Day 2 – TRANSCRIPT Adoption/Certification Workgroup

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:

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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.


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