American Health Information Community
Personalized Health Care Workgroup #18
Tuesday, October 14, 2008
Disclaimer
The views expressed in written conference materials or publications and by speakers and moderators at HHS-sponsored conferences do not necessarily reflect the official policies of HHS; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.
>> Alison Gary:
Okay, Judy, you’re all set.
>> Judy Sparrow:
Thank you, Alison. And good afternoon and welcome, everybody, to the 18th meeting of the Personalized Health Care Workgroup. Just a reminder: This is a Federal Advisory Committee, which means it is being broadcast over the Internet, and there will be an opportunity at the close of the meeting for the public to make comments. Workgroup members on the telephone, please remember to mute your telephone lines when you’re not speaking and to identify yourselves as you begin to speak.
On the phone today, we have Doug Henley, Cochair from the American Academy of Family Physicians; Paul Cusenza; Allen Rudman from FDA; Amy McGuire from the Baylor College of Medicine; Steve Teutsch from Merck; Andy Wiesenthal from Permanente; Grant Wood from Intermountain; Katherine Color from CDC; Michele LloydPuryear from HRSA; Elizabeth Mansfield, also from FDA; and Ronald Przygodzki from Veterans Affairs. And here in the room, we have...
>> Laura Miller:
Laura Miller from AHIC Successor.
>> :
(Inaudible)
>> :
(Inaudible)
>> Chuck Friedman:
Chuck Friedman from ONC.
>> Greg Downing:
This is Greg Downing. Thank you for joining.
>> Judy Sparrow:
And Marc Williams from Intermountain has also just joined. And did I leave anybody absent?
>> Allen Zuckerman:
Yes. Allen Zuckerman has also joined.
>> Judy Sparrow:
Okay. Thank you. And with that, I’ll turn it over to Dr.Henley.
>> Doug Henley:
Thanks, Judy. And welcome, everyone, to our what will be our last meeting of the Personalized Health Care Workgroup. More about that later. Apologies to my Cochair, John Glaser. John had to have some urgent budgetary discussions within his health care enterprise, given the events of the last couple of weeks. So he will join us probably in about an hour to finish the conversation. So we will delay shortly his discussion update regarding the AHIC Successor and get to that a bit later in the agenda before we adjourn.
So with that said, let me turn to the first item of on the agenda about approval of our meeting summary from our last meeting of July the11th and see if there are any comments from the Workgroup members about additions, deletions, or edits to that summary. (Pause) All right, and hearing none, we will consider those approved.
As I mentioned earlier, we’ll skip the presentation right now from John regarding the AHIC Successor organization as a whole, but rather go into the discussion next about transition of the activities of this Workgroup and how that will, again, transition over to the AHIC Successor. So let me ask Laura Miller and Mary Jo Deering for their presentation regarding those activities. And I believe that you have a slide presentation.
>> Laura Miller:
Doug, hi, this is Laura Miller. I did talk with John Glaser earlier and am happy to give an update on AHIC Successor organizational activities as the Interim Executive Director.
>> Doug Henley:
Okay, that yeah, that’d be fine, Laura.
>> Laura Miller:
So let me start by just reminding everyone that AHIC Successor was incorporated in the State of Delaware on July the12th with three incorporators, who are John Glaser, John Tooker, and John Perlin. And since that period of time, we’ve been working hard to develop the infrastructure so we can move forward with the real work of the organization.
And, the first step of that activity was the assignment and the appointment nomination and appointment of the board of directors, which has occurred. The board of directors were announced at the last American Health Information Community meeting. And at the current time, the plan is for the board to meet for its first meeting on November the13th. And in addition to the 15 board members that were announced at that point in time, there are the three incorporators, who will be serving for 1 year; and then there is the announcement with the announcement by Secretary Leavitt of the three federal liaisons. The federal liaisons are very critical to the work of the organization. They are entitled “federal liaisons” because they are prohibited by law from having a respo fiduciary responsibility to the board. But by virtue of their names, you can tell they’re going to have significant input. And those that were named by Secretary Leavitt were himself, Secretary Peake from the Department of Veterans Affairs, and Dr.Kolodner from ONC.
At the current time, we’re developing a set of bylaws. The bylaws are now on the AHIC Successor Web site for public comment. So we invite any of you who are listening to go onto the Web site and review the bylaws and give us your thoughts and comments for consideration by the board at its first meeting. In the bylaws, you will see that there are four standing committees. However, there are many more opportunities for involvement as we move forward than the four I would call them organizational committees, which are typical of the corporation, the finance committee, the nomination and governance committee, the membership committee, and the executive committee.
One of the major activities that the board will be engaging in, in its first meeting, will be the strategic planning process. By virtue of the grant that AHIC Successor has received the cooperative agreement with HHS, we will need to have developed our strategic plan by the end of December. And so, there are various major elements to that strategic plan, one of which will be consideration of the recommendations that Mary Jo will present shortly that come from ONC. Secondly will be a consideration of a process for prioritizing enforcing value cases from a broader forum and then also the development of our membership plan and our outreach plan.
In our meetings with Secretary Leavitt, he has advised that we should plan on a mechanism to be sustaining ourselves within a 3year period. And so, membership will be an important component of the ongoing sustainment capability of AHIC Successor.
As I mentioned, the next meeting the first meeting of the board is November13. And then there will be several meetings beyond that on about a monthly basis, as we have a lot of work to get up and running and to move forward with all of the work that is has been in process and is pending.
One other comment I want to make and then I’ll wind up and that is that we have started the process of the solicitation and recruitment of a CEO. There is a statement of the responsibilities and requirements for a CEO that is on our Web site. There is a point of contact, should anyone care to submit a resume or a name. We hope to move through this process as rapidly as possible and get a nationally recognized individual on board as our CEO sometime in January. And with that, unless there are other questions or comments, Doug, I’ll end up.
>> Doug Henley:
All right, thank you very much, Laura. And any questions from the Workgroup members to Laura relative to the AHIC Successor update? (Pause) Okay. Hearing none, thank you, Laura, for going in and doing that in John’s absence, and we’ll see if John has any additional comments to make later on. Let’s then go into the transition of our activities to the AHIC Successor. And Laura, back to you and to Mary Jo.
>> Laura Miller:
And I’m going to defer to Mary Jo, because this is truly an ONC initiative.
>> Doug Henley:
Thanks.
>> Mary Jo Deering:
Okay. Thank you very much. Is someone able to getthe will the slides be presented? There we go. Thanks (inaudible). Thank you so much. Well, I don’t know if I’ve been introduced to you all before. I am here on detail, taking over Kelly’s responsibilities while she’s on maternity leave, only for this the issue of setting up A2 in the transition from A1 to A2. And then I will return to my home at the National Cancer Institute, where I work on the CAB initiative. And so, because of where I was at your Workgroup, I will say on a personal note that it’s been of great interest to me all along. And I did sort of kick us in a little bit on your family health history activities from time to time. Again, I just am very interested in a lot of the work that you’re doing, and I welcome the chance now to be here in this capacity.
So what I’m going to present to you now is the what you’re going to see is still in draft, but they’re coming close to the final for this how ONC itself is pulling together some priority recommendations for transitioning the work of the workgroups over to the AHIC Successor. And what we will be giving to the to A2 or, as we’re now calling it, the AHIC Successor, Inc. or ASI A2 has a little more caché to it, I think, for us in the informatics world. But we will be giving them a prioritized list of activities for Year 1, which I emphasize are a very a much shorter list of activities that are couched at a higher crosscutting level than some of the more detailed workgroupbyworkgroup-level recommendations that have emerged in the workgroups. We will be giving them a fuller list of transition activities, which would include those that could be carried forward by A2 with or without other entities, or sometimes only by those other entities, such as the Federal Government or a backup.
We have drafted a possible transition approach for the first 3 months of operations I’m going to be sharing with you, and a sample organizational model that they could consider using as they advance these activities, and even a sample staffing and level of effort. And so, I’m glad Laura is here. She’s a little bit familiar with some of these, but they have not been formally and officially presented through A2 yet. The next slide, please. (Pause) Next slide. Who’s...? There we go.
