I think what we are expecting is the EHR is certified for use of and containing a problem list and allergy list, way Med List. And have the function to manage that. If that function is obtained, a service from the warehouse and that organization, I think that is potentially acceptable as long as it is in use.


For example if we use here at traditionalist, two it encounters a car with a doctor, they’re required pitch – – whether you access it by clearing the HR directly or querying a data warehouse, would be fine?


I think your question would be what if they visited somebody and did not have a medication list? Or allergy list?


I cannot count the fingers and hand in this room that the numbers of medical centers have a difference record for inpatient and outpatient and the metal or third record, they’re reporting for quality measures, there are – – it does not imply that anyone of the users of those three systems have a consolidated problem list or medical West and so forth. I am happy for us to do anything that actually measures quality and that is fine. I am having a hard time connecting it to paying for one of those three EHRs in that setting.


I get the challenge and interesting question for the group is let’s imagine that the hospital has out information system with CPT and EHR and prescribing software and has a warehouse and it turns out that you did get a medication list, but it actually came from one of the data sources and used for reporting qualitative measure the they still get credit, because the quality measure came from the Organization, that is an interesting question.


The only thing I would say differently about the question is they have EHRs. Our assumption is that they have en EHR for the entire organization. That is how we are organism ourselves conceptually so the different products they are putting together have to be [ INDISCERNIBLE ]. They have to be really clear on that because it is not the state of mind that people have when they buy brand X for ambulatory even though they have brand wife for inpatient.


Take my own organization, I have a single jay-10 across my own physicians except for the transplant team. They have a very peculiar need for doing specific reporting so they use a different EHR and then I have a different a chart for my none known physician in my community. For me to do declare meaningful use, I have to report to three different system capability reporting the measures.


For you to report quality, you would have to do that. Okay. [ LAUGHTER ] we are clear on the confusion.


The take home point in all this, that final bill comes out, there is a notion of linking the EHR to the capacity report quality, we really have to make sure that the data that came prom EHR and ended up in the warehouse versus some other system and in the organization reported it. Or we have to knowingly accept that we made a compromise that we will move forward.


I think you are next.


It occurred to me that the readiness if any of these measures seem to be a function of both how easy it is to capture the numerator and denominator, as well as the maturity of the vocabulary that is used to code it. I was curious to know how you plan to assign a read it as a value to these measures?


Actually, part of the redness, it you will hear more from Jamie in the operation side, but it is the maturity of capture and the maturity and availability in use. The terminologies. Snowmen is there, but how often it is used, – – Snowmed. You will see that it can be used in 2011, but it will be expected to be used in 2013 and 15. So hopefully that helps to answer the question, but that is what we would look at, that ease of capture and the maturity of terminology.


You would take what ever comes Jimmy comes up with and factor that in their assessment to how easy it is to capture the value and then assign the intersection.


In some cases like the eight sample of every time I send a person home from the office, I have to enter another code, there is a measure technically, technically can said it is mature, there is a G code RC P2 code that will do that, but that is considered by our team to be contrary to workflow and adds an extra step so that was not felt to be what the team wanted to use.


This is work that will go on over the next month because the books were writing that will really want this information available so our next work-group call.


Regarding WESs, an area, we have not said the work certification in terms of getting the source data consistent to any kind of mechanism, is that another group of people working on certification decide us? Of that EHR? In meaningful use – – the ability to exchange quality measure, should there be an entity that can receive them. Just a capability to do this. Comments that you would make? I do know that CCH IT has an advance Quality certification workgroup that is working in the very near term to have advance Quality certification criteria for EHR, but I believe that is 42013. There are currently certification criteria for EHR to use the problem less. TSA Med List and reconciliation. I believe, one of my additional responses to Wes’ comments, in order to achieve if I remember the wording correctly, to achieve meaningful use, you have to use a certified EHR and you have to use it meaningfully. So the assumption was you are using when we look at these measures, you are using the certified EHR and using the certified components, you are meaningfully obtaining the data needed for the measures. That was the direction we talk.


2011, looking at the metrics, requires the reporting of this quality measure to CMS been one thing that is not specifically discussed is CMS capacity to receive them at this point.


That is correct. I agree.


I think next we have Chris and then Kevin and then dug and then Wes.


Not clear to me that this is a fully question, but I will ask it to the room. It is picking up to what Wes had said. In the context of the earlier presentation, John, when he was presenting, what happened at policy particularly with H. IT, it begs within the enterprise communication, and the Fargo is the whole notion of patient safety, if it is the whole notion of meaningful use within the context of the enterprise, then multi vendor environment, effectively might require if we think this through, the moral equivalent of a HIE with an enterprise. Be that manifests as the warehouse, the benefits of some other kind of communication between systems because in our own environment, the May 0 clinic, we have the campuses and we struggled fiercely to make sure that what happens in Arizona is known to Minnesota for those patients that move back and forth and in a smaller scale, what happens to the transplant surgery might be useful to other care providers and vice versa. It gets at the scope of, you can have meaningful use of in and instituted and an instance of an EMR, but it is not really from the perspective of patient safety and perspective of meaningful use across the enterprise. Where we want to be, but how we reconcile that does not seem to have been addressed.


The H IT work-group is looking at enterprise the Enterprise Communications and we recognize in the interest of coordinating care, making our own organization talk to themselves can be a challenge. Although we have not in our particular deliberations talked about our architecture issues inside the organization, mandating specific code sets within the organization, we have always said border of organization. We may use proprietary cards, but if you transmit to the outside world, they must be translated into these industry standards and the man cultures. Your issue of encouraging people to get their own houses in order if they’re going to commit to the outside world is a very good one.


Kevin?


I have two comments. When the Apollo with what Wes is saying. We have to accept the fact that we will have multivendor environment. By multi vendor, not necessarily a multi more bender, you will have some vendors that built the airport tools and have left capabilities and E prescribing and longitudinal records for patients, and so there is going to be the classification of meaningful use should be down to the level, are they providing an ability to pull this reporting and capability of storing the information sources are my using System A, B or C? Because there is the best of breed approach in the technology world and then the single vendor approach and I don’t think it is who is this committee to describe which of those is the better path to take, single or multi vendor. Especially large enterprises, it will have multivendor environment. And you will have partnerships that created between the technology companies to fill the gaps to help meet the meaningful use criteria. My real question is maybe this is for Jody. A lot of the measurement, because of the funding and the incentives are Medicare based, are the percentages that we are talking about just around Medicare patients since it is tied to Medicare incentives or are the percentages is tied to all patients? Data physician sees. I’m not sure that – – I heard there will be a CMS regulations. Is it specifically around a percentage of populations from Medicare?


Certainly Medicare and Medicaid, but I would think all patient is the goal.


I did say we would be looking for your advice on that and then figure out legally what we can and cannot do I would defer to David and John. We would go on within HHS and your point Kevin, is important. It is not without precedent that CMS has taken the perspective that [ INDISCERNIBLE ] has relationship with the fast – that is of course the relationship that was established with the aid to cap patient experience survey. That is very well taken because [ INDISCERNIBLE ] architecture in his internment different system related to set of patience and there is a broader sense to – – will take a moment to recognize that we have been joined by Dr. QI proc, the chief technology officer for the White house – – Dr. Chopra.


Kevin’s point is a very good one. Let us reflect for a moment on the three possibility of the certification market recently outlined that the comprehensive EHR and the EHR composed of modules and the [ INDISCERNIBLE ] a chart. If you have an IPhone App for laboratory – – resulting and another asked for E-prescibing and they are completely different bet vendors and system and capable of – – from a clinicians office, should that be – – rather than a single comprehensive test EHR? And you would think that would make a complete sense.


I think we have dug next. One of the things that strikes me when we are thinking of the quality measures, but we are trying to do is measure things like evidence based practice and what is the best care and ways of both quantifying where we are and if you take a look at the gold that 2015, we want to be driving to with continuous improvement. One of the things that strikes me, do we need to consider as we think about the quality measures to build into the process, the ability to support clinical research or be able to do comparative effectiveness as part of gathering this particular information because if we think about it now, it may be much easier for us when we get to 2015 to continue this process. So that it is not just that we have 90% of the diabetics that are under good control, but in fact, we start driving further because we have a instrumented our system in a way that would support ongoing clinical research and clinical quality improvement.


[ INDISCERNIBLE ] has been working with H. H. S. and ANC and Working Group, clinical research and Data Standards and your point is a good one. Many of the data elements we’re seeing are not gathered as a byproduct. The actually require at putting the form putting to – – that are related to the clinical trial and go into a repository. It would be reasonable I think to have our body of work reported to this committee at some future date. And I know Floyd have a comment.


As I look at many of the measures in our database, many require additional data elements which we would call quality data set elements to look at risk adjustment and identify other issues are around a population that is being measured to add to research. Many of them already do that. The measure is self may include five or six elements or 15 elements but there is another set that gets reported with that for the purpose of risk adjustment and analysis. I would see that as an additional quality data set element to do the same. As John was saying for a clinical trial, there were elements that were not normally be in the record and many instances should not be in the record because not part of routine care. Many of the elements can be. One of the efforts of that clinical Research Group is to take what ever can be from the record and have that mapped into to pre filled the form and allow manual entry of everything else. A number of the measures already have risk assessment analysis – – to do that and I think will add to research. So [ INDISCERNIBLE ] continued to work on the – – like clinical research and trial. We will make sure this is coordinated with OSC and brought back to this committee.


Wes.


I want to comment that there was a breakthrough. I am not sure whether the breakthrough for a group or I finally caught up with the group but either way it is a breakthrough. That is that meaningful use that stimulus money, incentive money goes to either a hospital or a physician. And it is not directly tied to whether they have one product or many that the breakthrough is our criteria has to be specific enough for meaningful use. If they had many there, they are using them over their population as opposed to only some subset of the panel of patient or something like that. If we think about it, it is the responsibility of the organization to do meaningful things. Whether the organization maybe a practice or a hospital then I think that helps clarify many of my questions.


Based on these comments, I want to clarify the policy committee that they feel that interpretation that is the physician that needs to demonstrate the quality measures, reporting that these are being done. Regardless of the infrastructure it could be a self built in MSDOS as long as they can do the stuff. It is not the system is an malpractice. The doctor or the hospital.


John we have comments or thoughts?


I think it has been a terrific discussion. I am trying to InVision the real-life setting of 80 – – to suggest that – – all the answers and queries will come out of one ideally certified system is probably wrong. The juxtaposition of multiple system, front and, Data repository, logic engines, the query, et cetera. I think that you are right, Wes, there is a breakthrough, it is not monolithic, it is not one-to-one relationship with one of the systems. That implies a recommendation, I don’t think it implies that we can set policy, but it is – it strikes us. If I am hearing a consensus, there is an interpretation that is likely that the data element that are sought have to relate to the system that is meaningful that we use and certified. But the elements are probably captured by some relationship of multiple settings in many if not most seventh. I think we need to feed that back to the Office of National Coordinator and as John suggest, to juxtaposed with the policy group. That really is a clarification that is important to point out an exhibition that we also waste that is useful in terms of the relationship to the five elements that you described it. Is that helpful to the group in terms of setting that?


Nancy.


The follow up on that very theme, I think it would be as we work on the recommendation to zero Wednesday, we also need to clarified that that particular issue that the provider organization we need to be able to pull this data across several either several platform system platform or whatever so that they can report on their population of our panel. That very strongly talks about the vendors. The need to be able to have standards between themselves. There should not be – absolutely any to have commonality in that information exchange. Particularly, what I hear coming out is that clinician is going to need to see how the decision support is coming into play. So they can answer the question. Not it’s strictly a EHR to capture the data, they have to answer the question that how many patients that I will need to find out on aspirin, or insulin, or my immunization profile for my kids. In my family practice, very quickly, and I need to have good querying capability within the EHR. In my organization, I absolutely – I have different packages and the inpatient environment for critical care versus what I am using and part of the ambulatory and in heartier, when are part of entry occurs. That is a very critical across the continuum of care. We can never want to rely on one single product, but we want to be able to create a single view for that patient or population. I guess – I think in 2011 or 13, I think we should be able to say that as we talk to this and put this out in the vendor criteria population that they more than anybody will need to see the need for standardizing the information interchanges to support this.


Certainly the ideal world, the vendor systems themselves will in price of a controlled vocabulary. We know in the interim there need to be a proprietary card that are now between the system and some vendors may refuse to change. Might be an interesting challenge internally.


I love reading the materials and I am excited about the project made and I had a quality question. South of clinical trial and north of just running the practice and running measure, are we starting to see some consistency and in the business analysis six of activities that are people running – my perception ties that there is a team of smart people querying the data that decide whether A or B intervention makes sense. They may not be treating has a traditional clinical trial but looking at mechanism for quality improvement, are we starting to see some consistency on how people of a running back analytics and what can we do to help the major that is incorporated?


Good question. I think it varies with an institution from place to place. In small ambulatory practices, I don’t know we are seeing consistency. There are products that are geared to collecting data for the purpose of the specific measures, pre identified and when something changes or new one comes out the update the system. I think in most large organizations, there starts to be some consistency. I know there is talk that standards organization like HL7 about how to combine the terminology and the data from using for research and clinical care. I know some of that work is still in progress. Not done. I think some of Barry’s by in this institution and how we encourage that I think through – semantic inoperability tomorrow. It is not the EC solution.


I think there is an amendment when answer as well.


I am a researcher for the May a clinic. It is not clear to me that the analytic infrastructure is the critical piece. But part of it, Floyd was saying, it was the information inoperability. I want to point to the clinical research tiger team within its be that is starting to recognize that clinical Research Information Standards really must align with clinical information’s and the because if we have differences in those world, at the end of the day, quality improvement is really a kind of research at quality people do not see it that way, but it is. To the extent that we have comparability and consistency between the way they conceptualize information and the way clinical trial folks can sexualize information and clinicians conceptualize information and commonality across the mains, and if you – in first – best becomes frosting on top, becomes arbitrary because what is an important is to – – the underlying information is compatible.


Last week, I was in an integrating that enterprise meeting, in Chicago. It has been two years since there was a domain develop coal quality research and public health trying to see how to coordinate the data among all 34 you use, research Quality Measurement and clinical use. It was very interesting conversation that occurred when for the first two years, there was discussion of clinical research the state that that’s how I mapped and because of the research tiger team, the comments went through and we need to get research looking at data as a clinical use and not map it. There is a strong movement now to court denied that and I think it’s be tiger team itself.


We should move on to Jamie’s presentation.


I want to go back to your point about communication of the policy committee. The discussion emphasizes that need for information exchange and what I know very well is that hospitals and physician practices using EHRs are not necessarily capable and probably will not be capable and a time soon of sending Snowmed transactions. I am very concerned about the environment where it stands today and the likelihood of a small thing moving to 2011 pennant implementation and it is really important that we communicate that to the policy committee and the world that the health information exchange can play in that is standardizing of that did that and being able to report back and the Standard as format.


One of the important roles of the health information exchange is data information that you will get in format – – or they can provide a unified view.


I know that administratively, Judy, you want us to take action on this presentation and that is will there be any objections to accepting this report as – – work in progress and there is additional work going forward?


Okay. Very good. We will accept the consensus, thank you very much, Floyd and let us move on to Jamie and clinical operation.


This is Liz Johnson. We talked about in years – and this committee last week, Thursday, we heard adoption. Are we going to do any correlation between 2011 and adoption of your one?


John?


This is a discussion we had in the clinical operation meeting and that is John, you have been the case of HIT policy committee and meaningful use has the sliding multiple years, do standards slide as well or do we really want to say Snowmed is is a statutory requirement by used in 2013, you cannot release slide that.


You may want to use the microphone.


You have to consider the fast movers and hence the requirement that front. The fast movers will be start early in 11 and in place in 13. If you want to put requirements out in 13, fast – that is my suspicion. But you ought to debate. Does that make sense.


If we go through in some detail in Jim’s presentation, our Kendal years rather than meaningful use ears.


You are going to guide product development and some years the met some people will be 13 in meaningful use three and they have to be – I don’t know – my sense is this is the guidance that you will all the side. You know more about calendar years, mean pull years is payment related mechanism than it is when the vendor products or self development or whatever the strategy, when do day – if you are in meaningful use year three and you ought to move to proprietary from standard then you will do – – if you are a vendor you better be ready in calendar 13 even if the customers are in meaningful years one. If that makes sense at all [ LAUGHTER ]


To summarize, we as you’ll see in Jamie’s presentation, ICD nine is acceptable for 2011 and Snowmed would be great if you can do it, but by 2013, you will be doing ICD 10 and Snowmed so we build calendar year progression based on the statutory agreements going on in regard to changes like ICD 10.


I understand you are saying that the interpretation and the rest of the world was when we talked about adoption year, if you chose to make 2013 your adoption here then what we’re now calling 2011 standard would apply to 2013. If you look at the slide as a meaningful use presentation, that is the way it showed. I am confused.


What I heard the policy committee say was – there are two requirements for getting your incentive payment. One is that entity adopted a certified product and the other is they are meaningful use of that product. What I heard is the second half, the meaningful use part. Recommending that if somebody enters and begins to adopt in 2013 that they should meet the criteria for meaningful use year one. That does not necessarily – I did not hear them say that the certification requirements should be different. For the product. So let’s assume that ICD 10 is a standard for 2013. Somebody who starts adopting in 282011 will have to move and ICD tend to 2013 and somebody without in 2013 would have to have a product that utilize ICD 10.


What [ INDISCERNIBLE ] was given? What I heard was if you are in the first year of adopting, you might not be able to report the quality measures because it you are for starting to get your system up and running and capturing data. Perhaps if there was a requirement to have the capability of reporting on a particular measure but not reporting in 2011, there would be released in 2013 from having two up the reporting requirement the activity that they’re doing.


If they have CBOT for 20% of order and C POA for 50%, somebody who stars adoption at 2013 will have – will be held for the 10% Hispanic so that is really is. What I hear is there is no relief on the standard side. Is that correct? What we are saying is you may get a relief on the CP 0E adoption by fourth here getting to 70%, for example. In a standards perspective, the way you report the data, it will step up whether you start in 11 or 13.


The measures will be by Ed captioner, but the standards will be by calendar year.


Let’s see your presentation then I’m sure we will have a lively discussion.


Thank you . I am Jimmy Ferguson from Kaiser Permanente eight. First I will – I have a slide listing the workgroup members and most of whom participated in a series of calls. We did have similar to the quality workgroup, we had additional cost, we had some joined with them and we have had quite a number of hours on the phone in the last few weeks. Coming up with the recommendations. I want to thank everyone for their participation. First I will summarize what the whole presentation says. We have it used to a two phase process, the first to identify applicable EHR standard and then to assess the feasibility of implementation of those standards for widespread implementation according to 2011 versus 22013 versus 2015. We addressed almost all the measures. INT the very end there are a couple measure we missed and I will ask for permission to go back and look at the same and information as it applies to. We started as we were instructed looking at the applicable department adopted recognize or accepted standards. So that is what we are recommending for 2013 and 2011 as they apply to the measures. We did identify some gaps in the standards that might affect the use of the scope and measures for 2011. And lab results, there are no adopted standards for every four blood bank and surgical pathology or genetic test results. How those kinds of results can be reported in a standard, no currently adopt the standard that is something that we will work through. In general, while we are setting a level of standard that is the current adopted standard for the 2011 measure, I think we should be required for 2013, for 2011 we are allowing a degree of flexibility in our recommendation in terms of the use of unstructured documents including PDF and text instead of structured continuity of care documents and also allowing local and proprietary coding systems to be used instead of ICD Snowmed. There is some flexibility and I will go through the reasoning so that is my summary. In terms of the process that we used, first we did go through in reviewed the meaningful use objectives and measures. We focused initially on the quality measures and came later to the coordination of care measures. We identified dies existing DHI standard that could apply to the meaningful measures. We looked at that existing adopted recognize and accepted standards first and also looked at and listed other widely accepted and widely deployed standards. That could potentially be alternative. And look at and listed those as they may apply and also identified caps and the standard for the measure. And we did this process looking at standards for the measure both in relationship to the text of the way the measure was written but also looking at quality data sets the regard from our joint work with the quality team. In identifying what is in the measure the way it is calculated by the basher stored. We also identified the feasibility whites. Implementation of the EHR standard by 2011 or 2013 or beyond. We followed the same taxonomy which is also referenced here earlier. Finally and throughout the process, we took a formal step of saying what is our reality check on what we are recommending and we made some additional notes and wanted to make sure that this was a realistic set of recommendations.


That is the process that we followed and go through a particular example in some detail. As Floyd said, the existing standard for quality reporting are not geared to EHRs so the measure will now need to be calculated in terms of EHR standard in the future. So deeply here, we are we using standards that were adopted for different purpose. Some standards that were chosen for clinical interoperability are now being recommended for quality reporting. In particular exception to that, as Snowmed CT is recommended for the same purpose, but adopted for the consolidated informatics standard adoption which predate Hitsbee using Snowmed clinical documentation. When you look at the matrix of recommendations, you will see and you look later, you will see the same thing that are here and the visibility column and having been translated to the current the command of Hitsbee. That is the transmission between the process and actual recommendation. In this particular measure at we are looking at a position that is high risk for card it events for has been and identified that in terms of the adopted and recognized standards, we could use the standards that are referenced in the Hitsbee continuity document for E-prescibing and medication management. We did not see that there were any other widely accepted standards that were needed are applicable to this particular one of. We identified a couple of gaps. So back to the quality workgroup, we need a way to identify high-risk patients but also we did not bash the measure itself included a calculation that in part was based on patient self reporting of medications and there was not a specific standard adopted for that purpose. We thought the standards and that are the recognized standards were widely feasible for implementation by 2013. That is what we have in our 2013, but for 2011, we thought that a local proprietary code may have to be used. ICD nine may have to be used in 2011 and at the same time we do not want to penalize those who are able to get to the standards earlier than 2013 so you will see in the recommendation for each of the measure, we have in the 2011 column, the 2013 standard selection or recommendation and what we recommend as the allowable variation in terms of the local and proprietary closed, that appear in almost all of them. As acceptable alternative port for 2011 because we thought it was not feasible for 20 widespread implementation for everyone to get here for the 2013 recommendation. You can see in the reality check that we saw for the particular standards, they adopted standards are not currently widely deployed for this use. We have this discussion about that. As Floyd described, after these adopted standards approved for this purpose, and it gets back to the quality work group to oversee the detailed definition of the actual code ballets for calculating each measure and the particular recommendedstandards. We had a number of discussion during the process, I want to reprise some of them. We had a lot of concerns raised regarding the ability of those who have not yet implemented EHRs to get here. As well as a lot of discussion about those who have already implemented legacy to alternative and how they are going to get to this level. One of the main concerns for new implement terse, that was a ICD 10 and doing the same work all the work at the same time, but the greater proportion of discussion was really about the legacy system implementation that was already in place and what it takes to get to standards. As a sidebar, and Kaiser Permanente day, when we brought the different region two migrate to, system standards ourselves, we found that the loudest objections came from organizations that had already made that clear to commitment and investment in local proprietary system and alternative standards and I would not expect anything different. We had discussions on that. What we talked about was the longer the legacy systems are in place, the longer the proprietary and alt are in place, the more it gets built up around them and the greater the cost of upgraded to the standards. That is part of our discussion and making the recommendation. We believe we consider that fully. That is part of why we are allowing the degree of variation especially for 2011 and 2012 reporting. To summarize the recommendation. We’re saying that meaningful use based on the standards that are in the recognize and accept that accepted Hitsbee capabilities detailed in the attachment, it is recommended for 2013 and 2011 implementation of the 2011 measures. If you look at the detail that is in the attachment, and an actual Hitsbee documentation, there are many uses of the continuity care document as a summary record and specifications that are in there, the use of labs, are ex norm, drugs, and other standard, Snowmed is one of them and I want to point out that in some of the conversations and earlier part of the meeting, some folks recommend Snowmed will be required for 2013, that is not correct. We are saying that Snowmed or ICD 942011 or snow mad and I see the 10 is recommended for 2013. We anticipate the criteria should match the recommended standard and we did not have any length a discussion on certification criteria or process in particular. We are going to go through a single example, detailed example of the recommendations with this the percent of diabetics with under control [ INDISCERNIBLE ] that Hitsbee capability, you have to look at the attachment and the list of numbers to get the full context. The capabilities when 17 and 18 are inpatient and ambulatory prescribing. When 19 and 120 are structured and unstructured documents. 126 and 127 our lab results. You can see that this is a translation of what we have. When we went through the process we document things like CCD and labs. And actual recommendation, we translated that into the current document numbers that are used and accepted and recognized standards. When we say that ICD 94 Snowmed have to be used we are not specifying how BSI is stored or manage internally, but we are saying that you must be able to represent your data in ICD nine or Snowmed for this purpose. That principle was a subject of a lot of discussion and it applies to all the recommendations. Another thing that I will point out on this detailed example, you can see that we have local and proprietary cause and unstructured documents, they are recommended as allowable for this meaningful use measure in 2011 as alternative to basically what we’re calling 2013 standards. Those are removed from the 2013 recommendation for the 2011 measure. Also in 2013, we are recommending that ICD nine replaces ICD 10 and that is consistent with the CM’s timeframe four ICD 10 implementation and the current final roll from CMS. Instead of having 2015 column for say, we have what we call directional statement of intent. The direction that we think 2015 should go in and it is the recommendation of that direction, but we did not want to be prescriptive that fared far out. Remote device monitoring, there are is a lot of sender’s work and the way for home health device monitoring and so forth and it may be possible that those standards and specification for measure in 2013 but almost certainly in 2015 should be added to this particular measure. Snowmed CT so for clinical documentation, we believe is the target and should be used by 2015, but we did not want to be completely prescriptive about that so we are calling the directional statement of content is critical documentation is really the problems for this purpose should be done in Snowmed CT and now no longer ICD in 2013, but – – so we had long discussion about the feasibility. Of changing the documentation. Ozal this is about EHR implementation where ICD is really a classification system for administrative purposes and if you read it the CMS – that describes that – – ICD is for administrative and billing purposes. We wanted to maintain that split and we are really talking about clinical documentation of problems in health record use by physicians and hospitals. That is why Snowmed is then adopted standards for that purpose. To summarize the recommendation, we are requesting – the detailed recommendations are attached and a matrix so we can go through those to the extent that folks want to. We are requesting committee approval of the recommendations for the 2011 measures to be forwarded to zero Wednesday. We also missed a couple. These are in the second bullet here. Percent of encounters where it med rec reconciliation is performed, – – submitted a – – and that 30 day admission rates. The 30 day admission rate we deliberately delayed that one because we thought it would take too much time and we wanted to get our vote recommendation on the table. They’re the ones, we’re sorry we missed them. We are asking for permission to go back to see if the body of standards that were recommending or suitable for the purposes and we could ask for approval of an end to go ahead and recommend those but not to go outside of those and great new stuff. We also realize that the caps had to be filled somehow so we wanted ask Wednesday to determine what the process is for giving these gaps. A couple of comments, you have received electronically that document that identifies all the capabilities so if you see Jamie use those numbers, you will see them referred to the index. This is available in and an electronic form. As a PDF. As of this morning, all the Hitsbee work are available in indexed x HTML, you can find it in Wiki that – -


Makes it AZ to navigate because it is HTML-based.


Gaps. I think you heard Jamie highlight the yes. Important that coming out of today’s meeting because there are a series of gaps identified that we will work with ONC and that ONC will want to make sure that these caps are addressed by Hitsbee or organization as a prepared because we want to make sure that we fill those. It is important to see the division of labor between clinical operation and clinical quality. You saw will it come up with the measures. Jimmy came up with the mechanism by which the data is gathered, but floored once again came up with a specific code of values. When we say ICD nine will be used, you tell us that is to 50 that XX, and snowmen concept and that. That would be good coordination and interplay. It also purging make up about structured and unstructured data. This is the escalator over all over again. Would it not be plugged tablets if they have a – – a completely structured allergy list with you and II clinical designation on every substance the higher allergic to, food, medication a component and every encounter broken down into a Nye’s History of Present illness and chief complaint. We are not there today and in 2011 it will be a stretch. We will see in the recommendation is they have said 2011, structured great. Unstructured, okay. If you can take a PDF of the encounter that happens to have a human readable problem list medication list and note, that is okay. By 2013, we really want to have atomic and granular. It is a road map of getting us there. With that, we would like to open up for questions. Mark might have the floor.


We have a fundamental question that I must admit somewhere along the story here. We talked a lot about what standards and what Hitsbee constructs might be adopted. It is not clear to me because in one hand a little bit earlier we talked about we’re not worried about what codes and structures are used within an organization. But only when it hits the barrier. Are these the standards for transmitting because in some ways the measures described, with is the percentage of patients that have adequately controlled hemoglobin based on some criteria, and we are talking about CCDs and things like that which does not really – I don’t understand that.


Mark, this is Jamie. We are talking about a list of standards for example within CCD, Hitsbee made specifications within each template and same thing if we look at Labs, the number of different specifications within that and what we’re saying is the standards that are referenced in the specifications should be the one in this case the quality workgroup, specifies the core values for the calculation of the measure. We are not saying that this is the way that the data have to be represented and an internal database or anything, we are saying that it does have to be able to be whether through translation or mapping or other means, it does have to be reliably used for population of the measure it and in a specified code set.


The CCD is the part that throws me.


From my perspective, Mark, the transmission of data between two organizations, whether provider to provider or provider to buy surveillance or quality matrix organization, these are the standards that the work group has proposed for those transmission between organizations, not for use within organizations.


In terms of our use of CCD and recommendations, many of the recommendations have to do with coordination of care. Both providing summary records for example, encounter summaries, longitudinal summaries both to providers and patients. For that purpose we are saying CCD is essentially the format for transmission, but we are not – in other cases, we are using the terminologies that are referenced within the Hitsbee standards that should be used for the calculation.


To be clear, when we are talking about transmitting the quality of measures, we’re talking about sending for example a percentage of diabetic that are controlled. There is no accepted standard for doing that. There is ongoing work. There is discussion, clearly level two or three standard or category three, whatever. For that purpose.


Floyd ORG Jamie, you want to talk about KU RDA? KU RDA is work in progress.


KU RDA is address the standard for HL7. The patient level report which is all the data it is a level one. That is not calculated, what is your performance. It is for each patient. What are all the data elements. Level two is more for aggregate and three is higher-level aggregate. Level two and three is in May Testing – – is in a testing and level one is still is work in progress but addressed standard. And uses CDA format.


What is in our recommendation is not the actual transmission of the measure with patient level data, but what we’re talking about is the calculation of dent numerator and denominator by a meaningful user.


I do not understand what that has to do with CDA or CPD.


To summarize, and Jamie and Floyd, jump in. We wanted to do a couple things. There is clinical care coordination which requires a summary problem list medication list and laboratory information between organizations and that is the CCD. There is the measurement of the individuals performance process, outcome with regard to quality measure and you have specified the vocabulary is needed to do that. There is the transmission of numerous and denominators which is very much a work in process. What you said, Mark, QRDA, very early in standard creation process.


Those are the three levels of standards that we are looking met in the committee. My point is I think it is premature and inappropriate to include CD a, CCD under the bullet items that are quality reported items. Certainly appropriate for sharing information between organizations that CCD is still fairly early in terms of abilities to deploy. In the real world.


Right. Certainly CDA is widely used, CCD is emerging and the question I guess, coming back to the committee is we have specified the vocabulary that would be used and you will come up with the code sets and values, but the transmission of actual patient identified data to a quality registry, that is getting to the heart of Mark’s question. You see that the CCD document per patient or the see that as a different type of message board does that – – is that work to be done? We have not considered and specify that question and we have not specified in that consideration. It’s


In that case, for example, the Hitsbee 62 Guide for CCD includes some terminology, vocabulary standards in the relevant sections and those are the ones that are relevant to the calculation of some of the measures, not talking about a man’s of transmitting patient level data to a quality data recipient.


I would suggest to clarify that to avoid confusion by others by removing that reference. I do have another comment.


The work for the committed to clarify it once the measured at the patient level has been done and once observation has been made, how is that transmitted to a quality registry? David. David Macaulay. At risk of piling on, I want to agree with Mark’s point. The use of CCD in this context was extremely confusing because CCD is a data standard for transmission of a snapshot in time. There is no specification of what the snapshot has to be. Could be a single encounter, could be last year. It is for moving data from place to place. Does not represent internal state about the patient. CDA, describing clinical document about a critical does it may have a included the that that has specific instance. A CCD will not work in that context. Clarification is really important. Otherwise, vendors may assume that you are trying to imply that the CCD is a data structure which is


As chair of the revision process, I am painfully aware of the provisions of ICD. That being said, I have asked about snowmen. Specifically, while there is, in the Hitsbee documentation, a clinical numeration that is the list. It is not actively maintained, the best I can tell. It is widely acknowledged to by its developers to have specific gaps. It does not have pediatrics information at all. How do we sprays this politely, it has other shortcomings. Furthermore, the National Library of Medicine yesterday released a clinical problem subset of [ indiscernible ]. They are the National League designated Center for snow implementation. While I personally have not examined it, Bob has suggested to me that they are different. So, we are — since the clinical problem enumeration is such a core component of these recommendations set and very few clinical organizations have implemented this and even the men’s of what constitutes clinical problems, how do we for is this a tad fuzzy in United States? How do you see the reconciliation of the reconciliation of this moving forward as bearing upon Snowmed?


