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>> Thank you for the opportunity to give you an update, progress research the researchsubgroup.I'll try to model this along the outlines of the plan recommendations and milestonesthat I think we have all been committed as a mechanism for systematically tracking progressand for tracking what remains to be done.In terms of events that have occurred, just want to let you all know about three weeksago George, Harry and had an opportunity to testify before the house foreign affairs subcomittee,Africa global health global human rights enternational organizes on follow-up to the G-8 summit.We asked to provide a summary there, you'll be hearing from the three of us in fact aboutthe G-8 summit itself so I won't go into detail but it's a nice opportunity for visibilitywith members of this committee, not one before whom we are customarily testifying but indicativeof the appreciation of the global importance of Alzheimer's disease.Organizing these few minutes of comments I'll provide for you will come from the Alzheimer'sdisease summit recommendations, many of you recall which led to a series of nap pa researchmilestones an now talking action that has begun and with a little summary of what occurredin 2013 and outline to give you a sense of the targets for 2014 the way they're beingapproached.So in 2013, eel give you each of the milestones that had 2013 as a starting point for theirinitiation.There was the area of genetics a request milestone to establish consortium of genetics and genomicsexperts to execute large scale sequencing.This has gone extremely well, I'll give you details where it stand right now.Initiating a searchable database that investigators worldwide have access to the outcomes of thegenomic information and those links are shown here.Both through DB GAAP as well as Alzheimer's specific genomic database that NIA is supporting.From so this began February 7, 2012 when the presidential initiative included one projectthat involved collaboration of NIA and genome institute, NHGRI, large scale sequencing thetarget was with families and with case control studies.These designed to identify both risk factors and protective factors from Alzheimer's disease.The support was $25 million in genome centers as well as participation from consortia thatNIA supported who over time generated populations of affect and control individuals and familieswith careful phenotypes of their status.Terms of where we stand now, the family based study, whole genome sequencing was the firstto be done.Of the 500 individuals who were mentioned to be targeted, data from 410 representing89 families was made available by posting on December 2nd so available to the investigatorimmunity in terms of what comes next.The remainder of the whole genome sequencing of families a toll of 582 subjects expectedto be completed by March next month.The whole exome sequencing 5,000 cases an 5,000 controls by the summer.So very much on schedule as a result of the funding that was initiated in 2012 and 2013,there will be an unprecedentd wealth of data identifying new genetic risks and protectivefactors which will be a starting point understanding the pathogenesis of disease and one approachtowards determining interventions.There is in addition to requirement to do this sequencing and posting the data, greatdeal of analysis that needs to be done, it's sophisticated,ing takes investment of a lotof folks with expertise in the area and in order to facilitate it NIA issued a RFA setaside of funds for U-19, the cooperative mechanism involved that will fund institutions to carryout analysis of data so it's timed to coin side with the availability of the data asI just noted over the next years where the funding the analysis of these data so thisarea moving along quite well and expeditiously.Other goals, milestones for 2013.There was to then and has been a completion of database which we are populating with internationalfunders of Alzheimer's research portfolio is growing, as we'll touch upon in a bit.No opportunities to meet with international leaders have facilitate and we hope will acceleratedthe global nature of this database.Also another target for 2013 was to bring together a group to pursue a public privatepartnerships that might facilitate testing.This happen happened April 30th, 2013 and the link to that productive meeting is shownhere so once again happy to report we're able to meet that milestone with this meeting whichwill set the course now for further action.Now for 2014, we're just beginning to account it to fiscal 2014, these are the milestones,give you a sense where we stand with them until we had a budget for this year whichis only relatively recent that's still formerly not finalized, we couldn't move forward butnonetheless as we have become used to in the past, plan for the eventual wallty of havingfunds.So we have noted one recommendation advisory committee to advance national drug and conventionaltherapy.Right now our discussion has been that it might be most useful to conduct that meetingin a broader research context as part of the 2015 summit which will be a year from now.Establishing agreement among stakeholders to expedite refocused drugs there's not aformal initiation as yet, I should point out how far this area moves forward.You'll know that past trials reported with GINKO BILOBA and progress using insulin areexamples of broad area which this does continue to be the case.A there are candidates available we have not established a stakeholder forum for this particularpurpose.Next, the attempt to initiate efforts to identify and characterize efforts for at least 6 noveltherapeutic targets.Identifying 6 is the aspirational goal, the end point of the effort but the effort habegun with a number of awards in 2013 taking advantage of modern systems analysis withsome very exciting possibilities that we think are very much on course an likely to carryus to this goal as it's described here.Initiating testing novel pet ligands, other novel biomarkers.Multiple studies in