What I wanted to emphasize is that the emphasis here is not on transitioning the workgroups as workgroups. The Secretary was very clear, when he spoke to the incorporators in September, that he was not expecting them to take on all of the workgroups and to just simply pick up and carry forward the work exactly as it had been done in the original AHIC. So what we are trying to do is look at the synergies of the recommendations that emerged from the workgroups and see how there might be some overlap some duplications where the type of work was very similar. You just had a different domain name attached to that functional piece of work that was being recommended. And we thought it was especially important to focus on what we’re calling sort of the intellectual capital of the workgroups. You know, it’s the energy and engagement of the workgroup participants. We think that will be as valuable to ASI as any of the recommendations about the substance.
Now, let me tell you that the report that ONC is preparing and that I’m here talking to you about today is just one of several types of input that the ASI will have at its disposal when it considers how it wants to move forward. I think most of you are aware that one of the four transition workgroups was one specifically on the you know, looking at the workgroup transition process. And it has indeed submitted a report looking at things that should be carried forward. That was at a fairly high level. It really was almost a conceptual a nice piece of analysis of what might be carried forward. Anyway, that certainly is available to the Successor.
And equally important, for any workgroup that has actually prepared a detailed list of its own recommendations, those are not going to be censored by ONC in any way shape or form. Those are part of the record, which will be available to the Successor. So again, this is just to emphasize that what I’m talking to you about now and what ONC is pulling together is a higher is a more crosscutting look at what the opportunities are.
So if your slides go as slow as they do, is there any way to...?
>> :
Just keep talking. It’ll catch up.
>> Mary Jo Deering:
Well, what I wanted to do is almost skip over the next two for a minute. And can you skip over the next one, too? I know you’ll just because these are so detailed. I wanted to go over the process okay, there we go and then we can get back to those slides afterwards.
So, in this more detailed list, there were over 50 activities that were identified as recommended for transition to the Successor; and again, as we’ve said, that some of these might be taken on by the Successor itself, some by the Federal Government, some by a FACA. And then some were singled out that data standards development organization might do it, an academic organization a local government might take it on. And again, that will show up in a in the full report that ONC will be sharing. Next slide, please.
The next slide is going to talk about a recommendation that we’re making to that we will be making to the Successor. And this is truly notional. This is draft. What you see here is you know, is still subject to input. But what it represents is our effort to suggest a process for bridging the two groups and to help A2 come up with an approach to digesting all of the input that it’s receiving and, on its own, developing an approach and a workplan. What we’re proposing here does not presuppose any particular output or any substantive output, but it does suggest that if A2 would consider creating this new additional transition committee that it might be very helpful.
And again, just by way of draft proposal, we’re saying, for example, that there could be two of the new board members that would be on this that had a particular interest. And perhaps one should be from the Federal Government, since it sort of carries over the Federal Government’s needs. But again, this is a proposal that perhaps two to four seats would be filled from the membership of the ASI. And if given the fact that it may take a while for the membership to actually get engaged and formally in place as members, this might be an opportunity for those stakeholder organizations that know that they want to become involved to conceivably be given an opportunity to play a role, if it’s so appropriate.
Again, it might be that from each of the existing workgroups that there could be a cochair that is recommended to be part of this committee. Or it could be that there’s an individual on a particular workgroup who’s been really stellar and really engaged and has a very strong interest in moving forward, you know. But one way or the other, we are certainly suggesting that there be a representative, you know, from the workgroups and then, finally, someone from ONC who can be helpful in not only the institutional memory but also the status of where other recommendations may be in the pipeline or the relevant federal activities.
And again, we are going to be suggesting that perhaps, at a minimum of 3 months perhaps working from the first board meeting to the third board meeting, just even to come up with some preliminary approaches to how to structure this effort. You know, it could help maintain a sense of forward motion. I think people are very concerned that if A2 has A1 if AHIC has had its last meeting on the 12th, and if the new board doesn’t get around to looking at these issues until, you know, January or February, then you’ll have lost a significant chunk of time. And so, our proposal may be that not that a substantive process be in place that dictates the outcome, but that at least you set in motion this a workgroup or something like this that can begin to pull it all together. The next slide, please.
So we’re thinking that these types of committees might be of use to the Successor. I don’t know if you can read it any better than we can here. I hope you all have it perhaps in hardcopy at home. But I’ll just interpret it for you at a high level. What you see there underneath the board are four vertical types of committees. The first three say “Provider Perspective Committee,” “Population Perspective Committee,” and “Consumer Perspective Committee.” These represent the broad committees that are currently in place for HITSP (inaudible) HITSP. We’ve added the fourth to the right, which says “Research Community,” because this is an emerging area of interest to many people. And so, we thought that these might be four primary domain committees. But then, on a crosscutting basis, you certainly have confidentiality, privacy, and security issues. And then quality is also something that cuts across it. And so, this is just a notional approach to how committees might work to address some of the suggested work that is, you know, going to be proposed again, depending on which of this work is prioritized for action, and to try and identify, you know, policy and business improvements as well as technical improvements. Next slide, please.
And we’re also just going to be suggesting to them, purely based on our experience in staffing AHIC committees which many of you know very, very well that, you know, we do think that there should be a rich crosssection of members on those committees. And we would be recommending that consumers be represented on all those committees and possibly, if there are enough to go around, a federal representative on all the committees. And again, we’ve teased out for them what we consider to be roughly the level of support that’s needed.
I’m actually going to ask you to now go back to Slide 4, if you would, whoever’s controlling those. And I don’t want to go through these line by line. Oh, I guess maybe you can’t even read them, which may be a good thing (laugh), because I don’t want us to get bogged down. But let me again give you some guidance how to read these, if you do print them out for yourselves, if you are looking at them on a on your own screen as opposed to over this the Webcasting. What we did here was, we really did look at all the recommendations from the workgroups that came in that were very specifically tailored to what they felt was their unfinished business or new business that urgently needed to be taken up. And then we tried to take it out of its own original domain by saying, “This is just a personalized health care recommendation,” or, “This is just an EHR recommendation.” And instead, as you’ll see, we have done a piece of analytical work to look at those recommendations and come up with statements such as well, the first one is, “Develop a plan for NHIN oversight and facilitation, including governance and development of organizational policies related to confidentiality, privacy, and security.” Those columns off to the right are the topic areas that have represented workgroups in the past.
And as you can see and we’ve even presented them in a way that those recommendations that touched on the most of these separate domains are listed first so that you can see clearly how crosscutting they are. I mean, just for example, the one on the very bottom of this slide says, “Drive the identification and harmonization of standards for data elements in EHRs to enable quality measurement and improvement and health information exchange across providers and institutions.” Well, you know, that certainly touches (inaudible) what were previously considered to be the EHR and the quality domain. But by definition, those are really very crosscutting purposes that would be accomplished through that. Next slide, please.
And the next slide is really very similar. Again, just to give you an example, there is you know, the one on the bottom of this page says, “Develop and implement a model for standard clinical decision support knowledge repository that can collect, organize, and distribute clinical knowledge and CDS interventions, including information regarding associated IT standards and technical capabilities.” And you can see the domains that we think that that is relevant to.
So what I I think we would welcome your, you know, thoughtful input on this, recognizing that it’s hard to go over these two particular slides that have the detailed list of transition activities in real time now. But we’re happy to take a little bit of time if you like. I think there’s a little bit more time on the agenda to talk about this, and certainly for you to take this away and give us feedback, say, what, by the end of the week or so would probably also be helpful. So I’ll stop there now and take questions and discussion.
>> Doug Henley:
Thanks, Mary Jo, very much. Good summary. And we’ll see if the Workgroup has any specific questions regarding the entire presentation or specifically the two last slides that you mentioned, Slides 4 and 5.