Obviously, there has got to be in maintenance process for the specification of not just Snowmed, but also the last summit list of labs and drugs and so forth. I really thought that was out of scope for our particular work group. If the current list that is an adopted standard is the list that is used by the Kaiser is VA my understanding is that NLM will be maintaining a problem list and that whether it is there a Hitsbee or another mechanism, there will be an adopted standard for problem lists. That is what we should be using. In terms of the maintenance of it and the degree to which if it does not meet the needs of the code values that are identified by the quality work for these particular measures, then it will have to be updated for that purpose. So — There is a broader question. Starting CHI work where Snowmed was first adopted and through the Hitsbee and FDA use of the problem was so upset, that is what we are keying off of. I am not disagreeing that has to be maintained, but we have selected what is there now.


So the question is, given that we have this rather long will these year ramp up, will we be able to achieve the clarity that you ask in these multi years? I have just received the above NLMs problem list subset. We are going to be implementing a tester over the next year. Certainly, I would be able to report back in 2010 how that is going and how to limit actually reflect on the 2013 application for Linda, I think you’re card foul. I imagine that you have a comment.


Just a recommendation to the subgroup to go ahead and invite the [ indiscernible ] to come and talk to you. You are referencing a number of things taking place in the federal space. I have done standards for a long time. Nobody has paid any attention. Now all of the sudden it is getting quite a bit of attention. There should be some fixes coming to the federal activities that are taking place. The more verbal you are, the more we have provider’s doing that feedback loop with places like the National Library of medicine. There will be able to advance quite quickly. Keep those communication lines open.


Stand.


This is a bit of a subject change, but as part of the deliberations on the subcommittee, there is the column there that is sort of, what is the feasibility and the timing appropriate for these? In that deliberation, the question comes to my mind is sort of, what is the target we are shooting for, feasible for what percent of the population or for what percent of people implementing systems? This is really not a question as much as is — a question, I guess, not in a sense for the subcommittee, but a question for policy or even maybe some insight into those who passed the legislation. Is the intent that we should set feasibility in that sense at a level that we think 90% of the institutions would be able to benefit or 75%? We are shooting for sort of an unknown target when we say whether this is feasible. But now, there is such a step, except from of skip — such a standard. Leading institutions would be able to meet almost any standard and others that are, basically, not automated of all, you are setting the standard. I am asking, I guess, if there is any direction that could be offered about whether we are trying to shoot for 90% of people being able to achieve this if they work hard or 7/8% or 100% or 50%. Is there any direction that you could give about how hard we are trying to make this?


And I think our last meeting, there was the question to David, are you go into place a number? It has been discussed previously that 70 set of all hospitals and 90 percent of all doctors will have a electronic record by 2014. Should we shoot for 20% or 80%?


I think the better part would be to repeat David’s response. There is no number on the table. We are just shooting for this. I think there is a judgment call both here and in the policy community about what represents terrific progress. There is this judgment call. Ideally, there would be a number. Legislatively, there is not. I think it is a hard one to pick, even if you picked it to justify. I think the other thing I was thinking goes back to one of West’s comments on the certification. When I am listening to you, there are Standard directors. [ indiscernible ] versus Standards more for the exchange. There are really three categories that place simultaneously. Part of the question is, if we are going to certify EHR, what exactly are we certify in here? We have three categories going on. Do them — do you roll them all into the EHR? I suspect the reason that is sort of irrelevant in this particular percentage conversation is that organizations made in a modular cents could be larger ones from EHR from the quality reporting apparatus and from the exchange apparatus, I can meet the standards even though I am extending — I think it probably still have to think about having the EHR pass all of these things for those organizations. That is what they have got. They will not have the larger apparatus. They will rely on a vendor. Nonetheless, I don’t think we have a percentage. We are not like to have a percentage. Use your judgment credit I think we have to rely on industry about how best to go after that in fighting ways that are clever. We do not have a number for you.


And what we can up with in our [ indiscernible ] was 20% of the industry has deployed it. Ready for introduction was a two, well-developed was a three. In a sense, we said 20% of the industry has already deployed it. It is at the Gardner threshold where the hockey stick will likely occur. So, we have not come to this point, come up with that we think it is 80% achievable. We just think it is mature enough for introduction. We have several others. Let’s go ahead with Doug.


One of the things that sort of a person is that there are seven capabilities, and structured documents, ICD nine, and [ indiscernible ] one of the charges of the Quality group is that we have to come up with a value sets that will help define those quality metrics. So, there are five or six different kind of standards that might feed into a this quality metric. A variety of different lawyers have been associated with them. Some people might have X norm or they might have Snowmed or they might have ICD nine. There is a whole number of different permutations that this specific standard that the quality group needs to take a look at. When I look at that, and I am not even sure exactly how to interpret local and proprietary codes. I don’t know if that is something we define as what that would be or that would come from the local systems. I personally, as I am looking at this and trying to figure out the impact that has on the clinical quality group, it would seem to me that at least we need to identify a couple of these measures, and we need to kind of go and flush them out in detail, not all of them necessarily right away, but at least one or two. Just to see what the impact of the operations group is in terms of defining those data elements, how that is going to impact the quality metrics come and the number of possible equations that we have to define both in terms of numerator and denominator to support those standards.


Let me just ask Floyd, do you want to make a comment on that?


I know you are on the work group. When I saw the local codes and the free text, pretty much my assumption was that a value sets that we come up with for those measures will be — we would expect that someone locally is going to use some analysis to take the free text or two of the local codes to the value sets provided rather than expecting that we would be able to provide some value set based on all local codes as an example. And I also — I think I discussed with Jamie earlier that we would not necessarily, if we came up with the Snowmed by use that, we would expect locally that that could be mapped to ICD in nine and use their local codes in order to do the appropriate reporting. Is that an agreement with where you are in the operations group, Jamie?


Our thinking was that where we specified as an example, Jamie as an alternative to Snowmed, we weren’t working, coping that the quality work group would define a specific code values that would be used for calculation of the measure and not leave it up for local limitation.


I will add to that. For retooling, we would expect to do that. The caveat is for those that have been retooled under the Hitsbee work effort. Like the stroke three, they have been retooled with Snowmed. That would take extra effort to add the Jamie ICD-9 list.


Just to reflect on this, I think what is being said, for certain kinds of data exchanges, I think we understand the structure and unstructured makes complete sense recognizing that support will be better if it is structured, but it is human readable. For quality supporting maybe we cannot be quite as close as saying, any local codes set could be used, because then there is not a code set that can clean the map to it. We may need to get a little more restrictive sang, in 2011, we recognize if it is a problem, well, diagnosis is a proxy for a problem and [ indiscernible ] is accepted. If it is a medication, we know the [ indiscernible ] is not widely applauded, – deployed.


I just want to emphasize that I think there is a lot of value in actually taking these and looking at one or two examples. In the process, we are going to learn a lot. It could be the combination of ICD-9 and NDC is better than Snowmed — and I am making this up. We are able to better identify certain aspects because of the way in which those systems work in terms of identifying raider and denominator. I really think that we need to do that. We will learn a lot in the process about informing the rest of the work that goes forward.


Right. The next call of the clinical quality group and clinical operations may want to consider a joint call.


One more comment on that. In the process of doing that, we need to do it with the developer of the original measure, because often there are concepts that are not necessarily written in the specification that led to the choice of the set of values that they are using. That is the experience we have had. We can show some examples from what has been done in the Hitsbee effort. You can read a paragraph of what they are looking for, but there are some nuances to it that only the developer and the measure and those in order to come out with that result. We would have them at the table as well.


Very good.


Nancy from the zero d. In this discussion — as this committee starts to mature in its meetings, I would like to ask if we could clarify what role this committee has in identifying standard is that need to be evergreen or that need to be fleshed out in more detail as soon as possible to meet 2013 or whatever. What do we do about where we see gaps did we know that Hitsbee has some roles in there, but there are some Brodericks — broader perspectives that we are dealing with. I would also say as an example, four organizations as we try to implement ICD-10, [ indiscernible ], which is probably the right direction because there is specific context to use it. How do you maps that up to a coarser categorization of ICD,s. It has been a big problem. It is very difficult. We proved that in the demonstrations. Our organization had to call and a group of people and said, what do you think this problem is? Many organizations use extender codes for the ICD-9 today, like unique extender code. I think many organizations are trying to grapple with, are we going to have to do the same thing with ICD-10? Is there a better granular the in those, or should we use Snowmed? I think if these quality measures in these issues — if we could give some guidance in that area, that would help quite a few people. I know my clinical staff is struggling right now. How are we going to collect these data for the quality measures? We probably have to add more extender codes to ICD-10 credit I think we could very well help organizations say, we recommend that you do this in the Snowmed context or do this in here. It is very expensive to think of continuing organizational unique extender codes in the ICD environment. If you have tried to buy a product and you want to continue that and you know every year you have to do continued organizational reviews, you are looking at a grim process from experience. My two questions are, what role do we have in helping identifying gaps and where there should be rapidly will agreements? Second, what we do about making helping, should organizations look at the ICD and Snowmed relationships?


In the chart that we were given that shows the relationship of all of these various groups, a the HIT standard committee can consult with Hitsbee and others as is necessary to gain implementation Guide and harmonize standards. Presumably, we will report directly backed with ONC. The could Commission standards to be harmonized or create them as necessary.


Or create these thought you said. You are going to be testing the 6,000 problems. I think that is a very big problem.


I think the answer is up to us to identify gaps and work closely with ONC in together figure out how best to apportion them.


Also, to reflect back on your questions about gaps and Evergreen Standards, part of our recommendations are in fact to ask ONC for guidance on how to deal with gaps. What is the process for dealing with gaps, and how should that be addressed? What I have heard in a couple different comments here so far, Chris’ and others, we’re about Hall do standards get maintained? How do specifications get expanded for additional measures? I think that relates directly to this and should be coming in my view, a recommendation that we make as a committee. Again, probably to ONC to request guidance on how to deal with the need for standards maintenance, which I would call that all different aspects of standard maintenance.


It is a multi tear effort. Not only do you have to add to the content of the standard, you then have to continue to maintain the specifications and the update specifications for the use of that content.


Pam.


Thank you. I cannot emphasize enough the slippery slope of proprietary coding to be involved in any of what we are doing. Because of the fact that we are relying on this to grow in the future, we need standard — sorry. And we need standard coding officially recognize coating with an official maintenance process with a regularly expected release schedule, so that we did not end up having every implementation of our EMRs take eight months because of the proprietary coating that has to be installed. I cannot emphasize enough. Strongly enough to where I would not approve with a the wording of the proprietary coding in the clinical operations. We have really got to stay with standard coding. Whatever standard ones exist and then work with whatever entity maintains them.


So what you’re suggesting is that the ICD-9, [ indiscernible ]?


Exactly.


Into the recommendations that they all — I think that is a recognition based on our discussions. It is not feasible for a widespread implementation all of these standards by 2011 in that timeframe. Those who can get there, we certainly want to encourage and not penalize, but at the same time, for calculation of the measures, not everyone can get to all of the standards in that timeframe.


I respectfully totally disagree. It is a slippery slope that will not recover after the 2011 if we cannot meet the requirement, then we should back off on the quality standard that we are trying to measure. If we did not have a coding structure to support it. I have a question on the side. I think I have made that point. I can move on. I need to understand the incentive process there are two different incentives, as I know of. One is for you to give financial support to install EHR, and the other is in Medicare payments being less or more, depending on if you have one. Is the meaningful use tied to both of them? Do you have to have EHR that is certified for meaningful use in order to day in the payment — day in the payment incentives on the road? I ask this because of a comment made earlier. That was that hospitals can have anything out their credit there are providers or doctors a who will not participate in a certified EHR. If they were able to somehow pull the data together by whatever means they could, do they then qualify without a certified EHR for the incentive payments?


Sure.


That helps me understand how the two are tied.


There is Medicare and Medicaid incentives. The Medicare incentives do not fund you to go out and buy EHR Credit they are paying you a in 2011 for the meaningful use of EHR.


It is a set of functional criteria, but the definition of what a certified EHR is is evolving. We could say, certainly, we have seen in the waiting — latest meaningful use integration that you must have 10% of your transactions in a hospital entered through an electronic ordering system, whether that is itself a bill ordering system or whether it is a commercial product I do not think has been specified. Just to clarify, to my knowledge, there are not any incentives to acquire EHR other then the Medicaid I believe does allow some early acceleration of some of the funds if you love greater than 30% that might assist with the systems.


We want to be sure that we do not overstep. I think your questions are good. I am going to take your questions in the spirit of trying to understand the relationship to the specifications.


That is where I am coming from.


It is clear from the comments that there is still ambiguity hovering over the last discussion. From the last discussion, I think we recognize that there is no singular system that I am aware of that would answer all the different utilities. It also appears to be that there is an invasion in the certification process that is evolving that will define certain components that are going to be fundamental. I think the final policy in rulemaking through HHS will define that relationship between the cert peace and a meaningful use piece. I think we would be overstepping before any elaboration. Is that a fair working approach?


yes.


Let me step of my role and say, how am I approaching this? My interpretation is that a certified EHR would be a very Corps piece. There’d be certain actions like provider entry that is a component of that. However wonderful function they are in terms of that utility, many of the quality measures are derivative data that are entered for a variety of sources. Order entry plus the pharmacy system, for example prodded the conjunction of data to some sort of derivative calculation may live in a data repository. Just as an individual and thinking about this relationship and looking forward to that policy.


That was helpful. Thanks.


I also want to be a little bit cognizant of time. I want to make sure that there is some extraordinary work done on privacy and security. I think these conversations are also incredibly helpful. If we are not clear on these points — I really appreciate bringing it out, but I don’t think anyone else likely is either. I appreciate that. Let me turn it back to you.


As far as standard codes, I want to [ indiscernible ], who I think said clinical standards is as clinical standards does. What I mean by that is that the whole issue of standard coding has come a long way over the last few years. We have gone from being a for the we could not afford the cold sets we had in some cases, having cold sets that were so big it was hard to say how to use them, to applications where people are not talking about identifying standards subsets. We figured out how to pay for Snowmed there is no doubt in my mind that somebody is starting a new and would prefer to go with standard code sets rather than try to make all that stuff up again. Even though it is not trivial, you still have a lot of work. It was not there before. We have almost astute use of IT being done by places that had to improvise along the way. I have been thinking about, how you deal with that, and how you deal with all the other stuff? The thing that strikes me is that we are really talking about three kinds of interoperable Libby and one kind of in probability here. We are talking about the inner upper ability that is conveying to hospitals and physicians what we mean by a clinical standard. It is the reverse direction. There has been a lot of work done both in Hitsbee and other communities and in this work group to nail down what we mean by that. Some of the research in this work group was to look at what other standards were all in use in order to inform what could be used to respect quality standards. Just to give the unambiguous or possible [ indiscernible ] creditor there is the interoperability about sending it out. There we have more work to do. There are measures for meaningful use that are more about just getting the information from one physician to another to support a transition in care regardless of how well a computer can deal with it. We did not actually have all lot of studies, I think, that show that that is useful. Certainly, we know that it is useful in respect to the environment. We know it is the lack of information for people going in the nursing homes and all kinds of things. I would not want to do anything toward measuring quality that got in the way of enabling that easy stuff as a step on the escalator, as a physician. If that means I am anti code, I will go fight it. I was interested in capability 120 in your document, which in effect says, for now at least, the way it is used — for now you can at least send as text for PDF. What it doesn’t say, which I would like to get feedback and is should be considered is if you can send it as an image of a document. There are a number of EHRs and now that have some structure data in them it seems like. Being able to access that information at least for awhile makes a lot of sense.


And that is also in capability 120. I did not see it said in the document.


I think you have to go to the next level of detail, which is the thicker document.


Oh, there is a thicker document.


Let me summarize all of this very good discussion. I think there are some elements of confusion between those standards used for the continuity and coordination of care, those that are used for the transmission of quality measures at eight denominator and moderator level. There is some concern. At least state [ indiscernible ] and something basic. The other is, innovation has happened with proprietary codes that have worked in the past. How do we actually figure out how to leverage that bucks maybe it is good for care coordination, but it is hard for quality. It seems to me that, and I want to get the consensus of the group that based on all the comments we have heard, there needs to be some revision done to this work so that it is a little bit more clear to all of our stakeholders. Again, I would ask a point of order from the ONC folks. If we want an end to I just — wanted to digest all of this and revise it and bring it back at the next meeting incorporating all of these comments, how might we do that? Do we do an inch from acceptance pending the revisions? Do we say, we will table it until the next meeting and we will bring the revisions back? What has been done in the past?


That is a good question what the policy committee did when they wanted to go back, they tabled and came back. Our timing is such that it is going to be challenging, because in order to get regulations written and published by December, we are trying to get our heads around this or we will not make our deadline. I would say if there is anything that you are comfortable with four working on in the interim that would be helpful. Obviously, if you want to think more about it, that is your decision. We would be happy to hear your thoughts on these recommendations.


Just thinking about the work that has been done.


I wonder if there is a way to porch this into two pieces turn a one is to ratify the standards, but also an agenda item on the ongoing discussion and on the in this novel. One thing out there, the performance level for any of the metrics, which will not be set by us, may ultimately resolve the issue of the one thing this are ready for adoption. Again, I believe the entire trust of this effort is to help make people succeed. I start with the frame of that all this coming together is in the interest of propelling the help. Whatever their performance levels, but ever the difference pieces, they are not meant to be barriers. I think this is for the privacy and security is such an incredible contribution credit is all friend as elements of support. Here is my suggestion. If the group feels ready to adopt the granular elements in a general sense, come back to the use of the data centers for the director of functions and recognize that whatever the outcome of that second piece is ultimately going to be calibrated to the performance levels that are identified elsewhere. Does that some like a proposition given — you know, essentially what we set out to do in the timetable?


And try to make very specific recommendations to say that we agree as the group that the continuity of care document is an appropriate means of sending a summary from place to place for care coordination. We have a goal to use all or X norm and Snowmed as the vocabulary’s, and we do have some additional work to describe the path to get there. Is that what you are suggesting?


If I can just point out, I think that is actually what we have in our recommendations. That is exactly what you are saying. I think what you are suggesting is, in fact, the recommendations would be adopted as they stand, but we would have to come back and review the application of the recommended standards to quality reporting and the transmission of quality data.


The chair accepts that as an motion.


[ laughter ]


Is there anyone who has strong concerns? I see a lot of head nodding positively.


This is Mark. I have a strong concern. I do not think the CCD reaches the category one Standards requirements.


Your concern is that the notion of using CCD for care coordination data exchange in 2011 would be a concern?


Yes, to the extent that category one standards are those that are at adoptable levels. I think it is pretty hard to make the argument that is there.


I just want to point out, our recommendation is that that would be a 2013 requirement. In 2011, unstructured documents, including free text and PDF also could be images used.


Mark, with the understanding that this capability 120, which offers the unstructured option, which could be taxed, PDS, image, could also be HL 72. and setup. Mark, would that meet your criteria?


I think it is our least conceivable.


Okay. What we have is a motion on the table that has been seconded with adopting these standards and recognizing that as they articulate with the quality measures, there will be clarification made.


And that I have a question — a consensus with [ inaudible ] I am falling. Are we in agreement?


I still have my issue with proprietary coating, because I do not know how it relates to?


Let’s make sure that that is noted. Stena right, and I understand the majority.


Any others?


Can I just asked? Just for clarification purposes. Does what you are saying mean that the table we have where its as recommendations for 20 of an implementation is, basically, those are the recommendations –


2011 and 2013.


Okay. Thanks.


That are in the attached table?


That are in the attached table.


Thank you for that.


We will work diligently over the next month to clean up language to incorporate –


At a guess a friendly amendment to the motion is that we are also recommending that we continue to clean up the last couple of measures that we did not get to and see if these standards can also be used for that purpose in the same way. We are also recommending that ONC determine the process for filling the gaps.


Okay.


I look at — the question was, are we are proving the power point or the matrix? If we are approving the matrix, I see a line here that says — It is hard to tell, because you have to read the page before. Percentage of all this is page 73% of all medications entered into EHR is generic when the chair — generic options exist in a relevant drug class. I see recommended for [ indiscernible ]. Care document and a number of other things. It does not say or. I cannot even know what this column means. Does that mean that the EHR has to do all of these things? I just don’t know how this applies to that measure? I mean, if I understood, if it was informing the discussion on whether the measure was feasible, I understood that. If it is implying that there is a requirement to either certified or use these standards to achieve meaningful use, one, it seems to contradict. Two, I am having a hard time. I do not know that [ indiscernible ] is available in 2011.


Let me clarify this. It is the and that is confusing you. It is saying that and the unstructured documents may be used in a local and proprietary code set may be used. Structured documents are not required to 2013. It is the fact that the exceptions are added to the end of this list.


The way the wording is also developed is that and says in the specification of the measure that will be done or overseen by the quality work group, they will use the standards that are referenced here in the and statements. Perhaps it would be clearer, and we did go back and forth and it has been suggested that these should all be or. If we want to consider these all as or, that is –


I wonder if the original mover who did not always make a motion at the time would accept it as a motion and they would consider a friendly amendment that the substance of the documents that are available for ONC staff to use, but that there would be a revised publication that clarifies these issues. I think it is easy enough to explain it to staff. It is really hard to explain it to people who are not here today.


I just want to be clear that I do not think we are going to see the quality work group come out with a [ indiscernible ] or how to determine something out of a PDS. When we developed any of our value sets, they might be ICD-9 and Snowmed, but they are not going to be using local codes. That is not feasible. The way that was worded makes it seems that could happen. In the spirit of what we are getting at is contained in the power point, the wording is confusing the added to the understanding that seat 32 would be used to coordinate care, and in 2011, a PTL for on textured format might be used. Recognizing you are coming up with value sets, structured values will be used and we will continue to work on the mapping of the standards to the quality transmission.


Very good. I know we are behind time. We want to give time to Dixie, but I also realize that there are some biology breaks that need to take place.


How about a five minute break, but let’s convene at five minutes. Understanding — I appreciate the very good discussions. I just want to recap. The general matrix, the concept. The work to come back with the uses for quality. This discussion will be captured. ONC staff will work with John and Jamie to capture that in an iterative, kind of revised document. I appreciate that.


Basically, as I understand it, the recommendations are approved, but we have to go and revise our documentation to clarify the points that Wes and others have made here.


Okay. We stand adjourned for five minutes. We will reconvene shortly.


[ HIT Policy Committee Meeting on break until approximatley 12:23 EST. ]


[ Captioner is unable to make Brian Ahier's comments due to being on a listen-only line. There will be a new captioner on at 12:30 EST, so please repost your comment so that it can be made during the public comments. Thank you. ]


We will be starting shortly.


We are ready to resume the meeting. Can you please take your seats? Can you please take your seats so we can resume the meeting?


Thank you all for sticking to a tight schedule on the break. I appreciate the dialogue. It’s an interesting discussion and obviously a lot of issues that require continuing work. Please understand the commitment is that critical operations work group will be addressing all of those issues that were identified for further, work. Obviously, and have an interface with the clinical quality group. I think the sense of the group about the uses of the standards was clearly expressed. I appreciate that discussion. Someone let me and note and honestly I cannot read it.


The Microsoft Web has requested that she make a public comment. I’m a doctor, I can read this.


I am sorry to whosever hand writing that was. We will move to public comment after the next session. Let me go back to you John to moderate this final piece of work.


Dixie and Steve will present the standards for security and privacy as well as get inside to their impact on the consumer. Why will all of this make lives better for us as patients? Dixie? Next will be the brief warm-up act to Dixie. In the interest of time, I will take less time than we planned on the consumer part. We wanted to put a little bit of this in context. First I want to thank the members of the work group, the active members who were on two or three or four or five calls over the last couple of weeks and especially thank Dixie who was fearless and tireless and did an enormous amount of this work on her own late-night and on airplanes and that sort of things and she was shuffling around the country. We owe her a deep debt of gratitude. We wanted to establish a little bit of context before Dixie dives into the technicalities. What is we are obviously seeing lots of polling in surveys during the last month on health care reform, some of them in response to the proposals in Congress. Some negativity is appearing in some of those. This was a survey released last week which reminds us of the dissatisfaction with our health care system and move to the next one. On the subject that we are addressing today in the context of the discussions, this was part of the same survey again released last week. The very sobering for all of us, the basic finding here consistent with other surveys we have seen, 68% in 2009 were not at all confident that there EHR would be protected. Only 12% were confident they would be secured and particularly note the jump. It is sobering from office from 2008 to 2009 from 38% to 51% of 1000 people responded saying they’re not at all confident that their electronic health records would be secure. Just a reminder really as we died then that we are living in a world that is unacceptable both in terms of our health system and in terms of the paper based and faxed based system we have. We need to move to a system that is going to solve that problem. I think I feel confident that the work that Dixie has done in this committee has done in the work group, it is going to move as a better place in terms of security and privacy. I would make an addition to the points made here, I won’t read them in the interest of time, I think it we will be better in able to, the electronic records protected when enable consumers to participate in decisions that improve their care in the doctor patient relationship. Whether we all know, the use of computer networks introduces new risks to personal privacy. I will be labour the point again. The main reason for the consumer and patient perspective we need to do this are listed there. Again, I will not read them. On a personal law, I learned a lot participating on this group there have been discussions much like the one we have half and hour or so ago. I still won’t claim to know the difference between the. [Speaker Faint/Unclear] But others on the committee, I am getting there. My big play and I made this to our group is that we have to pay attention to communicating this stuff to folks be on our realm. I make a commitment to do that as best I can. Turning to Dixie for the technicalities. Thanks.


To encourage the broad adoption of EHR, the stimulus bill offers reimbursement to eligible providers to meet two different, but complementary requirements. First of all, the have to acquire a certified EHR product for service and second lady had to demonstrate a he or she is using that product or service meaningfully. The standards committee, all of this here me to recommend both criteria for certifying products and criteria for demonstrating that an applicant is using that product meaningfully. I think we too often get those confused and think we’re simultaneously certifying both the product and its use and they really are two separate steps and, in fact, two separate steps of criteria. For privacy and security in particular, certification that it defined function our service metes a certification criteria is not sufficient to demonstrate that it is being used meaningfully or that it is being used at all. In particular, for example let me give you an example, I am certain that the certification criteria for EHR products Fidelity will include a requirement for an audit capability. The capability record audit of actions. As anybody who’s worked on the system knows, you can turn off audit team. A second example is the encryption. I am sure that these products will be capable of encrypting information but if the EHR is used within a hospital that is physically protected, in all likelihood you probably won’t need to use the encryption. If you post that system on a laptop that you carry around the community, you probably will. It is important that the security and privacy workgroup specify both of these types of criteria. We have adopted an approach that addresses both the certification of products and the demonstration that the user is using, the certified product meaningfully. In these two citation read the approach that we used. We started with a eight priority areas of focus identified in the long and we extract it does and identify those that are particularly relevant to security and privacy and that security and privacy can speak to. Then we looked at being standards reference in the HITS P it we identified standards and will identify gaps. Ultimately out of this, we will have service is required, certification criteria standards required and then if they product meets all of the certification criteria, it is certified. Moving on to the meaningful use, we anticipate identifying a subset of those requirements for product that would be absolutely required for use or may be required for use in the following set of circumstances. That will become part of the meeting for use criteria along with security IT infrastructure and required and secure operations. For example, we want to make sure the risk assessment required by the hip of law and the security standards, its current and up-to-date and that the risk management approach is current and up-to-date as well as the current contingency plan. As we pointed out in the introductory remarks, security does more than protect confidential information. It is equally important to protecting the integrity of data and the availability of services and critical information at the point of care. We want to make sure the contingency plan that specifies the backup and recovery of information, the continuity of operations plan and emergency operations plan are all current. All of these are important to ensuring that that product can be used in a meaningful way.


Using this approach, the seven following two slides, identified the eight ARRA prior is a focus. First of the technologies that protect the privacy of health affirmation and promote security and qualified electronic health record including the segmentation and protection from disclosure of specific and sensitive individually identifiable health information. This one particular area of focus is specifically security. Some of the later ones that are very relevant to security is not as straightforward. This area of focus requires just about every privacy and security service out there. It requires identity management which is issuing that a person, when they are given an account, is to the claim to be. That is a process as well as technology. User identity authentication, once you know the identity of the individual they have provide proof they are who they claim they are. Identity and role based access control, access control is a Service determines what resources an entity or user can access as well as what actions they can perform with that resources. There are basically three types of access control. One is identity based which says that Dixie Baker can access this resource, while based says the administrative system can perform the following operations. Identity and role based access control, one or both are present in most systems today. Even on your desktop system. The label based access control is a type of access control of access is based not on the identity at the user but on a clearance that user has been given. They are clear to see top-secret information and matching the clearance of that that user has with the sensitivity label that is associated with the resources they are attempting to access. That label based access control came out of the Department of Defense and the intelligence community, but it is also being used and other industries that. That is a third kind of access control. Consent management has to do a consumer’s consent. Consent is a loaded word. That includes both my authorizations to use or look at my private information, but it also has to do with informed consent on what actions I have given my consent to happen. What procedures can be performed, what research databases my name can be in and even what clinical trials I might participate in. Managing all of those types of consent is another requirement here. Transmission integrity, integrity is really important to safety. A good example is if you look at me and somebody modifies my weight in my health record and makes it 180 instead of 80, I could die from that modification in my health record. The integrity of data is important. Finally the transmission of confidentiality protection. The protection of confidential information when it is transmitted. On the right-hand column, whether the EHR standards with security and privacy standards, they do not address label based access control. I do with the caveat that. The priority area of focus mentions the segmentation of information. To me segmentation means label based access control. It means segmenting the highly sensitive information, information traditionally known that is deniable such as HIV. Actually it is up to the policy committee to set forth that definition which they have not done yet. Consent management, I will talk a bit more about label. It is partially addressed because consent management is a complex challenge. And there are standards in. [Speaker Faint/Unclear] That address part of the problem, but we don’t think it is addressed control the second area of focus is a nationwide information technology information structure for the electronic health record. This requires secure communications channels that protect the integrity of data as well as the sensitivity of information and secure e-mail. Both of those are addressed. That era of HI eat in 80 years, we will identify more security services associated with that. The third one is the HR certification. All of these security services address certification. Technologies as a part of a qualified electronic health record allow for accounting of disclosures made by a covered entity. This requires auditing of actions on an individual system, but auditing is certainly not the total picture. To capture an audit record, and you have to have a consistent times ours especially if you’re auditing across multiple systems are between systems as an enterprise Theresa ability. Enter price trends ability is our turn for what ARRA requires which is accounting of all disclosures. As information passes from entity to entity, we need to maintain a Theresa ability of what happens to it. Finally, non repudiation. Non repudiation prevents someone from denying having taken some action. The most common mused technology in this agreement is the digital signature, but there others as well the fifth priority area – let me go over that. Three of the four of those are addressed under the HITSBY standards. Enterprise traceability is not beyond auditing. The use of certified electronic health records to improve the quality of health care is number five. Security is often equated as a privacy mechanism but in truth it is absolutely essential for assuring the quality of health care in that a protect the integrity of information and provide this assurances that information and services will be available when they are needed. The HITSBY standards address integrity protection transmission and non repudiation. Service availability, the HIPPA standards address Service availability, but it is not clear how will ultimately defined that one. The sixth one is technologies that out individually identifiable health information to be rendered unusable, unreadable are undecipherable to an authorized individual. This requires that transmissions be protected or encrypted. It also requires the identification, anonymous Asian and or pseudomonas Asian. These three approaches in particular the the last two in public health, the identification is clearly defined in the privacy rules exactly what 18 elements one needs to remove to Ranger to identify. Anonymous Asian and pseudonymous Asia are methods used, they don’t fully Dee identify information and nomination takes them out, pseudonymous stations inserts a link said that the data can be re identified at a later time if necessary. Finally the limited data set which is an itemized which of also the minimal data set as well. The identification and anonymous station. And pseudonymousation, is partially is really not in HITSBY. The privacy income security work group made and number of general recommendations. The first of which is that certification criteria should not dictate policy beyond what is specified in ARRA and the HIPPA saw security role. We need to specify standards such that a doctor can configure the products to its individual policy based on its own risk profile. We don’t want to tell everybody exactly what the need to implement, but we need to tell them what standards they should use and give them the flexibility to configure it according to their own needs. Second, product certification should address both functional requirements which are the service providers – services provided and the insurance levels. Assurance levels are orthogonal. It is important to assess the strength of a mechanism be used to implement the standard. Secondly, the implementation itself, the strength of the implementation itself. For example, you might have a standard that requires authentication. Two factors is a strong mechanism to meet authentication then it single factor authentication. How the authentication is integrated with the products is a measure of the insurance level. Assurance level is also measured by penetration testing, conscience efforts to break security mechanisms. It is really important. The strength of the projection is equally as important as the functions that the protection provides. We are recommending that the common criteria, the international standard, criteria for Information Technology, Security evaluations, the, criteria specifies a number of evaluation assurance levels and we are recommending that being zero and C look at the criteria and recommend evaluation insurance levels for cases. Third, for greater openness and brought inoperability, we recommend that the ONC prefer standards developed by international standards. There are plenty of them. HL7 is an international standard. We think this is really important. The next recommendation is that certification criteria and standards should enable design possibilities that leverage fundamental principles and standards. Once again, we don’t want to lock anyone into solutions. We want to recommend open standards that allow them to apply fundamental and generally accepted design principles to develop their own solutions. Product certification criteria should build full inoperability with Healthcare Partners and consumers. This is what people have been referring to all day as the escalator approach. We believe it makes sense for 2011 for securing the enterprises themselves in accordance with HIPPA and privacy standards which is what the policy committee recommended, plus some simple shared and sharing with Healthcare Partners and consumers. We think secure health exchanges with Healthcare Partners and HIE is better to look toward 2013. In 2015, we think full integration with consumer preferences with enterprise and Exchange access controls is a good target.