progress already so the clinical trials which began notably last yearhave a wealth of biomarkers involved.And I can say that there are additional efforts at the NIH level in collaboration with Pharmathat will soon allow us to announce some expanded efforts in this regard.Doing even more by way of establishing bioimaginging and other biomarkers so a very active airare with a lot of excitement in the research and clinical and I hope Napa communities.Begin to launch research program develop sensitive neurological assessments not yet initiated.Once again we'll consider whether having this forum be a part of the 2015 summit is ideaor whether it better be done through a separate meeting, those discussions are still ongoing.Develop and test standards for immunoassays for collection MRics and imaging, this isvery much an ongoing effort led through ADNE and biomarkers consortium to NIH, two largeefforts and come to the gratifying way, the leadership of the Alzheimer's associationADME has become worldwide so some of these efforts are global, not just national.Establish a panel of epidemiology clinical trialists to make recommendations for bestpractices.Not planned for 2014, this could be one pivotal session in the 2015 summit about a year from1now.1Initiate expansion of epidemiology to major cohorts to include subjects in mid life, no1new cohorts are accomplished.1In part because of the fiscal and infrastructure difficulty establishing new cohorts these1days but I would point out that in a number of studies currently involving individuals1in their 50s, that's the range of mid life this is days an on, we are very much expanding1the use of imaging markers, cognitive testing on existing epidemiologic studies which come1in this age range which I think is going to be effective way to proceed we'll be talking1about some of them if you wish in detail discussion but they include HRS, (inaudible) survey a1useful population based study in this country that allowed estimates last year, cost and1prevalence of Alzheimer's disease.1As well as the use of supplements to a number of studies such as those conducted through1the national heart lung and blood institute, looking at populationses tracked for cardiovascular1health which we have done extensive supplementing with neuroimaginging biomarkers and cognitive1tests I think looking at a broader age range take advantage and leveraging with our populations1in existence.1Infrastructure translational centers for integration of multi-modal analysis feeding towards pre-clinical1therapy development.1This is very active area of planning NIA and as we come down the next weeks and months1to determination of the way in which the current appropriation will be used, this is one of1the high priority centers, hopefully tell you about it in our next meeting.1The creation of national IRB, this is somebody collaboratory we're working towards and making1progress and we may have a chance to discuss that if you wish.1One example is this is more than NIA, this is national collaboration public and private1towards all these goals.1Establish a working group to verify Stan outcomes in clinical studies.1Ron may want to comment himself since he's involved but this is an area we already have1a good deal of standardization and we face the usual countering priorities of standardizing1while allowing individual studies which have their own goals an targets to have some flexibilities.1But overall, we have strong efforts towards standardization and be happy to discuss this1further.1From in the area of study recruitment and participation, you'll be hearing some of this1in a subsequent presentation from Jane who is here but there has been real advance in1these efforts to improve on recruitment through establishment of -- recruiting older adults1into research and I think I can leave this page worth of bullets the presentation you'll1hear in a few minutes, another area of good progress in the 2014 milestones.1There were two RFAs specific hi for research that were sent out to the field last year1which we expect to be funding this year.1They are in human cell reprogramming for functional genetics.1This is such methodologies as IPS, these are stem cells that are reprogrammed from human1cells from skin or blood, very distinct it should be said from embryonic stem cell technologies1and then opto genetic studies, cutting edge area for looking in the brain at the phenomenon1relating to very precise regions within the brain.1So in little more detail, this is the nature of studies towards IPS or stem cells.1This is involves taking cells from individuals involved with Alzheimer's disease, the early1familial Mendelian determined or the more common late onset and with control and normal1cells looking at the individual -- the opportunity to learn through the cells about the biology1of disease and potentially using these cells to screen for new pathways of intervention.1Then the optogenetics using these tools, so far this is animal model studies to look at1effects of activating specific neuronal areas through some very neat and exciting new technologies1in this field.1The 2012, 2013 Alzheimer's disease progress report by NIA and we eel be communicating1to Congress and public soon, I refer you to here, as I week or so ago it's accessible1online and is a summary and substantial detail of research progress over these two years.1I would point out ongoing right now at the national academies of science is a meeting1public health dimensions of cognitive aging through institute of medicine supported by1NIA along with Mcnight brain research foundation, NINDS neurology institute at NIH and American1association of retired persons, very much related field germane to the topic of today's.1That is the end of my presentation.1Ron, leave it to you whether we do discussion now or wait.1>> Why don't we take some discussion right now or questions for Richard.1Thank you very much, Richard.1I think that's an impressive array considering that milestones are relatively recently developed1yet you and your staff have made significant