>> :
I have a question. You want feedback on the prioritization or feedback on your categorization across the different domains or
>> Mary Jo Deering:
Well, I think we’re happy to take whatever feedback you like. You know, if something really jumps out at you that you think we may not have considered, by all means, we’d certainly like to hear it. We are doing this kind of a presentation or discussion with all of any other workgroup that has asked for it. And so, you know, to the extent that we can accommodate, you know all of the input but we certainly want to hear it.
>> Doug Henley:
Additional feedback from the Workgroup members? (Pause) Okay. Mary Jo, any additional comments?
>> Mary Jo Deering:
No, except I really hope that you, individually and collectively, as a body of people who are interested in personalized health care that you will stay very much attuned to the evolution of the AHIC. I think they’re going to be very important opportunities for you. And I think the more engaged you can be, the more likely it is that, a year from now, you will actually see some tangible activities that we can all be proud of. So thank you very much.
>> Doug Henley:
Thank you very much. Laura, any closing comments from you?
>> Laura Miller:
I would just echo Mary Jo’s comments about being involved. If you have not signed up for the AHIC Successor listserv, I’d ask that you do that, because that’s where there will be announcements about opportunities to be involved (inaudible).
>> Doug Henley:
Okay. Well, thank you both very much for that. Let’s move now to the review and status update for the Workgroup recommendations from our particular Workgroup. And I’ll turn it over to Greg Downing for that presentation.
>> Greg Downing:
Thanks, Doug. Before we get started on our recap, we have short comments here from the Deputy Director of ONC, Chuck Friedman. Chuck?
>> Chuck Friedman:
Thank you very much, Greg. And good afternoon, everybody. On the occasion of the last meeting of each workgroup and this is the last meeting of this Workgroup Rob and I have been taking just a quick couple of minutes to express our appreciation for all the hard work you have done. Margaret Mead said that a small group of committed people can change the world, and I think that statement would certainly apply to the work of this Group. I think this relatively small Group has taken significant steps that will change the world. So on behalf of Rob Kolodner and myself and the staff of ONC and I’m sure I’m fully conveying the sentiments of Secretary Leavitt as well I really want to thank all of you for everything that you’ve done. I also want to thank John Glaser and Doug Henley for their superb leadership of the Group and, of course, Greg and his colleagues in the Personalized Health Care Initiative for their leadership and support of the group from the federal side.
Just a word from my personal perspective: I’ve been extremely interested in the work of this Group and wish I had had more time to participate. From my viewpoint, the work of this Group is going to help health care practitioners, consumers, and researchers take full advantage of amounts of data far too massive to deal with otherwise. And that is, in fact, what information technology does best and perhaps only can do. So clearly, the IT applications that build on what you have accomplished will be of inestimable value going forward. So again, thank you all for your time and your effort and, above all, for your creativity.
>> Doug Henley:
Chuck, on behalf of the Workgroup, thank you for those remarks. The Workgroup members have done a huge amount of work, as have staff, so thank you for that recognition.
>> Chuck Friedman:
Oh, you’re very welcome, Doug. And thank you again.
>> Greg Downing:
Great. Thank you.
Let me pull up the slides here. We would like to just recap and give you the status report on three sets of recommendation letters that have come from this Workgroup. As many of you recall, we began in July of 2006 with this Workgroup and, in the winter of 2006/2007, had a priority-setting meeting, which led us to an agenda of the activities that we believe we’ve been fairly successful as a Group in making recommendations for AHIC.
So I’d like to briefly update you on the status of the three letters in general and the recommendations that went to AHIC. On the first slide is that, in July of 2007, we had a family history and genetic testing set of recommendations that went forward in terms of trying to develop standard ways of communicating genetic test results and information about risk assessment to utilize the electronic health record and network exchange capabilities to facilitate transfer of information to support more informed clinical decision making around genetic tests and predisposition to disease. A use case was developed with a large amount of input from this group and many others that focused on specific activities of how risk assessment utilizing health patient-reported information as well as laboratory information, and how to represent that in terms of capabilities, primarily in primary care of how test results and when the ordering of tests would be appropriately done. And this has garnered a great deal of enthusiasm along the way.
And in the July recommendations and in 2008, a use case was developed that focused around family history and the genetic testing reporting. As many of you recall, there were no existing standards for family history per se, other than in the genealogy world, in terms of representation of families. But from the standpoint of representing historical information and the reporting of a pedigree of relations between related member family members that there were no existing standards for this. And a concerted effort was put behind developing a core data set of categorical information that had would be basically de facto becoming a standard for representation of collection of family history information and its display as a pedigree. We did this with a great deal of outreach. And Doug, you were one of those that pushed us to go beyond the federal boundaries to include the input from a broad array of primary care communities, patients, vendors, and so forth. And we’ve worked a lot over the last year to facilitate an activity that went beyond just the development of the use case, but also into some related activities that you’ll hear about a little bit later from Dan Weikart, our Project Manager on the family history tool enhancement.
As many of you may recall, there’s a substantial amount of work that had been done in prior years around the Surgeon General’s My Family Health Portrait tool. That is a Web-based capability and was the foundation for which the core data sets were developed. You’ll hear more about that, but the good news is that the use case development process went forward and is now with HITSP. We would anticipate next year, by this time, that the CCHIT and the certifications of these standards within vendorbased EHR systems would become a reality. And I think we’re all very pleased about that. A great deal of outreach activities went on during this period of time.
And sort of one new sort ofproof on this is that, through our clinical decision support activities, we’ve been able to look across the landscape now to see a variety of risk assessment tools that are in development now or emerging that will build off from the family history tool itself. We’ve been working with our federal agency partners to assure that these tools that they develop are going to be interoperable with the standards that emerge in HITSP and CCHIT. So the good news is that this activity has likely spawned a new wave of interest in clinical decision support around risk assessment.
I’d like to move on to the next category, and that is the newborn screening. As you’ll likely remember, in the not-too-distant past, we had a series of activities and recommendations that really focused around the information exchange around the screening for genetic disorders and inherited traits in the newborn population, as there’s a substantial amount of activity involving federal and state agencies overseeing the categorization of tests and renewed emphasis on trying to identify inherited disorders at as early a time point as possible. A fairly substantial amount of activity went into developing a use case prototype as well as a reference matrix for analyzing conditions. And over the last 6 months or so, a fairly substantial amount of work led by Peter Van Dyke and Steve Downs is on the Subgroup for Newborn Screening has continued to make progress on developing a resource document or a reference matrix for analyzing conditions that has been in its first wave completed. And as Allen Zuckerman will tell you more details about this later today. But this complementing the work that was done on the core data sets for family history will likely become an important tool for facilitating communications to the broad base of stakeholders involved in newborn screening activities.
A variety of activities have taken place since this Workgroup’s recommendations went forward on clarifying the sharing capability sharing of information across state boundaries, as this was a major issue in terms of the use case overall. And in discussions with CMS and the Office of General Counsel have been able to clarify some of the issues that restrained the sharing of information about newborn screening test reporting.
We wanted to very briefly update you where this is currently. The use case prototype is out for public review in a single review process that single-phase review process that ONC is orchestrating at this point in time. And the re public review for the use cases will come to conclusion on October17. And then this will be brought forward to the HITSP process, barring any major changes that are needed in the use case prototype as it currently exists.
As mentioned, the resource database prototype, which is a Webbased tool that we anticipate finding a home for relatively soon, in terms of maintaining an index of linkages between LOINC codes, ACMG codes, OMIM designations for diseases and conditions, and so forth they cross-walked through this; I think you’ll agree with us is that a fairly impressive amount of work has gone into harmonizing standards across common conditions and analytes. An implementation committee has been meeting for approximately 6 months among federal agency stakeholders looking at opportunities, predominantly in the Medicare and ACF programs, for taking and enhancing their health IT integration components to facilitate integration of these standards and facilitate interoperability among primarily primary care and the laboratories, as this is probably where the most need is in terms of critical values of test results and getting them to the hands of decisionmakers.
Over the last several months, we’ve been working with one of the other advisory committees the Secretary has that relates to this. And we’ve been meeting with them for over a year. But in this particular case, it’s establishing an interface for the health IT and information exchange about newborn screening results. That’s with the advisory on heritable disorders and genetic diseases in newborns and children. We have most recently met with them on October2 and shared with them, among the information we shared with them, where the prototype and the resource guide and the matrix tools that would have been developed.
