Overview of CCHIT
Jon White, M.D.
10/7/2008

Slide: 1
So, this is, kind of, bureaucratic version of send in the clowns. So, my name is Jon and I am a doctor… mimes later. Thank you for coming and listening to us today, I am always amazed when people turn out to come talk about standards but when I started doing this job in AHRQ, I got the mego, my eyes glaze over when everybody starting talk about standards. But I have come to appreciate that in order to live up to the world of what we want help IT to do, somebody said you got to have the plumbing underneath it to do it. Now, we do have other names for turn you beside plumber. I cannot share this. So, my collaboration with Tony and Tracy and their colleagues at CMS has been a lot of fun for me because we don’t regulate things at AHRQ. This is one of the things we don’t do. We inform policy and we do that by generating evidence. So, our role has been to be, kind of, a science partner, I think. Tell you probably have others names that he call us we don’t know but to be a science partner with CMS, it help provide some good robust testing for the standards that they are now requiring everybody views. We are going to talk about certification. Today, I live in a couple of alternate realities, I think it is how I described it earlier today, whether it is my role as the portfolio director or whether it is working with CMS. I am also an ex-officio commissioner for the Certification Commission for Heath IT which means that I don’t vote but I participate in discussions as a federal representative. So, we are going to talk about certification today not because it’s how you get your incentive payment necessarily but it is how the prescriber knows that they are using a system that is meeting the standards or using the standards that CMS is requiring or at least we think that is the way it is gonna be. Without having to actually look at the transactions and results and say yep you are are right. How many of you are prescribers, here in the audience, raise you hand. Okay, you care about this somewhat. How many of you are vendors of e-prescribing applications. Okay, you guys really care about this part because this is this surfing us to stand up to.

Slide: 2
I am going to try to go through the slides quickly. I think that you are free to read them at your leisure but I don’t think they bottom line is what you want to see at the end.

Slide: 3
So, the certification commission has a theologically correct mission and goals that we can all probably agree to reduce risk, facilitate interoperability, and things like that and that sounds great.

Slide: 4
The organization has been around for about four years now. The only thing that I am going to point out here is that a year after the founding of the Certification Commission, they were awarded a three-year contract through the Office of the National Coordinator for health IT. So I mentioned Dr. Brailer who talked about that earlier today, I am not going to go and add it length but the main thing for you take away is that there is a length to Federal Programs and federal interest in incenting adoption of health IT.

Slide: 5
So, strategically what does that mean.

Slide: 6
CCHIT is at the center of standards and certification

This is a really busy diagram what you want to get out of it that CCHIT is at the middle of it, okay. There is standards work, there is prototyping, there is privacy policies, and there is AHIC, some stuff like that and ultimately in theory strategically all this goes to CCHIT. That is how things get embodied in the products that get used under the world of clinical care. So, whether it is e-prescribing standards or whether it is particular type of architecture for national health information network or whether it is privacy policies or things like that. What is in vision is that certification is the way that that becomes manifest and that when a product has a CCHIT good housekeeping sealed approval that it meets those principals and standards.

Slide: 7
And the organization is backed up by a number of professional societies. One of these is my professions society AAFP. The point is that we as providers, our professional societies are behind this group and to a degree there is some impact. You see the numbers here, the bottom number, I think, it is actually probably a little low, it was from March of 2007 and my guess is that since there has been a lot of talk around incentives involving certified products that number has probably gone up.

Slide: 8
And speaking of incentives, public and private sectors displayed for you here. The only thing I think I would point out to you is that Mark Leavitt who is the director for CCHIT said that he thinks that this slide is out of date, I won’t say the number but 150 millions is what is up here. He said it was multiples of that and then when if you add Mepo on top of it, you probably do not know the order of magnitude either. So, incentives that are tied to certified EHRs are out there. Actually, I will call when thing out, the viability insurance. I don’t know if any of you have paid attention to this but this actually came to light several months ago, that is kind of neat. Suddenly, there are viability insurers who will give you a discount if you are using certified EHR, I thought that was kind of interesting.