progress from the summit.1Couple of issues then I'll open up.1A few item were not met.1A you would expect.1These are milestones, they're targets out there.1Is there an overriding issue as to why some were not met?1Is it resources or is it just the field has not evolvedded sufficiently from a scientific1perspective?1What are row blocks if there are as much >> There's several categories.1Some involve planning and convening of meetings as noted we're looking at strategies that1might incorporate to the summit.1So there is one category.1There are other areas, where highest priorities, it was gratifying to report progress but it1shouldn't be mistaken for having done all we could do if we had the resources.1So in the very central areas such as initiating clinical studies, clinical trials, in those1trials pursuing the maximum number of biomarkers to be informative.1We have gratifying work to report.1But there's more to be done with resource constraint budgets limiting those.1Similarly in the areas of basic science including the network analysis but also two RFAs that1were issued the amount of funding to support those, is conditional, gratifying this year,1we expect to move forward.1I'll ain all the research areas the common factor is though we are most grateful for1the funding we have had and increase now, it remain it is case progress in all these1important areas from basic discovery through translation an clinical studies an trials1is in all aspects limited by budget availability.1>> Richard, that was a great presentation.1Thank you.1I have two questions, one of them is about what you just mentioned.1What is the process or is there a process by which you and your staff assess how much1is needed to achieve the milestones that you have set?1So sort of front loading a discussion that we may have later when we talk about the research1subcomittee recommendations but if you, based on those milestones, can say we didn't have1the resources to achieve them, then how does one set the amount that's needed to achieve1it?1And second, what is the process by which you and your staff update the milestones?1Are you waiting for the 2015 summit to then do a reappraisal of these milestones or is1that an ongoing process or an annual process?2>> To the first as you know we have had these discussions within research group.2The issue of identifying how much funding is needed the carry out out all the efforts2meeting milestones is one in which I think the participation of the research community2and the non-federal members of the group is going to be very important.2We can identify a we issue each solicitation the kind of resources we can set aside, the2amount needed to reach the goal is the kind of speculation which is translated through2a budget request for the federal participants we really are not best able to do but we can2certainly support the efforts of those of you carrying out such.2Now, the milestones in the revision, I think we need to be open to reexamining at every2time, first the process we track milestones, we have through our division of neuroscience,2behavioral and social research through our planning office, look carefully at initiatives2as they go out, funding when it occurs, meetings when they're held.2So ongoing basis -- the revision of milestones we are flexible about.2We lock forward to for example outcomes an recommendations from Napa here which we think2in some cases perhaps be translated to milestones but as you point out we expect there will2be a substantial relook.2So we want to be flexible.2I think some of the recommendations you'll be talking about do involve milestones that2we can add to those that were originateed from the 2012 summit.2>> Richard, I know it's complicated and I don't mean for you get specifics but is there2a planned allocation, the 2014 allocation given the time frame, we're already into the2fiscal issues we discuss.2Can you share your thoughts with us right now?2>> Happy to.2I smile with trepidation as I try to explain some of the aspects to y'all.2So in 2012 and 2013 as you know, we had important increments of money for one year.2So we use special mechanisms to support them because we didn't have the outyear fund with2which to continue them.2This year there is an important gratifying difference in that the additional budget is2into the base of NIA and all reasonable expectation though not certainty, it will continue to2be there.2However, I need to point out and you can tell me if I -- if this is clear or not, if we2were to spend all $100 million or so, if that's the amount, this year funding the first year2of five year projects, then there would be none of that left next year for new projects2and we'll be back to where we were last year.2Our planning, I have to explain the strategy is to invest money this year in such a way2that next year, and the year after and year after that, we will additionally have increased2amounts of money for competing rewards in particular in a year such as the follow on2to the 2015 summit, the new recommendations we need to have funded.2So as you see what comes forward, you'll see the strategy which is involved in ultimately2giving us an increase in our base ever year for new research thought the year.2That constraint, this is a technical issue of funding, in 2014 as you're alluding to2by nature of the time, we have some RFAs planned.2I showed you those.2The response to those can be better met with the research that we have.2In 2014 it would be difficult if not impossible to now de novo issue new solicitations.2In large part we'll be spending 2014 funds in a way to follow-up on the RFAs I mentioned,2Sommertorious applications that came in response to previous solicitations.2We funded all we could but we have some remaining on those lists of well reviewed applications2we can go on to and now it's our strategy in outyears we have begun actively to start2planning priorities for 2015 because here we can plan the kinds of initiatives, identifying,2setting aside fund as we did in 2012 and 13 forward looking and making sure we have funding2available