A substantial amount of community outreach through a number of not-for-profit organizations; professional societies; state groups and organizations; and those affiliated with child care, in particular the March of Dimes and the American Pediatric Association, has been one of our key roles and activities of being able to garner such broad input into the use case that’s been promulgated thus far. As mentioned, we continue to have dialogue with a number of organizations and ONC and with the AHIC Successor organization about both the family history and the current newborn screening activities, once standards are approved and certified, that these are teed up and viewed as prime candidates and primary care practices for NHIN demonstration as well as with other networks. Next slide, please.
Out of the in our sort of rectifying the letter of transition, if you will, we’ve identified several things that came up in our newborn screening activities as they relate to continuity of(cough) sorry Public Health and Clinical Care Connections Workgroup, as you know, has several members that participated in our newborn screening activities. And in their last recommendations to the AHIC last meeting, they noted a particular interest with regard to child maternal and child health recommendations and standards in this regard. We’ve, throughout our Workgroup activities newborn screening have continued to have conduits for information sharing around what we’ve been doing in newborn screening to facilitate other information transfers that relate to newborn care in particular. And some of this is related to the information sharing around immunizations, also on eligibility for the WIC program, and also in school health activities. We’re in the process of finalizing some of our comments to the PHCCC Workgroup’s transition documents to harmonize what we view as priority areas for clarifying some of the CPS activities, as well as prioritization of standards adoption to support newborn care in these particular areas and to further emphasize the work that’s been done in the newborn screening areas.
I’m not sure how much longer I can go at this, but I’ll keep trying. The status report on this is that we’ll continue with our interagency transition activities here. And as the standards evolve through HITSP and CCHIT, we think this’ll create new opportunities within the federal programs for augmenting the incorporation of the newborn screening standards into the child health information systems as they evolve. And so, this Workgroup has been actually quite active and is continuing to look at resolving policy issues as well as the possible ways in which leveraging of resources invested at the health IT levels health IT at the state levels might have the potential early wins for impact on newborn screening activities.
We were very fortunate as we went through our Workgroup activities to have test money from a large number of good number of states who have already been implementing state registries and hearing early hearing detection and newborn screening overall on the bloodspot work. We met last week I’m sure Allen will go over in some detail about this with the advisory committee and the coordinating units at HRSA for newborn screening activities. And they, too, have continued sustained have sustained interest in promulgating the standards around this. I spoke with Dr.Duke, the administrator from HRSA, last night on a number of related issues to this. And she compliments this Group’s work in this regard.
I think that’s all the slides I have on updates. We will have more of the on detail on the newborn screening and the family history as we move through these presentations that we believe represent some of the activities that others may want to pick up on and continue to work on as the AHIC transition occurs. So Doug, I’ll be happy to take any questions at this point on the Workgroup’s activities.
>> Doug Henley:
Thanks, Greg, for trying to fight through that with your cold. Any questions from the Workgroup to Greg on these issues related to the Workgroup recommendations to date? (Pause) All right. Hearing none, let’s move on then to an update from Dan Weikart about the family health history tool. Dan?
>> Dan Weikart:
Thanks, Doug. This subgroup here for personalized health care had a number of recommendations that was sent on to the AHIC group at large for approval. And among those was this concept to develop an actual family health history tool that’s a public facing tool wherein a user can come in and document their family health history according to a prescribed dataset that was generated by the Workgroup and then store that in a standardized format so that it can be shared freely.
So HHS the next slide so HHS has a pattern a history of establishing family health history tools and the My Family Health Portrait tool from the U.S. Surgeon General essentially established this pattern. So what we’ve done here for this project is taken that general concept and updated that, again, using the dataset approved by AHIC, and then also centering on the an interoperability and portability specification to allow the free exchange of the data.
As part of doing this effort completing the requirements for this effort, we’ve engaged with a multistakeholder workgroup that includes a number of participants across the Federal Government as well as private industry. And one of the other key differences between the historical tool and the tool as it will exist in the future is that we’ve re-architected the tool so that it’s based on open-source technologies with the expressed intent that anybody that’s out there that’s interested in using this type of tool for family health history can freely download that tool, install that within their environment, and customize it for their own needs. Next slide.
So a little bit more detail about what exactly is the interoperability or portability specification. The chosen standard for this case is the HL7 family history model. We’ll use the SNOMED clinical terms to map to user interface, disease, and conditions. And we’ll use HL7 vocabulary for the relationships the familial relationships and LOINC when it comes to expressing the age of the users, as well as the age at on set for diseases.
A key tenet for this particular project is that we need to demonstrate this interoperability and portability with partner organizations who have collaborated for a number of months, if not years now, and have built or will build capabilities to accept this standardized file into their health record systems and/or their clinical tools. The next slide.
So the next slide is just intended to give a general overview of what the potential capabilities of this type of tool are. Essentially, you have a use case of sorts where a user will enter into the family health history or the Surgeon General’s tool their own family health history or their own personal health history as well as the health history for their relatives and be able to save that in the standard file. In this case, we’ve chosen that that should be an XML format file. And because it’s based on the standards, organizations external to this particular application will accept those standards and take that information and essentially upload it, if you will, into their own EHR or their own risk tools or even potentially the personal health records.
So a likely scenario would be: a user gets on; save the files; visits their physician, who has developed the capability to upload this information into their EHR, and so they share that information that file with their clinician organization. And now it becomes part of an electronic health record. And the next slide.
So what will the user experience as they come into the site? Essentially, the current Surgeon General’s tool has a Wizardlike interface wanted to maintain that ease of use, to have very simple instructions that guide the users through the data entry. Of course, we need to be careful from the usability perspective to make sure that we use terms that the user understands and also be efficient with the user’s time. A target that was thrown out there was sort of a 20minute exercise. Whenever it comes to family health history, I think we all understand that it can require a lot of research sort of behind the scenes, engaging with your family and collecting information to enter in that information as well.
Then it’s important to allow this user to view and print information in either the pedigree or the chart format. The chart form here is a table format where along one axis would be the family member, and along the other axis would be a selected disease or condition or set of diseases or conditions. And so, you can see very visually, across your family, which members have been impacted by certain diseases certain conditions.
For this tool for this implementation of the tool, it does save the file to just a local location, as specified by the user. So we’re not saving anything here on a government system per se with its application. That data is completely controlled by that user, and they can share it as they see fit. And then we want to provide a straightforward way to save and access that information. So there’s this human-readable file; a pedigree chart in pedigree drawing in the chart; and then also the machine-readable file, which is the XML file that I spoke about before. Next slide. And as Greg mentioned in the last presentation, we’re targeting a public launch for this particular application in September2008.
And that’s my status update. Are there Doug, do I kick it back to you for questions?
>> Doug Henley:
Yeah, thanks, Dan. Well-done, and great update regarding the family health history tool. Any questions or comments from the Workgroup members?
>> Marc Williams:
Yeah, this is Marc Williams from Intermountain. Thanks, Dan. I just wanted to make a brief comment on that 20-minute interface. I think that’s a great target to shoot for. I would also note, though, that the Utah Health Family Tree Project in Utah here did show that people were willing to spend up to 45 minutes at that interface. So I think that shooting for 20 will build in a lot of leeway so that, hopefully, we won’t have too many people dropping off.
>> Greg Downing:
Yeah, and the way that the sort of screen flow of the application is very simple. You can essentially get in and, within one or two screens, fill in well, one or two screens that repeat for each family member fill in all the data that’s necessary to be collected. So there we targeted that 20 minutes as an efficiency target there for usability. But if they’re willing to fill out more, you know, the application, of course, will be available for as long as they’d like to fill it in.
>> Marc Williams:
Right.
>> Doug Henley:
Thanks, Marc, for that additional information. Other comments from the Workgroup to Dan? (Pause) Okay. Well, Dan, thank you very much for that update.
>> Marc Williams:
Thanks.