I would add that the 2011 recommendation is consistent with what the meaningful use working group recommended that John went over earlier. We believe the meaningful use criteria should be rules based and to specify what certified teachers must be used and how within the context of the plant operational use cases. As I said earlier, if you are a hospital and physically secured, you will have a different use case and if you are a doctor traveling between hospitals and homes and carrying your laptop with you. We think meaningful use should include the criteria for meaningful use and should include at least required certified teachers and their configuration within the applicable use cases. She cure IT infrastructure, the current HIPPA risk-management and current HIPPA contingency plan as I mentioned earlier.


The widest and perhaps most urgent gap that we identified maybe consent management. Consent management involves several functions. As I mentioned before, it is a complex technical as well as operational problem or challenge. First in a false recording patient elections, the privacy operations and their informed consent in a consistent way such that both humans and computers can interpret the elections consistently across systems and across organizations. It requires transferring the selections among entities that handle their PHI so that basically elections should consist of the data elements they referred to. Third, it involves transmitting these elections into access control rules. It is not sufficient to have the elections on a piece of paper and filed in a filing cabinet when the information itself is being sent from provider to provider or two labs and to payers. Finally, it involves managing the continually changing elections. The law allows that for someone to change their mind. I might say that anybody can see my information but the next week, I may be diagnosed with the condition I don’t want people to know and I may go back and change that election. This is an evolving consent. There is work underway and work that has been done, some good work that has been done in this area. I think what is needed more than anything is some clue to bring these efforts together. HL7 is developing a consent, at the referenced information model for version three includes the sensitivity label and HL7 is developing in the process a hierarchy set of consent vocabulary that can be used.


John has done some work and postulated a consent assertion markup language. These be 15 tepee 30 includes the HIE privacy consent profile, the BP PC captures patient consent and to find a method to enforce it. The one I didn’t put up here is. [Speaker Faint/Unclear] Which is a standard being developed by oasis which as a great deal of potential. XACML and able to capture of both up enterprise policy and access rules as well as access rules. We believe these pieces need to be brought together. In particular, none of these efforts to address a standard way. BPPC talks about a method to enforce but there is no real standard for transmitting access control rules from consumers into access control rules enforced by the system.


I see this as bringing the away says, the HL7 and the BPPC together. Consumers are beginning to play a much greater role in defining how their information is used and shared. It is important we take the initiative and the ONC stepped up. We are encouraging the ONC to encourage and support the rapid well-informed diplomat of consent management standards that comprehensively address all four of the points I went over.


As John mentioned, we have assigned these readiness ratings to the standards we have identified. They range from 124. They put forth these four definitions at our last meeting and they thought they were good and applicable. A rating of one is a mature standard, why they are used in using the guard our measure of at least 20% of industry. Not just health care, but industry in general. A rating of two is that it is ready for introduction, but is probably not probably on our 2011. A rating of three is well developed and that work is in progress. It might get it 2013 or 2015. Four is a loose guide. We think this is needed, somebody started it, but it is not real as of yet.


I’m certainly not going to go over all of these listings, but you do have three pages in your slides of standards that we are recommending. As I mentioned before, the oasis extensible access control – it’s an approved standard but it’s not widely used in any industry. It is very powerful because it does provide a means of capturing both enterprise rolls as well as individual consents. We believe it has a lot of potential. Oasis’ security assertion markup language is one that is widely used within the enterprises, but it is not widely used between enterprises. We gave it a rating of run because it is used extensively within enterprises, but it is with that caveat. Some others I wanted to mention, a tea and a, audit trail and note authentication and and note IT Praia, it defines basic security between modes and the uses the TLS by direction all. One know the authenticate itself to the other and the set in node authenticates it back before the transmissions can occur.


The. [Speaker Faint/Unclear] Was developed by MIT. This is been around a long time. A decade or more. It is authentication between to identities and uses a trusted third-party. Synchronous encryption and symmetric encryption. The important part of it, the reason I am pointing that that it is exactly Inc., that is really what the you an uses. There is some sort of quasi duplication because EUA uses Perot’s. I think that is all I wanted to point out there.


I talked about the HL7 data consent which is vocabulary that needs more work. I talked about BPPC. All of these are very standard for cat four and establishing a standard time element. There are several here, SDX was on a previous slide. These standards are not exactly security, but they’re not clinical operations either. Jamie and I got together and decided we would put them on the Security and privacy list. There really fundamental infrastructure standards. I don’t want to keep you here forever. Transport layer security, this is what is used every time you go to Amazon and buy a book. This is beyond one. It is also known as asset FL. I think that is it.


Very good presentation. Thanks so much. Comments or questions from the group? In the interest of time, I am just going to ask, I have a number of questions some I which I think are pretty important like the VAL certification, for example,. Is this document going to be moved for approval today or is it a chance to go off line and get questions answered?


I think given the time frame that ONC is under that this document would be moved for approval. The floor is open if their particular concerns your head. Just a question then, maybe there is an easy answer. The EAL approval, as far as I know that requires an auditor who has been approved to do, criteria certification. We know that CC HIT took a lot of gaps because it cost a lot of vendors on all of the functionality security and the inoperability. What is the cost to a vendor of that enterprise system to be certified for EAL?


There are six levels of assurance EAL levels. The first level is strictly performance testing. The first level is exactly what see CHIT has been doing all along. The common criteria does not specify who does the evaluation. That is specified to ever develops the protection profile or specifies the EAL level. ISO does not specify. Level one has to be an independent tester.


ISO 9000, to be an ISO 9000 you have to be authorized as a certified, that is not the case. [Overlapping Speakers]


Not, but I know of. In the case of the common criteria evaluations that are done with in the U.S., they are all done by entities that certified by a missed. What I understand is in endorsing the use of the common criteria, we’re not buying in or endorsing a specific level and there is plenty of time to work out the issues.


That is what I recommended that the ONC recognized the specific label based on the use cases. I think there are probably cases in which a Level one would be perfectly fine. There are other use cases that it wouldn’t be. I think we have gone so far, there hasn’t been any flexibility to do that.


The next question is, it is your recommendation say yes, no or is it silent on the issue of consent be on the consent levels they are associated with HIPPA?


It doesn’t say. The only thing I am saying about – I take that back. I am recommending that when we capture consent, the approach used to capture consent be able to capture not only the privacy authorizations which are HIPPA, but other informed consent that are required in the delivery of care and in clinical trials.


Consent for release of information, I don’t want this information to go to anyone who is related to any of my doctors. I am talking about the granular parity of consent for information release.


I have personal opinions about that, but my working group hasn’t discussed it.


We’re not buying into a specific level.


[Audio Faint/Low Speaker]


Role based is different.


He is talking about how much discretion a consumer can have to limit the use and disclosure of their health information?


Potentially to other Pratt tittered shutters in the course of giving them care.


We have not gone be on HIPPA.


This is where the standard gaps exist, I give consent to certain conditions and are given institutional provider, we are not quite there yet.


I think if the ONC takes our recommendation, I think what’s your question is really getting to is will be the most difficult part of the whole thing. I think it is also essential that if we’re going to be exchanging health information across the National Health Information Network that everybody has to understand the consent they receive means and that they be able to interpret it in an uniform way. Developing would be an uniform data model that could be implemented across an HIN.


My main concern was by the fall buying into something I didn’t think we are ready to implement. Lastly, there are specific topics in here such as encrypted e-mail that I called highly used, that in effect are used in environments where there is a public infrastructure and available. I am questioning whether it is reasonable to assume there is a net stoke public infrastructure available any die waiting standards for use.


I think it is unreasonable to assume that. Particularly for 2011.


There are used to use PKI. You can have portal to portal secure e-mail. I agree completely. It was e-mail I was concerned about.


Secure e-mail can mean many things. It can mean. [Speaker Faint/Unclear] Or web based portals, but they don’t exchange using TLS. We do not assume there would be and national PKI.


That exactly what we were assuming for 2011.


My question is is exactly this topic up PKI but also digital signature. I know this cheapening category three. What was the thinking behind putting, I think those are widely used and I am wondering what the thinking was putting those a category three purses perhaps category two. Is there a question of certainty, we definitely want to go there, but it will take more time or is it?


We really want to get there, but it will take more time. We at a digital standard signatures in HIPPA if you recall. I don’t see a health and PKI growing up in the next two years.


You think it is still on reasonable for 2013? To have PKI infrastructure? I was just wondering, but the work group discussions were.


I think is possible for 2013. I don’t think it is a done deal. That is why we gave it a three.


Any other questions?


We are evaluating slight 13 through 21 which includes recommendations to ONC on how certifications should deal with privacy and security, particular standards as well as how standards should be selected and consent, is that true? Is that the scope of what we’re recommending?


The scope of the recommendations today are the matrix which includes all of this selected standards plus in their level of maturity and there are specific recommendations for the feeling of gaps that we would want to work with ONC anything else to add to that I read through all of these standards yesterday on the plane yesterday. There is some slight duplication and editorial type of thing we would like to fix. The hand out that has the complete citations of the standards.


Primarily, 19, 20 and 21 is what we’re looking at today?


Yes.


There were some issues within the recommendation slide, but I guess we’re not actually accepting those today in terms of looking primarily at international standards organizations, international use standards will help what we’re trying to do here. We probably don’t want to limit ourselves to just that and also using the constraint language with an intent to leave by about IHE. We have had a lot of work with IHE that has been provided by the organization. I don’t believe they aren’t actually.


That is why I use the work preferred.


So we want to probably used internationally used standards. Why call it out if we were going to constrain it with a preferred in front of it. This is not part of what we are accepting today.


What traceability says, when we can. [Speaker Faint/Unclear] If we have to go to an U.S. realm, fine. When we think a SDO, what is the definition of a SDO. There is also the implementation guide writers etc. I think report was suggesting we would want to use the internationally accepted standards and then possible as a preference.


You’re getting to the other questions of HITSP. HITSP has been a wonderful success in a short amount of time. I appreciate, Jamie’s presentation looks familiar and comfortable. It is very much following with the. [Speaker Faint/Unclear] Model. I don’t see that in this presentation here and what to get that assurance.


They had all been lifted from the HITSP capability.


I would point out HITSP and its latest teams did not identify capability for privacy and security. They seem to privacy and security cut across the capabilities. Every bit of this work is based on traceability. Just so folks understand, sometimes you can say capability and it exhumes a whole variety of privacy and security. This is all completely consistent. With that, today, we’re looking forward to an acceptance of this report and the security and privacy workgroup and those standards as named in the last three slide and in your matrix. Of course, their recommendations on gaps will like to go forward with. Many of Jackson’s to moving forward with accepting the work as a bid by Dixie and Steve? Okay, we will then move forward. A wonderful array of presentations, we do have refinements to do, but I think we have got some clear marching orders. At this point I think we would like to open it up to public comment.


Let me think all of the committee members of our group. I think everyone present appreciates the matter before. I just want to reiterate, there are terns and areas for confinement that the process will go forward. I appreciate the latitude to allow the national coordinator to do the work they need to do. I think for a comfort zone is for the work is appreciated and understood. I thank everyone for working out that. I apologize to the public members that this part of the session is delayed. It is in my estimation the most important part that I have received feedback on a logger. Next time and a better calendar. I think I appreciate all these complex issues. If you please identify your name and organization and limit your comment to questions to no more than # two minutes.


Thank you. I am Mike with the McKesson Corporation. I would like to commend to all the work groups. I think clearly the work product showed a thorough and disciplined approach. I would like to go back to a comment that Ms. Baker made in her presentation that she believes is occasionally this committee is confusing standards’ for meaningful use with certification standards. I appreciate the analysis of the profs Security and privacy to separate this to, I would really like to see the work product from both the clinical quality group and the clinical operations group clarified as to what is designed for meaningful use versus what is suggested as the certification criteria. I am not sure that ONC can move forward with clear guidance and I would just like to say that I believe that any state colder weather is patience or positions are hospitals or any technology vendor can move forward until we get this clarity. Thank you very much.


Thanks for your comments.


I am Kathleen Connors and an analyst and I have been of all but the standard settings organization that has been involved and with HITSP. The technical committee’s products and I am not an anti-Semite did not write that note. On behalf of the Microsoft Corporation I wanted to think HHS, ONC and the committees for the rapid progress for the high-tech requirements in such a short time line. We remain committed to promoting a future that liberates and leverages health data in ways that will empower both of the consumers and providers to improve health outcomes. For these reasons we support the policy committee’s position on the following, a limited and flexible certification process focused on validating the v h Technologies and get appropriate security privacy and data interchange capabilities and our able to report meaningful use measures. A definition of meaningful use that is focused on outcomes rather than peaches and functions and proposals for the health information exchanges that recognized that timely adoption must leverage the inoperability infrastructure already in place. To ensure the goals are accomplished. [Speaker Faint/Unclear] Both current and emerging, it is imperative from our a few that the meeting for use standard is the Technology neutral, platform independent and architecturally agnostic. Our concern is much of the progress could be avoided if the HITSP Standards Committee narrows the standard selection process to those that support only comprehensive v h are and help information exchange. Such an approach would not recognize any affected standards that would be critical to ensure effective safe and widespread it data interchange. HITSP standards have been selected to address the limitations of legacy EHR and for the most part inappropriate for alternatives EHR and. [Speaker Faint/Unclear] These non legacy HIT solutions which are used by providers and consumers include modular components for medical devices and quality measure reporting. Alternative to documents 8IE for the majority of the health information exchange organization which kept up adopted the IHE architecture. [Speaker Faint/Unclear] And laboratory orders and results and clearinghouses which might also be able to support the health information exchanges and helped platform such as Mike yourself Health wealth and Microsoft. [Speaker Faint/Unclear] For providers, dossier, Google health and other health applications on mobile devices. These alternative EHR and HIV technologies can conform with non traceability standards such as messaging standards. [Speaker Faint/Unclear] In the last reporting networks. HL7 matches thing. [Speaker Faint/Unclear] These can convey the same data that is being put the CD a profile. A widely used alternate to document standard is easier to implement then ACC beat and didn’t is in use to coordinate care. Computer before soap privacy standards that protect health standards far better than what is possible with standards being proposed for use with legacy VRH and more robust security standards that has been proposed by HITSP for secure note of that vacation. [Speaker Faint/Unclear] For data in motion as specified for safe harbor under the H. H. as notification guidance which has not been adopted yet, but we know it is likely to go forward. Microsoft supports the selection of technology appropriate standards for meaningful use certification to promote availability for affordable and easily to adopt VRH Technologies for low-tech and non tech providers in the Greenfield market and want to augment the installed systems with innovative the modules that will enable meaningful use. We see the reverse HIT technology ecosystem’s leveraging is the staying 8IE infrastructures, enabling privacy protection in data liquidity for systems and providing inoperable on ramps so that meaningful use objectives can be met while promoting market innovation. In closing, Microsoft thinks the HIT Standards Committee for considering our perspective and asked to consider recommending standards for products and services. Lighter weight and more agile and possible affected meaningful use technologies. We look forward to working with the closely on this and to sum it up, we see the boundaries you’re talking about, allowing enterprises to maintains the standards that they use. We must also use as and resupply to ecosystems such as the networks we are considering for HIE. Thank you.


Thank you for your comments.


I am here to represent our objective to director, Dr. Robert Bass, and the National EMS officials. What they would like you to hear is that of the. Hospital care data set has a wonderful standard out there in the form of the National AMS Information System Data Dictionary nexus. It we would want you to consider reducing that as the standard for many, many reasons. It represents a consensus pick it is well on the way of being implemented. Our state is going over to that standard, and I am in that process as the Project Manager.


Thank you very much for your comments.


We want to remind the phone audience that if you wish to make a public comment, you need to press star one of your phone to indicate that he would like to make a comment. We have a comment from Debra appeal. Would open her line please?


Thanks so much. I am sorry that my voice is so bad. I got this on a plane. I hope you can understand me. Patient privacy rights would like to suggest that even though this group just accepted the report from Dixie and Steve that their recommendations are so critical that there be a formal public comment. The work group address and include recommendations for the public for this incredibly important part of health information technology and health information exchange, because the health privacy advocacy community and the privacy advocacy community — fourth level, our coalition, which represents 10 million Americans, has not seen this before. But there are many peculiarities about it that require some study and some comments. Even though you all have a very tight deadlines, part of the purpose of the committee was to ensure that there really is adequate public input. I think, simply, passing on the recommendations from the privacy and security work group does not give us adequate time for public comment. We would recommend that you set this aside or develop a process to take in public comments and require that they be addressed and incorporated into the matrix and into the recommendations from the privacy and security work groups. That is, essentially, my first comment. The second comment or question that I would like to address to the committee is, you know, Dixie and Steve put up eight key areas of focus for privacy and security that came from ARRA. The most significant and historic and consumer privacy protection in ARRA is the ban on sales of protective health information without consent. We do not see that particular requirement of the ARRA on the timetable for of the health IT Standards Committee, so that is my, essentially, my second question. When is that going to be addressed? That is a central protection. How can the privacy community privacy advocates and the public interface more effectively with this committee in the development of key privacy and security standards?


Thank you very much for your comments. I do not know if you would like to offer any comments.


I just want to respond to the question about the provisions in ARRA about the data. That is something that we are in conversations with the Office of Civil Rights on. If is something that would be incorporated into any modifications they did on the HIPPA regulations, so that is something that will absolutely be addressed as required by ARRA. I am not sure that is something necessarily that the standards committee would be looking at. It is something that would end up being a legal requirement as opposed to being a standard for any electronic health record.


Is there a process for the public to be involved with 0CR and the development as that moves forward?


I cannot read event — represent the Office of Civil rights. There will be making public comments and incorporation and consideration of those comments before coming up with final regulation.


Thank you, Jody. I hope someone could react to my question or concerns about the recommendations from the privacy and security work group.


I hope you were with us for the whole conference, because there has been some discussion about the next phase of Commons and activity.


I was.


I just wanted to make a couple brief notes about the the some of the questions. Let me first ask if there are any other persons online or in the audience who would like to offer any comments.


We have no more comments on the phone at this time.


Just one really quick. I am Robin. My comment comes from [ indiscernible ] top health panel. That futuristic for 2013 or 2015 when you get into a consent, I just want to know that the examples were like human beings in charge of their own consent. Don’t forget that when you get into kids and you don’t know where they came from, you are not sure the data is, though not forget the layers of consents — Do not forget the layers. But forget that group, since that is one of the ARRA eight.


Thank you for your comments.


Any other comments? Okay. Well, let me start with the theme. That is the public commentary throughout the process. Of course, all of the meetings have been open as required. I really encourage the Federal Advisory Committee Act and its process. Jodie, maybe it seems that there still is a great deal of interest — could you describe once more the different threads for cover public comment? I will just press is that anything that is recommended to C M S and C MS takes up, they will have their own public comments. Let me turn to you for that, Jody.


Sure. All of our activities in the area of standards and certification, all of C M S activities and developing incentives and defining meaningful use, all of provisions regarding modifications to the HIPPA privacy rules that were in statute, which we have not talked about until just the last comment. All of that will go through our normal rule making process. The rulemaking process is designed to be a two phase process where the agency comes out with their best proposal on a set of rules. We look for comment. We are, in fact, to — all of the activity that this committee and the policy committee are advising ONC and CMS and also some comments that might be directed. Folks can be part and hear the deliberations as well as be able to make comments on the record as folks just did at the end of this meeting for the committee to hear. I think in some ways we have sort of confused the process a little bit by having a separate comment just on the policy committee hearing on meaningful you started that is not something necessarily required or frequently done, but it was something that was optional that the committee thought was important to do. We support the committee in doing that and received quite a lot of interest and send that information back to the committee. I am not, you know, at this point I do not really think there was any intention to do other informal comments. If at some point in time the committees are interested in doing that, we can discuss our ability to support that, but I have not heard an outpouring from the committee chairs on doing that at this point. Basically, just in some, all the things we are talking about will go through formal rulemaking. There will be public, a process used for that. Comments will be posted on the web, very prance — transparent as we will explain how we address all of the comments. Again, we encourage folks to participate in these meetings to make public comments to give your voice to the committee members in their deliberations, etcetera.


Terrific. Thank you for that. I think the themes that we have heard — I appreciate in the privacy and security, given that there is such work to do in and around a meaningful use, they chose a process, which is already codified. I hope that addresses one the set of issues, because it is already dealt with with far more stringent set of criteria. I think the comments that were also made are very helpful in reminding us about the importance of making sure that our work continues to facilitate innovation and that it is work that addresses this as well, of all honorable populations and addresses the needs of care delivery, a better environment other than the hospital and doctors’ offices. I think we heard that as well. I think the point about certification and meaningful use, there is a bit of a sequencing problem. This is now the time for some of that work to come together all of those points are points that we as community have felt the obligation to reflect upon and incorporate into our next set of activities. We certainly have marching orders in and around the next novel of the standards and their use and writing measures of quality. Let me turn to the committee and ask, are there any other issues or items you would like to put on the agenda? Anything for the good of the order before we break today, reconvening on August 20th, I believe is the date?


Just recognizing that standards are always a journey. I know that sounds a bit Zen or something like that, but what we will do with each successive meeting is continually constrain the variability. I think we have learned to today at the comfort levels we all have and the next meeting there will be more and the next meeting there will be more. I hope you all take this particular day as a step in that journey, and I’ll look forward to working with you.


Well said. Let me, again, thank you all of you. The numbers of hours is incalculable. Today we know there is more work. [ indiscernible ] and to realize the aspirations of improved health-care safety we’re not affected and more efficient by virtue of moving the data. Thanks so much, everybody. Thanks for your great work and leadership.

TRANSCRIPT – HIT Policy Mtg 7/16/09

July 16, 2009

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.

    Day 2 – TRANSCRIPT Adoption/Certification Workgroup

    July 15, 2009

    These are the materials and rough draft transcript from the 7/15/2009 HIT Policy Committee Adoption/Certification Workgroup meeting: 

    Meeting Materials:

    This is the audio of the meeting

    This is the rough draft transcript of the full meeting:

    Top of Form

    Event Started: 7/15/2009 8:49:01 AM ET


    Good morning. This is the second day of our public work group meeting, and according to the agenda, John Glaser has opening remarks.


    Thank you, my apologies. Welcome back to all of you. I only had two comments, Paul Egerman and Marc Probst will be presenting — yesterday, today, other input, if you have the opportunity, open, public meeting, I encourage you to listen in, hear what they have to say, et cetera.


    We are still working on the timetable, public comment period, open to receiving written comments, proceedings, in conversation of yesterday and today, material they will present tomorrow, so you and those on the listener line know we post in the federal registry, and the ONC site, look forward to other things to factor into this conversation, and with that, I will let you gentleman carry on.


    [indiscernible] will be moderated by Steve Downs.


    We will have a final public panel this morning, will involve different flavors of systems that our candidates for certification, and we are going through in the order listed in the agenda. We have Edmund Billings, David Kates, from premattics, and Carl Christensen.


    Edmund?


    Thank you very much for having us. I want to give you perspectives from our experience over the last three to five fives in regard to taking open-source — open system marketplace a quick background on med sphere, we got the vista system through the freedom of information act, combined with other open-source components the interface engine, GT database, the CDR, other technologies to provide an open-source stack, the health service, so we advance the Vista core database and product with their help. We are deploying outside of that, of that customer, deploying in small to medium-size hospitals, state systems, and don’t have a vendor model. I was pleased by the name of this panel. We think it’s a distinction that when you give the software away for free, and the customer pays you for support and services, you have to prove those every day. You don’t have dependence on the software. They could — there’s an industry around Vista and those customers are not reliant on us alone. That makes it quite a merit uke a mer — you can go into different settings and have different outcomes. It’s about the outcomes.


    Now, this is the most glaring problem here, that we have 1.5% adoption of full EMRs in the hospital market. If you look at the VA, put their hospitals in the mix, it doubles that.


    If we look at the adoption model, age six, even of that 1.5%, to get full clinical adoption, meaning physicians, nurses using the ordering, documentation, we have even a fraction of a percent.


    So we haven’t crossed the case chams. Chams Chasm; the same functional set as in the 1990s. The early adopters had resources, physicians, clinicians to put on projects and those innovators help drive the complexity of these systems up. Early adopters drive for the 100% case. What happens is those products don’t translate to the main stream. 1.5% shows us that.


    The vendor model is a dens model, no financial interest to be — to be less interoperable, you get a lock on the customer, they come to you for all your systems. So it’s the business model. The full-blown, the term used in committee meetings, full-blown EHR is just a division that hasn’t translated. I hear over and over these systems are too much, too expensive, too complex, and we can’t A to adopt them.


    We talk to main stream customers, they either go with us or don’t do anything. We have not lost a deal to another vendor, because they can’t afford the other vendors. So this is spot on, by Clayton Kristen son, technology brings more affordable product to use, opens new population of consumers that can then afford , have the skill to use.


    I will talk about an example customer, Midland Memorial Hospital, 320 beds. They had an end of life on their information system. It was a $20 million upgrade, they had no capital where with all to go with that, they looked at Vista, called med sphere, attained stage six, then went on and got involved in the Institute for Healthcare Improvement’s project, and a case study with [indiscernible] systems.


    They implemented the product in three years with a budget of around 6 million. These are the other 10 hospitals that made that first cut of stage six hospitals as of 2008. There’s 50 now, but this was in 2008. With gorilla research we came up with these estimates. In terms of time you can see it’s about a third to a half of the time, and the cost. On a per bed basis, the 65,000 — Midland spent 18. You can see the ranges there.


    This is their budget, software was free, they paid us for implementation, consulting and support. They had the full budget here, comparable was 20 million for the software without services, the incumbent, but they had enough wherewith all in the budget to get a financial system, bought computers, laptops for physicians, put in 400 access points, knew access is how you drive adoption. The point is, if they are not spending on software licenses, they are spending on adoption or transformation. This is the adoption curve was physicians A fill yaitd, some don’t order anything, over nine months got to 150 or approximately 100% of the physicians were using the CPOE.


    In the five million lives project, they went to — ventilator-associated pneumonia, 77% improvement, and medications, 59% improvement.


    This is our [indiscernible] based — if they attain meaningful use that it would pay, basically the ongoing investment would be paid for in 48 months, 46 months. The point there being if they had spent the money to the $20 million system they would never get a return on investment from ARA. The main stream needs complete solutions, not comprehensive solutions. Complete meaning they solve, directly address meaningful use, but don’t have to do everything but the kitchen sing. Bell and whistles get in the way a of adoption. Less is more. These organization don’t have the resources to buy technology. They need it packaged as services and they need partners for results. Connecting first, this whole idea you should automate the practice, then get connected, is backwards. Look at e-prescribing, took off when there was a network. Start with a network.


    So the recommendations are, do not require certifications on comprehensive criteria, the EHR C, between 2007 and 2009 there were 36% increase in criteria. That’s not going to stop. It’s called bloat ware. Certified solutions to protect the customer, plug and play, certify modular solutions to support incremental adoption, continuous innovation, customer choice. Certify sites on demonstrated meaningful use and foster an on the ground service industry. That’s where the rubber meets the road. A product can be useable, the question is, is it being used? Requiring [indiscernible] for electronic communications can obviously shift the value to wellness. If the business model isn’t there, standards and certification are meaningless. Support Vista RPMS, [indiscernible] connect, all the national projects as they are going public domain and open-source, they can be leveraged and you can see results in terms of open-source ownership.


    David Kates?


    Thank you, it’s a pleasure to present to the committee here. By way of ground I have been involved almost 30 years to the day I was first working on cardiac monitoring in the basement of the hospital at Beth Israel, technical expertise around applying the advantages, tech nonology with can bring too healthcare. Over time I have moved from large academic medical centers, to community hospitals, large clinics, like Mr. Christ yen son was describing into the small practice, where most of the focus of Prematics is, most comments addressed today. By way of backgrounds, I was a founding board member of HL 7, served on HIT since its inception, I am quite familiar with the efforts undertaken and driven by the industry for quite some time. I want to address comments as it relates to how those do and don’t apply in that small physician practice setting where adoption rates are low and barriers are great, many will be addressed by the funding, incentive stimulus plan provides, but we need to be careful about where we focus adoption settings, to target most meaningful use and benefit to cost, care, delivery system in the U.S.


    So, as you know, and we understand, most physicians in the U.S. practice in small group settings and where most care is delivered. As mentioned, adoption, technology in general, clinical information technology specifically in those settings is woefully behind, even the hospital marketplace because of the myriad of obstacles, funding, incentives, as well as resources, skills in those settings. The focus of this discussion isn’t so much on premattics, — informed by the experiences that I personally and Prematics has had. In those settings there isn’t a widespread use of this technology and the need to go provide something of value fits into the work flow, and can be adopted in a meaningful way in those settings that benefits the physicians, office staff and patient is crucial to getting a significant foot hold in those settings, and while important, because of the sophistication, focus, lack thereof IT in the settings is crucial, significant, it needs to be focused in efforts that are appropriate in the lines of modular, EHR certification undertaken.


    So, the numbers behind the statement most physicians practice in small groups, ambulatory, the 600,000 or so physicians, more than half of them, 71% in total are in 10-doctor or less practices. More than half in one or two-doctor practices. Turning that statistic on its side, you look at number of physical addresses, 90% of physicians are in small physician practices, less than 10 doctors. Looking at the one specific area, those familiar with Prematics, think of Prematics as an electronic prescribing company, it is in fact a service company that delivers clinical information at the point of care into small physician practice and does it around a prescribing process. Today, being able to deliver a work flow automation tool that allows doctors to be able to write a prescription, deliver that safely, efficiently to the pharmacy where it can be filled, mail order or retail, on the face of it, but really introducing technology into the doctor, in their hand, in the exam room, while with the patient, providing meaningful information in the context of writing a prescription and informing that by clinical information related to other medications the patient is on, and formulary information that might drive the use of lower cost or generic alternatives. The opportunity to deliver other clinical information in that setting, driven by an embedded application that’s sticky, that can go and provide value to the doctor initially around the prescribing process and ultimately around other processes is key to what we are talking about.


    In those settings, we walk into a doctor’s office, our service is free to the physician, includes not only the electronic prescribing service, but the handheld device, wireless network and the like. We walk into doctor’s offices, and as we all experienced, the technology in place is unsophisticated to say the least. They have PCs, I didn’t realize there were still dos machines in the world, but there are. To fit into the work flow, be adopted in those settings, they need to integrate information around what patients are in the practice, the schedule, work e-prescribing. We are providing the full information. Wireless net workses, you may think — they do by and large have Internet service. In central Pennsylvania that wasn’t the case, but it’s typically limited to doctor’s office, looking up information at front defg, eligibility checks. Not in the exam rooms. Wi-Fi, generally because the broadband provider has that built into standard router, but not designed to have access online to the Internet, other resources as they move through exam rooms and in the practices.


    What we see when we walk into these settings, we have to build the infrastructure from ground zero, in the less than 10-doctor practices, and largely the one or two-doctor offices. The spouse at the front desk, it’s nobody’s job responsibility to manage IT. Focused around delivering care, getting reimbursed under the current system as best they can for the care delivered in those settings. The notion that, and we all know this, but that physicians are not interested, afraid of technology, is not the case at all. It just needs to provide value in those settings. As we walk in we find an eagerness to adopt the technology, they just don’t have the financial or technical skills to be able to take that on themselves.


    What we see in the context of services we provide, and generally based on the collective experience of people in our organization, myself, Kevin, Dave — have been in the small physician practices, they need to be able to adopt in a modular or incremental fashion. A work flow like prescribing, infrastructure is there to support the work flow, access to clinical and financial information that’s relevant in the context of writing a prescription, being able to fully automate the process, thinking about where the printers need to be located, so when the patients leave, used to walking out with a piece of paper or prescription, they have something reminding them of what pharmacy will — the form of therapies delivered. Being able to deliver that incrementally is crucial.


    Focusing on key work flows, and the discussions I have listened to, participated in around meaningful use have always come back to key clinical information, work flows, electronic prescribing, lab ordering and entering, support system, being able to manage a problem, being able to access information in the context of registries for managing chronic diseases. That’s where the big benefits are, center for technology, leadership studies, affairs around the benefits from EHR, health information exchange. They all come back to core processes directly relating to this information, being able to share that, manage effectively.


    The comprehensive EHR, I forget the term used, but the complete, comprehensive, full all-singing, dancing EHR, in the past, traditionally, and I have been in those businesses in prior lives in my career, a lot is geared around creating a comprehensive progress note, soap note, the reasons for that are many, but for the vendor and the practice, to have a compelling reason to get the doctor to make the investment in IT, and in that small physician’s practice, cost around dictation, transcription, run into the thousands of dollars a month, the documentation needs are significant, both because of litigation they are trying to prevent and reimbursement today is tied to the complexity of the visit, the EM code, the business code, the EMR vendors need to drive. The certifications have really geared around that progress note, the structure, which has great benefit in being able to derive useful information, lead towards comparative effectiveness, all the things we strive for. But that’s the running comprehensive thing. I happen to sit on the technology committee operations subcommittee, and some of the things we deal with in terms of quality metrics that need to be addressed, measuring hemoglobin A 1 C, for diabetics, or smoking cessation. Even with the tools today, those discreet elements are hard to get and can be a pain without the comprehensive, codified notes that are really driving a lot of what’s in the EHR C certification.


    In terms of certification, we, and those I work with in the industry absolutely applaud and see an incredible value in certification. It is, as expressed, an unsophisticated buyer that needs guidance, and in terms of interoperability, may not be of direct benefit today given the current reimbursement model, those are all spot-on in terms of the value certification can provide. The paternalistic side, making sure that physicians are investing in a quality product, well-placed, making sure they have some of the comprehensive, full-blown, over-blown capabilities around documentation needs may be putting the cart before the horse. There are things we absolutely want to get to, provide value to the industry, but need to focus our efforts, even though the stimulus act provides incentive money to overcome the financial barriers that have impeded adoption, we still need to overcome adoption hurdles about their ability to use, and have it embedded in work flow. The work flow efforts target the electronic prescribing, access to quality information, I think where the greatest benefit can be derived, and these more comprehensive documentation tools are where we can get in an iterative fashion.