in 2015 to meet those needs.2>> That's an outline of the\n-- that's an outline of the process.2>> Richard, I only slow to understand what it is that you're saying.2Is it the case with this 100 million or if that's the number, you will fund applications2that were unable to be funded in 2013 and also increase the pay line for 2014 applications2that are related to Alzheimer's disease?2>> Yes.2>> But not -- >> And meet these RFAs, the applications.2>> That you mentioned before.2>> Yes.2>> So in other words, instead of 5% pay line, it will be now maybe a 10% or 15%.2So the thing that you won't do is put out new RFAs to be funded in 2014.2>> That's right.2>> And you are hoping but not -- can't be sure of, that this 100 million will be -- that2it will con on into 2015.2>> By all precedent, this is money that's into the base budget of NIA and should remain2there through all future years.2Nothing is certain about budget but we will be planning with confidence that that increased2$100 million will be there for outyears as well.2Nor to have it available for competing new research activities as opposed to just the2continuing years of things that we might fund this year that we have the look at the balance.2But we have no reason to doubt if the $100 million is going to be an increase in the2budget available for Alzheimer's research if that's the number we continually say, for2not just this year and next but subsequent years.2>> So Richard, is it possible for you to say with confidence that any subsequent analysis2yours, ours as a council, any outside analysis in reviewing what you will have funded once2you do, would have been directed toward success on the milestones, despite what you and Jim2had the exchange on what you said initially about funding previous RFAs as opposed to2issuing new ones giving timing if I understand the point.2That all these funds would be expended toward advancement of the milestones and that you2are confident, I'm checking to see if you are confident that there is sufficient qualified2science in what you're talking about funding from prior applications that we wouldn't be2funding lesser science as a result of that, that we will be funding qualified science,2I hope you're going to answer, toward the end of the milestones.2And that we would thusly be advancing what would otherwise be the progress against those2milestones at least to the degree funding is occurring and science is occurring, recognizing2fully with can't be sure of the outcomes of any science but it would be aimed toward the2ends that you would be confident in the science that would be funded.2>> I think I can with great certainty and confidence respond in affirmative to your2question, namely that the additional funding that we intend to pursue this year will be2funding applications that have been judged by peer review and by our own administrative2review to be outstanding and highly meritorious.2There's no compromise in quality of research whatever.2These are in large measure identified with milestones.2I say large measure rather than entirely because afterall, these milestones as critical and2similar as they are, do not cover necessarily every area of research that is critical to2Alzheimer's and our goals.2So we have investigator initiated research which has for a long time and continues to3be a vital part of what we do and funding the most outstanding of investigator initiated3research often associatable with milestone but not necessarily in detail in each case3is another important part of the overall plan.3>> Maybe appropriate for this research subcomittee and also for this council to identify what3is important about that element of science that aligns with the plan if it is this stage3not truly covered there.3If I heard you correctly, that's something for us to look at in the research subcomittee3and ultimately the council level.3So when you give your report otherwise,ing Richard, as Ron indicated, there were several3things that were not yet initiated or otherwise, you have told us before, on ask specific question3do you have enough money to achieve all these things, I'll just add -- I'll repeat that3question.3Do you have enough money to achieve all milestones at this point.3>> Funds are limiting the degree to which we can invest in pursuit of all those milestones,3the probability of success, the intensity of our pursuing them remains limited by available3funds.3>> So you don't have enough money.3>> We do not have enough money to support the highly meritorious research which would3contribute towards success against these milestones.3>> Echoing the points made earlier, naturally while we are certainly excited about the 1003million, and agreeing with Dave and others that we have many other things to do, not3only in research but otherwise in the plan, we certainly got lots more work to do but3specifically in research clearly we're going to have to see to it that more is funded,3if in fact we're going to meet these -- when we meet the milestones, we get 2025, one of3my concerns Richard in terms of even with what I would agree with as a positive report3for as Ron put it milestones that have only shortly lived thus far, I hear a lot of things3moving out to 2015.3Naturally we have people in this virtual meeting who have the disease today, they regrettably3know that this takes time but they are also eager rightly to see us advance on this as3swiftly as possible.3When are we going to be able to identify in the reports I have not personally yet had3a chance to read the progress report.3We will look close at that.3When will we be able to see deficits occurring?3If you have answered as you have today and previously, that you do not have enough funds3and that we see things that are not being initiated, when are we going to clearly see3where we are falling behind the path to 2025?3Seem clear to me if we don't have enough money and we have this set of milestones though3it sound like we need to add things to capture the balance of whether needs to occur in science3to get to 2025, when are we going to start to