>> Doug Henley:
Let’s go next into the update on the Newborn Screening Use Case. And I’ll ask Allen Zuckerman to address those. And again, I think we’ve got another slide deck to look at as well. Allen?
>> Allen Zuckerman:
Yes. Unfortunately, I cannot see the slides, so I hope someone can change them for me. And also send regards from Steve Downs, who cochaired the Newborn Screening Group. He wasn’t able to join us today, but he was there with me at the Advisory Committee on Heritable Diseases in Newborn Children and will be with me again to discuss this at the Association of Public Health Laboratories meeting on newborn screening in November.
The first slide summarizes the five key points of the update on newborn screening. Are you able to see that now?
>> Doug Henley:
Yeah.
>> Allen Zuckerman:
And the essential points are that the Newborn Screening Use Case has gone forward as the only new ONC use case for 2009. And the Draft Detailed Use Case was released on September19 for a single 4week public comment period that ends this Friday on October17. And with that, we released a companion document, which we now call the Resource Guide, for the Draft Detailed Newborn Screening Use Case, to essentially replace what we used to call the matrix and spreadsheet form that was prepared by a subgroup to deal with coding and mapping issues. And this same Resource Guide is also now available as a database and available as a Web application that can collect comments and can display updates as they’re made while development continues on the use case. At the same time, a Newborn Screening Use Case Implementation Workgroup is continuing to meet to facilitate implementation of these standards that will be selected for this use case.
And on the next slide, you can see how the use case stands out as the last use case to be undertaken by the first AHIC and will be carried out concurrently with a variety of gaps and extensions to the previous use cases from the 3 prior years.
The next slide summarizes, again, the purpose of the use cases, which are basically to describe the high-level needs of many different systems, stakeholders, and individuals. One of the activities of the Personalized Health Care Workgroup has been to identify the diversity of groups involved in newborn screening. And this material has made it into the written use case, which is organized around information flows grouped in scenarios between different perspectives on information exchange. Each one covers a series of events that trigger the information movement. The actions need to be taken. And there are summaries of the various requirements and barriers that may occur. And finally, there are the sample datasets that will be used by the organizations participating in the use case.
On the next slide, we summarize the use case scope, which was built from the recommendations to the AHIC that came out of this group back in March. And there are four essential features that drive the use case. The first was to integrate all of the results from six different clinical domains of newborn screening, including early hearing detection and intervention into a single comprehensive clinical report, and to have that report expressed both in clinical terms physicians screen for and the quantitative measures. The second area was to prepare a consultation referral document that would include the initial screening results, track the completion of confirmatory testing and referrals, and identify all of the providers who are interacting with the patient. The third area is reporting back to public health and sharing of deidentified data to help the research community and the public health screening program management community optimize the programs and maintain registries of individual case reporting for individual services as well as population health. And the final area, which is incorporated into the use case, is the need to address consumer needs for educational materials about the newborn screening process and about conditions which may be either suspected or confirmed through newborn screening.
The next slide moves on to summarize the perspectives. And you’ll notice how the clinician is divided into an ordering clinician, who’s essentially taking care of the newborn in the hospital; and the pediatric clinician, not necessarily a pediatrician, who’s taking care of the child following discharge and will need to act on the results of the screening. We’ve also separated out the different roles of health departments, testing facilities, and laboratories that may be internal to health departments and external in developing the standards that will be used. The audiology services are included and, in a somewhat abbreviated form, many of the other data users that have an interest in the availability of newborn screening data.
The next slide summarizes the key features of the first of two scenarios: the one that deals with the initial screening process, the ordering of the tests, the dried bloodspot collection in the hospital, and initial hearing testing and ends essentially with the reporting of the results, which may either be normal or trigger a second scenario to follow up on abnormal out-of-range results. And it includes pre-education prior to screening. It includes the data collection process, decisions about the need for second tests, and routing the results to the clinicians caring for the child and hopefully will include closing the orders loop to acknowledge receipt of results.
And the graphical representation, on the next slide, of Scenario 1 includes both, in the square boxes the small square boxes, general information flows for educational materials and, in the circle, specific patientspecific information flows among the different perspectives and among other interested parties summarized in the large box on the right.
The next slide moves on to Scenario 2, which deals with the abnormal and out-of-range results and essentially covers the diagnostic workup or the completion of the hearing evaluation and includes, at this point, a number of touch points with other use cases, such as the collection of a family history, the performance of confirmatory testing it might include genetic testing that needs to be integrated into records. It may involve emergency treatment. It would involve case reporting to health departments, consults and referrals, and referrals to other nonmedical support services for dietary or educational services. And of course, it includes bidirectional communication, educational materials, and the use of deidentified data to support population health. And so, that, again, is summarized in the next slide graphically, in Scenario 2, which enumerates all the different points at which these things will be selected and harmonized by HITSP.
The next slide discusses some of the dataset considerations, which will help to standardize reporting and facilitate other both immediate individual patient use, program management, and research use of this data. And again, in line with the recommendations approved by the Workgroup, the use case does call for both the summary clinical reporting by conditions screened for as well as quantitative reporting of the analytes measured by newborn screening.
The next slide, of course, summarizes the method for submitting comments, which do need to be in by Friday. And on the next slide, we take a look at the next steps which will be needed to actually complete the use case. We anticipate a final use case to be out in December and is to be handed over to the Health Information Technology Standards Panel. The Public Health Informatics Institute and HL7 are already under way with developing an implementation guide for newborn screening results that will be essential to the work of HITSP. And the Resource Guide that we’ll show you shortly will also serve as an important source of terminology and coding standards. And after these standards are accepted and recognized, they still need to be implemented by the individual state newborn screening programs.
On the next slide, we talk about some of these features of implementing the use case and the importance of members of the Workgroup now continuing efforts to make people aware of the use case and to generate interest in using the standards which will be coming forth. And we’re only going to see these results getting into electronic health records and physician offices if the health departments and screening laboratories implement the standards to communicate and we bring that into the certification of electronic health records.
And of course, because of the limited rates of adoption, particularly among physicians caring for children, we feel that Web interfaces’ reports will be essential. Deidentified data will be essential to move data to the existing National Newborn Screening Information System and other reporting programs. And it’s important to realize that the use case is essentially a work order and a statement of requirements for the standards, and it’s not a design of systems that will actually (inaudible).
And on the next slide, we summarize the key features of the resource guide, which has three major sections: one listing the conditions with their various codes and linkages, another listing the analytes for quantitative measures, and then the mappings of analytes that may be abnormal and suggest a condition or the various analytes or abnormal presence of the condition.
The next slide gives an example of several conditions from the ACMG primary targets’ amino acids category, and shows the variety of genetic and diagnosis codes, and also shows how it incorporates both the name of the enzyme that’s abnormal as well as the name of the clinical disease.
The next slide gives you an example of the same process for analytes, here drawn from (inaudible) mass spectrometry area, and shows how LOINC codes have been identified for most of these and will allow electronic reporting of these types of lab results, and that we include not only the primary raw data measures, but also commonly used computed sums and ratios of analytes.
And finally, we illustrate on the next slide how hearing loss has associated with it specific analytes and tests that, rather than generate continuous quantitative measures, are stored simply as pass-or-refer. And we’re trying to integrate this into the reporting process from the use case.
And the last slide in this section is an example of the mapping for a particular medium-chain Acyl-CoA dehydrogenase deficiency the various analytes that may be abnormal in the face of a condition. Of course, one condition can produce many different analyte abnormalities, and a single abnormal analyte might be associated with more than one condition.
As I said, we’ve moved what’s on paper onto the Web through a database. On the next slide, we have the URL for the temporary location. And in the next slide, an example of how each section of the print report now has a button to trigger a Webbased report with explanatory material on the entry page. And on the next slide, we have the example of displaying a condition. And you’ll notice that there is a filter box just below the list of selecting conditions so that one can look at endocrine conditions or primary targets or secondary targets. And you can pull down the control key, select multiple items and on the next slide, you should see a sample report for a particular selected condition and, on the same page, definitions and pointers to the different coding systems described.