    As I touched on, the approach that CCHIT, heading to Chicago right after this meeting to chair one of the work groups, this model I hope to learn more about, I think is the appropriate direction. We just need to be careful about what we acquire and when on the comprehensive EHR, so we can meet the needs of the small physician practice and the goals we have as a country and as this committee is striving toward meaningful use, adoption in those settings, and getting quality, cost effectiveness we are hoping to attain by providing technology, making this huge investment in IT and those physician’s office for the benefit of the whole. So, in conclusion, certification is great, it’s crucial to the objectives of what we are trying to obtain and should focus on the areas we get the greatest impact, biggest bang for the buck and in an incremental fashion.


    Carl Christensen: Good morning. This talk will reinforce the previous two talks, with a slight different focus, that being that I firmly believe in-house development is having some, across the country, is key to innovation. A lot of the products we are using today have their starts in that way. The point that the comprehensive certification on a broad set of features and functions is a barrier to us for innovation and feel the right approach, like the previous speakers, is a focus on meaningful use.


    As background, we are a large specialty practice serving across the northern half of Wisconsin. Our physicians, around 800, 45 sites, see 400,000 unique patients per year, translates into 3 and a half million encounters, roughly a billion in revenues.


    We have been at informatics a long time. The group I work in formed in the early 1960s. Our first electronic medical record application went live in 1985, and in 1994, you cannot practice medicine at Marshfield without encountering a computer at every — you had to at least sign your notes electronically. Part of the physician group practice, PGP, demonstration project. I will talk about that more later. It’s real important, I believe, in this discussion. We are certified with CCHIT in 2006 and 2008 standards. We sat last month for the 2008. I believe we were the first in-house developed CCHIT certified system.


    We have an HIE of sorts, all the characteristics, these dots represent the facilities across the state, within the Marshfield Clinic system, healthcare information electronically. We have a shared EHR model within the region across multiple organization. That means the same instance of the electronic medical record is used by multiple organization as their legal electronic record. We have hosted, sponsored a large network, have a laboratory network that connects to many net ork organization throughout the state and the country.


    I believe we are the first in-house developed system that received certification against the ’06 standards, and sat last month and passed on the ’08 standards


    We spent 65,000 hours over and above the ’06 tasks to certify on the ’08, and for a group of our size, that is a significant, to say the least. A significant portion of the work added little or no value, from our definition of value. Probably somewhere in the negotiate of 20% added no value whatever. Of the other 80%, roadmapped in the same time frame, and probably half of that we would have done in a different way. This diverted focus away from what we would say are other high-value enhancements, away from those to working through this checking off comprehensive list of features and functions for the certification.


    One example, this — there’s a number of — probably caused the most grumbling within the group. I would argue we have one of the most clinical data warehouses in the country, coded diagnosis that go back to 1960, right from the start we have had a warehouse for four decades now, and have been adding coded information to that, have been doing some pretty significant things from that.


    Given that it far exceeded the reporting capabilities required, however the logistics required us to write a parallel reporting system, which added no value, and specific things around the logistics were the testing process required that you be able to report off of your clinical data warehouse immediately, and clinical data warehouses don’t work that way, other than in a vendor-based demonstration.


    Unless this requirement is changed or we choose not to certify, we will not maintain this parallel reporting system forever, which essentially will not be used because it is inferior to the large CDW.


    A few observations, echoing the previous speakers, the biggest benefit in my opinion to CCHIT certification is the reduction of buying risk for purchasers of HIT, in terms of adding that value to Marshfield was minimal. The physician group practice, pay for performance CMS demonstration project, had a very large impact on the health information technology. Improved the quality of healthcare, we demonstrated it significantly lowered cost before we added any of these ’08 features, many, some of the ’06 features. We have driven down hospitalizations significantly for the care management groups that we are focusing on, with IT being a key enabler.


    When our board approved, back in 2004, that we would be part of this demonstration project, our entire focus on IT changed overnight. It changed to very much an out comes driven, how are we going to meet those quality and cost metrics, and our focus was on, then, translated into that, which was very much doing the right thing.


    We did not see the same things, had not seen the same things by coming from the certification process.


    Again, the quality of the implementation process is far more important than the feature list, and we should be, if we are going to incent HIT adoption, we should be focusing on that, not checking off the comprehensive feature list.


    Recommendations of these incentives should be based on demonstrated improvements, efficiency, effectiveness, competitive scorecards, interoperability, E-prescribing, all great things to focus on, should not be based on a list of product features, and in summary, if we want HIT to support evidence-based care, the features should be evidence-based as well.


    I would argue I don’t think we are quite there. I don’t think we really know yet which features within these systems actually, certainly on a comprehensive manner drive the results we are trying to achieve.


    Thank you very much. Now we will move to Question and Answer, and I will look to the work group for questions.


    Seeing none immediately, I will ask one of my own. I am curious of the 65,000 hours spent, would you be able to estimate the split between how much was developing features to be compliant with CCHIT, versus the process of going through the certification?


    We did not, in our time accounting, did not break it out that way. My estimate would be probably 90% was spent on features as opposed to 10% on process. Something along those lines.


    Thank you. Charles?


    Good morning. When we talk about a modular approach for deployment of health IT, can you comment a bit about the resulting data structure you might see? In other words, as we deploy the solutions, hoping to create a foundation for clinical decision support, cognitive, whatever you want to call it. As you do this modular type of approach, how do we ensure we are creating a data foundation that will be supportive of decision algorithms?


    Great question. I think the modular aspect of what CCHIT contemplates and my comments addressed more around the features, decision support, work flow automation tools, but I do think, both from interoperability standpoint and overriding data model, what the information is that needs to be shared, so the modular components can access that data and support quality initiatives, there does need to be definition, and architecture around how the data would be structured so the modular features that assess the information, support quality initiatives are driven around a common framework.


    Do you think that should be part of the modular certification process or how might that happen?


    I think on the edge of how the information will be accessed, the modular certification process needs to enforce this is how information will be exchanged and here’s how the data will live, whether in the cloud or a system local within that organization. It does need to be cognizant of that, there are more definitions, but should focus on [indiscernible], not necessarily where it lives, what is — more comprehensive in the feature model.


    Marc Probst: With Vista, I don’t know a tremendous amount about it, but being an open-source product, and I am not sure how many clients you have, can you give me an idea?


    We have the Indian Health Service and their 200 facility network, and we have the state of West Virginia, public health hospitals, seven of them, and seven other commercial hospitals. The stimulus package is definitely, has simulated the marketplace and we are seeing a lot of interest in this type of approach.


    That’s what I am interested in. Is there a lot of variability between the sites? The reason I ask, certification seems like a snapshot in time. If you did it in 2006, you will do it in 2008. I am interested in how much variance there is between your site and is that a challenge?


    Well, the concept of open-source –


    Open-source concept scares people. We don’t use open-source when we talk to customers, we talk about freedom, not locked in, control. Everyone thinks there are fin Finnish developers working somewhere. Red hat, developed by a bunch of Finnish — if you have more time than money, you get Linux, do it yourself. If you have more money than time you hire Red Hat. The venders model was going in with an empty database, build the system. Each hospital is different. That’s not the case. The VA proved you can go, can build a system, the best way to build the best practice is to build into the content. Meaningful use, configuring the system to go after meaningful use criteria is wonderful in terms of cutting down the variance. That’s what we are talking about in terms of helping customers.


    Efficient system, how you build it, is how you start to do that. In terms of certifying, as I said earlier, the rubber meets the road at the use of the system. We heard it over and over again. Certifying a system protects the customer, but doesn’t get you any results. A certified system can be used, the same system can get completely different results. We heard that yesterday. It’s not the certification, it’s the deployment, implementation and focus on results that gets to those results.


    And I guess to follow-up, I was kind of interested in, the concern has been both self-developed and Vista, these change in a very rapid cycle, may not be typical vendor cycle of every six months, may be more often. I wonder what the impact of certification on an environment like that.


    Obviously, a two-year cycle, doesn’t match, we come out with service packs every three months, the project itself, community around Vista is quite large, development going on all the time. It’s like herding cats, and you have to publish the certified solution, that you provide to customers. That’s where the editing comes in. That’s what we have to do, to be the committers of the code that goes into the certified version of software. It is much more of a quarterly, every — customers can only swallow so much improvements, enhancements, upgrades. The code itself is advancing much more frequently.


    Steve disfollow-up question on that. Say there are four or five — out there, each servicing, supporting, offering a version of Vista, do you see each of those organization seeking a certification?


    They are right now.


    Essentially of that product?


    The same code. We had two — we have two versions, open Vista, commercialized, and RPMS, and we have to certify both.


    Are you suggesting there should be one certified version of it?


    Yes. And you combine that with the comprehensive criteria, it’s overwhelming, and you are not building in value, you are building features and functions. If we take people from ground zero, the modular approach to certification is the modular approach to adoption. You can’t adopt all these things at once, it’s not the way technology gets adopted by the main stream. Main stream adopts more grad you’llly.


    Thinking on that, the vendor submits a version of Vista for certification, should the next one that wishes to sell Vista say Vista has been essentially certified, the first vendor, should be an equivalency recognition?


    Or a different model, since no one really owns Vista.


    Linux has multiple distributions, comes back to the company that deploys it, has to package and certify it. It’s a much more difficult equation than if you own all the code yourself.


    Paul?


    Couple questions, first want to say thank you for being here, and say to you David Kates, I also worked in the Ceressteen building, but following up on the issue of open-source certification, if I understood your presentation correctly, you suggested instead of certifying this comprehensive medical record there should be a reduced focus, perhaps on meaningful use. My question is, if we took that approach, hype thetically, what would be the impact in terms of certification for open-source software? How would you go about it under those circumstances?


    The modular approach, focusing more on meaningful use.


    Correct.


    Obviously there will be, the criteria would be much more based on demonstrating you can get those to those meaningful use results. If I look at the matrix that came out, it’s very much data, and transaction-driven results. There was 18 or 19 in 2711, a much smaller list. A fraction of the comprehensive criteria. In terms of number of crate ya, focused on demonstration, I personally believe certifying at the site is where the important aspects are. As mentioned earlier, interoperability, patient safety, those are the items that you really need to do at the product level protecting the customer. To gets to meaningful use results, I think it’s a site-specific implementation-specific validation that’s really required.


    If it was a reduced [indiscernible] more focused on meaningful use, you would advocate for some sort of site inspection process.


    If you look at the bottom on that — in all three of those cases, at some point the site has to submit for meaningful use. The slide David Kates and — showed, the bottom line is the site has to prove its meaningful use to get the criteria, not just submit a code saying the product is certified.


    Last week I spoke to another member of the open-source community, hope I am saying the name right, Joseph van mulen, from Vista, I asked the same question, he gave a different answer. Was very positive about Vista, described it as a national treasure we have, very thews yaftic about open-source, but says the open-source community needs to compete with the commercial products on an open playing field.


    I don’t disagree with that. Vendor products shouldn’t be competing on comprehensive feature function either. We have 1.5% adoption. I think the point of my model is not about the open-source, it’s about competing for service and results, not competing on product and code.


    But my question, though, I am very focused on how you certify open-source software. If you want to compete on a level playing field, commercial products, shouldn’t you have the same — certification process, but that’s not — [indiscernible]


    Open-source product, saying the same thing I am.


    Saying modular.


    Or site.


    The devil is in the details. The slide, that’s as much as we know. The devil will be in the details about what the criteria are in modular, how frequently they are done. He did talk about the version control issue. Obviously the ownership, inheritance of a code base that’s certify said, download to my site, and implement, I shouldn’t have to go back and get that recertified. There’s a number of items to be addressed. The open-source community generated a list of improvements to the process that would make it work for open-source. We are not looking for a separate certification process. If I were sitting here with a — we heard it from Dr. McCallie yesterday, he said the same thing, he’s from sirenner — modular, if defined correctly, where we think we could certify our product, and because it’s focused and modular, and secondly, we think the site-specific certification shouldn’t just be for home grown. You put open soirs source in, it’s not buy or build, it’s both.


    I saw the 65,000 hours, wasted, it was heart-breaking to see. Interesting piece of — trying to understand, are you advocating for a site visit approach for home grown systems? How, what — what should we be doing so that other people don’t have to waste 65,000 hours?


    I agree with the previous comments, a site-specific certification certainly is the only network for a home grown system, focused on meaningful use or something around there, as opposed to going through a comprehensive list of certification of features. I would also argue I don’t think it only applies for in-house developed systems. The issues that we are raising, either you run a large monolithic enterprise system, fully certify said; or you are an in-house integrator, bringing in multiple systems. So, I am blocking on who said this, but you get to a certain size of enterprise, you are doing in-house development. You may not be to the extent we are doing at Marshfield — the site-specific certification is the only practical way to go forward. It is not to say that having some good housekeeping seal of approval or something for buyers of modules or systems is a bad thing, but it should not be what is really, certainly shouldn’t be what is driving the incentives and focus, enforcing organization to focus on that.


    When you say a site certification, let me be sure I am hearing you correctly. I am thinking about a site visit, or site inspections, somebody goes on site, virtual process or something, that what you mean?


    Yes. That’s what we mean. Possibly could be accomplished 100% based on some sort of meaningful use criteria, looking at other areas where we have had a certification, accreditation, that’s typically not the case. It’s somewhat akin to saying you do your JCAHO inspection by reading policy manuals for the organization, not actually going and doing an inspection. Or doing a cap inspection by only reading the manuals and checking that off. That is not — I would advocate some level of on-site certification, with the focus being on not — features, what we are accomplishing, setting out to do.


    Thank you.


    Mark?


    You are kind of answering, from a statement you made, Carl, the 65,000 hours concerned me, but what concerned me more, is a significant amount would have been done in a different way and gave example of reporting. Is there something criteria or requirements making it so inflexible or slanted toward a set of technology we should be talking about, addressing that?


    The answer is yes. We seem to be heading on being, driving into a more and more granular level of, on the certification, more and more detailed, losing some of the flexibility and ability to innovate. We have to be careful to not drill in too deeply on the criteria. A dozen, areas of reporting, the biggest, when sit through, I sat through some of the test, I thought we would be in trouble in how we were managing our problems list, it was coming down to the criteria of how you make a change in the problem list. We did a dictionary based approach, and one of the proctors was, his interpretation is that dictionary based approach is not what we should be doing, we should be doing it on the actual value, not attributes of the value. That’s getting a little bit too focused. If you drill down too deeply, the goal should have been, can you modify the problem list.


    Did you pass it?


    We passed it — but –


    You were able to convince the proctor –


    We ended up passing, but actually had to go in and change, make data dictionary changes on the fly so we could present it in the way the proctor was comfortable with. I was fortunate we had that flexibility, and we were not anticipating –


    As you go through the criteria, it’s an RFP on steroids. The level of requirement is a level up from this. Meaningful use is a level up from that. It’s completely over specified. If you go in, almost to the point of push this button, get this list.


    My comment is along the same line of Carl and Dr. Billings. We said modular, I used that term, it’s a term CCHIT introduced, I think we are talking more about core capabilities, not overblowing the features and functions there. Oftentimes facilitating work group meetings with physicians, vendors trying to look out for their brethren, purchasing a system or what not, it becomes a wish list, all the bells and whistles you might want. The work group struggles with what is core functionality, the ends, what are we trying to accomplish, improve, quality and efficiency of care. If you go through the litany of things in there, it’s the core functionality. Modular is a term introduced, but means you will have piece parts that all come together, create the functionality defined in comprehensive. That’s not what I am talking about.


    We have a roadmap within [indiscernible] VA has a roadmap, puts code out on a regular basis expwrks a code map with the regular customers, CCHIT is — you saw meaningful use I described, asking for more meaningful use functionality. To be distracted, have to pull resources, put effort into something ever engineered, off course, more complex is a waste of time and energy.


    Time for a few more questions, John? Larry?


    I am sure you have a [indiscernible] coming out, though you passed over all.


    Interested more in the site visit angle. You mentioned a certification process, focused on meaningful use, up to 1000 feet, but the intent is to say the product, however obtained, is capable of doing these basic core elements. One form of inspection, for lack of a better word.


    CMS has another, you want our money you have to prove how you do this — some discussion of a site inspection, largely to address an aspect of the former, which is it might look great in the lab, but in the setting other than great, to test the fields, make sure the field experience was what was the lab experience, et cetera. It gets a little messy, there can at times be the supplier hoodwinks somebody. That’s the implication. At times, we screwed it up, nothing to do with the vendor, we misconfigured the darn thing, whatever. You have a failing in the field, whose failing is it? One, you go after the supplier, CMS is clear, go after those who think they ought to get paid. What would you do in a site inspection and who is being inspected? Marshfield Clinic or — one of your customers, implementation, the vendor? Trying to get the greater clarity on intent of the site inspection.


    I think it’s the site. The thing we are trying to do is empower the site to change, help them change. It’s when they take this tool, use it, treat it like a tool, a platform to improve, that’s when they improve and governance gets aligned, everything aligns around improvement, if you don’t have that, that change management, you get the other results, isn’t being meaningful used.


    Is that more the CMS side, to make sure you are good regarding payment, more in that camp than the product camp?


    Closer tied to getting paid, the closer you will get business models, industry forming around organization to help them get there.


    Coming from the small doctor practice setting, I don’t see how that scales. I want to go on record, there’s got to be surrogate measures, some metric whereby we can infer, certify they are using in a meaningful way, performing certain actions, providing certain information.


    We have a couple more questions in the queue and very little time. If I can ask for very crisp questions and answers. I have Larry and Charles.


    Let’s see if I can keep this crisp. Maybe we can skip it. Thank you, Larry.


    [Laughing]


    I hope that’s not catching.


    My question is back to the EHR M approach. The question I have is, looking back at CCHIT slide you showed, David, for providers who prefer to integrate technology from — sources. The thing that jumps out is the challenges we had around integration, interprat int interOpperrability — how do we — provide a path, not a bridge, a series of piers, how do we manage that risk?


    My first comment is back to earlier statement, I think modular EHR, the way CCHIT is defining it puts the burden on an organization to create EHR comprehensive. What I am really talking about more is narrowing the focus of the certification effort around some core features and functions. The modular approach has merit, whether large organization, ability to do integration, the adoption, ability to integrate the tools into the work flow and practice, I am describing as a modular approach. In the smaller physician practice, other settings, it’s not what’s in the caption, on the slide, saying that integration wants to integrate on their own, that certification, adoption needs to focus on, take baby steps to support meaningful use, and be able to buy technology, adopt technology in a modular fashion. Not integration focus on that side.


    I would add, you can think of modules as these siloed — that’s not going to work. You need a foundation platform with the interoperability data model, liquidity, that support to allow it to flow across modules. If you have a separate — today, if we have a separate emergency department system, integrates through our system, we can’t catch core measures at the point of entry into the system, flow-through to the main record. We have to re-do it. It needs that modular, longitudinal flow in the platform. When you see the successful models around sugar CRM, building on top of common platform, that’s the what’s needed in this module.


    Paul, I will defer to you, I know you have a question and it’s time, time to go back to you.


    I will ask my question, then say thank you. Anyway, my question is, in the discussion you were having with John Glaser about the site visits for open-source. I wonder if that puts open-source at a disadvantage, if you want to compete with commercial vendors –


    I am not talking in terms — this is true for any –


    If I am the purchaser, buy the commercial vendor, but if I buy open-source I have to go through the site visit thing to get certification. That creates a risk.


    I think we should change the terminology. I agree with David, we should get comprehensive versus core, or complete versus comprehensive. Complete to do meaningful use, not necessarily comprehensive, to the point discussed by Carl. That should be what the products get certified on. Open-source, proprietary, vendor, any of them. Should be done in a way you can do it in a modular deployment, development, and the site should also be — we heard from the Leapfrog group, over and over, we want product certification for safety for the customer, but we need to validate the usage in the field, and if we build that close to the financial model, you are going to get a whole industry of these organization get there.


    That’s very helpful.


    I will say thank you, Steve, for moderating, and thank you to the panelists. We appreciate your efforts, we had a number of questions for you because you are saying important things in how to accommodate these processes. Thank you thank you very much.


    We are heading into the public comment part of the agenda. Hopefully if you are washing watching, there’s a phone number you can call, and a microphone here in the room if anybody has questions. As John Glaser said in opening comments, the work group will be making a recommendation tomorrow, Thursday, I think at 2:00 on the agenda, if anybody has public comments this would be an important time. Folks are just on the phone, you need to press star 1 to indicate that you have a question, the phone lines are open one at a time.


     


    With the College of American Pathologists ology, I will would like to ask a question to this august committee, has a technology program been approved we it look at, and if so, who is the point of conon that?


    The way the public comment works, this is a place to make a comment. We don’t actually answer questions.


    So, when has there been an approval on technology platform, or discussion on a single platform for terminology?


    Could you explain to us — [indiscernible]


    What that means to you


    On next week, July 21, the standards committee, set up as part of — will submit three work groups on clinal, privacy, quality, security, making recommendations regarding standards, these are related to meaningful use, presentation tomorrow. To the degree platform is defined, recommended standards, vocab lar standards, privacy, security, you will have a opportunity, as will the industry as a whole, to hear the recommendations from those work groups next week, still finishing up, probably premature, although I invite you to join, listen in, hear the first wave of what they will recommend.


    Thank you for your time. >


    Two on the phone, the first phone caller? >


    Anthony, informatics: I am used to asking questions, but I will phrase this in the form of an answer. I basically wanted to echo, build on what John Glaser, the line of questioning he had been going with. It seems to me as we discuss more about certification, people seem to move into the direction of site visits and actually evaluating use, saying that’s going to be more valuable. You seem to creep close to the line of what had CMS will be doing, measuring when they check meaningful use. Without knowing exactly what that’s going to be, and how the inspection or submitting clinical data to qualify for money, how that will work, it seems you are guessing at where that line is, and either you ramp up with the site visit type approach, or you scale back, make is a basic functionality type level, that goes against the trends of adding on more levels of functionality. Just my observation and will leave it at that.


    Thank you very much, valuable comment.


    Did you want to make a comment here in the room?


    Yes, [indiscernible] American Physical Therapy Association, on behalf of the association I will thanks the work group for the valuable work you are doing to move us towards this health information infrastructure. Our comment goes very well with what you are talking about this morning, certification, adoption, making sure all of those particular criteria are inclusive of all healthcare providers. We think that’s a critical link to collaboration and coordination of care.


    As we look at CCHIT and their certifying criteria set forth it does not allow for that inclusion currently. For instance, if it’s required E-prescribing capabilities, it’s an important component of care, physical therapists, other healthcare provider and professionals are currently limited in their ability to prescribe medication, order tests, and in many jurisdictions this makes the requirement quite burdensome. The credit ya set forth by organization like CCHIT prevents products designed for use by non-physicians from being certified. Therefore, we ask as you go along with your recommendations, move towards finalization, we strongly urge the work group to put forth a recommendation that first represents comprehensive care and ensures EHRs are use utilized by a wide array of providerring, and provide pathways for [indiscernible],


    Thank you very much, we have somebody else on the phone?


    A number of phone callerses.


     


    Brian Ahier says: How will an electronic health record, particularly web based personal health records be made avaialable to those with disabilities? I have not heard anything about accessibility and am concerned that the ADA might be overlooked. Thank you.


     


    Brian Ahier says: My comment is worded as a question, but it is an area that I would like to committee to explore in the future…


     


    Brian Ahier says: Thank you for your assistance :-)


    Terrific, thank you very much, that was appreciated and valuable.


    The next caller?


    Richard Thor son, HMHSA. Hold on one second.


    To listen to the almost day and a half of discussions, it seems to me that — [indiscernible] lack of familiarity with it, it’s not been completely clear that CCHIT is not constrained, and has not been constrained in the past to use only standards that have become ANSII approved standards. If you look at the criteria used in the certification testing. A number of those have no source other than the volunteer committees. By itself would be all right, except that the volunteer committee assignments are not an open process. Quite unlike H 7, X 12, whatever, we have a nonHITSBE, non-open process leading to a set of certification criteria not constrained by having gone through standards processes. For an industry that commands 2.4, $2.6 trillions. Seems to me a somewhat shaky approach. Thank you.


    Very interesting comment. Thank you.


    We have another caller?


    Yes, but the callers that were in the queue got knocked out of the queue. If you were in line to ask a question, please press star 1 again.


    We are not receiving anymore by phone right now?


    Anybody else here want to make a comment?


    Okay, so, I will close this day and a half, one caller said he listened to the entire day and a half on the phone. That person probably deserves a medal for dedication. If they contact Judy Sparrow we will get an official HHS medal to anybody who did that. That will be sent via the U.S. postal service, may take a long time to receive –


    We actually have the two people back — Andrea Pennington from Logical Images.


    Hi, thank you for taking my comments and question. This is Dr. Pennington and I unfortunately have not been on the full day and a half. I apologize if this question is repetitive of other comments and questions. I do strongly agree health IT can address many of the problems with cost and quality. The modification of EHRs, others, I think it’s a step in the right direction. I respectfully suggest for clinical decision support software be included and eligible for this modular certification. To that end, I wonder if you can comment on, with the new modular certification, additional resources, will they be made available for reimbursement incentive through ARA, to encourage adoption, to those who see value in decision support.


    We really can’t comment on the question, unless you tell us you advocate we do that. If you want to make a comment about that, that would be helpful.


    Well, certainly, yes, we would advocate, indeed this happen, simply because of some of the other comments suggested. There are various providers who either do not need the full, interoperable because of their practice specialty, or have already adopted, or see the value for the “smart systems” the national research council suggested there should be greater emphasis. I would like to get comments from your work group on that.


    The public comment is that we consider the public’s comments and as John Glaser said, we will announce a recommendation tomorrow. Thank you very much, Andrea for your comment.


    Thank you.


    [Captioner transition.]


     


     


    The line of Rochelle Spiro, with Spiro


    Hello, I am Rochelle Spiro. I come from the long-term health care that involves the pharmacist technical advisory coalition, national council drug program, HL 7, and I am currently working with the work group project that is standardizing the HL- , which was on the fast track which was working — fast track working on the electronic records.


     I am in full agreement with that process.


    Pharmacist and the rule that the pharmacist that the pharmacist play in the — pharmacist play in the health care arena, comes from my different aspects. If we are going to have the electronic health records used electronically, we need to keep the pharmacist linked up as we are relating to what the pharmacist do clinically and professional with the scripture information, and that is just a piece of that information.


    And the key piece that we are working on the pharmacists and the professionals and the organizations — there are six of them — we are providing a electronic health record where we want to go through the certification process. We have seen those involved, but these are not involved in the work groups, they have gone through the certification process, it does work well, and that is one that we feel should be moved forward with the adoption of electronic health records.


    Thank you Shelly, it was great to hear the comments.


    Our group will reconvene from our closed session in 15 minutes, thank you.


    FULL DRAFT TRANSCRIPT: HIT Policy Adoption/Certification Workgroup

    July 14, 2009

    These are the materials and rough draft transcript from the 7/14/2009 HIT Policy Committee Adoption/Certification Workgroup meeting: 

    Meeting Materials:

     This is the audio from the morning session

    This is the audio from the afternoon session

    This is the rough draft transcript of the full meeting:


    I am John Glaser, my best buddy Charles is keeping me out of the light, helping me here. I would like to welcome all of you to the meeting of the work group on certification and adoption of the healthcare IT policy committee. I have a couple opening comment and will turn it over to the chairs. Paul Egerman and Marc Probst.


    I thank you all here in the audience and on the phone, I appreciate your devoting time and intellect to this important undertaking.


    In the high tech legislation, there are a few key attributes, but at the center, in order to receive the financial incentives, providers must engage in meaningful use providing certified every EHRs. The adoption work group, chaired by the colleagues at my left and around the table, the committee asked them to spend time looking at the certification process, not an immediate focus on criteria; that will come out on of the standards work going on, but the process by which electronic records are certified for the high tech law and payment meek mechanism. An examination of, understanding of how the process might work, such as open-source software or internally developed software. We ask them to do that, they had some I rememberings and are scheduling today for overall thoughts.


    We want to encourage you to evaluate all processes, but we want to make sure we thoroughly examine, look at a wide range of possibilities and potentials, and want you all to feel free to explore innovative ideas, new approaches. We want you to feel free, where appropriate, to be complementary, and to be critical, we would like to hear that. We look forward to a candid, wide-open, thoughtful and constructive discussion, and again, it thank you all for taking the time to be here.


    I want to get introductions of the work group members.


    Steve?


    From the Robert Wood Johnson foundation.


    I am [indiscernible] practicing gynecologist in Massachusetts, immediate past chair of the AMA.


    I am John — office of the national coordinator.


    My colleague and friend, Charles Kennedy with WellPoint.


    I am Paul Egerman, software entrepreneur and co-chair.


    Marc Probst with [indiscernible] healthcare.


    Adam Clark, the Lance Armstrong strong foundation.


    Any work group members on the telephone?


    Good morning, I am still Paul Egerman. We have a few work group members on the phone, Terry [indiscernible] is going to be calling in, the chief information officer of the State of California, which is a state on the West Coast of the United States. Happy to have her, it’s very early in the morning she is. As John said, this is a meeting of the certification adoption work group. At this meeting we are only talking about certification, not adoption. Adoption is critically important and there are a lot of issues, but that’s not the focus of the meeting today, and we are not talking about meaningful use, only about certification. We are talking about that because, as John says, it’s something that is critically important. We do have an exciting group of speakers, and some very interesting panels. We have been meeting pretty much every week for about the last two months, gathering information. The purpose of today and tomorrow’s meeting is really information gathering. We are trying to learn upon more information about what is needed for certification, and what we are trying to do with many of our panels is to put people forward who have differing point of view on a lot of these subjects. We realize they are controversial, there are always controversies, related CCI it, what purchasers need, verpdz vendors, we are trying to have discussions about some of those differences. The purposes of the public comment period, at the end of the day today and tomorrow morning, for you to tell us whether or not we have gotten the right information. If somehow we go through this, we do not know what people are going to say, and it’s possible not every viewpoint has been expressed. If there’s a viewpoint that has not, we want to hear that. That’s the purpose of the public comment period.


    The work group will be meeting in closed session, executive session this evening, and also tomorrow afternoon, and we are hopeful that we will have some consensus for recommendation on Thursday at the HIT policy committee meeting. If we are able to come to some consensus for what I would call preliminary recommendation, it will be printed in the Federal Register several days later and there will be another public comment period. There will be ample time for people to make comments. Any recommendation we make would be preliminary based on receiving additional feedback.


    Those are the things we are trying to accomplish. As we went around the room, the people in the HHS staff did not really identify themselves. I want to thank the people in the HHS staff who have been very supportive, helpful, besides John Glaser, the lead, but Judy — the contract office, am I saying that right? Something like that, she’s a chief honcho at HHS, we very much appreciate your help, and Jodie’s, and we also thank HHS, who has given us autonomy to make whatever decisions we want, so our first speaker is William Stead, will be talking about a study performed at the national research council. So, Bill William Stead.


    William Stead: From 2007 to 2008 I was privileged to chair an NRC commit assess the gap between healthcare IT as deployed in the best places it’s being deployed today, the gap between that and what is required to support the Upon institute of Medicine’s vision for quality healthcare. Today I want to share the observations and conclusions of that committee, and then to add my interpretation of what it means for the task of this working group.


    The ideas that I am going to talk about challenge the status quo, so I will go through the presentation relatively quickly, so we have about half of our time together to let you explore the pieces of it that are most interesting to you.


    These are the central conclusions of the report. The first was that if we continue our current efforts without change we will not solve the healthcare problem that’s underpinning reform, and we actually could make it worse. That, as I will try to make clear as we go ahead, does not mean we could not and should not act quickly. We can, we just have to be careful about how we we do it.


    In particular, success will require much more attention to helping people think about what is in fact going on. In essence, we are interested in information technology, because the healthcare world is faced by an insurmount able cognitive problem now. That is actually the root cause of a lot of our overuse, underuse and misuse. That’s what we have to pay attention to. What the committee saw in the places using this technology a lot, is the patient is actually being lost in a sea of transaction-level detail.


    Therefore, our recommendation of how one can move forward quickly, is to manage the effort, to focus on measurable improvement in healthcare. If we do that, and we don’t focus solely on the tool, then we will be able to adapt role, process, and our use of the tool to get the outcomes we want. It’s not possible if we simply are driven by the tool.


    This is the committee that we put together. You will see there are bridge people like myself, that bridge biomedical informatics and medicine, we ID a, others bridge to computer science, Peter Solowe vitz, and — experts on bioinformatics, human factors, databases, on data spaces, embedded sensors and large-scale distributed architectures. That’s the group that looked at this.


    What we did was to start with the IOMs quality [indiscernible] recommendations. We basically said, what are the information-intensive capabilities that would be necessary to support a system that was, say, effective, patient-centered, timely and equitable. This slide summarizes them. The first is that we have to have comprehensive data about patients across lo kales.


    The second is the idea of support for people thinking about problems. I will give examples of that. Tools to manage populations, rapid integration of technologies, and empowerment of patients and their families.


    The places we visited are listed here, a mixture of government, for profit, academic, can community and places with commercial systems and home-grown systems.