Slide: 9
Mom and apple pie, the foundations of credibility, I am not going to get into but the bottom line down here is what you see at the bottom. ‘CCHIT’s most important asset is the trust of its stakeholders’. If people who are buying EHRs who at this point are providers, right, these are hospitals and these are doctors and we are the ones who are kind of bleeding out money over these products. It is that if we don’t think CCHIT certification is important then it is not, as I said John and we said this morning, it is like trust in the financial markets; if it is not there, it is not there.

Slide: 10
Overview of the 2009 development process

There is a development process for certification criteria. It changes every year. In theory, it becomes more stringent as time goes by. The 2 things I would probably point out to you is that: #1. It is almost a year long process and once they get certification criteria, those are the criteria that products certify to, okay and they go through jury testing and things like that. What I point out to you is that there are 3 public comment periods, the folks who developed the certification criteria are volunteers for the most part and there is 10s and 1000s of ours that are important to development of these criteria but importantly they don’t go into a lock room and they come out with them. They have at least 3 times when people can comment that doesn’t mean that they are going to listen to you, first you get a chance to say which is we know, kind of, important and plus there is some pilot testing that goes along with this.

Slide: 11
So, now to the meat of e-prescribing. If you have a CCHIT certified EHR right now you can e-prescribe because that is a requirement in the current certification criteria that your EHR has e-prescribing capability. What is not in there right now are the initial standards that Tony just laid out for you because we didn’t lay them out until April 2008 and there hasn’t been time for them to be incorporated in certification criteria. Now, I can’t speak to you what happens at the end because it is the product of these work groups but I would be very surprised if the standards weren’t incorporated into certification for future years but what they haven’t done until this point is certify stand-alone e-prescribing applications and the big news is that at this September 23 2008 commissioners’ meeting the group were that that is what CCHIT should do, that in addition to certifying e-prescribing in robust EHRs that they certify stand-alone e-prescribing applications. I think that is reflective of the reality that not everybody has a full blown EMR and that folks are going to want to use stand-alone solutions for this. We hope that eventually we do go to EMRs for reasons that we can discuss but that is the plan. They are going to pull from the current criteria along the lines of functionality and interoperability and security. In addition, they are going to focus on patient safety, interoperability, and efficiency. I said this morning too that when we talk about patient safety and efficiency and inoperability, that sounds great; when you get down into the details of it, it gets a little bit cloudy but that is what they are aiming for. I am going to include the public comment and the pilot testing that I mentioned. The certification will be open with criteria beginning in July 2009. Products will begin being certified then having that good housekeeping seal of approval in around 90 days after that. So, three months after July 2009 is when the stand-alone products will have that seal of approval and then it will revolve through the year. Folks don’t have to come in at one given time in order to get certified. And again I just want to reinforce, this is not how you get your incentive payment by using a certified product at this point, okay. Once the criteria incorporate the standards that we have talked about today that is when you know that the product that you are using meets those standards. There will be guidance coming about that at some point in the near future. So that is the end of our discussion about certification.