The next slide shows the same process for analytes, which, again, display their LOINC codes in units. And on all of these report pages, you have two email buttons: one to email a copy of the report to yourself, and another to email to the staff working on this comments on any of the items in these automatically generated subject lines you know, which conditions, analytes, or mappings you’re looking at so that we hope to get more and more individuals involved in reviewing the database so that when the use case is ready for implementation, we’ll have a solid collection of codes to support the report.
The next slide shows the process of mapping from a condition to an analyte.On the slide first slide, you select the condition. And then, on the slide that follows, you see that condition and its listed associated analytes. If you click on any of the analytes, you can look up the associated coding and other information. And on all of these pages, you have buttons to both generate print copies for yourself as well as to send comments, because this is an array of newborn screening on which there’s some disagreement on exactly how things map together.
The next slide talks about what’s going to be needed to maintain this resource guide after the Workgroup ceases to meet. And at the moment, because it is a work in progress, we’re going to put in a great deal of effort to complete this over the next few months and hopefully involve other groups in continuing to review and submit this so that a revised version in December will be the beginning of an ongoing maintenance, adding new codes as new tests are added, and continuing to reach consensus on the right way to report newborn screening data. As part of that consensus building, we anticipate more genomic information and links potentially to other databases to become part of the resource stuff.
And then, in conclusion, on the final slide, we of course will appreciate any comments from the Workgroup on the use case and the Resource Guide and any efforts to continue to raise awareness that this is coming and that we hope that, by July of 2010, this will be something that will begin to move data between the hospitals, the health department, and ambulatory care practice between primary care specialists between those carrying for individual patients and those involved in public health and population health. Thank you.
>> Doug Henley:
Well, Allen, great work. Great summary. Great work. And take a deep breath, and let’s see if any of the Workgroup members have any questions to you relative to this update. Comments from the Workgroup?
>> Mollie Ullman:
Yes. This is Mollie Ullman from Partners HealthCare and HL7 Clinical Genomics. Hi, Allen. I echo the compliment: Great work. I’m just wondering if we might want to think up on these standards to make sure that they are synergistic and complementary to the ones coming out of clinical genomics so that, let’s say, a cystic fibrosis stamp finding resulting in a newborn screening test is reported in a similar fashion to one resulted through other avenues of genetic testing.
>> Allen Zuckerman:
I think it’s a very important point, and we’ll make sure that those issues are raised, both as we approach more of the laboratory directors, and also as the Public Health Informatics Institute continues its work to develop an implementation guide and as HITSP starts to harmonize standards. That’s a particularly important area on the resource side, because cystic fibrosis is an example of an area where clinical genomics is already in use as a form of newborn screening.
>> Mollie Ullman:
Right. So, Allen, in that vein, the Clinical Genomics Subgroup at HL7 has been working with Intermountain Healthcare and National Library of Medicine and has essentially extended the Laboratory Message 2.5.1 for transporting laboratory results for genetics from the laboratory into the electronic health record. And that has already been validated and continues its path to normative. And in that, the contacts would be either Clem McDonald, myself, or Stan Huff, because I was unaware, even though I’m Cochair of HL7 Clinical Genomics SIG, that a group within HL7 was working on structuring newborn screening results that are genetic based. So I imagine you might be working with a laboratory group?
>> Allen Zuckerman:
That work is being led out of the Public Health Informatics Institute.
>> Mollie Ullman:
So we should I think we should think that this sounds like a great opportunity.
>> Allen Zuckerman:
Definitely should be. And although it’s hard to see on these slides, the use case seems to very clearly identify the genetic reports report of personalized health use case for genetic data. And those same standards are supposed to be integrated into this use case. This case is unusual, because the standard crossreferences and on their full set of diagrams, that’s one of the points of contact was identified, because again, in our recommendations in our materials from this Workgroup, we alerted them that newborn screening is changing and does involve new forms of genetic testing and that the reports of newborn screening need to use standards for that.
>> Mollie Ullman:
Oh, excellent. Thank you very much, Allen.
>> Doug Henley:
Great points and great synergy. Other comments to or questions to Allen?
>> Marc Williams:
Yeah, this is Marc Williams, Intermountain Healthcare. Having spent a good portion of a plane flight last week reading through the use case in preparation for submitting comments, I again would extend my congratulations to the Group for taking on a very complex subject and doing an excellent job in a short time frame. And I have two questions. One is, given the what looks to be the movement to ICD-10 in the United States by 2012, if I’m not mistaken; and given that ICD-10 has a much more robust list of metabolic disorders than ICD-9, was there any consideration given to also having ICD-10 codes mapping into this?
>> Allen Zuckerman:
Oh, absolutely, and that has been included. We’re under a number of very difficult time constraints to get the initial Web version launched, to get this out on the time frame with the other gaps and extensions that are being done simultaneously. But ICD-10 has definitely been identified. Clem McDonald at NLM is really the one who has led a lot of our efforts on coding. In other versions, not the ones we’ve brought up publicly and on the Web, we do have placeholders. And it’s simply been a lack of time to get it. It’s definitely my hope, and particularly with some more assistance from Mike Watson at ACMG and others, that by the end of December, we may have the ICD-10 codes added to the database. And we have designed it in a way that will be extensible to add additional codes. But we’ve already received some comments at ICD-10. It’s definitely part of our long-range roadmap. The work just simply hasn’t been done now, because it’s not yet in use, so it’s going to take more time to complete.
>> Marc Williams:
Thanks. The second question and last question is I hadn’t been aware of the resource guide, and I’m looking forward to going in and playing around with that. In terms of the home for that, you mentioned Mike and ACMG. It seems to me, at least from the little bit that you presented, that this would be very consistent with some of the work that we’ve done relating to newborn screening, and also given that the college just got a large grant to pull together national resources relating to newborn screening. Has there been discussion about ACMG as a potential home for this resource?
>> Allen Zuckerman:
We will probably begin meeting with them later this month. That grant was just recently awarded. They’re actually at other conferences now. We also will continue discussions with the HRSA-funded National Resource Center that Brad Ferrell is involved in. And National Library of Medicine might be a place to physically make it publicly available, but we need to bring in the expertise of both the National Newborn Screening Resource Centers and this new translational genomics network to optimize the content and maintain it.
>> Marc Williams:
Thanks.
>> Doug Henley:
All right. Other questions to Allen Zuckerman? (Pause) Well, Allen, again, great summary, great job, and thanks for the important update.
>> Allen Zuckerman:
Okay. Thank you very much for all the support we’ve received. And it’s gratifying to see that it’s being completed before the end of the workgroup cycle.
>> Doug Henley:
Indeed. Greg, are you up for the pharmacogenetics update pharmacogenomics update?
>> Greg Downing:
Thank you, Doug. Before going to the slides, we I wanted to alert you that we’ve updated the Personalized Health Care Workgroup Web site within AHIC to make the letters of recommendation and the final actions by the Secretary pretty clear and on the front page of that. So if you ever want, in the middle of the night, for reflections on what work you’ve done, they’re relatively easy to find now. And you can just, you know, download them with a click of the button. But they’re all in one place.
The other comment and compliment, I guess, is that this Group took upon itself because in some ways, the forwardlooking aspects of the material and the recommendations and use the cases a good number of publications at last count, I think six they came out in some direct or indirect fashion from the Workgroup activities. And those are, I think, being widely utilized by a variety of communities to indicate particular work that’s been going on and potentially needs and other areas.
And then finally, the clinical decision support activities, which I’ll relate to here a little bit, continue through a federal activity known as the Collaboratory. And they’ve got a good number of successful meetings over the summer and invited a number of speakers who’ve come in. And I think there the a number of you have participated in those. Those have been useful. And I think the surprising part to pleasantly is the risk assessment and the elements of the family history and other prediction aspects based around genetics. And the work of this Workgroup has been well-represented in the federal Collaboratory around clinical decision support.
I’d like to briefly update you on the last set of recommendations that were brought forward at the July the June3 meeting of AHIC. And if you could put those slides up for me, please...