see the deficit?3Any of us could project the deficit today already, the curves are going to be diverging3more widely.3When are we going to see that captured in the progress report?3I'll just add additional thing that I think is absolutely apparent to anyone, I'm confident3yourself included Richard, there would be motivation on the part of the administration,3any administration, not picking on this one, to indicate what would be the positive progress.3More so than identifying what would be the absolute and certain deficit under the circumstances3we have.3Not yet enough money even with addition of new money to achieve what it is we have to3do.3So when are we going to start to see that in the reports?3Do we see that in this one, Richard, when we all -- read it?3>> I think that the challenge is a little more complex than stated, if you allow me3to amplify.3There's a bit of a Washington monument here.3If we have number of item listed as milestones and we think they're terribly important and3we say we simply couldn't do them at all, that's a compelling argument.3What is more likely going to be the case and is already the case, is that is going to be3the intensity and degree to which we can invest.3So if there's a recommendation for new clinical trials or research into cognitive instruments,3we can point to the fact we are doing some.3We have to be more sophisticated I think in our analysis of keeping up or falling behind3optimal or suboptimal than just begin able to touch a button and saying yes we have done3this.3The question is have we been able to do it optimally.3As examples I mention to you the able to initiate some very important prevention trials was3a positive accomplishment but we were limited in our ability to fund all the trials possibly3including the one that would have been the break through by funding.3We will be able to correct this a bit.3So I'm suggesting when we start looking for neating milestones or not, initiate -- meeting3milestones.3Initiating studies to achieve X we maybe able to say was done but we have to pay attention3whether we were able to carry out all of the research that but opportune in terms of scientific3opportunity, not just whether we did something in that area.3I think as likely to see gaps there, perhaps more so than simply having failed to do anything3in a given area.3Our strategy is going to be to try to make efforts to meet milestones to touch upon them3all.3We have to work together the understand how assess what meeting a milestone means in terms3of intensity we're able to pursue it.3That's going to be a very important factor and ultimately getting to the goal as you3point out.3>> Accepting the reality of the additional complexity as I think you put it, Richard,3I would just say to our group first that I think we're going to need to really monitor3what would be the progress reporting.3As you said Richard, working together you would hope we can be clear about the deficits3that begin to occur even if they are complex and keeping it at an even simpler level for3what would be policy and particular near term in terms of the budget.3I would hope that the administration would take very seriously what I think what Richard3and I are discussing here which is a gap that will exist.3Again, being truly a respectful and thankful about what occurred.3The president funding 80 million, the Congress stepping that up to 100 million in research3recognizing what Dave talked about in terms of other needs for long term services and3supports and the other elements of the plan that the administration has put forward in3the recommendations that again are represent a gap between the recommendations and the3plan but if you look back to what occurred for example in HIV AIDS, some people think3that the budget went hole from zero to its conclusion.3It would be ideal of course if we can get that right away, but recognizing that that3is not the way things work, it again being thankful of the money that just occurred,3what I would certainly hope and I think everyone could unanimously agree on here is we would4see the ramp up which is currently in the recommendations of this council represented4in what would be the budget of the administration in this next move.4The AIDS budgets increased on a ramp and sometimes at significant increments.4I think there is a grown and growing recognition on the part of the Congress as well, and I4think the administration has already demonstrated its understanding of this issue, that would4be if not truly ultimately fulfilled, truly recognized by what would be an increment in4this next budget that would be appropriate to succeeding against those milestones in42025 which I think Richard if he didn't want to absolutely, as a result of this discussion,4has recognized as likely being impossible under funding that exists and without the4intensity of the investment, I believe is what you said, Richard, which I take to mean4the sharpness of the curve of the upturn even in these most difficult times recognizing4that the cost of this disease, at the human level and the economic level are not tolerable4to not see that kind of ramp up occur again in the next budget cycle.4>> I want to say I heard the message.4Thank you.4I will bring that back to the powers that be.4You have a very clear message.4>> Thanks.4>> I have heard it.4I'm also eager to hear from -- I can only stay a little longer, I'm eager to hear from4Shari is up next, from CMS.4>> Right.4So good morning.4We'll provide a brief update and this actually is just the outline for the update on the4clinical services work group that we'll be providing starting with an update by Joan4that just will be a verbal update, no slides, touch on the national quality forum measure4prioritization project that is ongoing, inform you of a listening session that is planned4to does cuss outcomes and focus of effort in the quality and clinical space and also4share with you some time lines of work underway so let's start with Joan.4>> Good morning, everyone.4So in FY 2012 we funded 45 GECs with $2 million and they provided 