    They were picked because they are amongst the leaders in use among this technology to improve quality, and we ob served that. We saw many successes. But we also saw challenges. They are summarized on this slide. I gave you appendix C of the NRC report that spells them out in more detail. The computer right now is increasing fragmentation. We made rounds, and saw five different sub-teams of the care team, each with computers on wheels, standing in a circle, facing their machines, talking to each other, with the only integration taking place in the conversation, and none of them being able to see whether they were collectively looking at all the important pieces of the record.


    There’s no consistent way, even with insights in which people go look for information, systems are often used after the fact. We think about check lists as important, but if you look where checklists work, it’s where roles have been changed so you have a pilot and copilot, used use real-time, if you don’t do it that way, it does absolutely no good. Most of what we saw was in fact, after the fact.


    Very little support for evidence-based medicine.


    The best of places are working four to six major improvement projects at a time, each taking six to 24 months, very important work, but a small fraction of what we’ve got to do. Centralization is the primary method of standardization, and yet everywhere we found innovation, it was local, every single time.


    The timelines are glacial. If you look at the time it takes people that have achieved “level six” it’s over a decade. There were places where we saw as four generations of systems running in parallel while people were still running level one have some other while developing level four.


    What we came away with, maybe healthcare is doing 5% of what it needs to do to improve — four to times times more better than the average, and yet the gap between that and what we actually need is simply insurmountable by current techniques. It’s like trying to get into outer space with a jet airplane, instead of a rocket. It just gets to a point that you can’t get there.


    Now, there were a couple of key epiphanies along the way of looking at this. The first was that there are four primary domains of computational techniques. Marc point ed this out. Automation is a technique that works when you want to do a well-defined process over and over the same way. Other techniques, connectivity, connecting people to each other in systems; data mining, discovering relationships between disparate non-regularized data sources; and decision support, helping people make choices. Those are quite different computational techniques. They work in the face of complex adaptive systems, which is what healthcare is; and they cost on order of magnitude less, and take an order of magnitude less time than automation techniques. When we look at other industries, we discover other industries balance their portfolio amongst techniques. Healthcare is almost always automation and when current vendors use other approaches they bolt them on to an automation core, so that becomes the rate-limiting step of are ability to handle complexity.


    The second epiphany is the step in how clinician’s heads work and the [indiscernible] of IT. Today’s healthcare — people trained like I am, I am a nee frol gist by background. As a new piece of data comes in, we compare against the model F it fits, we keep the model, understand what that piece of data tells us. If it doesn’t fit, whoops, maybe the model is wrong, back up, re-think what’s going. Well, healthcare IT today doesn’t let us work that way. It focuses on transaction-level data. The results and the orders. What little decision-support today’s healthcare provides, it provides at that transaction level data.


    What physicians would like to be able to do, and nurse practitioners, other people that are really responsible for understanding the patient; they would like support in working with an abstraction of what is going on with the patient. As new data comes in, they would actually like to see how it fits or not fits, or help with that, so they know what to worry about and not to worry about.


    If you have a person who is infected, have a low white count, that means you are being overwhelmed by the infection. If you have a person infected and they have a high white count, that means the immune response is — we don’t have that basic level of support in most of today’s system.


    To carry out the rest of the model, what will be needed, we need the way to deal with raw research data, biological observations, research protocols that build the data, the resulting medical knowledge; then we need to generalize that medical knowledge into medical logic, and then we need to make it specific to the patient context with decision support. That’s actually the set of components we will sometimes have, the support the kind of healthcare we are talking about, even if approximate we got full adoption of the best of what we got today, we would have about two-eighths of what we need. The message is to be extraordinarily careful that we move in way that’s do not lock us in concrete.


    The committee came up with a set of are recommendations to support evolutionary change in the short term, and a set of recommendations to support radical change for the longer term, because what we are talking about in healthcare reform is radical change. Today’s healthcare process cannot deliver the results we want. We are not talking about healthcare IT, but connecting today’s healthcare process, but to radically reengineer the process. Improvements in care, so that if we focus on outcomes our deployment of technology will be self-correcting and will not end up letting us go far down the path of unin10ed consequences. A statement was made yesterday, beginning to get on the first rung of the escalator. There’s got to be a way of making progress incrementally. A key idea that I think is lost in today’s healthcare IT, that is quite do-able with today’s technology is to simply record all the data in all the form — whatever form it is. At Vanderbilt we keep — what is working, not working, people understand, don’t understand, users, et cetera.


    In terms of principles for radical change, this idea of architecting systems so they can accommodate disruptive change. Anybody that has one of today’s IT systems and feels that it accelerates their ability to rapidly change work flow, raise your hand.


    That’s what we’re talking about. It takes a different approach to the architecture. We should only employ automation at the component level, where we have a process perfectly designed to do what we want to do. When that process becomes obsolete we swap out the process, component technology, roles, plug in something new. We can do that at component level, can’t do that if it’s the complete neurologic system of our healthcare system.


    Managed data separately from applications. I will come back at that, back at that and back at that. That is a key thing, frankly, if we only certified one thing, that’s what we certify. The technology let us manage the data separately from the applications. Then it will tolerate change in those applications as healthcare changes.


    So that’s all I am going to say about the committee report. We can come back to it in questions. As I have thought about this, worked with other groups since that report came out at beginning of January, an idea emerged, in the standards working group, board of regents of the national — in January. The first idea is we need to redefine interoperability. Instead of interoperability being one version of truth that can be explicit, always the same, in all systems, which we believe simply does not reflect the nature of biological data. What we are talking about is we might are redefine interoperability as data that can always be correctly interpreted. In the light of today’s knowledge or in the light of tomorrow’s knowledge. How do we manage data if we want to handle the transition from 1979, two types of diabetes, 1997, where there were four and genomics, greater than 20 and know it’s going to go higher. How do we handle an archived data that lets us tolerate those kind of dramatic changes in our understanding of how to interpret it. separatability, and the decision support content, and finally, narrowly limit our use of standard data, by which I mean data that can have only one interpretation, whose meaning is stable over time, such as [indiscernible] ingredients. If man builds it, I believe we can define it with standard data. If the creator builds it, I believe we have to have more flexibility in how we will interpret the data across time. This is just another way of looking what the paradigm shift might be. This idea of moving from one integrated set the of data, the single source of truth, to ready access to all the sets of relevant data, multiple sources. This idea of capturing raw signal, annotating with standard terminology.


    Within the Vanderbilt world, we collect information from any source, archive in its original source, may be raw output of monitor, we use parsers and — to attempt to interpret, show it to humans, let them annotate it, keep the human and machine interpretation, also the raw signal, so when knowledge changes, re-run the algorithm and it’s current again.


    This really gets to where you are thinking of how we get a robust version of truth. Saying earlier, I was an intern, potassium was high, I would do a rhythm strip, would treat it, looking at getting robustness in the signal by getting two different sources.


    The final piece of the paradigm shift is rebalancing our use of the computational techniques. We still should use automation, but in our hands, at least, tackling the electronic health record much more like a secure Google problem than a data processing problem has made it easy to get all the information together. We did this for the Memphis RIO, each hospital, different vendor, costs $2 per citizen per year and took 18 months. That’s a secure Google approach versus data processing approach. Similarly, our disease management desk would pull information from any system, don’t care if it’s a payer, clinical system, ancillary system, we do care that it shows the status of the patient in real-time. The are rest rest of that is probably self-evident.


    What does this mean for certification? This is the challenge, trying to put together function, the use of the function, and the effect we want to achieve. The function takes a combination of software, patient data and decision support content. Truth be known, except for something like ability to keep the data separate, you cannot certify the software in a consistently performing way without the associated patient data and decision support. That’s the reason the leap frog tool that’s been used to let people access how, whether CCHIT, identified C POE blocks medication errors. Since the data is still in paper, press, I will say less than 50%, in the right range, not greater than 50%. That’s because we certified the software separate from these other things. That’s a mistake. We also have to recognize that the roles, process and training are an integral part of whether this will achieve meaningful use.


    I think what that says is for certification we need to recognize that less is going to be more; we should only certify something where the definitions are precise. At all costs, we should avoid freezing work flow, content or technology, because of the magnitude of change that is still in front of us. That argues to me that we actually make this concept of liquidity the foundation of what we certify. That is not the way that we started. We started by what today’s — the certification process, I am in the middle of it, may be interpreting wrong, but my impression is it started largely with what the best of today’s systems could do. It did not necessarily start with what was, in fact, the essential ingredient that would allow a person who bought something to know it would work over time. And I believe liquidity is that piece, and it’s liquidity of data, decision-support content and the audit trails of how something got to be.


    I think then we need to certify on a very granular basis, take E-prescribing. There are roughly nine decision points in E-prescribing, from the decision of what I want to do, task of formulating into a presubscription, translating, interacting with the pharmacist, to administering it, monitoring it, and refilling it. Each of those steps requires different decision support, different data requirements about the patient, it has different measures of what an effective completion of that step was, and has different dependencies.


    I would argue we should certify a set of the absolute minimum number of functional building blocks, and building blocks necessary for effective use, and we should do it with all these pieces.


    Then what I would do is add another idea. What is really an effective post-market surveillance. Think of the trouble we have gotten into with the drug industry, adding more and more stuff to the FDA pre-market approval process, because if stuff gets out through that process, we have very poor data about — takes us a long time to discover Vioxx, for example.


    If in fact we had much better post-market surveillance, we could let things out — put a hold on it. We want to think that way about certification. What’s the absolute minimum we have to do at the front end, and then what would happen if both provider and their vendors were required to report, roll up on things like this. What’s the actual ease of learning, the set of function a role has to do, how long does it take to learn, and how long until they are at peak of efficiency.


    Ease of use, what’s the time to complete an error rate of task, specificity of information retrieval. Content support, what percent of users with a deployed system, system, decision support content, patient data, what percent actually handle a piece of new information correctly?


    Adaptation to time, from discovery of an urgent update to a drug interaction content, how long is it until that has been reflected in the decision support of all of a vendor’s deployed operational systems. Right now the answer is never. What should it be? Effectiveness, what percent? We have to give people the data to help them understand the process and fix it. What percent of alerts are overwritten, what percent of — follow an override, and absence of alert. If you put together a family of effective meaningful use as the goal, and we manage to that, a foundation of granular certification and a middle tier of robust reporting, not punitively, but to give people the information to fix the technology, to fix the process, I think we could really win this one and win it in the near term. Thank you.


    Thank you very much, that was a fascinating presentation. Questions?


    Thank you for that very interesting presentation. The question I have for you is, you are advocating a different approach, one that is less about automation and transactions, but more about knowledge support. My question, you mentioned we are flying a jet engine when we are trying to build a rocket. Can you evolve the jet into the rocket or do you need to literally scrap it and move in a different direction?


    you


    You can do that, but I would narrow down my use of automation, and set beside that my data mining tools, so instead of trying to scale up an automation system to do everything, shrink it down to its components, give it an information foundation that is data mining, and then use these decision-support and social networking and other tools up on top of it to let people work with it. I think what we have is actually a component of the rocket. Our trouble is we tried to make it the whole rocket. If we could narrow it down, put the other components on, I think we could get there, and do it now. This change could let us get to 2014, not stand in the way.


    Thank you.


    First of all, I didn’t want to be the only person in the room to raise my hand, but I actually think I am better off with my technology, than I was before. Let me just ask you about the — I am not quite sure what it is you are getting for $2 a citizen. What is in the center there? I am trying to understand what it is you are exchanging.


    I guess I would say we are exchanging, we are having the six competing hospitals in the three-county region around Memphis, 22% of the population of Tennessee. Those systems, the two loops of safety networks, key reference labs, and one of the key payers, all export data into a regional data bank, which has facility-specific vaults. They can control the data, and yet, the region can then run algorithms across it that identify what person it relates to, what type of data it contains, and it constructs what looks like an electronic health record from a secure browser, and can –


    Is it clinical data, like patient’s past history –


    Yes, discharge, lab results.


    Well, the lab results — but what I am trying to understand, without interfaces, somehow something is all getting dumped into one place, even though there are six different vendors or 10, whatever number of vendors there are, even though those vendors are storing things in different ways, somehow it all gets into the center and everybody can use it, I am just –


    Yes, and the reason — I have been very careful about some words here. Said it’s not an exchange, it’s an aggregation, data mining and visualization capability, and that difference is important. We are not taking information from hospital A, mushing it around in a way to pump into hospital B. That would be my definition of an exchange. That would require us doing the end-to-end work [indiscernible] we have gotten to where we can do that for the less than 100 labs, a small fragment of what we are working with in Memphis. We have everybody publish the information, as a text report, tagged text report or as real data streams, doesn’t matter. Then we use parsers, simply semantic algorithms that recognize structure, can break something up into fragments and concept matching algorithms, use the knowledge of the national library’s medical thesaurus to construct something that looks and feels a lot like a electronic health record, the way Google crawls across all websites, lets you answer questions without the people that set up the website intending for you to be able to use it that way. Secure Google is the closest analog to what we are doing in Memphis that I can describe. Does that help?


    Yeah.


    Thank you very much for the presentation, and I should disclose, the Robert Wood Johnson foundation was a partial supporter of the study. I say that for disclosure, not credit. So much.


    [indiscernible]


    Steve Downs with the Robert Wood Johnson foundation. I think it’s easier for us to wrap our heads around certifying a system rather than a soup to nuts system providing a full range of functions. As you start talking about the componentized approach with this sort of base, and multiple functions layered on top of it, could you perhaps help us understand better what might be in the base, the foundational components, and also, if you could give an opinion on, do you think the certification should extend to the different apps that would run on top of that base or functions that would run on top of the base?


    William Stead: I would like for the certification to be that the data is interpreted equally effectively outside of the system as within the system. We have got to change the incentives that have allowed the current industry compete on making the parts of their system work better together, which by definition means they work less well with other things. We’ve got to break that. The key is accept separatability –


    Let me is stop you there, say it is a data recording and capturing, and function to make it available on equal basis to applications that can use them.


    William Stead: Yes, we are trying to solve getting the information and putting it in front of each person that needs to know it, according to their need to know it, as they are making decisions about what to do next. That’s what’s going to solve the overuse and underuse problem in healthcare. The misuse part or part of that part that will solve, another part takes automation. Don’t misunderstand me. I am not against automation, I am very in favor of it at the component level; but that would be the base. It should come up above that, I would actually work out the key definitions of each of the components of what we have now lumped together as e-prescribing. When I had discussions with a very well-informed leader in Tennessee, very interested in these efforts, he was very surprised to discover that the e-of prescribing effort counted on — [indiscernible] drug interactions, for example. It could, if everything elsewhere there, but they were not counting the most essential thing for what they wanted to solve. That wasn’t obvious to him. For us to get really clear, this is the component. If you use component, this is the data you have to have. If we made that clear, people would know what choices they are making. Right now they don’t, because we lump it together. I think we have to be — if, in fact, you are a well-contained practice, and all of your patients are contained in your practice, all your data is in your practice, today’s monolithic systems work. That is a vanishingly small part of our problem. In 2000, the median care beneficiary saw two primary care, five specialists across four practices. Any approach to healthcare IT that doesn’t deal with that, reality isn’t going to get us there. We have to get that in at the start. So far we have left it as a to follow. That’s where we made the mistake, if we made a mistake.


    I wonder if you would comment a little about — Larry with Kindred Healthcare. Thank you for the challenge to how we are think being this. Would you comment on the apparent paradox, focus on data, ability to share, aggregate the data. But your example of bringing together systems that didn’t start with clean data definition, but able to create useful integration is not the right words, but something, useful bringing together of information.


    William Stead: My only point is what are in those systems we brought stuff together from is actually unimportant, and therefore in theory shouldn’t need to be certified. Because what we did was mine it, regardless of form and source. You may want to certify that latter. Can you construct a dash board that shows all the management — plan against real-time. That is an important thing. That is unlikely to be in any system within one enterprise. Yes, they can do it within the enterprise if all the patients are in the enterprise, or if all of their automation data processing interfaces with everybody else are in place. But I am sorry, not by 2014.


    Our challenge is how to certify something now that will get us to 2014.


    My struggle is you create a overarching system when you brought this system together.


    William Stead: Just like Google brought an overarching system when you –


    Google did that built on HTML standards, HTTP, a set of core standards they built on, a huge variability in what’s there. Some from the ambiguity of English and other natural languages that when they bring things together, as the recent Bing ads point out, you get interesting cross-threading.


    William Stead: Amen. And the fact we have gotten all the power of the Internet with three simple standards, how you locate, display and transport it without any standardization of content. Look what that has done. If we could have the same effect on healthcare between 2009 and 2014 that the web, those three simple standards had between 1994 and 2000, wouldn’t that be wonderful. I know it wouldn’t be where we want to land, but wouldn’t it be wonderful.


    My sense is, to achieve that, we would back off on some of the more engineered aspects. Some decision support requires you have common semantics across those data sources.


    William Stead: Well, I would have common semantics where common semantics are in fact biologically — drug interactions, we can have common semantics. Let’s nail that one. If we in fact got to where all of today’s commercially available systems used an enhanced R x norm, with adding in drug class from the VA system. We then made all systems tag whatever they did without reference standard, we would have solved a huge problem. We could solve that one — when I was a member of the systemic interoperability — we laid out a road map showing how that could be solve by today. In print, reindorsed by the — it’s do-able. I am not saying don’t do those things. I am saying focus them where that approach actually makes sense, giving the structure, nature of the information, and use very different approaches for this big C of constantly evolving new and different sources, genomics, proteiomics, things that will hit us much harder than what is –


    [indiscernible]


    Yes.


    As an example of changing understanding of classification schemes we are using.


    Very much so.


    Thank you.


    Great, Charles, last question?


    As you put together this vision of how this will work, as I am interpreting your comments it sounds like you are saying build something centrally held that a certain amount of transactional data is flowing, you want to build a component of something that fits, I will use the word centrally, algorithms, other things can run against. My question is, I agree the cognitive decision support is the most important thing we can achieve out of this. In thinking about certification standards, other than liquidity of data, is there anything else that comes to mind you would do to support cognitive decision support –


    First, I am not talking about a central model. I am talking about breaking the problem up into pieces, having algorithming to aggregate, interpret whichever of those pieces you have the governance okay to do, and you need for the task. It is very much of a breaking the problem up, instead of trying to make it holistic. That clarification.


    I think the — we need to start measuring, really the reason I put the things on this slide. We need to start measuring the cognitive, the ability of our systems to in fact enhance decision making. We have, today, the best of today’s systems actually work by get key information at the right point in the work flow. That’s key, that’s important, but it is much less global than really making sure we understand what’s going on with the patient, which is going to be necessary for care coordination across the continuum. It’s going to be necessary for saying let’s not just give the patients — make sure each drug, there’s evidence for, but given the evidence, the patient’s problems, what are the top X drugs that are the highest priority. We can’t take all the ones for which we have evidence. They can’t pay for them. We are so green there I can almost suggest we need to start measuring. I really did struggle. That list wasn’t a casual thought. It was a good day and a half when I was asked to make this presentation. That’s where I would start.


    This has been a terrific presentation. I want to say thank you very much, Dr. Sted, for coming.


    Thank you very much.


    [Applause ]


    Moving right along, trying to run this meeting on time, I will have to tell you, as former software vendor, doing anything on time is a very new concept, but I am doing my best. The next presentation is from the national constitute of standards and — I believe Gordon Gillerman also, and will present information about compliance testing, certification process they use for other products, and related topics. If you through the legislation, you know NIST is our partner in this process, funded as part of the process. We are very much looking forward to your presentation, thank you very much.


    I like the term on-target, in-target, good phrase.


    I want to thank you for the opportunity to talk about NIST and what we do. We are one institute, the National Institute of –


    I apologize.


    I thought you were more than one, you are so good.


    We appreciate the complement. I wanted to give you a few minutes of an oversight of NIST, there may be people in the room not as familiar with our activities, then turn it over Gordon Gillerman, the lead — capabilities at NIST.


    I want to remind people of our overall mission. We really work to support the U.S. innovation and industrial competitiveness. We call this the what, how and why slide. We are focused within the Department of Commerce on the economic strength of the United States, that is our mission.


    We do this through measurement, science, standards and technology, and that’s what we are here to talk about today. The breadth, to enhance security, and improve life. Anything NIST touches you are aware of, not necessarily because of us. The browser standards we talked about earlier, when you get that little lock on your browser telling you that you are secure, that’s one of our standards we dealt with many years ago, a key management capability.


    When you get your time, synchronizing your computers and atomic clocks, that’s reaching our signal. You pump your gas tank, you rely on the standard the states put on the gas pumps, they are referencing back to our standards. You weigh your groceries at the store, the states are references back to our standards. We provide reference materials, reference data, standard development and complementary conformance testing. One thing Gordon will do, go through examples of various ways we touch. But I wanted to give you the breadth of what NIST is. We were speaking to people yesterday, thought we were one slice of what we do. We are very broad, appreciate the anticipation there are several of us, but we touch a lot of things, in very accurate, precise measurement standard ways. Let me go to the next slide.


    I want to touch on our responsibilities in the ARRA. You all certainly have read these things we are specifically — the funding we are in line for is for continued work on advancing healthcare information integration, certainly the topics we are talking about today. It is ARRA also directs NIST to update the federal strategic plan, voluntary certification programs, consult on assistance and health IT implementation, provide pilot testing of implementation and testing, and grants program for health integration program centers. The one we are here today to discuss, provide understanding of Vol voluntary certification programs.


    I want to turn it over to my colleague, Gordon Gillerman, he will give you — tell you how things can be structured for the future.


    Gordon Gillerman: Good morning. What we do at NIST, help federal agencies and industry understand how certification programs work, how they can be adapted to fit certain national needs, and how they can be implemented to be effective and efficient. We provide agencies, federal agencies with assistance and policies related to development of standards and general conformity assessment systems, administrative infrastructures, and also help design the programs themselves. Usually that is our role, to help build the understanding with the agencies, design programs, implement the programs, but not to run and operate the programs within NIST itself.


    In this particular area we have been directed specifically to look at certification, with an eye toward making the program work and having a program that’s effective and functional and efficient. Our role in this is defined by the national [indiscernible] advancement act, to coordinate federal, state, local activities to reduce redundancy and effectiveness for the nation’s good. One role we play is trying to help organization and federal agencies developing conformity assessment programs to do so, so they are efficient, other programs working in similar areas to integrate programs to reduce redundancy.


    You notice I use the term conformity assessment, and not certification. A term defined in international standards, the term covers the broad umbrella of tasks, systems, relative to demonstrating a product, service, process, meets requirements. General conformity assessment. A lot of activities can be used. Certification is one, not only one. Certification has a specific meaning in the international norms for conformity assessment. You will notice the refers to ISO, ISE, the international standard which has definitions for conformity assessment terminology. This series of standards produced by the ISO — group, really defining the way conformity assessment is carried out, both in industry, globally and more and more in governments across the world.


    In conform assessment activities it’s important to — the parties in the process, classical business definitions, the first party for seller or manufacturer, second party for purchaser or user, and third party is very special party, an independent organization with no interest in the transaction between the seller and buyer. The concept is that third parties can give a high confidence objective opinion about the conformity of certain objects that the first party or second party could not convey with the same level of confidence. Those organization have a vested interest in making the transaction happen.


    In conformity assessment in this particular area there are several things to look at when making a decision. One is testing. It looks inevitable some of these products will have to be tested in order to demonstrate compliance with certain requirements. There are other activities, like supplier’s declaration of conformity, certification, accreditation we will talk about in more detail. You notice on the slide where the definition of terms come up, we define clearly which party can perform the conformity assessment. On this slide we define the testing can be performed by the first, second or third party, depending on what the system needs and expectations are. Testing used when characteristics to be evaluated can be measured under specified conditions, describes what a test is. A special kind of test set in conformity, carried out on samples of products intended to represent the production. In software that can be a challenge because there’s usually a lot of ongoing changes to software over time. The challenge that you often have is understanding how the tests that have been conducted can be representative of software after the software has gone through a couple of revisions.


    Testing can be an elements of both a system that uses supplier’s declaration or certification program. The laboratories which conduct testing have a standard to meet in the system, defined as ISOICE, for operating the management system and driving technical competency in the laboratory environment.


    Supplier’s declaration, this is first party conformity assessment, used when the risk assessment for compliance are reasonable, penalties in the marketplace for removing non-compliant products and mechanisms for removing noncompliance products from the marketplace. What is the likelihood of noncompliant products being brought to the marketplace, standards for [indiscernible] associated with supplier’s declarations of conformity, enumerated on the slide. Supplier’s declar rageses come in two forms, formal, standards, requirements the first party is attesting conformity too, population of products, and very informal processes like that used on a box of 35 MM film where you may have a number in the corner saying 200. Well, the 200 number is really in this case the film manufacturer’s attestation that this role of film meets a certain ISO standard for film speed sensitivity. The manufacturer is telling you I declare this product you are about to purchase meets the ISO 28,000 standard rating for film speed 200.


    We see a couple different flavors, generally speaking about 80% of transactions in the marketplace, in the United States, based on some form of a supplier’s declaration of certification.


    Only third parties conduct certification activities. Certification is typically used when the risks associated with nonconformity are moderate or high. It includes several steps which are well-defined, evaluation of the evidence, some may be in the form of laboratory test data, but there are other forms of evidence, inspection of products, evaluation of people.


    There’s a compliance decision based on an evaluation of that evidence, versus requirements for certification. Then there’s a public attestation of conformity by the third party certification organization. The last step is surveillance or follow-up. This is to give the third party confidence in ongoing conformity. So the laboratory tested a product, you end up with a snapshot in time this product has a certain set of test data associated, for the product tested in the laboratory, complying with a set of requirements. Now the vendor is going to manufacture 10,000 units for the marketplace starting tomorrow. The third party needs confidence every single one of those conforms to the requirements. The surveillance is the third party’s mechanism of obtaining that confidence. There are standards for everything, for certification, and it’s ISO 65, currently being revised. The new name will be IOS 17-065. I brought a couple examples of certifications, ubiquitous in the marketplace. Certifications take place for many reasons.


    [Captioner transition]


     


     


     


     


     


     


     


     



    This is a program to give the market and the Idaho potato industry that all of the potatoes in the back with that seal come from Idaho and not somewhere else. The potato industry once you to be confident and part of that process is an industry certification program. In another example has to do with motor oil. In this case we have another industry driven certification program and is the petroleum industry and the American Petroleum Society has a certification program for the motor oil according to a set of standards produced by another organization that was formally called the Society of Automotive Engineers, SAE and 10W30 . So you buy this motor oil and if the motor oil is one you could end up with a $10,000 paper wheat. So you assume a lot of risk when you introduce new motor oil in your vehicle and they want to give you confidence that it’s accurate so you are willing to take the risk. It comes to a lot of forms and favors for a lot of different reasons. Accreditation is the conformity assessment of conformity assessment organizations and their programs. So in many ways this is who is watching the watchers. It’s used to give us confidence that laboratory certification bodies and other conformity assessment organizations do their jobs according to the international standards, and with integrity and technical confidence. We have some examples one is operated by the National Laboratory accreditation program that accredits laboratories to ISO ICE 1725. And you notice there is the standard for the creditors to operate under as well which is 17011 so laboratories in seven fires have the standards and the job of the credit for — and certifiers have their standards. And there is also private organizations. There is a private body that also provide some services for accreditation and the American National Standards institute has a suite of accreditation services which covers both laboratories and product certification. As he said surveillance is a key part in many of these programs. Both in accreditation and certification there are some of the surveillance functions. And it’s a vacation is to give the certification organization ongoing confidence that all of the products continue to meet those requirements. For accreditation organizations, is there to make sure that the accredited laboratories and prior certification bodies continue to do their job in accordance with the standards and operate with competence and integrity. So it sets up a system or a hierarchy in conformity assessment. Where we have accreditation bodies assessing certification organization and laboratories. And those organizations initially of solve the compliance of products and other areas with requirements and the certification bodies can certify based on those test results and their surveillance activities. So it sets up the hierarchy that we can use and depend on in order to have a system that can be functional. A couple different models that we have seen used to put the government’s role in place in the certification program. We will go through. Here we have one that is the limited government will. We have health care and NEC products and new requirements from the selective standards — and IT products and these are two characteristics of this product that need to be assessed. We have laboratories and certifiers conforming to ISO ICE standards for certification in D.C. A-plus here that we may choose to develop sector — and you see a plus here that we may choose to develop sector specific requirements. So we may want to create some additional requirements that focus on the technical, and sees necessary to do the kind of testing that the Health Care IT standards will require. And you may find additional requirements beyond those would be necessary to have a system that we could have enough confidence in and operate appropriately. The private sector can be running all of these levels, we have organizations and the products can come from private sector vendors. The government is over here participating cooperative Lee and in a coordinated fashion with the credit her body or bodies to make sure that their processes meet the needs. So this would be one potential model. It would limit the amount of government resources necessary to be deployed. One of the interesting things in conformity assessment is that it’s not necessary just to have funding for this. This would be an ongoing system and it needs to be sustained and it needs to be sustained well. Generally speaking the systems are designed so that the private sectors are paying for the services from the organizations that they apply for so that the products from the vendors will pay for testing and certification, and the laboratories and certification organizations would paid for this and health sustain this overtime without a long-term funding. A more significant role would be very similar but now we have some form of agreement. Be it a memorandum of understanding or contractual agreement between the government and the creditors to make their role in the open stronger in the process. These are other ways of doing this but these are two examples that could be deployed in an area like this. We have designed programs like this in other sectors. And using that experience to guide what kind of models that we see working over the long-term. One of the things that is valuable to consider as you look at this is how much conformity assessment do we really need? I have a lot of government agencies and private sector organizations that come to us and ask for assistance in developing certification. All lot of times what they really need is something else. We have developed things like this, tools to health us understand that what we need to do is look at the perceived risk associated with nonconformity. How bad will things be if these products do not meet the requirements? Can society tolerate the nonconformity? And over here we have the independence and weaker of the performance assessment system itself and down here we have the we should do is nothing area. So if they do not meet these requirements we should not put any resources on conformity assessment. As we move but we moved up two systems were we can probably rely on first party separations of conformity and in here there is a lot of room for developing hybrid systems but maybe we would require third-party laboratory testing but not third-party certification. Although all the vendors, I’m sorry, to claim or declare compliance. So some different ways that we can use the system to adapt to different needs. Some of the things that will look at again is primarily wish to associate the amount of resources that we throw up these kinds of problems and at — and they should be proportional and this risk base model tends to drive a lot of rethinking as we develop these systems. If we do too much will ask cost — we will add cost and burden to the system. If we do not meet the company’s needs and we just fail. So we have to find the sweet spot between over the sign and a design that makes the system function efficiently and effectively with the right cost burden for conformity assessment. As we said if there is significant penalties for noncompliance we can probably reduce the conformity assessment. There would be a tendency not to be motivated to bring these products into the marketplace. For other kinds of products if we have a functioning ecosystem, the automotive industry is a great example of the functional recall system and we can recall nonconforming products before the societal impact is intolerable. So we have some system examples of the ones that we have built for other applications. These are examples of other areas where NIST has provided assistance in developing the structure and the process of the conformity assessment program. This is a diagram of a system that is likely to be used for the rollout of the Internet protocol version six technology in the U.S. government is likely to be an early adopter. And we are concerned that the systems that we adopt this technology to continue to work and serve the public and government well. We have built the system that is primarily based on suppliers declaration of conformity and profits works like this and we have laboratories who test our products. They test it against requirements that have been determined. The labs are credited for this testing. So we have an accreditation program, third-party accreditation body to give us confidence that the laboratories were in the test and the test results are high integrity test results. The test results are returned to the vendors and they evaluate the test results and make a determination if these demonstrate that my product that I have submitted to testing meets the requirement. If that is true the vendor create a declaration of conformity. And the Declaration of conformity is used in the transaction as the vendors evidence that the product meets the requirements. In this case it specifically ties them back to the accredited testing laboratory and the test report for that product. And this is how the transaction happened with the NIST assessment system. Again this is not is a vacation program but a supplier’s declaration based on accredited results. And one that is likely to be used successfully since it has not been deployed yet in IT related system. And to be timely here is a system that we’re hoping the industry built for the safety of [ Indiscernible ]. Everybody remembers in 2007 there were highly publicized recalls of toys because of lead content it and in excess and others because there were design issues with small magnets used in toys for the standards for safety did not anticipate the features and characteristics of those products and did not have requirements for the hazards associated with them. So we have a certification model. We have an accredited certification organization. This is a much more complex system because we have the evidentiary inputs to the system. When this test results, initial tape testing and periodically testing from accredited laboratory. And we have a design has an analysis which is conducted by between manufacture themselves to look for emerging hunters — which is conducted by the manufacturers themselves to look at emerging hazards and the system to develop the quality of the production facilities in place. All three of these ingredients or pieces of evidence come to this accredited certification organization. The certification organization evaluates that evidence, makes a compliance decision, and issues a public attestation of the toys compliance with the system’s requirements. And win this system is rolled out that public attestation will be in the form of a mark on the product or the toy product package that will be on the store shelf. And this — state owned decertification mark they enter licensing agreements with the certification organization so that they can authorize use of the mark for toy manufacturers whose products have been determined to comply with all the requirements of the system. A very complicated system to address a very complicated process and issue. We have manufacture and allocations of certain products and we have decided those products and other locations. We had a myriad of different test requirements that have to be tested against and a lot of laboratory competency to be necessary to do the bulk of the testing necessary to demonstrate conformity with all the documents or standards for toy safety saw was a very large-scale certification be and that is the end of the presentation. Thank you.


    Thank you, you did a great presentation. Any questions from the work group?


    Do you have any examples of certification or the process where it has been driven by the government whether its reimbursements sitting out there and has to be certified for meaningful use to get that reimbursement paid a lot of examples that you showed us was edging toward a field of approval that this was okay. Do you do anything like that or have any examples?