One of the first recommendations had to deal with the clarity or helping clarify the roles that the National Institutes of Standards and Technology had with regard to standards in the area of pharmacogenomics and genetics in general and how that was distinct from the standards activities that HITSP and CCHIT were providing. And this sort of goes to the point that just when you think you know how everything works, you learn something new.
We’ve had several meetings in the transition period over the last couple months and networked with senior staff from this who’ve been involved in the health IT and genomics space, which I actually didn’t know that NIST sort of has an interagency agreement with the Office of National Coordinator for a variety of activities that may be beneficial to the continued promulgation of the standards activities that this Workgroup has had to support. And they have been primarily focused on the supporting the architecture for the National Health Information Network and developing testing systems and capabilities and means to assess the effective use of standards and the interoperability specifications that have come out of HITSP and CCHIT, when deployed through the domain of the National Health Information Network.
So we’ve learned a lot about this. And I think, when looking at the capabilities of deploying the family history tools and the standards about them and newborn screening, this has given us some insight into what kind of testing capabilities for network exchange these kinds of information might be needed in the future. They also have been a primary supporter, in terms of being able to determine the security and validate, basically, security and privacy methods that have applied in exchange of health information overall via the network. And that obviously has been our primary concern of this Workgroup overall.
With regard to the NIST role in genomic testing, formally they do not have any particular roles dealing with CLIA or any of the federal agency oversight activities typically nested within HHS. They have specific roles in developing standard reagents for particular types of DNA tests, in some cases, and including other testing reagents associated with the protein measurements and so forth. I think that was pretty clear that they’re not in the activity of developing standards around the testing results, data transmissions, nor the clinical decision support aspects around genomic testing themselves. But we did identify in our discussions with them, and are seeking to further clarify in a document, where there may be a gap in their organizations or the approaches that we’ve been taking in terms of standards for pharmacogenomics platforms between basic research and clinical diagnosis. As many of you know, the testing platforms often used in basic research are similar to what’s used in clinical diagnostics. And standards have emerged in those environments, but there is likely some still gaps and needs for standards development to support these activities overall. Next slide, please.
Several recommendations themselves were focused on the ability to utilize the electronic health record to support clinical research activities, including pharmacogenomics data. And the way we really kind of got at this was that a number of teamoriented science enterprises has evolved to study the applications of certain genetic tests for clinical application for example, the Warfarin test. And that’s one of the challenges overall is that just a simple nomenclature of one common test with a small number of genetic variations that quite a number of permutations in the coding languages for the transmission of the test results creates problems when trying to look across broad populations for interpretation of test results overall and the clinical applications.
One of the things that we developed as a recommendation was for the again, supporting the notion of a use case around clinical research activities. And the activities that we’ve been engaged with subsequently were developed were approved and considered by both AHIC as well as the AHIC Successor organization as to make an effort to develop a public/private partnership as an auxiliary pathway, utilizing the same HITSP and CCHIT certification pathways that have emerged through ONC under the oversight of the American National Standards Institute. And that has been approved, and we’ve had an exploratory interest group that’s met several times over the course of the late summer and early fall, with the notion of establishing a Workgroup that would formulate priorities for clinical research use case and related standards needs. But this has been an ongoing process that Dr.Glaser is involved with and Laura Miller, who’s still in the room and may wish to comment on this. But I the idea is that during this transition phase and the ability for the Successor organization to not yet support a Workgroup activity, we’ve had a combined act combined effort amongst a number of organizations, including ANSI, to find a way in which to continue to support the momentum that was built behind this particular area of interest. So I’ll go on to the next slide, please.
Recommendation 1.2 from the last set really focused on the use of development of core dataset of elements and the relevance of the outcomes of clinical interventions driven by pharmacogenomic tests that need to be captured by EHRs. And this is a series of discussions that led up to these recommendations coming from agencies and organizations interested in outcomes research. We just wanted to bring to your attention that AHRQ has made some awards and contracts to generate and evaluate genomic test decision tools. They’re still learning somewhat about these, but a couple of the examples are in developing tools for primary care practices and consumers in general to understand that circumstances under which certain genetic tests should be recommended, driven in large part off from the family history tool around... specifically breast cancer, in one scenario.
And then another is where it is a more specialized approach to considering when gene expression profiles have may be useful in deciding, by an oncologist or patient, when a particular test may have particular advantage. These tools, as I understand them, are not yet being developed but are being scoped for further development and are geared to try to help clinicians with understanding where the these special tests provide value. So it’s really around the clinical utility component of these that tools are being developed to facilitate that.
One of the key aspects that we’re trying to understand here, given the auspices of the Executive Order under the Department of the Secretary’s authority, is to make sure that the tools being developed by particularly by federal stakeholders are interoperable with the standards from the family history and the genetic test results reporting activities that we’ve talked about quite a bit here earlier today.
So one of the activities that we’ve been considering and I didn’t want to bring this up for today’s consideration in the Workgroup was whether it was necessary for a new recommendation to be created at this point that would basically require for of a federal acquisition to make sure that the tools that are being used for clinical decision support and being developed through federal investment be comparable or compatible with the family history tools and the standards that have been promulgated here. We’re working with OGC and our General Counsel’s office as well as with the staff and the Office of National Coordinator to leverage the authority that the Secretary has to require that these interoperability specifications for these tools are provided.
I think that one more slide here. And this has to do with the interface of potential means of which pharmacogenomics data and dosing and prescribing of therapies, particularly in safety considerations that the use of electronic prescribing tools looking forward and the transmission of pharmacogenomics data to alert pharmacists and others that potential adverse events may occur and that the consequences of having predispositions for either slow or rapid metabolism, for example, with certain pharmaceuticals was an area of quite a bit of interest to a number of AHIC workgroup members. And we’ve been working with the American Pharmacists Association on a small workshop that they’ve been planning for this winter to bring in experts and start to begin to shape the scope of how the interactions of eprescribing and genetic test information may unfold. It’s obviously looking to the future. The capabilities for doing this now are only an ability to send auxiliary messages along with the prescribing capabilities. But they’re very excited about taking this on and providing some shape and content to context to that vision. As you know, the Secretary and CMS have been promoting and pushing a great deal of policies on adoption of the eprescribing activities, and it seems as though this would be a means to leverage some of the communication needs needed around prescribing of various pharmacotherapies.
I believe that’s all we have. These letters go through a clearance process here in the Department. We’re very close to having the Secretary sign off on these and dialing them into the agencies under which these are being applied. I think that’s all I have, Doug.
>> Doug Henley:
Thank you, Greg. Any questions from the Workgroup members to Greg relative to his summary?
>> John Glaser:
Hi, Greg, it’s John Glaser. Sorry I’m late.
>> Doug Henley:
Glad you’re with us, John. I was just going to ask if you were there. With no comment to Greg, gentlemen, let me go back to you. Laura did earlier provide a very good update about the AHIC Successor organization transition. Any additional comments you wish to make on that?
>> John Glaser:
Yes. And again, I apologize for being late. We’re having a bit of a partners gathering about what to do with capital when the market’s all over the place. I think what I thought I’d just mention briefly is some key points about the Successor and I apologize if they have been covered by either Laura or Mary Jo and then see if there are any questions coming out of either my comments or the comments that they made earlier.
As you are perhaps aware, the Successor has been legally created. Its board has been appointed. There’s a fair amount of information, should you want to look at it, at the AHIC Successor Web site, which is www.ahicsuccessor one word .org, which lists the board members who’ve been asked to join us here. We have our first meeting with that board on November13. We’ll be meeting fairly frequently in the next couple of months. And there are a couple of key items for them to address including the usual setting-up of committees and things along those lines and electing a permanent CEO one of which is mentioned by Mary Jo, which is, “How do we transition the work that was done by the Workgroup such as this one to the AHIC Successor?” And Mary Jo presented some recommendations that ONC’s going to put in front of that board. But the board has yet to go through those and alter them or accept them as a whole and things along those lines.