676 professional and continuing4education offerings to approximately 34,000 healthcare providers an primary care.4They partnered with 376 organizations in the first six months of fiscal year 2013, they4provided 350,000 trainings and to date trainedded approximately 25,000 individuals with FY 13-dollars.4The FY 13 amount but also $2 million.4In FY 2012 ASPE provided approximately $200,000 to develop a training through Netscape.4That contract was let in September of 2012.4And completed in September 2013.4And the training went live and I had sent that to everyone on the counsel.4From September 23rd to December the 17th, approximately 30,000 individuals participated4in the training through Netscape.4Netscape will offer that training for one year and they will provide us an evaluation4of the training and pre- and post test results Anatol number of participants.4At the completion in September of 2014.4So in fusscal year 2014 we will receive $4 million through our regular appropriation4to specifically train on Alzheimer's disease and related dementias.4And our plan for using these funds is to develop the unified curriculum and to continue our4continuing education in a professional -- interprofessional offerings and expand that effort.4And have a larger reach to also include direct service workers and lay and family caregivers.4Through the other portion our regular appropriation which is not our designated dollars, our grantees4will continue to provide faculty training in -- on Alzheimer's disease so they can integrate4that content into the formal studies of health profession students and they will also use4those funds for clinical training of students across the care continuum.4>> Moving on, I want to provide a brief update on the measures prioritizing measured gaps4in Alzheimer's disease and related disorders.4Mind you, this is really project being that it is being conducted by the national quality4forum which as you know is a consensus building entity that will -- that has already begun4to take stock of what quality measures exist and build on the FNIH reports and work that4has been done thus far.4But really to point out where the gaps are.4And suggestions on what would be the most highest priority areas of focus to fill goes4gaps.4Take a step back as far as how this work will be utilized, quality measures where available4can be used for at least quality reporting programs across all care settings.4But also could be propose for programs that also build on value-based purchasing either4in the hospital, the physician space as well as in quality improvement efforts.4So this is actually a very important area in that where do we focus base on existing4evidence and where evidence is insufficient is also an opportunity to address in -- through4future research efforts.4Where we are in this process is that the planning meeting already took place as well as the4committee itself had an opportunity to document the outcome of this planning meeting and a4high level summary which was that the potential priority -- prioritization criteria will be4to focus on outcome measures where possible including patient reported outcomes and this4can also build on a separate project for patient reported outcomes that was conducted by the4national quality forum.4Patient and caregiver experience of care, another high priority area, that the work4must and should account for minority groups that are disproportionately affected by Alzheimer's4disease and related disorders and give consideration to patient whose do not have caregivers or4families.4Finally, a very difficult area is how to approach patient reported measures when people can4no longer speak for themselves.4These are the high preliminary high impact priority areas, full report of which is available4on the NQF website and as a pointed out here.4And to also make you aware that upcoming on February 25th will be a web-based meeting4to review a draft conceptual framework and also review the environmental scan.4And a in person meeting to occur in June.4This is work in progress but I think will lay an important path forward in the quality4space.4So I also wanted to inform you all that we are hosting a listening session that will4try to refine the area of focus for a larger public listening session.4Some of the probe -- prompts being considered are what health outcomes are most meaningful4to focus on for efforts -- for, personning with Alzheimer's disease and related dementias4and families an caregivers.4So what are the health outcomes that we should touch upon in clinical space but also converge4with research efforts as we move forward.4Given state of Alzheimer's treatment what diagnostic testing would be useful to patient4and families and how would we know this.4The third prompt to be discussed would be what do you perceive physicians and care providers4need to improve care delivery for the persons with early and moderate cognitive impairment4as well a for advanced dementia.5I will conclude with a brief update of implementation milestones with focus on some of the work5initiated in 2013 per George's request at our last meeting which was recent.5But the patient and family engagement campaign was launched with 5 dementia specific or dementia5focused quality improvement projects.5These committed to focusing on care delivery and engaging both patient and families, in5their care, to improve the quality of care received.5They're providing monthly updates, a well as provide quarterly updates that will be5available on a healthcare community.org website but also can link to the government Alzheimer's.gov5website, if that's something that would be useful to disseminate that information and5we can contemplate having a webinar to present the final report which will be forthcoming5by July 30th of 2014.5Similarly as far as the second area, the healthcare innovations awards, that are authorizedded5for implementation under the centers for med car medicaid inn investigation center, the5round 1 projects, there were 6 focused on persons with dementia.5Those projects have been