Slide: 12
And let’s get to questions answers. Thank you to our panelists. If you folks do have questions, please step up to the microphone. As I said the session is being taped and we need to use that for the recording. And not be rude, if you could identify who you are and where your from that would be great. And what your agenda is. That will come after the questions. Yes, ma'am.My name is Ester Shelpra and I just finished a fellowship at Harvard Med School in medical informatics but I am coming in from the computer science side, so I am into standard but this actually doesn’t have anything to do with standards, but you asked what my agenda is and that is my agenda but I just heard a talk from the pharmacist point of view and the guy from Ox Nord pharmacy in Rhode Island, David Finney. You know, it has got him so much financial benefit which, you know, I want to know. He has gotten so much financial benefit from having this and so in that circle of stuff, I didn’t see any monitoring incentive to the pharmacies to get them going and I just want to know if that is something you have considered and rejected and if you have rejected it, why?As I mentioned we have set in some regulatory guidance that we recommend that the part D Sponsors who are the only entities that we have control over. We don’t regulate pharmacies. Congress created the incentive fee out of part B and stipulated, you know, more or less how that would work and given too many regulations are coming out but we had no statutory direction for anybody to put money in that direction but we did suggest them some regulatory guidance that have appropriate way to align incentives, particularly for those pharmacies who see this as a barrier would be for the part D plans to negotiate differential dispensing fees out of the part D problem which would be considered administrative cost in the bids and born, therefore, subsided by the federal government. The biggest issue is the independent pharmacies. I am just editorialize on that, I think the original 2003 law we didn’t prescribe what any dispensing issues were and then in the 2008 law, the instead of payment is to the physician directly again not to the pharmacy and that is a negotiation between the plan sponsor and the pharmacies, so that is going to be worked out in dispensing fees not specific to the stature. We are going to alternate between the front and the back.Tony, John Poiqunan from UMass Memorial Medical Center. On your third slide you mentioned under the definition of e-prescribing that there is no manual transcription on either end. That the strict definition is very little e-prescribing going on?We didn’t say it is not part of e-prescribing, he said it does not require. We didn’t say it doesn’t have manual or doesn’t require manual transcription at either end.Then in order for full semantic interoperability, we need a standard for drugs, nomenclature, and the sig standard. So, where does that currently stand and second of all, in sort of somewhat follow up questions, will CCHIT look at the receiving systems and give the good housekeeping stamp of approval on the pharmacy side or is it only the physician side?I will let my colleague answer the second question. The first questions I point out in one of the later slides is we are conducting or about to conduct a pilot with the Ran corporation to test classify sig and the Rx norm and we are hoping after those pilot tests are done we will be able to move towards the standards through regulation phase but that will probably at least another year. We will have to see how the pilot testing goes. Once again when we tested them in 2006, we did not do a lot of live testing in certain cases. We also had to get back to National Library of Medicine to get some additional changes with the Rx norms. So, we think we are now at the point where both of them can be tested and hopefully that move to the next space for adoption. Just briefly, there is no plans that I am aware of to certify pharmacy systems, that is kind of a whole different world that the pharmacy know that. Just because there are no plans, it doesn’t mean that so I about it but I shall be surprised they have got their hands off before it right now what they have got so that is commentary. Well let me add my commentary. It takes two to tango, so I mean I would encourage please see through it and look at that and I am very excited about the Rx norm initiative. My commentary is that it seems to me that the perfect is getting in the way of the good and I am excited that things are on their way and look forward to that. Yeah, well you may be correct in that regard but that is not what we heard from the industry experts. We draw together after the pilot test and they felt it needed more work.I am John Milstein from Marshall Clinic, Marshall Wisconsin. A couple of assumptions and if any of these assumptions are incorrect, please let me know. Well, I guess I have revealed my agenda. We have an electronic prescribing system as part of our homegrown EHR but we are different because we don’t have a vendor, we kind of do it ourselves, so we have kind of unique circumstances. We generate about 1.7 million electronic prescriptions and are in the final phases of moving out a pilot for electronic transmission of them but there are a lot of other hurdles we have to get over. One, if I understands correctly, our billing system needs to be modified by January 1, 2009, so that each encounter has the appropriate G code on it, is that true?That information will come out in the mid that comes out in NovemberOkay, it is a big change that you have to change the billing system for near 1.2 million encounters a year?As I said, we are not the people here implementing that rule.And the others are sort of related. We have a lot of the features like drug-drug interaction and drug-allergy interaction and so forth but some are in planning. So, we are also stuck with the question of whose certification and when do we know that we have passed that certification and also practical issues like certification and pilot versus certification and production, all of these kinds of issues are very real issues when you are under a deadline of January 1?The one thing I would reflect back to you and I am very familiar with Marshall, great guy, great organization and you have done wonderful things with your information tools and systems, by the way. At this point, certification is not, as