    There are several programs that we have been working with with a variety of different agencies which will get how a federal grant money is spent. I to a lot of work in the organization at NIST with the Justice Department and Department of plant security. One of the issues is the effective use of a grant money for first responders. And one example is body armor. There is a newly developed body armor testing and certification program set up by the Department of Justice and there is also a program which is a grant program and the grant money to state and local law-enforcement agencies to purchase body armor for their officers. We want to make sure that this is effective for its use we don’t want them spending federal grant dollars on an effective body armor. So we work with the Department of Justice to test and certify body armor in an accredited laboratory and the Department of justice in this case operates as the certification organization itself. And based on that certification and the manufacturer’s name and model of body armor of. On a specific list that the Justice Department maintained that is with a grant recipient can go out and evaluate which models are example for them to purchase for their officers — are acceptable for them to purchase for their officers. So maybe not exactly a similar.


    With that a case where a certification program existed prior to that or was there nothing to test that function?


    The program itself was built before the industry have any program. The program was. Focus on the grant money and making sure it was used effectively. The regional program put in place was a testing program and not a certification program. Over time that turned out not to meet the Justice Department needs and what we did over a period of time was basically re-engineer that into a full-scale certification program.


    Adam Clark, Lance Armstrong Foundation and we will be hearing later today about the best practices for adoption of HIT and this is critical in my world of cancer will people will be going to their primary care doctor a specialist and HIT can enable coordinated care. Looking at some of these logically, though, is there a risk that the certification will cost too much or required to much work that may be smaller practices may choose that it’s not worth my time, it’s not worth my at effort to become certified so you create a division between small practices in cancer care centers, etc.


    Is a risk, yes, there is always that risk. As you saw in the presentation and a lot of the thinking in design the system is geared toward finding the balance between cost and confidence. And the issue that you run it is that confidence is not free.


    I thought you were asking is whether the physicians could be certified.


    What I am concerned about is the smaller practices, if it becomes a cost. For smaller practices for the certifiers to adopt that.


    The products being sold, it’s just that they are paying for the project. Not the providers been certified. That is what I thought I heard you say.


    I guess a clarification. The certification that you are discussing, is a certification of the position in the practice or that he is buying and implementing for the practice?


    A smaller sized practice adopting a certified Project. If the product, the certification product is expensive to actually get certified. Will there be a barrier?


    There is always a cost a sissy with conformity assessment. There is no question about that. There are costs for running a test. If all you need to do is test a product and you get to market 1 million of them based on one test than the vendors get to divide the cost of the testing across the total copy population that they sell. So I cannot answer the question straight out because I do not know all of the factors involved. There has not been in the development here, but part of that design is the balance between cost and confidence. So we always look at what is the competency of the stakeholders.


    Helmets cost is meeting them adding to the systems — versus the cause that is needed them adding to the systems and what the system looks like and how it gets implemented.


    Bill Heiman. I wanted to make sure I understand what NIST’s rule is in this particular process. The way I am thinking about this is the office of the national coordinator will describe what needs to be certified. And then NIST will design the process. Is that what I’m hearing?


    I think we will assist in the design of the process and help ONC make a more informed decision. I think that is the way it’s going to work.


    ARRA actually calls on a voluntary certification programs. So we are here to help.


    This is currently a certification organization already for health information technology. So what your role be dealing with the Office of the national coordinator or the current certification organization or both?


    We have been doing both.


    Okay.


    Would you play a direct accreditation Rolfe either as the contract or would you more accept the terms for what an accommodation is a vacation will look like?


    And certification right now we do not have a certification or accreditation role. NIST operates the National voluntary laboratory accreditation Program and in some cases it is a good solution. We work closely with other organizations who are in the business of running accreditation programs for product certification. And that probably would be the primary role. We do not anticipate developing a product certification organization as part of our role.


    To follow up on that, let state ONC wanted an accrediting organization or perhaps certification organization, ONC might have a contract for different accrediting organizations to bid on.


    You could have several models, there was actually a formal agreement between ONC and the accreditor and then a different model word ONC played a role in the accreditation body and kind of the structure and policy and all of that stuff. I really did not have an agreement. So there’s a lot of opportunities for developing that relationship and see how it works.


    Does NIST do any of those roles? Do you monitor their work? Was that something you don’t want to do or do not do?


    I think that answer is there are very narrow areas where NIST does those activities and similar things. We have generally found that working with organizations would to this as part of their daily work — that do this as part of their daily work tend to be more efficient and effective. Not that it can never be done or it’s not a possibility but in our experience those generally are not the best solution.


    We have an organization that already exists. What advice would you give us on how the organization should be monitored?


    I think the important things that we need to look at is to understand what are the requirements for a confidant competent high integrity certification in this area. And we need to spell them out in the document. What we typically recommend is that those requirements are added into the international norms for certification programs and in this case ISO ICE Guide 65, and we would add those extra requirements to and work with them to make sure that it includes both of the requirements of the ISO ICE and these additional requirements. So that this particular sector did its job and met the needs for the sector.


    Mark Perez. With new product certification you brought up the concept of surveillance. Is that done by the same third-party or cannot be done by a different party?


    The certification body could contract out the tasks associated with it pits a let’s say that we are certified in toys and what we will use is post market surveillance. So we will go to the store shelf and retests them and they could contact a laboratory or several laboratories to test them and report the results back. But the decision to maintain the certification or not maintain the certification must be undertaken by the certification body according to the international standards. That seems to be an approach that works.


    Larry Wolfe. You commented many different examples of certification testing. I sort of feel like the scope of what we’re looking at here is a lot broader than the examples you have used. So I wanted you to comment on the scope of what we’re trying to take on and models that might support that scope.


    It’s interesting. If I look at the portfolio of the things that we are looking at with industry and government and different kinds of conformity assessment models. Right now from the technology perspective but the bottom end is toys and Walker efficient toilets and the top end is a shoulder fired rockets for commercial aircraft. So we are not bound by how technical or technologically sophisticated products are. We can assist in the design of a program that can meet the need across that spectrum. If we are talking about whether we give certifying a person or a product, or the implementation of a product on site, and those are very different things. There are conformity assessment process is to deal with all of that. But that begins to expand and broaden in many ways. So whether we are looking at individuals to will get did they have the right knowledge, skills, and abilities and have a demonstrated that to do this kind of practice. That is a different kind of conformity assessment exercise. A personnel certification versus certifying software or a integrated hardware software platform. They are all different applications but there are systems in place for the most part and there are international conform the assessments that addressed all of those.


    I want to push a similar on industry examples. Two parts. Car there examples or models that were particularly in — are there examples or models that were particularly. So the electronic help records, he did not does put it out on a network. So examples on that. And we talked earlier about breaking systems into components and painted an image that you might have a system that comprises multiple independent vendors. Components that also worked together. So if I am giving a government grant to crunch numbers and they want my spreadsheet to work with that they want to certify both the spreadsheet and the computer on which the spreadsheet is wrong and they might be made by different vendors and how decertify the whole question?


    I will certify the second one first. The the second is a supply chain issue. So if you look at information technology sitting in this room, laptops or the projector and has a plastic enclosure that is made of plastic material that is made in some raw form to somebody who molds the closure. It has printed wiring boards in there and sent to a different organization who puts the tracks on the printed wiring boards and maybe another organization with the components before it comes to the organization that rolls this thing into end device. And in the of local safety division the device itself is certified to a standard. So in this case there is a standard called UL60950 and that is the standard for the complete device and there are also safety standards for the printed wiring boards themselves and the critical components such as chords and connectors and capacitors. And the plastic material itself as Wallace the inclosure material. All of these things have their owns a — their own certification program and combine together by someone who makes the complete product and the complete product is submitted for certification. Instead having to reevaluate, is the printed wiring board good stuff? Of the certification body gets to look at the information from the certifications of the supply chain of the equipment and avoid a lot of redoing of work. Also provides the industry a lot of benefits because the manufacturer of that laptop or projector can alternate Resource printed wiring boards from a multitude of certified vendors who’ve been into the system. So conceivably you could make a system that has several tiers to it. You could have complement tiers and a tier for the compilation of the components into a system.


    I went to make sure it because I think there might be a distinction in the example that I use. Because you are still talking about one vendor delivery in the final product of all of these components together. And I am thinking of all I by a Mac and I can load Excel or I can use Google docs. But the combination of the spreadsheet and the computer is sort of my own system that tie tailored for my own use.


    You are looking for unique integration.


    It could well be.


    Probably the best analogy that we have put that is the built environment. So when you build a structure, there are building codes then gave you the rules for the structure. Right? The contractors bring in conduit, rebar, concrete and assemble its on-site to a structure that needs the code and they say that they have to meet the conduit standards and have to be certified to the conduit standard. So the people who come in and verify that in that integration of certified stocks of that they got it right. That is a model that could be applied to something like this. The difficulty that we get into is that you have to do one of these conformity assessment exercises, and the inspection every integration of the component to give you confidence that this integration was appropriate. But yes, there are models that can do it.


    Joe Heiman again. Are there any accrediting organizations at the present time that could accredit a certifying certification for Health Information Technology?


    As long as they have the right set of requirements. As I mentioned all accrediting organizations who are operating on a large-scale moving to or have adopted ISO ICE guide 65 as their standard of operation. So if we define what in addition to this general operating certification program we needed in order to have a good Health Care IT certification program than they could take those requirements and deploy them effectively paid so the answer is yes, but we have to make sure that we develop what the requirement for that particular application of certification is.


    And we gave some examples. One of the examples right now, actually two of them, these both are in the business of accrediting businesses that do product certification pits of yes, there is a lease was up there for us to drive John Glasser. Also the ease of learning and ease of use and adaptation to change. What is your experience has been in the industry to get your hands around both measuring and perhaps certification of those areas or areas like that?


    I guess when I looked at that question I was — I thought about it a lot. I think the difference is, what he was really talking about was monotremes the effectiveness of the products that have been put in place. So if we assume that all of the products meet the requirements and we are looking at the effectiveness of the system. What we should be doing is looking for data and information to help us to enhance the requirements over time. What we are learning is not worth the requirements that we put into the conformity assessment system the right set and are they working for us? And if they are not we should be enhancing them. In the world of standards we do not write standards and walk away. We continually improve them. So what we want to do is build products that meet standards and put them into the appropriate use environment and monitor the effectiveness of those products. And go backward we have issues or see opportunities for improvement and improve the technical requirements for the product, and take those new and revised standards and put them in assessment systems of the next generation are better piece of this is an evolutionary issue.


    And some examples of what we have been working on in the same areas. And usability for instance. That is one of the things that we have been designing tests and augmenting standards and working with the standards community for several years. We have applied in the biometrics world and in the voting systems and what they have to reach. Declared an effective and useful. And we have also been working with ONC and tests that determine whether the systems actually meet the standards. So we can put prototypes’ together to see if we meet the standards and then the test can be adopted by other certifying bodies. So the experience in many of the things that Dr. Steve mentioned I was saying yes, because there is an understanding of separating he says and understanding how they need to be affective together and being able to design the test and things like usability is not soft at all. It’s testable and there are ways that you can come to agreement with international standards and test those against the standard.


    One of the things I think will be very helpful is to departmental lies a little bit the technical requirements of the product and the conformity with those requirements. That is what conformity assessment is. So we can use what we learn in the marketplace to improve the or we can say that maybe the products are not conforming to the standard. So we have to fix the conformity assessment process and improve the standard and implement them to conformity assessment.


    Getting back to CCHIT, when we started we wanted to be in the vendor community and raised the bar to a three year roadmap. But have been seen that type of approach worked effectively in other industries or have you seen challenges associated with it’s a moving target and vendors are challenged to create a moving target. What are your thoughts on that evolutionary strategy?


    I will start with the system. That is in my world, too. That is an effort that we are providing the government testing capability or the Government Systems. So working with vendors and setting the bar. But the standard is there and the bar is the standard. So being able to demonstrate that systems are meeting that standard is what we have been working with the vendors. So the vendors are actually supporting that laboratory that is doing the testing. They are paying for that. But it’s a constant interaction with us in the community.


    Did that standard stayed the same or did the bar race over time?


    The standard has been set for almost 20 years.


    That is the point I’m getting at, is there a need to raise the bar?


    I think that concept is a valuable one and it works in a lot of areas very well. In the world of safety is continually monitoring and are the standards that we put in place achieving implementation and products in the marketplace that are safe enough for our society? We have a lot of wriggle Tory agencies that help us understand what is happening. regulatory agencies and an excellent example is electrical Safety centers have improved over the years and the cycle works pretty well. Where the cycle is difficult when you have interoperability issues because interoperability you have to be careful as you are improving the standards that you do not lose the initial interoperability or maybe find a way to enhance that.


    So great care has to be taken in interoperability issues.


    Larry Wilkes. One of the issues that have been used as success in safety is airlines. And I assume there are a lot of interacting components that make that safety. Could you comment on how the standards process, certification process how that works in that industry and is that they could analogue for Russ? Especially over the decade — analog for us, especially over the decade.


    I do not have enough interaction or exposure with the system.


    Adam Clark. One of the issue is obviously with health IT is insuring that there is security behind it and is surveiling going to be a part of that? Will you look at that to see is it through these systems that we are able to actually — are there beaches of security so to speak in the patient identification? And if so what is the recourse if these systems are out there and we find out that there are ways to obtain this information.


    That is something again that I struggle with all the time because we have the responsibility of setting the standards for the federal government on cyber security issues. So the balance is always in the game now with the standards the to be and how the testing can be augmented to make sure that the appropriate things are being tested before these products are deployed. I am pleased that you bring it up because it is certainly one of the most critical pieces that we’ll need to be paying attention to.


    [ Captioners Transitioning ]


    Is there a typical time to get that done?


    Standards can take a while, the way the United States does it, and Gordon can amplify. Believing the standards process should be driven by the private sector. We do not dictate, as some other countries do, say the standards will be thus and so employ it’s a consensus based, voluntary process that can take longer than anybody want its to take. It can also move more expeditiously when the right people are in the room, and the [indiscernible] is there. We have seen both extremes. It gets a lot of bad press because the process is so thorough, and good, but can be accelerated by, again, providing the right kinds of testing tools, the tight loop between the results of testing and where the standards are developed early on, so cliert clarity of this works, this doesn’t. You can really accelerate the results, but can get a bad press because it can take a while to get consensus. The job we have in this space is to move as quickly as we can.


    Terrific. Thank you for a terrific presentation and making sure we stay according to the schedule, and Dr. Fall — we appreciate your presentation .d the work group will now have a 15 minute break, we will resume at 11:15:00 a.m.


    [Recess until 11:15:00 a.m.]


    I will ask you to resume your seats. Dr. Joe — will be our next — sees patients every day. Could everybody find their seats and we can get started. We have five representatives from the vendor community here. The first thing I want to make sure everybody understands, the fact these particular five vendors are here has nothing to do with the government iny doersing any of them, in any special way, only that they want to give us some information.


    We have allotted about 15 minutes for each of the four vendors. And we hope will you not only keep within the 15 minutes time, but if you can shorten it a little so we have more time for questions, that’s even better.


    Without further ado we will start off with Sheldon


    – Quality systems is an IP vendor, significant player in the IT space. We have fiscal year revenues of 245 million, over 1200 employees, publicly traded on NASDAQ, we are ambulatory HIT provider, and over 45,000 physician licenses.


    The products we provide are electronic practice management, along with ERH. We do revenue cycle management and also do community health systems. Probability one of the key features is integrated solutions for the healthcare community we serve. One question we were asked to talk about is what has been our experience with the certification process, and I would like to comment that we have been certified in years 2006, 2007, 2008, and for the pilot in 2009, I think relevant for this group here, our experience with the certification has been a very positive one. It has allowed us to do — the physician groups we service, made us follow standards, it’s made us as a company, most significantly R & D, and we can continually improve, ensure our future certification. We consider this investment in R & D a very good thing for IT, and very good for the community we service.


    Another question we had was who should perform the certification, there be more are than one group or other groups involved. We believe as one of the vendors, that C CCHIT should be the sole certifying body. You might ask why we believe that. We think they have had the experience, been doing it four years, they are up to speed, and we believe the process is working. They are doing a good job. They have a broad base of stakeholders, physicians, health plans, health systems, hospital or physician groups. They include the IT vendors, pharmacists, public health, medical record and hospitals. And they have plans to expand into the specialties. My question would be why would we change a good functioning system? Also, on that same subject is developing criteria. We put a new entity, four years behind where we are now, I don’t think that’s a wise decision. The time required any new entity to have public comments, would also be large. One of the things we have — let me go back here — we strongly believe there should not be more than one certifying body. You might ask why that is our position. If you more than one certifying body, different criteria, this would confuse the market, and we don’t think that’s a good idea. We think on a going forward basis, the CCHIT should be the sole certifying entity. The core system should have a high bar, don’t think you should lower the standards, think you should continually, as one of the gentleman here mentioned, to continually raise the statement. We think that’s a very good idea. We think the specialties should be an add-on after the core is met, so that if you are doing certification down a specific specialty, they should meet the core, then after, on top of that, get additional certification, pick specialties they are involved in.


    We think also that with respect to open-source, we think all those people should be included in the same certification process, should be no different. They have been able to certify system just as anyone else does.


    Another question was should the certification be [indiscernible] specific, we think again they should be both. That in order to do it properly they should be broad based with a — and the top of the core for the specialties. We think an analogy would be if you had a medical degree, fine; you went and got boards certified in sub-specialty, that would be the analogy that we would support.


    With respect to another question asked, should certification embody vendor fitness, we would like to weigh in on that subject, too. We think absolutely. We think the vendor should be financially sound, should have significant R & D programs, and why this is the case, we think, we want to be sure the business is going to be around to continually qualify and support its product. We think also this would avoid embarrassment to CCHIT for certifying somebody who is not around, and screening viability, you should examine recent profitability, cash, and balance sheets.


    Next question was should certification be viewed as a seal of approval. Our position is no, and you might ask, that’s a weird answer, what’s your situation here? We think that we can certify the processes, such as vendor implementation and support, nor can we certify the physicians will use it properly. Because we can’t do the process here, we think it should not be met as a seal of approval.


    With respect to — how should vendor systems be certified, and in-house systems and open-source systems. Again, we believe they have been certified in the same way as all the vendors are certified. Using the same standards, and open-source should be site certified.


    How should criteria related to prisere as aspects of ARRA. We believe it should be an integral part, used to encompass a social history piece, privacy piece, obviously should be HIPAA compliant. We should be documenting any release of information or information access, and when we give out information because of privacy concerns, the record is incomplete, obviously should be a notice on that information going out that we have incomplete data. Another characteristic is we should have what I would call a life and death, break the glass feature. In which case [indiscernible] the patient is in dire need of help, we can break that privacy condition in terms of giving out life-saving information.


    We believe the privacy issue should be driven by the patient or patient-advocate. The system can develop software to have features, but how they are finally used should be up to the patient and custodian. The healthcare IT should be provided with frameworks for these things, but the actual use of that should be in the hands of the patient and the custodian.


    We would also, somebody mentioned earlier, in order for privacy to be maintained, we believe that there should be severe penalties associated with breaking that privacy.


    With respect to security requirements that are also integral to this, we think they directly should be related to HR and be a function of the HR. Privacy shouldn’t be embedded in — elements of process should be left to the users. The security should be built in along with the privacy, how that is used should be a user ite .


    With respect to summary comments, we feel strongly there should be one certifying body, we recommend that on the basis of clarity, clarity for the industry, that there is just one certifying body, we also believe the bar needs to be set high with respect to the core, and specialties should be added on top. Then, certification should not involve just checking the box. They should be verified, that the features are really functional, operating in a live site. To do otherwise is to invite what might have happened in another industry called real estate industry, where people had wire loans and lowered their standards, which collapsed the housing market. We are looking for a very robust growth in healthcare IT. We think the opposite should happen should continually keep a high bar, verify information. It should be verified by the CC hit certifying body and even to the extent 6 seeing, looking at live sites to make sure indeeds this information technology has been used properly in live sites.


    Thank you.


    Thank you.


    Thank you very much. That was ambulatory EHR vendor. Now we will go to — hear from David McCallie, vice-president of medical informatics, and John John Traveis,


    Thank you for the chance to present this testimony. John and I will do this in a tag team form. John has directly supervised all of our current certification efforts and has insight into the details. I will try to provide you an overview. I am relieved to see William Stead has left the room, I am proposing a considerably smaller in scope and more focused than the grand vision, and that’s doubly true because Dr. Sted was responsible for me taking this career, my first boss right after college. He would probably be disappointed in what I have to say here for failing to meet the high standards he tried to instill in me at that time.


    We think the sharper the focus, the better. I agree with Sheldon there. The market needs clarity, and needs to move quickly. The timetable set by the statute is aggressive. Regardless bar set, it’s going to be a scramble. We think there are three areas that will come into focus. They all have something in common, which is they are really focused around the goal of achieving meaningful use. The first is interoperability, Dr. Stead and I would agree, interoperability is probably the most important thing to focus on in the short run. Second broad area would be functional behaviors. These systems are going to be purchased by providers who expect them to be able to do certain things well enough to qualify for meaningful use, and those functional behaviors should be what we certify against, and third, less tangible, equally important is pr product integrity. The purchasers expect them to be able to maintain intrinsic security, privacy, data validity. That’s not something easy for an end user to measure, should probably be part of the certification process.


    This slide is more or less to repeat the point I tried to make at the beginning, which is we think meaningful use should be the sole target fiduciary taring for at least the next four or five years, in the short hand we have come to use, whatever is necessary to qualify for stimulus funding, and to avoid stimulus penalty in the future when the funding rewards expire. Focus certification on the stimulus, would be our recommendation, and the other existing certification efforts underway should be aligned as much as possible with the stimulus-driven funding, certification criteria, in particular the e-prescribing, Stark exemption, annual recertification effort, and the Neepa e-prescribing should be harmonized around the same criteria, cycle, to minimize confusion to vendors who build systems and the purchasers, who have to ensure they qualify for these particular bonuses and incentives.


    We agree with the numerous suggestions that certification should switch from an all or none model to a modular approach. I am sure this will be talked about in great detail. We would simply suggest the definition of a module be based on sub-sets of meaningful use criteria. People could assemble a system if need be out of existing and piece parts, new parts, based on the pathway necessary to create something able to — someone may have an existing e-prescribing system, but need to buy a system that does CPOE, and a third that does quality reporting statistics. Put together a package that meansy sense to them for meaningful use.


    We think [indiscernible] is problematic, at least at this stage of our industry and the products. After hearing Bill’s talk, I am beginning to believe maybe we should start all over. He really painted a an unsettling picture of the maturity of our industry, from a software point of view, though you and many of us in the room have spent our lives in the — evaluation of a system would be difficult, if not impossible to build into the certification process at this time. One reason for that is, I don’t think we know enough about what is the right way to solve some of the use ability problems to lock them into received wisdom at this point. That might stifle innovation. The other problem, in our experience with clients, much of the problems of usability have to do with improperly configured systems. Improper is whose definition, where the rub comes in. Our client choose how they wish to configure it. Sometimes those choices aren’t the best choices. It would be difficult to certify a system for usability absent an actual implementation at a site.


    We think the certification criteria should be based on objective standards. The ideal, as we heard from the excellent presentation from the folks at NIST would be a machine-driven certification, where you have a harness, can hook up a system, run a test suite, get an answer. We think absent that, the criteria should be as objective as possible, and then absent that there should be an human, multi-person panel involved so we don’t run the risk of getting juror bias into the assessment of a system.


    Then, continuous availability. This process is going to happen quickly, the long time tables of the current CCHIT style roadmap are probably too long for the next few years. We think that as much as possible there should be an ongoing process. You notice the second point there, if the test harnesses could be made available to the sites themselves, not just vendors, to perform continuous self-assessment and know they are maintaining themselves in a certified state, that would be a good idea.


    Finally, watch out for hidden conflicts of interest. The certification should be based on the objective standard itself, not any particular network you have to hook up to, to test the standard, any network specific agreement should be separate from the certification process, to avoid inadvertently introducing essentially de facto requirements that are not really part of the standards process itself. We agree that an accreditation process, perhaps from NIST, makes sense, particularly if over time it’s necessary to support more than one certification body, if the process requires than one, accreditation is obviously necessary.


    John, do you have other comments?


    I think one last point on the — more than one certification body, I agree with the point made earlier that it’s very problematic as to the criteria development that may be put into place by those different bodies, in that underscores the need for oversight if that emerges. There’s an assuredness that those certifications hold equivalent meaning. At the same time if more than one emerges, vendors should be able to certify with one, have full standing for the purpose of the prerequisite requirements of meaningful use, not be compeeled to pursue certification by multiple authorities. Equivalent with each other, and oversight process assures validity and support market confidence.


    I think we are ready for going to the next speaker.


    Thank you very much


    Now we will hear from two niche vendors, the first is Donald Deieso, chairman and CEO of PeriGen.


    Thank you for allowing us to provide our comments today, and a special note for recognizing the importance of specialty solutions. We prefer specialty instead of niche, in that we track the therapeutic and clinical areas in which we serve. I would like to give a very brief presentation on the company, mostly as a representative of the many specialty solutions firms that are making such a significant contribution, and I wanted to highlight, too, advanced clinical decision support. Something that in the meaningful use definition today, as proposed, doesn’t really offer promise until 2013. I should like to give you evidence that it exists today, not only with us, but in many other companies and it’s functioning well.


    We are a company based in Princeton, New Jersey; a U.S. corporation, we work exclusively in the area of OB/GYN. We have a prenatal system set up in the hospital systems we serve, to improve patient safety, clinical outcomes, through advanced clinical support. In short, we connect our system to any host of, or any group of ancillary systems in the hospital, and at the clinic, including any of the enterprise EMR systems as well. The system is distinct, of course, in that bed side for the mother and in-patient setting, there is a screen, clinicians interacting with the screen. The mother’s condition, data would suggest, give indication of her condition changing minute by minute in real-time, proper alerts, notifications are given far beyond that of a linear CPOE and drug-to-drug allergy. We, like many firms produce clinical and financial — our clients have saved or $6 million a year in medical malpractice claims as a result of the system.


    Let’s talk a little about the specialty solution, and it’s role in the perspectives we offer today. First, there has not been a specialty certification from CCHIT. We are encouraged by several of the actions in recent months that suggest rei moving that way and we encourage that fashion. In the two categories of certification that exist, enterprise and ambulatory, the critical amount of function missing from the [indiscernible] or the specialty. We should also share with you the consequences, should the specialty solutions not be considered in the meaningful use and/or certification criteria.


    First, we believe strongly that the real powerful transformative advances occur in the specialty firms. Evidence of this can be founds by simply studying the enterprising EMR companies to see how they have been created, by acquisition and merger of exactly those specialty firms over time.


    Second, we believe that setting certification requirements based on the most common denominator of what’s available from the largest firms institutionalizes an average and discourages innovation. The most exciting opportunities, we believe, for driving improvements in healthcare reside at the fascinating intersection of clinical information and advanced in technology. It’s important that those advances be recognized and encouraged, not disincentivized through the measures you take here today. We also suggest that the incentive built into high tech is a powerful tool, not only it will be used to incentivize, drive this very important transformation of the U.S. healthcare industry, but may become a de facto standard with which medical malpractice claims are taken, beyond what we taking in this room. I can be confident plaintiff’s attorneys will use it to segregate those who are delivering care.


    Meaningful use and the proposal offered today does not include entire populations, nor can it. We do suggest, however that women’s health, given the fact that 4 million births a year, and those 4 million new children introduced into the population of the United States, if not properly measured, may not be given the start needed well into their A adult hood. It’s a special population. The certification requirements for specialty solutions must be encouraged. I mention the encouraging early signs of CCHIT in this regard. We have encouraged them and we encourage this committee to be sure that we are not disenfranchised.


    Defining the desired out come in summary, first, modularity, very, very important. Second, clear mechanisms for the dispersement of incentives for the specialty solution providers. For example, we have a number of hospitals that are regional, some rural, they don’t have enterprise EMRs, nor is one on their capital expense program, but they do have a system, such as ours, in OGEED, systems making huge contributions If the incentives are defined in a comprehensive way so it is hospital-only, much of those advances occurring today department by department will be lost.


    We are not quick for a solution, but we are very clear that it is an issue you hold in your hands, and significantly changes the fate.


    The vulnerable and protected populations, women’s health and pregnancy, one measure in meaningful use is associated with women’s health, percentage of women with mammograms over 50 years old, and the final bullet, one that is somewhat nebulous in its purpose, but quite important to us, that a national forum, a continuing forum that advances innovation, continues to share among those in HIT, what is actually occurring is very important, and we support it. Thank you for the opportunity to offer these thoughts.


    Thank you very much, our next specialty presenter will be Do you Wilson from Varian medical systems, oncology, rather. Dow.


    Waiting for the slides. Thank you. I am dow Wilson, executive vice-president, president of oncology at Varian Medical Systems. Very briefly, a little overview of what we do as a specialty provider, and talk a little about what we think the objectives of the initiative, application to oncology setting should be, things we are talking about. And last, make the case for specialty certification in the oncology setting, as opposed to certification requirements to specialty electronic health records.


    Who are Varian medical system system a leading producer of radio therapy, surgery, proton, we have significant software business, do practice management, treatment planning, and oncology informatics. We work with many centers around the world and our oncology information systems interoperate with enterprise of-level EHRs to ensure access to cancer patient data anytime, anywhere in the healthcare systems.


    We are installed in thousands of sites in the U.S., over 1000 internationally, and in addition we work collaboratively with the other oncology vendors, developing our view today, the principles for EMR certification, and I think I can say with some confidence our comments represent a very high percentage of the marketplace for oncology specific EMRs. Our product, called ar ya, designed to support the order, preparation and delivery of keepee therapy and radio therapy, encompassing a variety of work flow and decision support, charting, specifically provides a record and verify system for therapy treatments. Written over 1000 interfaces to exchange relevant patient information with that, information.


    In terms of certification and healthcare objectives, Varian and our oncology vendor community, we fully support the concept of certification and meaningful use as a way to promote safety, efficiency in the delivery of care. Several organization have put forth recommendations to the federal government for the implementation of HIT certification, recommendations from the Institute of Medicine, national research council, and demonstrate the need for specialty focus certification for oncology. The goals are general, ambulatory and specialty certification can remain the same, the criteria for implementation somebody different.


    In the few minutes I have, I would like to give a few examples. Recommendation one, electronic health record should contain comprehensive information relative to the patient’s condition, treatment plan, and outcomes. Electronic health records should meet this goal. However, oncology requires specific terminology, data collection to support physicians in the selection, planning, management of chemotherapy and radiation treatment. These are unique as mentioned by Don, very important to us, to develop practice guidelines, decision support, and many things we talked about before are germane to what we do in the electronic medical records setting for oncology. As a result, test cases for oncology, HRs should include oncology-specific elements.


    Recommendation two, EHRs should have the capability to integrate evidence based practice guidelines and research results into systems. Oncology focused include practice guidelines, other specifically for the treatment of cancer, meeting this criteria. However, if a test case or certification designed with a general ambulatory system in mind, ong oncology-specific vendors would have to go back, patients may have to wait for oncology-specific — cancer staging, chemotherapy cycles, tumor respoons assessment. Compliance of general ambulatory criteria will delay developments by vendors and could offer less value to the oncology specialist.


    Recommendation three, all EHRs should allow physicians to not only manage their own patients, problems specific to the individual, but when moves beyond the patient and impacting a larger population. Cancer measures, CMS’s — oncology-specific elements for data — quality care, oncology should permit aggregation, data mining and decision support elements to support good medicine and advance what we are trying to do in oncology.


    Data relevant in oncology, particularly trials, toxicity grading, adverse events, necessary for quality — without specialty certification, it would be difficult to determine whether the EMR is capturing the appropriate information to support values relevant to oncology.


    Certification of specialty, electronic medical records, Varian, other leading vendors believe the oncology department cannot be an information sileee if the — cancer care. Looking for options we believe it is essential loo separate, stand-alone certification must exist for oncology specific EMRs. Some are universeally relevant but — safety, efficiency, specialty disciplines, general criteria only provide part of the solution. If we agree that our objective is to improve the quality and efficiency of healthcare, and accept there are specific and unique needs required to achieve those objectives and the specialties, we must agree a sub-set of the general criteria, along with the specialty criteria would better serve the specialty community. A way to — baseline specifically for the oncology community.


    Varian encourages the HIT community to continue open dialogue with the oncology professional associations. This interaction is essential loo the development of meaningful objectives for certification. It’s crucial a separate certification for oncology EMRs be ready for the recovery act implementation. Should this not be rolled out soon it would be ex2R50E78 treemly difficult for vendors to become compliant for general ambulatory system as justed discussed.


    We want to ensure all providers, specialty or not are [indiscernible] forced into buying an EMR inappropriate for their practice, we offer our company as a resource for — to promote the best resource for the provider and patients they serve.


    We are going to have questions now, if you don’t mind, I am going to ask mine first, because I have the microphone.


    I have two questions. The first one is, in my community, we have six different EMRs, we have been trying to set up health information exchange for about five years, six vendors, we have a connectivity vendor. Despite the fact they are all [indiscernible] certified, we are having a Hell of a time getting health information exchange started because they don’t talk to each other, in spite of the fact they are certified to do so.


    I would like a comment on that. Then the second question is one of the possibilities would be to have two separate kinds of certification. One is a CMS certification that the products meet meaningful use standards. That might apply to any kind of vendor, and then there might be some other kind of elective certification that doesn’t have to do the stimulus package, that might be more similar to what CCHIT is doing now. I would like you to comment on both of those issues and whoever wants to come in first, that would be great.