initiated.5And the evaluation of which will be initiated in this calendar year.5It is anticipated that by 2015 at some point in 2015 hopefully sooner than later, that5there will be projects that are then identifieded for expansion or scaling.5And just to be a little more granular about what that means.5So by December 2015, there maybe learning opportunities that come from the (inaudible)5projects.5There maybe clinical guideline development that builds on lessons learned throw those5projects.5There maybe larger demonstration projects that are forthcoming building from the initial5sick a well ads an option of full scaling as part of CMS policy, what -- which of these5will be the outcome is to be determined.5As you know projects were sought and invited for round two dementia and dementia care of5which was a focal point called out in the round 2 announcements.5So although this actually crosses over into long term care services, area, I did want5to just share with you the latest update from quarters 3 of 2013 as you can see this is5the national partnership to improve dementia care in long staying nursing home residents.5Said another way, this is about reducing unnecessary antipsychotic use.5And as you know, we set a national goal of reducing use of unwarranted antipsychotics5to 15% reduction nationally.5As you can see, the trend lines, this is displayed by CMS region, but we also have more granular5data that dips down to the state level, from quarter 4 in 2011 to quarter 3 in 2013, the5regions and states were able to reduce antipsychotic use in long stay residents anywhere from 135to 21%.5So though we're not there yet completely nationally, we do know that there are 21 states that actually5already surpassed that goal reduction and even more that are close to achieving that5goal.5So I'll stop there and entertain questions and also if Joan, you can field questions5from the HRSA perspective.5>> Thanks very much Shari and Joan.5Appreciate that.5Comments and questions?5>> Shari, is that last slide in the packet?5>> Yes, it isful.5It's actually a separate two-page but it is provided.5>> Let me, Shari start back, and say what we think to be roughly 5 million people with5dementia in the United States.5They -- they are resident in a variety of care settings.5They are at various stages of the disease.5Do we have any current methodology by which we can assess what the quality of care is5today?5Or outcomeses are today, and thus we set national quality forum consensus standards on what5quality outcomes might be, a way to say this is where we are today and this is a path to5where we ought to be in two years, five years, ten years?5Do we have it in your head or on paper or somewhere approximate ability to say what's5the baseline of quality outcomes today and what it should be as we develop new standards5and how do we get there?5>> Thank you for that question, George.5That points out the opportunity and challenges in moving the needle towards delivering better5care with focus on population of patients an caregivers with dementia as a focus.5As you point out, there are quality reporting programs that span from the physician space5or outpatients to hospitals both outpatients and inpatients, to post acute care settings5including enstage renal disease facilities, long term care acute care hospitals, hospice,5home health and Lukely more that are currently not required or at least integrated into a5system or nationwide quality reporting program.5So at the first pass there are vehicles to implement exactly that, measures of quality5across all care settings.5The challenge become how do you assess and know who has dementia an who does not.5As you know, the quality measures for the physician space that currently exist focus5on people who already have dementia.5Using a specific set of codes, if you will, to identify this population by administrative5meanses.5All quality measures require that there be a population at risk, you will, that is defined5as well as a numerator population that may include persons with dementia, defined by5code X, Y or Z.5So there in lies the challenge.5What would be the codes that permit us to align measurements and the population across5all the care settings, administrative meanses would be one though recognizing that that5would largely be an understood estimate of the burden of cognitive impairment in the5population.5Then another question becomes so what would be the data source beyond administrative claims?5There are quality, there are legacy tools that already exist and are required for providers5to complete and submit including the minimum data set, the set that the antipsychotic measures5are built upon.5There also are in post acute care, there's the oasis tool for home health agencies, there5is a voluntary quality reporting tool for hospices, there is an inpatient rehab facility5based tool in patient rehab facilities but they don't all align in what the focus is5and how they measure areas of function or identify persons with a given condition.5So I think there is work underway there is interest in an alignment tool, the care tool5for post acute care, that includes elements that importantly are standardized.5So how you actually assess may matter in who end up in your population in the numerator.5There is the data elements being cross walked into what the care be tool which is really5more for outpatient setting and also for the promise tool which has common roots, research5base from NIH and yet with data elements an domains that we think could align well.5But these areas point out the importance of standardization and how we actually mindfully5pay attention to the details and how we identify a patient with dementia, it maybe there's6overlap using administrative claims between the veterans administration and the CMS, MCC6chart book but there maybe areas that do not overlap so there's not full alignment.6Is question is what should we include in that set of codes, what should we include in a6required domain of assessment.6And to do it in a way that makes sense and meets the needs of the