Second and this may have been mentioned, too, by Laura Miller and others is the value use case in other words, taking the current use case process that has been adopted by AHIC 1 and altering it under AHIC 2 with the hope that the result will be faster adoption of the recommendations that come forward from the use from the workgroups, and also to see whether there can be the ability to obtain from the industry and other interested stakeholders some support. From the industry, it’d be financial support or sweat equity support that needs to occur.
And the third major thing is really getting a membership organization structure put in place. And so, there’s an expectation that AHIC 2 will have members and that those members will pay dues of amounts that have been sketched out but are still need to be ratified. And then the rights and then the privileges of the members there have been some recommendations along those lines, but those have yet to be fully adopted by the board.
So I think what’s going to happen or hope happens in November, December, and January time frame is that AHIC tackles the issues of transition and gets them sort of squared away and value cases and membership. And so, we’ll be clearer than I am at this point. I think there’s lots of good ideas. I just think what we haven’t had is the AHIC board review them and debate them and decide what it would like to do here. So it’s possible, I guess, we could certainly do this for both this Workgroup and the others. As those become clearer, you arrange a conversation with Workgroup members. You just have to understand we’re given the work that was done, which we appreciated it and enjoyed and thought was effective, under AHIC 1. What’s the form of that under AHIC 2, and how do we continue to be engaging this? So I will just stop under those brief comments and see whether any questions have come out of what I’ve said, again, or the earlier presentations.
>> Marc Williams:
John, this is Marc Williams. I appreciate the challenges that you have to face. And I wanted to just kind of get a sense from you if you’ve had any feedback from potential member organizations and dues. You know, a model that has existed for a while that came out of an idea from the NIH, specifically the National Human Genome Research Institute, was the NCHPEG or the Natural Coalition for Health Professional Education and Genetics, which is a multistakeholder group where different organizations do participate in the dues structure. And a lot of educational initiatives from that group are being promulgated. The challenge I know has been to actually have a dues structure that doesn’t disincent people from joining while still paying the bills, as it were. And I suspect, particularly given where you were the first hour here, that there’s going to be a lot of discussions and lots of institutions about how this would work. So if there’s been any discussions about this, I’d be interested in a little bit more detail if you are able to share.
>> John Glaser:
Yeah, I think ahead of you, Marc. I mean, they’re with the Financial Sustainability Workgroup that worked through the summer on helping to get some idea on setting up AHIC and came up with one basic structure, which is this one structure for for-profits and one for nonprofits, and so, you know, a little bit of difference between the two. And then the actual dues themselves were based on revenues. And you can imagine a variety of categories of revenues and, you know, some, you know, ranging from three categories to some ungodly number of categories here. There’s also recognition that certain kinds of organizations may not be able to pay any dues at all or much. And they may be consumer organizations; they might be some professional societies that are really quite vibrant and potent but are not sitting on a treasure trove of information.
So there were and, you know, I’ll give you some of the numbers range from 0; to organizations that you really wanted to be members but, again, had financial reasons why they couldn’t; to a high end of $50,000 a year. High end would be organizations that had, you know, multiple billions of dollars in revenues. So your Partners HealthCare would be one of them. So would some of the vendors and some of the large health plans.
So there was a the we sort of covered that range. It wasn’t done this summer was to and you said that whole total had to add up to about a million, too. So that’s kind of what you bring in. And that might involve 120160 organizations to get that. Marc has taken that and gone out and tested that and to see whether people gag. And you might have thought it would be an okay number in the summer, but now, because the markets are so screwed up, it might not be an okay number anymore. So one of the first things you have to do in the first couple months is to revisit those numbers and at least get some testing to see whether we have got a shot at both getting the aggregate revenue, but also maybe seeing whether the current approach is going to cause people to say, “I’m interested, but forget it.” They’re saying that you have to the degree that dues don’t bring in 1.2million, then it will leave the Successor with saying, “Well, we either cut back on expenses,” which, you know, all the organizations on this phone know how to do, “or we’ll seek alternative forms of revenue,” and there’ve been some other ideas put in place.
So a long way of saying I think what is very, very important is that the membership include the broad array of stakeholders and constituencies here. We will have failed if it becomes a club of the rich for whatever set of reasons or it’s skewed one way or the other. The whole legitimacy of the thing will crumble, given that desire is still to sort of work out a structure that can bring enough revenue.
So anyway, we have some thoughts along those lines. We have some homework to do don’t have a good answer, although at the end of the day, the multistakeholder participation is more important than whether we get a million to or some other number.
>> Doug Henley:
Thanks, John. Other questions to John? (Pause) Well, John, thank you very much for that summary.
>> John Glaser:
Thanks, Doug.
>> Doug Henley:
Judy, I think we’re ready for public comment before we have some final closing comments.
>> Judy Sparrow:
Great. Alison, could you ask if anybody from the public wishes to make a comment, please?
>> Alison Gary:
Sure. For those online, you’ll see a slide on how to call in to ask a question or to comment. If you’re already on the phone, you can just press star-1 on your phone now to comment. Any wrapup comments while we’re waiting for the public?
>> Greg Downing:
Doug and John, this is Greg. And first of all, I just want to thank you thank both of you for your exceptional leadership and the wisdom that you’ve given us as staff. I’ve talked to recently Kristin and Lauren and Scott and the others that have worked along the way with us, and they all said the same thing that they wanted to get a prediction out of you on a very important national matter that’s about to come to our forefront here. And all of us are going to have to make a very difficult choice in the next couple weeks. But we wanted to ask you directly: On the eve of the launch of yet another national basketball collegiate activity (laugh, inaudible), I think we have our first practice coming up here tomorrow night, if I’m not mistaken. So from the great state of North Carolina, do we have any predictions this year?
>> John Glaser:
Well, I’ll say, Doug, they need to be great, because I think the Duke Blue Devils will do well in the league, but they will not do as well as the Tar Heels. And so, if you were going to put any money on this thing, you got some really long odds on the Blue Devils. A safer bet and given that we’re all trying to conserve our money, because it’s getting eaten away, I’d go with the Tar Heels before I went with the Blue Devils in the year ahead.
>> Doug Henley:
Well, I’ll agree with John on one point. I think the Tar Heels will be ranked #1, given the way they’re loaded this year. But you never know what happens at Cameron Indoor Stadium. So they’re always interesting games when they play each other.
>> John Glaser:
Well, Greg, I hope that gave you the guidance you were looking for. And you know, you what you might do now that’s the market up put all your money on that bet, and you’ll do pretty well as it gyrates over the next couple months. That’s what Partners is planning to do. That’s what we should (laugh).
>> Doug Henley:
As much chance of success as the market these days.
>> John Glaser:
I’ll tell you, it may be even better than the market these days. (Laugh)
>> Doug Henley:
Greg, thanks to you and the staff for all of the excellent work that’s been done over these last 18 meetings. But most importantly, my thanks I’m sure John will say likewise to the members of this Workgroup for the intelligence that you brought to this process but importantly tempered with a heavy dose of common sense about what’s important for patient care going forward, relative to this topic. So certainly, I thank you for your excellent work and that of staff as well.
>> John Glaser:
Yeah, I’m not sure I could have said it better, Doug. Thanks to you as a Cochair, it’s been terrific. And Greg et al. on the staff’s side and all you members, really nicely done. I think there’s been terrific conversations and terrific work product and some advancements that have resulted. And what I do hope we do and we may have to go into a couple months’ hiatus here while the Successor takes over is provide the opportunity for this work to continue. So we’ll cycle back at some point with a little bit more clarity, but so it’s been really terrific. So thank all of you.
>> Doug Henley:
Likewise, John. Any public comments, Judy?
>> Judy Sparrow:
Allison, anybody on the line?
>> Alison Gary:
No, there’s no one no public comments.
>> Doug Henley:
All right. Any final comments from other members of the Workgroup? (Pause) Well, again, our thanks on behalf of John and myself. Thanks again, Greg to Greg and the staff, and to all of you for your superb work on this Workgroup. And may our paths cross in other venues in the not-too-distant future. (General thanks and farewells)