I said, directly tied to either enforcement and requirements anything like that. I think it is meant to facilitate the translation, really. All of these standards and all these requirements into, I don’t need to know all this here, just tell me whether it works or not. For your purposes, for the purpose of an organization that has got a home grown system and a lot of staff, they are devoted to keeping that system running. You and the folks who run the system need to know that their standards are being used and they are being used correctly, and they communicate with the pharmacies and the community, they communicate with the DVMs who are responsible under MMA for making that happen. So, you wouldn’t necessarily have to have CCHIT certification in order to be able to participate here.When you do have CCHIT certification, but my question is, is that good enough and the answer I am getting is, we don’t know. We do have it and we are working now on the most recent versions and we intent to meet those as well but right now as you pointed out CCHIT has not finalized its e-prescribing standards and won’t do so until some time next year. Well, that puts us in a bind of January 1st is our deadline as to who is going to say. Now my other assumption is that the incentive payments will occur in 2010 for the previous year, is that correct?Yeah at the end of the year, right they come out at the end of the year.Albright, so the answer is unclear. Yeah, or not to be determined but may be there is. I mean if CCHIT isn’t the determining factor compliance with the existing 2009 part D standards is.So, this is a great question that actually came up in the talk earlier today. how does somebody know if you are not using the standards and the answer that Craig gave and now you can tell me if this is different and it is not different for these standards and the other standards is CMS doesn’t actively go out and audit but if they get complaints that somebody is not using the standards, they go and check it out and then there is a range of peerative actions to the actions with increasing severity that they can take if they don’t fix things?That would be true for a requirement on part D sponsor. So, whether or not a physical is using system that is certified or not certified wouldn’t fall under particular answer. I think the only ones that in term whether of course the HIPPA standards part of the HIPPA enforcement but the e-prescribing would have to be under the contracts of the plans.So that make sense that the enforcement of the standards for the doctors and their offices would cascade out of your contracts up with the plans?Right, because we don’t directly contract. We contract with the plans that would be a better contract with you. Or if the question is about is the physician system meeting the qualifications that are the prerequisite for getting the incentives then I am not quite sure that particular answer doesn’t answer that questions and I don’t know, have you attended the implementing the e-prescribing the basic session because that’s were the folks that are doing that part of the rule or talking about the incentive and that would be a better place to possibly ask that question. But the system certification may question here and I don’t know if I have heard a good answer.No that in the take for certifications, it is not there right now and it is not gonna be there for probably at least a year but that for the future it is anticipated avenue that it is there.I am Debra Kelley from Hospice of the Bluegrass in Kentucky, this is my question. For our hospice patients the hospice pays for the medications related to the terminal diagnosis and the way I am under the physicians will receive their incentive payment based on going through Medicare part D, these prescriptions will not go through Medicare part D. What is the vehicle or way for the e-prescribing note to be given credit for hospice patient, so that physicians can be reimbursed?Again, I think that is the question for the incentive payment. We are basically talking about standards and certification. You would have to go and talk to the incentives people. There are people here, if you can give me your e-mail information. Anybody here needs further information, we can get you in contact with the right people but some of this also these final rules are still in a clearance process as well. So, there may not be a whole lot more that they can tell you at this point as well but we will try to do what we can to answer your questions. They would have to hear the question.Alright, if you could me that information afterwards I would appreciate it.It is just important to keep in mind that the incentives payments are tied to the part B payments and not part D standards.Michael Milan, Script Medics Med scribbler EHR and Rx scribbler e-prescribing. I am sourly tempted here to advance my agenda and I am going to try in frame so my agenda CCHIT certification there there are 450 EMRs out there. This year you have only got a dozen who are certifying under the 2008 standard, unless that price goes down you aren’t really going to have credibility until that price comes down. Now, I hope that for e-prescribing standard that it is free because you are not going to get the credibility in the general market unless you do that. Vendors are just not going to bite, otherwise. That’s my agenda and my question is about we have seen that their standards and regulations for the pharmacist and for the providers but for a developer of a software there is a problem that is difficult for me to overcome and that is there doesn’t seem to be and the standards for the formularies. There is nothing out there. It is a requirement that I have this formulary eligibility and alternatives and all of that but there is no way in the dogs breakfast that I can form of prove that. The question is are we working on standards for the plans because without it you are gonna have SureScripts and you are gonna have the guys down e-power, whatever it is, down in Florida and as it stands now I am looking at middle six and upper six figures in order to get that kind of function in an e-prescribing program and then I won’t be able to spend on CCHIT?The part D plans are required to comply with the additional standards as of April 1, 2009 which includes the formulary and benefit standards. So as of April 1st, they are required to respond to request from point of care vendors and