    I would like to comment on your disparate systems not talking to each other. Principally, because our company, our NextGene developed exactly what you need, Community Health Systems, the ability for systems to talk to each other, only requirement is they be using standards. There are systems to help you do exactly what you are trying to do.


    Your second question referred to –


    Having two separate kinds of certifications. One that’s CMS, you meet the requirements of meaningful use for the stimulus funds, and the separate one more similar to what CCHIT does now, a more elective certification for any particular entity that wants to be certified.


    I would like to comment on that, too, we think also you hit the nail on the head with respect to certification for meaningful use, means one pot of money. Maybe all others in a different one. Yes, I think that’s a good idea.


    Okay, other comments from anybody?


    From the specialty point of view, I think the differentiated certification would make a lot of sense. You look at medical oncology, 40% of practices are digitized, 70, 75% of radiation oncology are digitized. One of the big barriers, the financial incentive to make that change. A lot of medical oncology practices are very differ fuse, small practices U outside the hospital, providing that incentive would be a big deal for those organization.


    I would like to comment on both questions. First, on the interoperability. The current certification effort focuses on just a tiny part of the interoperability equation. It’s like the plugs, but not what you plug it into. Until some of those health information exchange standards are settledded, agreed upon, it’s difficult for the vendors to know exactly what they plug into. Of all the real requests we get requested to connect to, every one of them is different, that’s just not nailed down yet. You can’t stop with certifying one half of the process, the plug, you have to certify the circuit you plug it into. With E prescribing, that’s much further along. We see proportionately greater success, and connects disparate systems together.


    Second question, certainly agree [indiscernible] further along –


    Yes and no, may be further along because the standards bodies did a better job of rounding up all the stakeholders, the NC CDP process, plus a clearer business model driving from the retail pharmacy side where they had a clear benefit and reason to push it forward.


    On the eligibility, the payer side, formulary, likewise, a clear business model for them to make that available. In the real model it’s still debatability, the long-sphainlt equation. The certification processes, certainly we were proposing the first of yours, meaningful use certification, so purchaser has high degree of confidence if they purchase, install properly they can qualify for — penalties after 2014. Elective certification I am less interested in. We feel pretty well engaged in the meaningful use issues.


    Other questions from the committee?


    John, you were in charge of certification for Sirna, is that what I heard?


    Correct.


    What was The overall impact for your organization?


    Your us, we looked, the acid test where there was an explicit — certification’s sake, for us it has to be more than a good housekeeping seal of approval, it has to hold meaning, both in its ability to enable requirements and [indiscernible] something they recognize, can have confidence in. We participated in three different certification programs over the last three years, with CCHIT, and I think we look at it as a very foundational element of what’s going on in the market. Early on there may have been vendor reaction of another thing we have to do, expensive, it’s ingrained. We know it’s there, have to deal with it. The comment was made by NextGen, driven to better embrace interoperability than they might on their own. That’s a value, definitely helped promote that objective and reinforce security, privacy standards. Which puts it in a new light, security, privacy, left to our own devices we would probably pay more attention to security and privacy within the four walls of our client. Those are real values.


    Where we have tried to take great care in evaluating, just not default, saying go for every certification that comes out, has been is it an ongoing, continuous value. We mentioned in our presentation our concern about the relationship between certification requirements under the Stark safe harbor and under meaningful use. We are driven to an annual certification process with Stark, whatever we say about it, CCHIT certification periods have been effective for two years. Used to be three. Under meaningful use proposed to be two years. I think we need a better synchronization of the time period, effective across the federal regulatory requirements that point to certification. To me that’s a consistency that should be addressed. We recognize the value of it. I think it drives behavior that might not otherwise happen in the market, very positive for things that are the not function, feature, user-demanded requirements. It holds value around that.


    This is a question targeted at — for the Nextgen and Sirna folks. When we talk about — are you communicating a narrowing versus a full CCHIT accreditation or is it in that comment a different emphasis, specific pieces of low-level functionality –


    I will take the first, two things. We aren’t saying certification should only be meaningful use. Certifying bodies are free to develop what is appropriate. The comment from the specialty vendors, there’s great value in certification for specialties. The Medicaid programs, state HIT initiatives, like Minnesota, they are emphasizing specialty certifications. We are not meaning that. I would turn it around and say if a certification program is being represented as meaningful use, being geared, scoped for that, that’s what it should be. Shouldn’t be saddled with de facto requirements. We have experienced situations where bodies that are participating in certification that CCHIT has formed out certain requirements to have their own requirements that go beyond the certification requirements. Specifically for electronic prescribing where we have conformance requirements, connectivity to network, data collection requirements, provider participation in the networks; that are embedded into th certification we have to attain, subsidiary certification, we present evidence to CCHIT. We have to look at those things carefully. Our point on the impartiality, independence to certifying body, the certifications need to take great care not tho enable a business model or requirements to any that goes beyond meaningful use demands.


    That’s the gist of that point.


    I would like to comment, please Somewhat in agreement that you need to have your standards for your core EHR systems associated with meaningful use, and that be very clearly stated. Those requirements should be, that bar should be continually increased as we go on in time. The specialties should be on top of that as a kind of different, post-graduate degree on top of that certification. That’s how I will weigh in.


    I would like to add one, maybe slightly dissenting opinion. I want to go back, from my notes, one of William Stead’s slides, touchstones, less is more, require precise definition, avoid freezing work flow content or technology, make data liquidity the foundation. I think that’s an incredibly important point. If we prematurely certify a particular work flow, way of doing things, we will suppress innovation, and we shouldn’t do that.


    We are still a very immature industry. If we certified cell phones at, say, Blackberry, we wouldn’t have an I or whatever is coming next. We have to be carefully to not aggressively –


    Do you worry about introducing any opportunity — the resulting system deployed might not be as coherent, any risk there?


    Certainly there’s a risk. I think assembling a large-scale system to automate the processes of care across a hospital is an incredibly complicated and difficult process. It takes years to do it. Bill said 10 years. If you build a system out of component parts you have more work than if you buy a package system, one of the selling points in the marketplace for years, still, if you bought everything, you still have to assemble, nobody supplies the whole syste certification could make the problem an easier problem than today, by being aggressive on interoperability issues. Usability, work flow — I think to


    We are on reality, especially for 2011, respective respect sayses, our clients have a variety of systems in use. Replacement strategy or mid-stream, they will look to vendors, to represent constituent, certifications, incentive requirements, they are not going to say to Sirna, I bought your catalog, will take me eight years to implement. I need something in 2011. A very delicate balancing problem will have to recognize organization have invested in whatever their production systems are. They are more likely, especially in 2011 to look to current vendors for updates to meaningful use, not engage in replacement strategies in 15 months. Modular certification is an enabler to those organization that have invested, for whatever reason, in the production portfolios they have. That’s their point of departure and it’s a rate limiting reality to what you do with certification. The bar needs to be set appropriately, but a lot of investment dollars have been spent, and they are what they are. Improvement should be made in systems as they are, not the only path is replacement, new plumbing. At my house, I am not building a new house for the sake of a new electrical system.


    Adam?


    Adam Clark, Lance Armstrong Foundation. Oncology specific issues, certainly that’s near and dear to the heart at the Foundation. Throughout these months after this committee was formed I received lots of calls from the cancer community, continuing to emphasize the importance of research in meaningful use, certification, in all aspects of electronic medical records, particularly as we look at pediatric population where 55 to 65% of those patients are on a clinical trial, or we look beyond with just doing comparative effectiveness research. We don’t know in radiation, number of — that will work best, for prostate the procedures that will work best.


    I was wondering if you could comment on, particularly in specialty areas, how clinical research and data collection can play in the certification process, things we need to be looking at, barriers to address to really try too help communities like the cancer community that rely on this information.


    It is a complex question. The percentage of pediatric patients on research, if you look at academic community, large community hospital community, 30 to 40% of general cancer patients are on some kind of research protocol. There has to be some capability. I know that our system has capability for managing those protocols, other competitor system does, what the certification requirements of those research protocols might be. We really haven’t spent a lot of time, but would love to think about that with you, as I am sure [indiscernible] will be as well.


    It is a capability that should somehow be there. It’s just such a large percentage of the cancer population.


    [Captioner transition.]


    That capability has to be reflected in the requirement.


    SUPERFLUSHWe need to be more aggressive about Interoperability. Can you give us more specifics besides just been more aggressive? What should we do to fix this thing?


    I can give you some opinions. Actually, John Glasser and I have exchanged some emails about this. One of the things that I am afraid of in the current timetable for specifying specific meaningfully as milestones is the potential of getting a of sync between the Interoperability file stunts community-based, health information exchange. So in particular, the states are aggressively pursuing the ARRA funds available to the states to build Rios and information exchange entities, they are not covered by certification timetables or the certification process and there is an indication Port, say, the 2011 milestone for the benders for that EHRs bought haven’t specified what the [indiscernible] is and going forward to try to build exchanges against an unspecified standard. So one thing would try to be to avoid the synchronization. So that we are Glen to have a 2011 Interoperability standard, let’s let it apply equally two everyone and get that kneeled right away. If it will be 2013, a [indiscernible] the vendors to whatever standard de pact, which may or may not be the ones that get blast in the long run. So that is just really a plea for speculation in the interest of flying across the communities.


    As far as the actual technique to do the Interoperability, I think it will get pretty technical pretty quickly.


    There are — and I probably should not go there, because I could spend the rest of the afternoon giving you opinions on exactly the right technology. I think there are standards out there that could be used fairly quickly based on the documents sharing model called XDS that could achieve a certain, the Interoperability. Whether those are the right standards are not should be debated quickly so we could settle or go forward full speed with an XDS based approach to Interoperability or come up with something different. The Model that Bill described in the that that’s where they are sharing a loss of textual documents and finding smart ways to search those is for an example, not a XDS bottle although it is a very powerful model and it is the is a better place to start than a very structured model. Some of that on the [indiscernible] vendor side make it hard for us to go and commit substantial resources until we know we are Glen to land.


    I probably did not answer your question.


    Well, it was helpful, but as you were talking, I guess one of the things I don’t understand, or maybe I to understand, is, what went wrong. Why do we find ourselves where we have nothing that can talk to each other? Why isn’t it working?


    Well I think it is a bit of a misnomer to say that nothing talks to each other. Everyone of us benders has implemented thousands of interfaces and data flows, absolver systems. We have a whole crew of people at Turner who do nothing but talk to other systems. That is their job, to build these interfaces. The vast majority of these interfaces are going to start with an existing standard and start with a small amount of customization on the client side and that may take as little as a day or 2’s worth of work or it may be bored depending on how unusual the system and what we are interfacing with. They’re is a tremendous amount of data that flows today, is just not plug and play. For example present and and and HL 72.5 out of the box. We have thousands of them and they work quite well.


    What is not present is the community level sharing and that is partly the lack of agreement upon the right standard of use but I would say it is more of lack of agreement for what it means to have documents and patients shared in the community. Does a regional based Schering model makes sense? Cure share is regional most of the time but when it isn’t, like if you go to that Mayo Clinic or the Cleveland Clinic, it is not a regional base model. Those arguments have been going on now represents the beginning of Dr. Brailer tenure at UNC and until they have been, this is the way we share data in the community and manage privacy and consent and charity rules across state lines etc. The vendors to have a lot of incentive to do the extra work to make that plug and play.


    If you look at what was actually certified, and kind of get inside that for a moment, CCHIT certified three aspects of Interoperability as to the types of data, so we had a lab, the values being exchanged, electronic prescribing for most of what the regulatory regime now relates two as advanced E prescribing, Medicare part D requirements and communicative requirements nothing in it for a cure a summary as to a transcribed physicians document or anything of that nature, so you had a CCD with what would be in moderate concept. But as of yet, what would be addressed by CCHIT proposed in 2009 that they still be part of their comprehensive certification for advanced Upper ability is anything to test XDS. So there is truly as of yet no test as have the ability to go approach H. ITI, present and resolve what clinical documents request for that document and any specific instance of that document. So perhaps buy that fail to cure relied on certified Systems is that none of those systems were certified to connect to anything for the purpose of collecting clinical data for any patient for resolving the identity to deal with consent. I do know that you will hear from HITSBE later this afternoon and and a part of that and we have spent a lot of time on data the management and provider identity management and the consent and the things that facilitate that but they are in the future relative two certifications even with the developments we have had today.


    Are there a standard mechanisms in place to pass trust from one system to another, but we haven’t agreed upon what do you trust in the first place. What is a properly arson ticketed provider? What is it properly authenticated patient who is requesting information from a system? As John said, these have not been settled so they are not in the products, therefore I do not get the plug and play that you would like to say.


    So the standards have not been set yet, that is the problem?


    Yes, in many cases they are not settled or the parts are not sufficient to build the and the two and system. The easy part’s have been done but the hard parts have not.


    And therefore they are not yet in the certification.


    And wanted to go back to David Macaulay ‘s comment, that the equity with an important point, and I wanted to see if I could take a step further and see if he’s got it made sense to make that a fundamental requirement of certification, in particular in the sense of the separation of applications from data?


    I think it is it part of what I think we’re heading torrents. And so the proposed requirement of the patient being able to get a copy of their data in the form of a CCD document or whatever the standard turn out to be, that is the liquidity point right there. That and not the 100% of that data in the system but that is the liquidity data — have it adjusted appropriately. So to the point that we can identify the course structured data elements and make those transferable between systems I think is the first set. And I think they’re should be some control bought back I will admit I didn’t follow that. I think that that doctor has a list that I am sure that everyone has heard him say, what he thinks those elements are around medications problems allergies, it is it for the smallest and I think all of us on the vendor side would agree that we will take the bull capillaries with their limitations. ICD9 is [indiscernible] how do you describe an allergic reaction and his vocabulary will use for that because there is not the defacto standard. If we settle a few of those things we can interchange the structured data fairly readily. That the rest of the data that is in the database, the non summary data for the data that describes the status of patient in the middle of a multi phase chemotherapy protocol, if you want to transfer that to another system, that is not possible yet. The Clinton systems but across boundaries, it is too complicated and the standards are not there. So I don’t know that we need to go and solve the most complicated data transfer problem, I think we can make a lot of progress with just the summary data. Many clinicians with take that summary and reassess the patient anyway, that is what they are engaged for, they probably don’t mind having 100% of the data there, they are engaging and having a second opinion with the new provider to start with the is and data and then taken and find out what got missed before and what is seen differently.


    We would be thrilled with a CCD that we could actually transfer the data from one practice to another practice. Right now, we can’t do it, even though all of the vendors are supposedly capable of creating a CCD.


    And that is an example of where the full scope of all of the steps are not well specified enough, so we could put a CCD on its zip drive and had it to issue an D ticket to the other provider who may or may not be able to import that particular file system into the system. You could wrap it into a security Mill message but providers not use secure e-mail, because people don’t go through the trouble of getting securities certificates in their e-mail systems. So there is a variety of ad hoc ways to solve the problem but there is not a standards based way to close the loop. It is doable, IT test has not been done.


    Mark approved. I agree — Mark probes to. The standards are now put out and define and given to you. What kind of level of effort is going to be put on to your clients to make these modifications? What kind of time frame do you see, what is the impact?


    I think you have to factor in one more item [indiscernible] organizations to adopt in the Interoperability space. Not all of them, certainly, but a number of them to function relatively with and they’re full walls relative to their health records systems bought back we have had a lot of discussion within Cerna about, is part of it is you can connect to an information exchange, what kind of exchange is it that will satisfy many people use. Is it that that organization can connect to the medical staff in their offices with whatever system is in place which doesn’t apply that a big [indiscernible] facilitate that change and pragmatically, as you put it, that is probably what most of them are interested in. In exchange data with the primary care physicians in my community that represent most of the pigeon population I see. For the most part that will be either my Munich referral services or the medical staff. Especially in an academic center and I think that is where the demand will start, that the systems enable exchange to the care settings that refer patients in the and also, are the primary referral sources Post discharge. So that is going to be the first motivation they have and we are already hearing a lot of questions from them, will that be a proof point that will satisfy meaningful use at least early on? Do we actually have two physically connect to some kind of regional HIE that maybe in its infancy corporate planning stage in our geography? They’re stages where there are very functional information exchanges but there are also places in the country that that is not true. But they are all held to the same standard and same burden of proof, so we have to take great care about what is the task early and what promotes growth over that period of time dropper ability point as to what they are connecting two and when they are asked for the burden of proof for that meaningful used, what is that measurement that they are going to require really going to mean?


    I am thinking about the time fringe around two edification, he talked about two years or whatever. Might be, and I am looking at Cerna or whoever, we have the standards out there and we can write Release 6.8 that now has those standards in that and practically, someone has to accept that. I don’t think it is just as simple as a plane that code in the hospital or the physicians office or whatever it might be, but I am trying to get an idea of what you might think that level of effort might be?


    From our experience, we really is an update to our software about twice a year that we consider a major update. Absent any of your decision, most vendors practice to certify a pretty contemporary version of their software. They are not certified exempting the released three years ago. It might take code back and certify their immediate prior release.


    Our client base we try to encourage to an upgrade about every two years on an individual basis, to what is that currently available release. So historically they are on a cycle of the upgrades about every 18 to 24 months and each of those efforts probably is inside of itself a six month effort at any rate to taken up date — take an update. And they are fully converted from what they are from us and it will go through that process. Some less, probably not a lot more. So if they sit here today and they go out and certify her next generally available release, that we just put out and the version which took thrown our own CCHIT certifications earlier this year is a version that is generally available just as we speak right now. So for argument’s sake, if that is what we had pork meaningful use, which should be able to take that code right now barring the decision to take anything back or make it available on any basis, if there is a cap around meaningful use, and there could be, I think especially for some of the measurements that are expected to be EHR based, I think our client will expect whether or not that measurement content and reporting is enabled by as so it can be reliably collected. They may choose not to use it, they the right to something on there but they expect that capability there. So there will probably be some were to be done to make that available. So they are looking at between now and at the hospital starting fiscal year 2011 to take what it might be just now putting out as general availability. And I think that somewhere between a very and the 40% of that time would be spent doing nothing but the upgrade process. You have deepened begun to consider how they are already using our software compared two meaningful yes. Had they implemented CP 0E? Or intimated prescribing? So they are called up right now and that is an exercise, especially with our clients, I think it was NexGen that said it. Well, we’re trying to help our clients planned but we got a what we are planning against. So it is hard to set the bar if it is not reflective of something that is barely within reach. If there reusing the software for everything today, they would still face the upgrade to take them about, arguably, to that end of the year to get in position using our current software. If there is any competition on top of that at new development requirements, adoption on their part, and commit modules, that is additional work. So I think we can all look at what an entity that has and implemented CPOE, there are lots of studies that will take us there.


    I would like to weigh in on that. With the expense to the company, you have to bifurcate into two areas. A product out and the other is how to kick it to the clients, two separate issues. And the timeframe that was mentioned by John is pretty typical [indiscernible] as well. So we have similar time frames as he quoted but it is important to bifurcate the two.


    A relative to the expense, if you are improving our product, which you should be all the time, it is something you are doing anyway. Tell it is almost not an expense on acidification piece of it, it is minor compared to the product development which you are doing anyway. So that incentive for everybody to get that, the people that already have in our system but don’t have the latest version is the meaningful use piece. They want to be in on the meaningful use and the money associated with it.


    I am interested in this question for the specialty vendors. I understand from your comments that the current certification process bills soared up over specifies in the sense that it includes records that are not relative to your specialties, and it also under specifies because it does not include things that are very relevant. I am wondering if the offer specification problem can be dealt with by ratcheting back the requirements to it. Course that of characteristics that are maybe applicable across a wide range, and in terms of under specification, can that be handled more in the medical use area brothers and certification?


    I think the first proposal opinionated is the proposal CCHIT has proposed in the modular, and that is, rather than have the specialty folks who are advancing that technology and so many deep Ways and to their area of other than forcing them to come back and replicate the based enterprise, there could be a certain core, and we agree with that concept. As to the question that now whether the certification can acknowledge the advancements that the specialty firms, that clearly is not on the table today, the meaningful use definition a very wealthy. What concerns us, and I think John describes it as classic best of breed and enterprise approach, is prior to the recovery Act, and we were prepared to go head-to-head in the marketplace as a best of breed technology. But the client decides situation, to recovery Act creates that will change in the entire equilibrium, that ecosystem that is so threatening at least to the specialty species.


    – John’s point about managing the development team to the various releases of the software. I would be interested in your comments on the certification process or the bar is raised every few years purses may be giving you the criteria of a way through 2015, is that a significant value to you in terms of planning, or is that of marginal value?


    I actually think that is of great value to us to know where we are headed beyond the year. But one of the things that I think CCHIT has done well is there three your roadmap. Now without judging what is on it or in it, we have tended to look at doing our cap assessment on the two your ruling basis against that road map. Three years is hiing variability and greatly subject to change, but within the two year period, especially with their criteria definition settled, we have tended to lock in on the second draft. Once that is published and to public comment, as it. Meaningful point to go down to brass tacks about what it is that we need to do. If we wait long prison that, it is too late for our current development year and there is such a high degree of change CCHIT, honestly, we would have to hold our fire until we see the evolution of public comment way in, but that rortmack thing is very appreciated, because we are typically working with detail planning on a 1 to to your horizon and more objective level planning on 82 to 5 year. But that helps inform prioritization. And I like that most organizations would be it that way and they are not just looking inside what will get them through that element there.


    I would like to echo Johns statement, and all of the information he would give us an advance is very helpful. “the market permission and the faster you get it to us is all very helpful.


    One question, and Cerna ‘s presentation we had this concept of the test harness, which was interesting. Could you tell us more about that?


    Yes, I believe that the current CCHIT process applies to test breaks for the vendors to use to test the software before the formal certification, and the idea was to simply extend that to the implementations, so our clients, the provider groups that are implementing systems could use those same test harnesses to certify that not only the software out of the box was capable of working, but the implemented version that they are actually running could also passed the test Parnis process. So it is the simple idea to extend it deeper into the delivery cycle.


    Is it difficult to use these tests harnesses? Copay two prison medical group to this?


    I think it certainly could be designed such that it would be trivial to use, it is probably not the case that it yesterday. It should not be any more complicated in an ideal world, and if you use sky, which is one of those pre Internet protocols, the voice over IP, which is what I used to communicate with my kids overseas. All he to install it and it plays a message back to you and you know it is working properly. For Interoperability testing, we ought to be able to achieve that after nearly down some specifications.


    Whose responsibility it is it to develop these?


    I would think [indiscernible] it could be NIST, although from what I heard this morning it is not likely to be them although they could help guide it to set one of those up.


    I would offer the comment that in CCHIT, a delight at the test tool that they used to validate performance and Interoperability specifications, part of it was to render a few to the and the user — a view to the and the user, and I now know if that is specifically [indiscernible] to DR practice is implementing it to ensure that something they receive is workable, but those tools were developed for cert. And I don’t know that they’re useless limited to certification, but they were open sores and tended to be available prior to any certification. And think what we’re suggesting is passing passion open not availability up two anybody that has the appetite or desire to make use of them for there and the deployments. Now whether or not they are fit for a fairly basic level obscure or technical savvy out of bed and the user is a step beyond where they are today. But the development of those or part and parcel to the certification process because that was the means by which Interoperability was certified, so it may be a matter of taking it a step further to help validate use.


    Well, I’d think we are ready for lunch.


    What is a thank you for that vendor panel, I tell that some of you came great distances, from Laguna Beach and one case, and Kansas, and that could be even further away, but I wanted to say thank you to all of the vendors.


    We will break for lunch until 1:15 p.m. Thank you very much.


    By. [APPLAUSE]


    (The HIT event is on lunch break until approximately 1:15 p.m. ET.)


    For those community members that are on the phone, please remember to unmute your phones during the speaking presentation. — you and your opponent during the speaking presentation. — MUTE your phones during the speaking presentation. Thank-you.


    Okay, Judy is telling me we have to get going, and we are a little bit behind time. So we would like to get going. Anyone that can sit down, go ahead and sit down and we will go ahead and get started.


    And this afternoon we will talk about the users of systems and talk about CCHIT as well and I would like to introduce our panel that we have today to talk to us on 84 purchasers and some of the things we are looking at, and the challenges desertification might bring to them, and what desertification mean to you as users [indiscernible] within the organizations. And some around the processes. [indiscernible] as much of it discussions so if we could get through your material in 15 or so minutes each, that would be great. And we have Doctor Keith Michael, there representing practitioner at one end at a bought back [indiscernible] in Texas, where well-respected in that neck of the words, and we have Stephanie real.


    And we look forward to hearing from each of you and I said, and we are done will get into some discussion.


    Thank you very much, Mark. As Mark pointed out, I am one of the rare breeds, about 30 miles from rural Vermont, a 99 bed hospital. And I decided to lead a hospital employe practice in 1998, and when I left, I noticed that my group was very slow to adopt an electronic medical record that I recommended to them. I really felt strongly committed to having and EMR were better patient care, and I bought a very inexpensive software that is still in existence, and it costs about $1,000 to get a site license. I developed and NT client server system that probably cost me about $13,000. And in the last 11 years I have been using extensive use of the faxes and scanning. I was really emphasizing his ability and having records on hand and at using EMR for patient records and I would give patience is a list of their medications and problems and act on it was interesting instrumental in keeping in touch with my colleagues. And I have no transcription costs over the last 11 years. I really needed a system that had very — was very inexpensive, I had a very thin profit margins that I had to borrow to by this system. I had separate practice management and EMR systems over the years until I get the CCHIT system which I just have plummeted. I have had four different management practice systems. Along the way, I decided that a new EMR system would be good, and I spent about $7,000 to buy it but I never implemented it, because when I looked at it, the compelling features I saw in demonstration or just not that obvious when we were using it. Along the way I have been entering a number of positions Bolton so the practice and group practice at EMR. I have also been using group administration but e-mail patients and I did plain old e-mail about eight or nine years ago, and then I developed a hippa compliant web portal through a national bender about three years ago. I have been using electronic backed servers through a web based service in the last few years, and one of my consistent problems is, I have been unable to import lab data into my EMR over the last 11 years, necessitating a lot of manual data entry as I tried to maintain blab flow sheets, and there have been problems with baffles system. I have been pretty diligent about doing backups myself, I have and the doctor of chief information officer, I can tell you about the and ask and he H. CP and TCP IP conflicts and the system, and that is really not as quite as and lightning and enjoyable as being an internist, but it is a necessity. And even though now we have more networking support people, it is still necessary on short notice to spring into action as a techie.


    I have been using a patient counseling and tracking program for doing and Clyde relation Management, sort of module system, and I have about 100 patients in my anti quite elation patient clinic and I have a questionnaire I can send people like e-mail or in the office and have them complete a pretty good medical history when they come in to see me. Unfortunately, it is a little difficult to use in practice, I would say maybe five or 10 percent of my patients is it. My office has been part of an experimental immunization registry, and that is a freestanding process that has an interface with my current EMR.


    About four years ago, our area become part of a statewide chronic disease management program that is sponsored by the state government and Department of Health called the Vermont blueprint for health. It has been a paid for performance system that has involved using a separate Web based electronic registry, the way to incorporate data from my current EMR into that and a lot of duplicate data entry has been necessary for that.


    Back in 2007, our hospital decided to find as grants EMR for primary care offices for the promulgation of the EHR systems. And I was in the task force that helped develop recommendations for that.


    We have required that people that use this grant be part of a shared community health record system, and part of the precept was, physicians have 15 percent ownership of the EMR and that the grant covers 85 percent of that EMR. I don’t think I would have done a new EMR had I not had this grant, because it was a substantial amount of money.


    (CAPTIONERS TRANSITIONING). Part of the requirement is this system be able to interface with state agencies, the mountainization registry, the blueprint, role RIO technology officer, I received a grant of $40,000, paid 15% of that, and the cost — any of the hardware costs, networking costs, I had to assume. We completed an extensive interviewing tool, readiness assessments, toured by the regional — the cost of the implementation for about two years, we are a little over a year into it right now.


    There has been a very long transition. We looked four or five months at different vendors, trained last summer in the practice management component of our vendor, we went live with the practice management side in 2008. We began training on the EMR part last November, and again, just went live last week. It’s what we have found in doing this, and this is very important for doctors in small groups, implementing this, even though CCHIT standards call for a two-way system, exchange doesn’t happen unless you have parties willing to negotiate with your vendors, and your value-added retailers, they are going to build custom portals. We found out in order to develop interfaces, be they lab portals — you have to pay a couple thousand, $3000 along the way, it’s not clear, despite having RIOs, who exactly is going to pay that, and it may take quite a while.


    For example, right now my web portal is not able toy directly interchange data. I use a lot of copy-and-paste to, to it into electronic record. The vendor who promised electronic prescribing isn’t really certified right now to get E-prescribing bonuses for people who have their module.


    What has been nice, though, I can integrate practice management, scheduling and EMR, there’s big improvement in usability. I think it has a very robust database, which is really important. Part of the C HIT requirements are electronic order registry, primary care office, very challenging when you have 10 or 15-minute visits with complicated internal medicine patients. I counted in one case 20 different mouse clicks to see a diabetic last week, tell my laboratory staff what labs to order, set up a future visit, including what labs to order and what kind of x-rays were needed to be done. It’s really not clear to me yet, although I am a new user, exactly how the information is going to exchange, how I am going to be using clinical pathways that the vendor uses to take care of my patients. It’s a challenging job, and I am concerned at the loss of productivity I will be facing, probably for the N six months, even though the vendor talks about a registry feature that allows me to get PQRI assessments. In talking to the vendor, it really doesn’t exist. They are CMF certified as being able to provide data in a registry format, but there’s no off the shelf product doctors in a small practice can use.


    What I have found is most physicians right now who don’t have a strong preexisting commitment to EMR are going to have trouble implementing without a strong member, super user in their practice to do this. We have to really work hard on pinning down people and at who is going to cover people, interchange. I am very concerned about implementation of software on a broad scale without some sort of incentive dollars out front. I mean, 2011, when you are a small practice looking some type of repayment is kind of a nebulous promise. Many practics are going to require loans from — or help to adopt this.


    I am concerned as I listen to testimony about the need to set the bar high, but I also see a need to rewards early adopters, those who have been on the leading edge of technology need something to keep us going. Right now there are major concerns about the future of primary care, about lack of man power. Many of my colleagues are concerned about EMRs being one of the factors, if overly promoted and underfunded, will push primary care to the brink. That’s, those are my remarks.


    Thank you, first of all, for inviting me to come join you and share thoughts about certification and EHR adoption in rural community hospitals. By way of level setting, [indiscernible] healthcare system, we are a non-federal, not for profit health system. By the numbers we look to have a pretty decent critical mass, 17 hospitals, just over 1200 staffed beds, 75 to 80 out-patient locations and a huge trauma program. We employ about 150 physicians, mostly in the primary care space. More importantly, we have a very strong commitment to our 750 independent medical staff members who comprise, and — we have a fair amount of critical mass.


    Over the years, we have been focused primarily on the delivery of care to patients in the community they live. It’s important to us, the CEO and boards believe people get better quickly when they get care in the community where they have family, support systems, and [indiscernible] dropping quickly from the 20-and 30-bed rural hospitals, would have a difficult time on their own. In fact a number of years ago, as identified as one of the fastest growing health systems, one of the key drivers to growth, ly related to hospitals was IT, providers couldn’t afford to do it on their own, take on those types of investments. Interestingly enough, the then and still poor state of IT interoperability dictated a strategy for us that’s been very slow and expensive. As hospitals joined the system, we had to throw out what they had, start over, couldn’t make what they had work with us. To do referral network, moving patients back and forth, couldn’t make that patient-focused, patient data focused view work. We had to take this slow, expensive approach to IT strategy.


    While we are organized as integrated delivery network, under the covers we are still a collection of rural community providers, with all the challenges. A quick minute on that, the hospitals are often the largest employer, vitally employer to the economic, some of the highest paid employees in the markets we serve, relatively long tenures with us, very stable workforce. But we are vital to the success of those communities as a key economic driver. We also serve an interesting patient population, largely static, high incidence of chronic disease, relatively low levels of healthcare literacy, not stellar lifestyle choice ins some cases. A lot of asthma, chronic heart disease, borne of a lot of chicken fried stake. It’s an issue we see. Because they are chronic, we see patients moving in and out of referral centers, frequent, constant, and the continuity of care ff us is vital, is critical. To all the referral centers around us. Physicians that work with us on medical staff there, have more established practices, been in the community a long time, and very, very loyal to the organization and to the local communities. Some more change resistant than others, doing things the same way a long time.


    We talk all the time that employees wear multiple hats. I tell the story, not kidding, it is the truth. The same employee will be the business office manager, IT director, admissions, admitting patients on any given day. I tell the story of one hospital administrator, in Trinity, Texas, 25 beds. In the summer, his only admitter goes on a well-deserved vacation, no in-patients in the hospital, cancels his lawn care contract and he and his son are out there mowing the grass because that $1000 a month is material. The leadership focus, capital, is relentless, it is a constant battle to stay afloat, literally. As I said, growth of system driven by the fact we had capital to help.


    A couple things about IT in rural community hospitals, they have been the slowest to adopt and will continue to be because of the challenges I just said. Primarily the availability of resources to help them get it in, people, capital, it is a particularly challenging environment. Many of the vendors serving that market aren’t currently certified, equally more challenging. One of my biggest concerns is the potential for unintended constituency consequences. As vendors scramble to update products, meet newer, changing certification cycles, might that result in more frequent release cycles, furthering the churn in hospitals already resource strapped. That’s a concern.