intermediaries for those files.Where do I get those standards then so that this is my other comment is very difficult finding where all of these standards are. They are on different web sites or the formularies?We can send you the link. We do have it on our CMS web site that we can send you the link. Its an NCPTP standard, formulary and benefit standard. Say, if you are a member of NCPTP then you have access to all of their standards as well as to their development.Now does that standard say that they have to publish in a certain format what their formulary is?Its not publishing, it’s responding to the request of a software.You are talking about 2 things. There are 2 different things. The one that we are talking about is Tracy McCutcheon comes into my office and send Edna request that says is this on formulary or not? What you are asking is which I would love to have as a family doctor is somebody comes in and they are from Edna and I can see everything that is on it and its formulary for Tracy McCutcheon?That’s one part of it. That eligibility certainly to find that out or to respond to that through an EDI to wherever can happen but for an e-prescribing program I really should be building that into my e-prescribing program and do quarterly updates or something so that it is much more manageable. I have several costumers that are now driving around in their cars. They don’t actually have an office any longer and they are running on broadband access. If I have to have them connect up for all of these things here it is gonna slow down the whole system. So, I am trying to build as much of this into what they are carrying around with them as what I can. So, the EDI part of it, if there is that standard I am happy to hear about that but really taking the formularies that are published by the plans and being able to integrate them into an EMR or any kind of system it is really difficult. CMS produces a public views file with the formularies in our format. It is not related to the format of the transaction and those are available for nominal cost from CMS. I forgot whether they are updated a month later or quarter later, whatever.These are for the 4,500 plans, it is all one file?Oh, that’s excellent.Tracy how can you get a copy of that?I will find out the URL for you.Claudia Shwasberg, I direct policy for the American Society of Consultant Pharmacist. I am trying to remember what my agenda is. I hope I can say this simply, the American Society of Consultant Pharmacist represents pharmacists who specialize in geriatric care and lot of our members working long term care either as consultant pharmacist or as dispensing pharmacist and as you know long term care is exempt from the standards. Now the industry at February both put the providers and the pharmacies and asked NCBHS to make recommendation to secretary Leavitt, to lift the exemption and in fact NCBHS did make that request, I think it was back in May but I am told that we are may be quite a ways away from that happening and my agenda quite frankly is to advocate and ask CMS and AHRQ and the secretary to reconsider that and move that agenda forward because the exemption is itself becoming an impediment to adoption within the industry. I am looking at the slides, Jon, that you had and the work group for CCHIT certification is you know, we are looking at 2010. I don’t know I am not quite sure what the little patch marks are around the box but it is pushing everything off into the future and this is an industry that is ready to move forward. Downstairs, I was told in another session that the reason for this and why the exemption is there and it has to stay there is that we still have to pilot test the standards. Well, we have had one pilot test for long term care standards and as I listen to the discussions here and in the other workgroups and at lunch and at the plantares, its already clear that in all of this we are still pilot testing many of the standards for the rest of the health care industry yet the exemption does not apply to them. So, given that we are sort of making the road as we go for everyone, why is it necessary to continue to exempt the long term care industry which has requested that this exemption be lifted. Again, our prescribers and their patients, many of them flow through the healthcare system. They are in the community, they are hospitalized, they are in the long term care setting, and they are back in the community. These are dynamic situations. Prescribers if they are going to adopt e-prescribing they need to be able to do it for their patients, wherever the care setting is and we are also concerned that with this incentive payments that we are leaving out people who have significant geriatric practices where their patients are gonna be in the long term care settings, so that is my agenda. I hope you can answer the question?Well we agree with your agenda. We recognize the need to lift that exemption and recognize the fact that as I mention the 10.5 is available and has been balloted now. I believe that we will move towards adopting that in the near future. We have a number of standards and activities going on and I am not trying to put you off that we are nearing the end of the administration where the Well yes and no. The no aspect of it is the fact that when you get to the end of the administration there is a bunch of standards and other regulation activity that people are trying to get through before the end of the administration. So, it is a tough thing to do at that point. So, it won’t get done under the administration. We hope to get it done as quickly as possible in the next year or so but I can’t give an exact date at this point but it is a priority for us to move towards that because we recognize it that it is ready to be lifted. The only other observation I make. You mention that there is talking about a lot of things are going on right now. You have all heard of that. CCHIT I would encourage you to look at, if you are an insomniac one night and needs something to help, look at the actual certification criteria. Very few standards are actually identified there. Right now, they are mostly functionality. They have been waiting for it and to kind of come out with the standards so then they can incorporate it in. So, I am with you. There is a lot of stuff going on and I am also with them. They are moving as fast as they can .... We want to thank our audience and thank you to our panel.