    My other big one, now that money is tied to demonstration of meaningful use, I am very concerned about inadvertent focus on features and function, unfortunate bi-product at end of a state of objectives, a real consequence that could be unintended. Rushing is the other thing. I am not the first CIO who has, after months of frustration after a project that went on forever, drew a line on the sand and said this is going live on such a date, always bad news. In the rush there are usually reasons systems are slow to go in.


    Ownership by the — whatever, always reasons systems take a while to put in. When you blast through those, whatever the motive is, there’s usually pretty ugly consequences. The truth is, technologies suggested under AARA, the benefits might be most readily realized, always struggling to do less, efficiency is a vital enabler for them to be successful in the future. It’s an interesting dichotomy between the challenges in front of us, small community providers and the benefits they can afford.


    As I think about purchasing EHRs, what are things I think about? 15 years being a CIO in a group of small hospitals, I am nothing if not pragmatic. Cost, that’s the easy one, but complexity in terms of scalability is huge. All of our eyes are bigger than our bellies. We look at demonstrations of vendor products, feature, function, we glaze over with the opportunities, possibilities, they are extraordinary. Our ability to operationalize some of that is far less than the opportunity would offer. In that disparity comes this day after cognitive dissonance. It’s because some of the systems are too complex for the benefit they could drive to your organization, to be worth that type of money, and resource intensity, scalability is huge for us. Usability is huge, and when I say that, I don’t mean not reinventing the wheel, having prebuilt is important, but we have seen systems go into similar environments and be successful in some, not successful in others. I will give an example on one of our ambulatory deployments of EHR, installed now in probably 60 of our 150, maybe 70 of primary care physicians. From the outside, similar practices, number of physicians, patient population, same technology, templates, implementation methodology, wildly different success factors. One group of docs loves it, embrace the full suite of products, features, functions. Just down the road, physicians are miserable, office staff is miserable, it is intangible, in leadership, focus, in the motivation of the clinic managers, nurses. It’s in so many things that had nothing to do with the product or even its usability if you are able to define something we can certify against. It is very difficult to quantify in any objective measure how you achieve success in that regards.


    Frankly, and it’s come up, the fellow fell sirenner made this point. Achieving success, the [indiscernible] that just came out, said 59% of hospitals they surveyed even started down the CPOE path. Whether or not CPOE, hospitals have correlated function, core of functionality we don’t want to throw out. I am very concerned as to the state of the certification standards that will allow us to leverage that technology without having to spend a lot of money replacing and starting all over again. We don’t have the time or money to start over again. Interoperability is fundamentally vital or we will have to start over again. Not just the custom interfaces we talk about. They are extensive, fragile, have to be tested to Nth degrees, every vendor, highly unusable in the community hospital arena.


    Frankly, until recently, the past few months, certification hasn’t been that big a consideration. Not that it didn’t have value, it most certainly did, but largely had value in vendor accountability, like RFPs did for us in the day. We would be sure to contractually bind our vendor partners to certain deliverabilities and certification helps in that regard. Hasn’t been a major determination as to whether or not a certain system would be selected, largely so focused on fit, implement ability, adoptability, raughty than feature and function. Those are tough.


    So U by my relatively simple way of looking at it, while I see certification as an objective measure of functional requirements, I recognize it will leverage powerful market forces on vendors, based on compliance, a number of mine are currently adding things they probably wouldn’t otherwise do if it weren’t for CCHIT, drives consistency standard, however, meaningful use is all about adoption, almost entirely qualitative measure, and that is dependent on things hard to certify, hard to achieve regardless of certification strategy, the ambulatory system that worked so well in one practice and so poorly in the one down the street. It’s the standard in my opinion that drives meaningful use, significant change, not certification. That’s an underpinning that’s important. My biggest concern is not letting the tail wag the dog. The dog is meaningful use, caring for patients, intelligent use of data and evidence-based medicine. The challenges, and what keeps me up at night, frankly, will the vendors’ focus on — over time I believe market factors will deal with poorly configured — but hospitals can’t afford the wrong choice. Before the market comes to bear on poorly architected solutions hospitals could spend a lot of time and money on poor choices. Timing concerns me immensely. Some of my largest vendors don’t intend to bring to release certified products until mid-2010. It’s going to be pretty difficult for us to implement those products and demonstrate meaningful use muse if we are already using — timing concerns me greatly. I support the notion of modularization of a certification process. At the end of the day the patient has to be the center of our universe. As they move within our enterprise, across the enterprises that represent the continuum of healthcare, will it do it at all? I am not so sure I have any real confidence at this point that it will. Ultimately my question is will it drive meaningful use or does it drive a baseline for functionality that offer assurances, but have little to do with meaningful use at this point.


    On the other hand, clearly focusing, this has come up a number of times, and focusing certification requirements in line with ARRA incentive payments can be vital. Clear requirements for true interoperability. So, to the example I heard someone use earlier today, last year I had to make the otherwise crazy decision to throw out one very expensive CCHIT hospital system because it couldn’t move data to another credit check hospital system. It wasn’t about will, those vendors tried like crazy, 15 months, major players in the market, and both very dear partners of mine. They work their tails off, it was about the architecture. A way to move that was sustainable, robust, safe. This interoperability thing is, to me, the single most important thing we can talk about. Again, timelines, they don’t interfere, certification timelines don’t interfere with the provider’s ability to achieve meanerringful use. As we develop time lines for vendor compliance, then the providers have enough time to implements and move into production. That same survey suggested for hospitals that know, implementing CPO oh, a minimum of three years are required, for those already in the middle of doing it. That’s from the moment they start. Assuming the systems are certified, installed, and implementation cycle ready to begin. I think that’s probably aggressive, too. I do. Remember, community hospitals, dealing with independent physicians, incentives, while generally aligned, aren’t the same.


    We have to work, do a lot of consensus building and a lot of time in the consensus building toward the adoption of technology like this, which is disruptive, and interferes with current practice cycles. We all agree it’s for the betterment of care, but it’s painful in the journey. The last thought I will leave you with, certified systems can — the possibility of success, real success is truly about the intangibles, and those are very difficult, impossible to certify. Thank you.


    Thank you. Stephanie


    First, I guess I would like to say thanks to all of you, not just for inviting us, but for the work you are doing, it’s terribly important. Thank you very much.


    We are big, complicated, took us more than three years to get in CP, oh. I am very proud to be in Hopkins, but every night I drive home, I have been beat up by the best of the best. Makes it worth it at the end of the day. Fun place to be, a lot of challenges and opportunities.


    One thing that, as we think about certification I guess the worry I have for us and for you is that we need to make sure we know what we are certifying, and it seems to me, no matter, you get off an airplane you hear the same challenges, issues. We are from different places, but dealing with the same challenges. I guess the important message hopefully, throughout the brief presentation, it’s more than technology, what we are really about, our mission, what makes us who we are, I think, keeps us honest, it’s more than health IT. It’s how we interact, make decisions, exploit the amazing talent of our care team, involve patients in the decisions as well. I hope we remember the reason we chose this profession is because we care about the people who are being served by our health centers and systems.


    I think meaningful use is a critical and important component, it involves all the things we do, the people with whom we interact to contribute to this lifecycle, and I hope we can remember to keep that in mind as we go through this, not just about the technology. One thing we learned on our journey, comes as no surprise, but takes program clinician leadership to manage the change process we need to embrace. Dr. Michael talked to you about how his practice is affected by our decisions. Paula’s hospitals as well. As we have a high degree of autonomy, collaboration, some consolidation to achieve what we are hoping to achieve, in fact until these systems are accepted, and later I will use the term infused into the culture, I don’t think we get the benefit at all. How you determine your mechanism for certifying for that will be a challenge.


    We have engaged our physicians in ways that have been incredibly meaningful to me and us, we have been able to embed clinical decision support because of the good work of our faculty. I would say to a lesser degree because of the good work of our vendor, although clearly that vendor and partner relationship that we do have has been critical to whatever success we have achieved. Again, remembering that this is about the patient and the patient’s family, the way we manage the delivery of care is what matters.


    As I think about the work we have done and the work you must do, how we measure whether or not we are making a difference, it really strikes me that we’ve missed something along the way about measuring what matters. I say that to my staff all the time, that back in the day we would measure how many minutes of downtime a system had in a month, or how many hits on a particular site, how fast the network was. But really, none of that matters so much. What matters is if we have a surgical site infection, a patient given a medication with which they had an allergy. If we aren’t measuring patient outcomes we are missing the point. To figure out how we figure out what we measure and continue to measure the impact of these information systems.


    In conversations with my staff any our financial systems, I say please don’t tell me how many days we were up or if the system can improve that, the challenge ahead for clinical collision support, comparative decision support. It isn’t what we have, it’s what we do with what we have that matters so much.


    All that having been said, your work is important, and the work of the certification organization is important. It will, we hope, stabilize the industry a bit, begin to help us understand how standards adoption can make a difference in interoperability. What Paula describes is true for all of us, two CCHIT systems don’t necessarily talk to each other, or at least not inexpensively. Can we make it happen, undoubtedly, at some cost. I would be embarrassed to tell you what we have spent to enable interoperability at Johnson interoperate Johns Hopkins.


    I think certification can help us focus. My concern is it my help us focus on things that will not promote the out comes we are all hoping to achieve, if our vendors are distracted, maybe it’s not a fair word. If they are distracted by certification, unable to innovate, we haven’t done a service to our patients and their families. Physicians run the risk of acquiring a system that cannot meet their expectations, but at this moment that doesn’t seem to be helping us realize that. With some clarity, I know you are hoping and soon to provide, I know this will get better.


    It also might level the playing field a bit. We may weed out some of the vendors who really aren’t able to meet the needs of an evolving healthcare system, particularly in the light of reform and may raise the bar. We will have to see if we can do that fairly in the environment in which we work.


    There are some risks, though, and I think we all have to recognize that certification could unfortunately introduce some further building on top of mediocrity, our industry is immature, the products are not yet what they should be. But if our vendors are so concerned of meeting the needs of a certification body, dedicated resources to certification rather than innovation, I think we have not done a service to patients and families, or providers either. I worry that things like usability, interoperatessability will become secondary to the concept of function and feature. That is a genuine worry.


    I also don’t want vendors to become completely risk-avoiding. This is an amazing country, and the reason we are such an amazing country, because we are willing to take risks, innovate. If we do such a job with certification that we eliminate that risk taking or innovation, because vendors can afford it, we will have done a great disservice, for many of them it’s any financial performance and how they play to the street. We need to be, I think, especially cautious about our use of scarce resources. It may also create barriers to entry in that — at the end of the day the market will prevail, but there will be a short-term cost that could be incredibly unfortunate if we are not careful.


    We can’t afford to do it twice. Many institutions in our case are getting by on small margins. Places like Johns Hopkins are blessed in multiple ways, but we can’t afford to use scarce capital in ways that are unwise either.


    I do hope we are careful. My humble advice to you who probably know much more about this than I do, be sure we don’t get caught up in these grand scale measures of certification, but that we focus on making incremental progress. Let’s focus on the basics at first. I think our vendors will differentiate themselves based on usability, quality, and the added committedment they make to the market, but I hope we don’t get so caught up in certification that we lose sight of why we are really here.


    I think we also need to figure out a way to ensure that technology is infused into our environment. It’s more than adoption. It’s really changing the way we deliver care, based on the use of information technology. It’s workforce development, as opposed to training, how technology improves the experience for both the care provider and for the patient at the sharp end of things.


    As you heard many speakers say already today, let’s measure performance, outcome, leverage the best practices that are in this wonderful country we all love and make sure we are using the best practices elsewhere, and sharing them collaboratively. I think there must be some way you can help us do that by building a system that allows for sharing and learning and leveraging of best practices with the use of information technology. We do it ourselves within the vendor supplied solutions we have, and I think more of that will only serve us better.


    I think our colleagues from NIST did a terrific job this morning explaining their role, and they have an important role to play in certification. One area where I think they could make a huge difference is in the area of privacy and security. We know we need their help. In this particular area I ask you to be sensitive to the fact that those of us who do research as part of our responsibilities, worry a great deal about limiting access to information in meaningful ways that could promote science in this country, which is another thing that makes us very special.


    Just a few more recommendations. I hope we focus on interoperability. I thought Dr. Stead’s comments were terrific this morning. It’s about data, data sharing, and many of you already agree. But ensuring data becomes reusable, data fluidity is the term used, I think, to free the data. We need a way to make sure we all have access to it. A lesson we have learned, it isn’t so were the functionality you get, but the flexibility that comes with functionality to be innovative, creative in what we do going forward. Keep your work open, welcome, encourage dissent. I think it’s important to hear from folks that may not agree with everything you have to say.


    In summary, I think it’s important to remember it isn’t about what you have, it’s about what you do with what you have. So help us understand ways we can prove it to you, or to CMS, that we are in fact using what we have incredibly well.


    Start with some of the basics, let’s get problems, allergies, immunizations shareable. If we can achieve that we will make a huge difference for patients and their families.


    Usability matters, let’s look at tools we have, and some of the other industries, ensure that in domains like ours, where life and death really do matter, let’s make sure we have tools that are useable. Maybe basically let’s create a channel where we can begin to share information, like building a real road, airports, let the market step up and do what it needs to do.


    I am reminded of something Arthur Ash seeds many years ago, suggestion was to achieve grateness, start where you are, use what you have and do what you can, that’s a responsibility we all have.


    It’s absolutely a pleasure to be able to be here, an honor to serve in any way I can. Thank you very much, I know we are all happy to answer questions interest participate in the discussion.


    Stephanie, Paula, Dr. Michael, thank you very much, terrific comments and we appreciate you taking your time to share some of this with us.


    We do want to go to questions. I think, thematically I heard, but I will ask the question. Assuming meaningful use will be defined here in the near future, and the standards are then defined to support that so we can get to some level of clarity, certification would become an assurance that meaningful use could be met — or certification could be that. If certification were an assurance that meaningful use could be met with the systems you purchased or deployed, or infused, is certification of value?


    It is. If it’s narrowly defined. We heard more comments. Defined along those meaningful use objectives, I think it is. One caution, I have seen a lot of printed claims about the certification status of various products. I don’t know if there’s any governance regarding future certified or specificity regarding certification representation in writing or verbally. I suggest that if it’s to be of value regarding achievement of meaningful use there has to be pretty tight rules about how products are referenced as being certified, to what standard, what portion of the products.


    Other thoughts?


    I think it’s critically important the vendor of the software tell the purchaser, okay, we’re CCHIT certified. Out of the box you will be able to use it, or you are going to have to spend a certain amount to make it operable that way. I use the analogy of PQRI and registry functions. That’s an important incentive, as is e-prescribing. We need to know as we make a purchase what the data interchange will cost us. A lot of us in practice were not used to looking at software specifications. We often find out the hard way, look a lot at how systems are working, functioning, but that certification, it’s imperative the certification process also certify to the purchaser what the implementation costs are going to be. It’s incredibly important thing to have, I am glad I went with CCHIT certified software vendor, it’s just the number of gotchas out there is pretty incredible for a small practice that’s invested 30,000 plus in just the software side of the thing.


    If it makes you feel better, it’s tough for the big guys too.


    I am reminded a little of the Joint Commission when they come visit every three years. They don’t much care what we have. They really do care a great deal about what we do with what we have, how we share information, how we ensure that every tidbit of detail is managed along the continuum of care. I think there’s value in certification, so long as we understand what it means. What it doesn’t mean. There is a role beyond certification, if we are going to be making investments in technology, organization like the Joint Commission will come in, take a look at how we are using tools. Understanding where the boundary is between the acquisition of a certified system, and the deployment of a useable solution. Questions? Steve?


    Thank you very much for your presentation. The last panel, Joe floated the notification of a two-tier, narrow, meaningful use, or more market based, functions — from a purchaser perspective, what would having two different certifications mean?


    From our perspective, we would do our own due diligence on the second level you describe. The first is consistent with what I was lobbying for a bit, to say there needs to be some fundamental, could be benefit from some level of fundamental certification at the federal level saying these systems meet the objective. As Mark said, it’s tough for the big guys to know what’s embedded in the application. The second level, voluntary part has value, undoubtedly. Those who can afford to do it will do a degree of due diligence on our own as well.


    I agree, for independent hospitals or physician practices, that second level might be a differentiator among those serving the markets. I agree, but I think for me and most of my colleagues that first one is the one most interested in, and I believe appropriate, given the focus of what the stimulus package is aiming us toward.


    The driving core functionality is imperative. I don’t make a statement on the optional, it’s too nebulous for me to get my hands around.


    Charles Kennedy. Thank you for coming and sharing expertise exper with us. My question is for Paula, you talked about two certifications, not a function of vendor cooperation, but technical. Can you expand on that a little bit. The second question, we heard Dr. Stead talk about the notion of liquidity, separating data from apps from decision support. Is that valuable in that particular challenge?


    I heard him say that, such a great term, I will take it back, credit him. It would have resolved the issues. This issue, two major players in the hospital vendor market, top tier vendors and top tier CCHIT certified products, but at the end of the day we couldn’t move, particularly meds related data, the core of what we need to move between systems and relates to patient safety. We couldn’t move those data between those systems in a way that was sustainable.


    Let me be clear. We could have, if we had spent another area and built an unbelievably hairy interface. It would have been horrific and expensive to — and frankly, dangerous. In that complexity is a built-in fragility. I wasn’t going to take the risk with my patient’s med-related data, for an interoperability concern. Architect, stored in the systems, in a way to move between the two products effectively.


    The other thing I would say — we talked quite a bit about interoperability, exchanges between providers. My circumstance was one provider, the challenge — between providers, still within the four walls of an individual hospital.


    A follow-up, say the comments you made about interoperability were all fascinating. Saying you couldn’t even get laboratory data, what’s the solution? Says in the PowerPoint slides we needs to do more, but can you be more specific? What do we need to do to fix this thing?


    Well, I will start quickly and let my colleagues take over. Again, data standards, standards are at the core of most of this. They truly are. Certification not withstanding, the standards by which data are shared, managed, stored, and identified. The Mechanisms by which patients are identified. We are out of thin air — far more important than certification. Certification has a very distinct role in the relatively narrow sub-set of the meaningful use definitions. I just — my fear is certification will become the tail wagging the dog, become more important than the underlying standards, which are really what are driving the problems. I would hate to see that happen. A focus on the raw standards by which data are stored, identified, and managed, is crucial to me. That drives interoperability. The patient process, I would love to see, true interoperability tested, demonstrable.


    To understand what you said, data standards, not talking about data exchange standards, but the standards about the data itself?


    Both.


    The laboratory results should look like — is that –


    Both. Really, ultimately about the movement of data, whatever needs to be done at the core level of structure needs to be identified as well. One reason, I share the same frustration as Dr. Michael, the ambulatory — you can pull reference data and hospital lab data, but we have a host of physician practices with individual machines in practice, don’t want to put whole laboratory information systems in place, no way to directly get those easily, no way to do it. Go into a lab system, a lot of overhead and expense for four machines in a two-person practice. As an example of where, same thing coming from other clinical modalities, patient monitors, other things, where the mechanism by which data are grabbed, identified, put into EHRs, populating EHRs is largely undefined.


    I would like to see it demonstrated that these are road-tested interoperability standards. They can go into an area, for example, with a data interchange. Vermont information technology is a data repository for about four different hospital laboratory systems right now. I need to have these organization come back and say we can take these data, populate your EMR on a very low-cost basis, without reinventing the wheel each and every time. I don’t know if that’s part of the mandate of CCHIT, but when I look at the big picture as to has 2 it all been worth it.


    In the prior discussion, one of the panelists suggested there be some sort of test harness that users could use to find out if their system works. Is that of value to you?


    Very definitely.


    The question isn’t whether small groups can use it, but solo practitioners have more practical experience than most of us –


    It’s easier to buy an equation, only convince one person.


    Steve — Stephanie, you made a statement that was fascinating, flexibility is probably more important than functionality. Can you spin that out a little, explain what you mean, and in my mind jumping ahead to how you measure that, identify it or certify it. Really try to get more detail on that.


    Not so sure it’s certifiable, although some of us will feel certifiable when we finish. I think it’s perhaps consistent with what Bill said this morning, that science is driverring the way we deliver care, for example diabetes used this morning, not two diseases, but four, or 24, and understanding the use of data.


    What I feel almost every day is that our systems are certainly capability of providing good functionality, but the science is driving us to think differently about the way care is delivered. Using example of more empowered patient, perhaps, the ability of a patient to contribute to a clinical repository is compelling, something I would like us to be more thoughtful about. I am sorry Dr. Hayman is not here, the great work he did was an example of empowering the patient through the use of a personal health record. I think our systems needs to be able to react, respond to those changes in a way not previously expected to do. Referring physicians may be another example. I would like for not just the attending physician to be instrumental in the use of tron health record, but the referring physician from the community the patient came, the family, to all participate in the aggregation of meaningful data, and in some cases the interpretation, verification of that data. The system, ones we deployed don’t seem to yet be able to respond. That missing elements of the empowered patient seem to be missing. That’s just one example. We talk about ingesting data from labs, values are different or analyzers have different criteria. I think having systems that can react to those changes is important.


    When I look at the Lance Armstrong Foundation, the great the oncologists are doing, being able to measure impact, the interventions, systems are not able to do it, at least not with the rapidity we need. We are up against some challenges that together we can solve if we take our time, focus on getting there. It’s a job.


    Thank you, I will follow-up. I heard in part there’s the notion of the applications being separate, flexible, but I heard flexibility in the data model itself, ability to incorporate different data types that may not [indiscernible]


    Correct. The architecture becomes the significant challenge with existing systems at least. They aren’t sufficient malyabl Maliable. The applications need to be flexible. If I might, I would say some of this could be funded more readily if we could also focus, not the purpose of this committee today, but focus on administrative — get that out of the way to focus on the things that do matter. That’s key to the way we are thinking about this.


    John?


    Yes, quick question, colleagues. The comments, couple of questions on the core meaningful use oriented certification which is pretty much “yes” or “no.” Also linked to the payment, notion of optional or on top of — features unrelated to me, do your own due diligence, but to assessment of — realizing the hard numbers, evaluation might be rough. You could come up with principles, things to look for, which are j. judgmental, would that — doesn’t preclude numbers. Would that assessment or judgment be useful? Different from feature/function under meaningful use?


    When you look at the class ratings as an example, there are always those data that are somewhat binary. There’s also a qualitative evaluation, insight as to product, market, I am not lobby for any particular — to say the system does or does not do the following, and in addition to that, some qualitative comments that the same certification groups could contribute that would be informative. How you do that without being pejorative I am not sure, but if there’s a way to be qualitative and objective at the same time I think there would be value. As a purchaser I would want to know what the certification group thinks about the flexibility, Mali ability components.


    I agree. If it’s something that can be identified, measured by a certification body, that would be very interesting, to have the second tier be more qualitative, focused, about data structure, architecture, usability.


    One thing I heard you talk about is problem of having a system in place, doesn’t meet the needs of another system, or system not quite right, didn’t install, few years later bought a new system, did install. Given core issues around data interoperability, what are your thoughts on we create this certification criteria, we can get great in-the-lab testing saying they can share information back and forth. Then we turn to you, providers, say it’s been done do it, you say haunt, I have an existing installed base. How are you thinking about addressing that?


    We were hoping you would address that.


    [Laughing]


    Excellent question. One of the speakers earlier today made the comment the same product deployed three or four places will have three or four entirely different outs comes, we have seen it among the people at this table. It’s a significant challenge. I don’t know. When you think about the RIO world, creation of extension centers mentioned in the high tech act. It’s an example of having some level of expertise that can ensure deployment is possible, but we are an immature industry, working in institutions that are dramatically different in the way they tackle these problems. I am I not sure.


    On behalf of the 3000 not for profit hospitals, this is the biggest concern they have, how to get from where they are to how to get to meaningful use without spending an incredible amount of money and still have the risk on the interoperability level. It’s the single biggest concern.


    For me it was imperative to get out from doing a quilt, patch work of different free independent softwares, looking more toward data integration. I am already doing chronic disease management database, involving a lot of extra steps for me and my staff. It was worth it for me to convert an entire EMR for one, manually key into another, just to have a common platform, database, one vendor, tightly integrated practice management schedule, clinical clin alert system. I think that having that common function in one desktop to look at in primary care is essentially –


    We pretty much managed to the time we had, I want to thank you all for being here, the great insight you brought to us. It’s clear certification isn’t going to guarantee success. But hopefully with what we are putting together, certification had help provide the value we need. Thank you to our panelists.


    [Applause ]


    We will move on to talk about –


    Can you, mark –


    Good afternoon, everyone we have a very press tiges panel. From CCHIT, the chair 3457B of the certification commit eye, Mark Leavitt. Bryan Klepper, healthcare analyst, to provide evaluation of strengths interest weaknesses of CCHIT. John Halamka, runs, the chair of HITSP, and Steven Waldron. Mark?


    Thank you very much. Let’s see if my slides are up. Great. Let me begin by offering my utmost ut congratulations. You have been given four days to do what I have been trying to do in four years. You have my ultimate sympathy. I would like to share where we are at. We haven’t solved all the problems, but have made a lot of progress. We hope you will be able to leverage that.


    To give you a quick overview for those not familiar with us. We are four years old, we were created as part of the strategic plan the first national coordinator created, David Baylor. And we are now a non-profit 501 C 3, to accelerate the adoption of health IT. The strengths of what we have done, and we will talk about the challenges in a moment. We actually, you are talking about it, but we have been doing it, for four years, developing criteria, basing them on standards. Every interoperability standard we can get our hand on we attempt to use. In many cases there is not one, but we drive [indiscernible] have a broad volume of stakeholders in the volunteers, and a development based process, such as NIST described earlier and come up with criteria. We have had very strong engagement, on a volunteer basis, the participants almost doubled in the past years. I will fly back Chicago, over 260 volunteers, we get twice as many apply as we can fit. There’s huge engagement. You don’t have to worry they are apathetic. They care very passionately.


    Very few people know, vendors know, but everyone else doesn’t. Our inspection process, firewalled off from the criteria development process, per formed by staff not allowed to have conflicts of interest with any vendor, even owning stock in vendors, demonstrated scalability, 45 apply in one month, got then through, handle the ups and downs of volume, never had the fairness of that question we used multiple — three juror panels, robust appeals process, retest process, been certifying for the past four years.


    If — one question I get, what’s been the real impact of certification. Ron Reagan asked if you are better off three years ago than now — the progress, the bill, EHR technology is in there, and the words certified before it, no other examples of certified EHR technology, we believe we added something to deliver on goals wanted. If you want to look at other factors besides Congress, the largest physician organization have endorsed the work, the American Academy of family physicians, American Heart Association association, American Association, even the AMA. They grumble when — have come onboard, usually the first year, all the areas we certified, we get half in the first year, and by the second 75%. 80% of the marketplace has become certified. Defining as we will in a moment and how that needs to change.


    change. That the certification might driveway out innovation, the facts don’t support it. 25% — last year 39% of the companies that came for certification were new.


    Perhaps paradoxically, certification has created a level playing field, they can compete with the big boys. The competence of payers, purchasers, recognized for purposes of the Stark safe harbor, health programs for EHRs, many require certification by CCHIT, practice discounts for having EHRs, and bridges to excellence use CCHIT certification.


    But, [indiscernible] changed everything. Before, certification was pretty much voluntary, you could come for the extra mark of approval. Rely on it if you need to, didn’t effect payment. With ARA, everyone with Medicare, Medicaid practices wants the incentive. That is one of the biggest drivers of change.


    Before we were only attempting to serve provider and hospitals who wanted extra assurance when investing in a new comprehensive EHR. That’s different now. Medicare, Medicaid providers at all stages of EHR adoption. Some have invested in pieces, modules, incremental steps, and they all the want to participate in AHR and — special attention to innovation, small practices that are capable of building stuff, assembling stuff themselves but are still struggling. The goal is to go beyond functionality, interoperability — we can’t ensure the practice or hospital is a champion site, we can make sure the software won’t be what holding them back.


    Let’s make that clear. We are not certifying the implementation, HHS rewards through the evidence of meaningful use. We are operating at the technology level. Saying this technology, for the sake of provider, can do what you want, not some fraudulent thing somebody through together to get the meaningful use money.


    As soon as the bill passed it became clear we needed a change, developed over the past month, presented in a series of town calls and other venues. We had a one-lane road, now we want a three-lane highway. Three paths to certification. EHR C, comhencive; modular, interest technology in place at a site or doctor’s office or hospital, that’s EHR S. All three qualify for ARA. The requirements are different. EHR-C looks like current program but because of separate integrity out from the basic program, M, we can step up as many here have suggested, measure, rate usability. We will require more than just the minimum. We will verify actual use at multiple sites in the types of ways required for meaningful use. We can make that deliver, rigorous certification, not everyone has to go that way.


    Vendors that can deliver that want to different themselves. EHR-M is not just for modules, but module certification, just the federal standards, it’s flexible. You can bring to us any prescribing system, registry system, patient engagement, physician/patient communication system, get verification for those meaningful use objectives, and we will specify which this system supports.


    Providers that want to integrate from multiple sources, don’t want to throw out what they have, can avail threms of those products.


    If the site wants to develop themselves, we will offer site certification. Because we won’t need to support as a commercial certification that’s protecting others, it can be very light weight, low cost, I will give you parameters here. The C program is like current, but more robust, will rate usability, require more live-site verification, interoperability testing, costing what it does now, 50 to 30,000 dollars. You need inspectors, need to maintain testing framework. These figures assume no federal support. Just being self-sustaining. The federal government decides this is an appropriate function to support it, the cost can be much lower.


    The M system would involve a demonstration, inspection of documentation, as well as technical interoperability testing, but going module by module, making sure it’s capable of supporting meaningful use. The lite version people are talking about, low as $5000, as much as 30, depending how many modules are being certified at once.


    In the HIE domain, we think it would be appropriate in this domain, if the system is supplied to federally qualified clin igs, serving under served populations, to decrease the cost of certification, make sure it doesn’t raise the price of products.


    The site, doctor’s office, small, large hospital, doesn’t have to be a single physical site, any system using the same — the road way for the next Thomas Edison, inventing EHR in their clinic, garage, not prevented for doing that, we can certify, whatever, if it’s on an iPhone, something we haven’t the seen before, they will have a route to certification, and will want to roll it out to others, get other types of certification. We can do this at low cost because we developed virtual inspection methodology, we have jurors watching demonstration by web conference, the tool is self-service until it’s time to do the test, we witness it. We can take the cost lower because we won’t have to have the juror online. You can capture, get the cost down, review offline, makes it very cost effective, fraction of a percent of the insensitives they would be receiving for clinic.


    Certified products can go any way they want. We think they will want C, existing criteria EHRs can fit in — don’t do everything in a comprehensive system, small Avs, light weight, the route a. HIEs, this is interesting, may start delivering EHR and PH R functionality. The M program lets them do that, get certified. Unconventional source, it can fit in the program.


    We are making one other change to accommodate open-source better, doing version lock-down, certify a version, then verify its use, vendor has to notify of change. If there’s a major change we have to re-test, vendors aren’t taking functionality identity. We believe we can allow future versions to inherit the certification, that removes a major objection of open-sources, the product depends on the fact it’s being developed, changed, strawnchest critsics, CMS program, turned around, think this can solve the problem, interested in details. You will hear from Ed billings, let me finish up with a couple of things. I want to emphasize, we are not certifying meaningful use, worried, how you do it, we are not doing that. We are certifying the technology. HHS is requiring meaningful use, send something to HHS, intermediary, report file to qualify, not going through us. We will given vendors a code, when certified, give the M vendors codes, and sites codes when they submit application and that proves they have a certified product.


    When we announce this new concept we had two town halls, had about 400 on each call. We were able to use real-time polling technology. Those colors don’t show up very well. 20% are very favorable, 51% are, 21% neutral, unfavorable are 1 1 percent. That pointed out when we look at the controversies, criticisms, the volume of the community representative, not proportion to volume of noise.


    I need to keep that in mind, when you are trying to do the greatest good for the greatest number of people you can’t let a small but well-spoken minority deny them progress or benefit. That’s what we have seen o. we think timing is of the essence, we need products on the street this fall. The latest people could start to buy, adopt, implement, have meaningful use by twents 2011. We will launch a program this fall, based on what you are — implement in January after HHS implemented interim final rule. That would be valid 2012 and in future years, we can talk about later, it’s a two-year timing model to match your model. I look forward to your questions, will turn it over to Bryan.


    I didn’t A announce, but we want time for questions,


    – I will be brief. A little about my backgrounds, probably the only person who will present today who is not a technology first. I am a healthcare analyst. I advise a lot of very large companies, starts-ups as well, in technology and other sectors of healthcare. I run an on-site indigent care company that offers home grown EHRs, clinical group ware technology to run those clinics, very comprehensive. While I have a big interest in this area, this is not my primary area, I am not as deep into it as everybody else here is.


    When I was asked to present, I wanted to present the most obvious issues that made sense. So with that, the principles, should represent the public rather than special interests. It’s clear that CCHIT is compromised in that way, it projects special interest conflict, the executive director came from hims, the chairman of the board is president of hims and is dominated by a vendor mentality.


    I only got here just before lunch, but the testimony I heard since I arrived is all about how we’re still in this place where we do not yet have interoperability. The place I work is about power and money. I think these are expressions of how corporations exert their influence in the marketplace. If we still do not have interoperability in this day and age after all of these efforts, it says something about who is controlling the process.


    The second principle is that we should have broadly aligned HIT policy that supports the larger reform goals, the rapid distribution of technology, usability of technology, and lower cost all through innovation. Currently, in the physician practice EHR space, CCHIT has focused on features and functions, rather than on standards, security, th