patients that appear6in these different care settings is quite challenging.6This is work that we need to do.6>> One thing that was striking at the discussions at G-8 is what the UK is doing, they have6a closed system so it's easier but knowing they have actual targets, national targets6for the percentage of estimated dementia population diagnosed.6With respect to those that are diagnosed they have a target who has a coordinated care plan6in place.6With respect to the percent that have a coordinated care plan in place, what quality outcomes6are being achieved.6So that you can set national goals here.6But if you don't have a view where you want to go, it's difficult to figure out exactly6what all of this stuff relates to.6National quality forum sound great, activities sound great but until it's aligned into a6logic framework that says we want to get dimen Shah diagnosis rates up, care, coordination6and place rates up, quality outcomes more widely disseminate and quality outcomes measured,6you don't know how this feeds into some sort of system where you actually are going to6get a better result for the people with dementia in 10, 15 years.6>> Your point is well taken.6I'll make it brief.6But as far as how it ties into outcomes then, it is feasible to assess outcomes we are already6measuring like hospital readmission rates and the like if we have a set of codes that6can be applied to the analytic files that already exist.6>> Brief from JEN and Dave and then we'll move on.6>> I'll make a brief comment that relates to the finer point from my spin on what George6was saying.6Which is that this whole processing is incredibly complicated.6But to have a ultimate -- to reach the goal that's set out in the national plan is going6to require a grid of some sort with immediate goals, midterm goals and long term goals similar6to the intermilestones that were set out for research.6I see you're doing an incredible amount of work but I won't understand progress towards6that until that kind of systematic goal is\n-- goals are set out and I see that in the6clinical care subcomittee group interim milestones number three seems to be part of what is being6recommended but I think it might need to be more ambitious and more broad and I would6push that group to do that because it is daunting and challenging and I see work is going on6but I can't see how that fits into what we need to do.6You can't count how many people, the quality of care until you diagnose people properly.6So these need to be ordered things.6>> Thanks.6Really quickly, Shari, thank very much for the time and attention that CMS is paying6to this really important issue.6Speaking for the public health community, we're excited to see the issue Wednesday of6the new home and community based service regulation.6I think it would be important for this group to get a pretty comprehensive update on this6new REG including any baseline data that you have and any plans to evaluate the impact6of the home and community based services.6>> Hey Ron, I know you got to move on.6I'm curious, I know Laurel can't be with us but I heard her on the phone, I'd be curious6whether or not, it's hard to break in on the phone, whether she has any points to make6or anyone else on the subcomittee, but particularly Laurel was the chair of that subcomittee.6>> Laurel.6Can you hear us?6Did you hear that?6>> If I can just pose one, effectively I agree what George is saying.6We know we have got at best half of people diagnosed.6We talked before here about -- we have got in place the annual wellness visit that based6upon prior discussions I think you would agree, none of us are satisfied with in terms of6the degree to which it's being executed even as it's already set up.6So even executing against that without -- I mean changing how we execute to achieve more,6and I like the idea that George mentioned JE next is talking about in terms of having6ontives for that.6We will talk more about that later but it seems even without getting to that point,6that pushing that particular set of executions would be fundamentally not only sound but6advantageous, we know so much about what happens when someone is diagnosed positively for them6in the system and certainly we know the parallel to that, what goes so badly wrong for them6if they are not -- even if they are diagnosed and not identified in the system, not having6it charted in the hospital makes so much difference in the person's life and the follow-up care6that occurs when they are discharged that this is a high return place for achieving6better care and quality of life for people already there and if we can increase the diagnosis6with it.6>> We'll touch on that in the recommendation section, we'll cover those issues.6>> Sounds like Laurel -- >> Laurel, are you with us?6Have you been hearing -- >> Can you guys hear me?6>> Yes.6>> I apologize.6I have to watch through the webinar and then get on the phone if I want to make a comment6so I don't give you feedback.6I was interested and curious -- in Shari's presentation and I want to tell people it6would be a better time for discussion about this after we do our recommendations rather6than do it now for the up stage some of that discussion which is why I haven't said anything.6>> Thanks very much, Laurel.6I think you're entirely on target.6Jane.6>> Okay.6We just as you might recall over the past year, the progress we have made in the long6term services and supports arena has involved a lot of collaboration across agencies.6Much of which is fostered by the recommendations from this advisory council.6So in 2013 and again in 2014 we're anticipating about $7.38 million to continue Alzheimer's6disease supported services program which focuses on dementia capability for home and community6based services.6We anticipate that focus in the coming year also and that's in align.6With recommendations we have heard from long term service and support subcomittee, the6non-federal members as well as other counsel members.6We mention -- mention was made of additional\n-- possibility of additional 10.5 million6for dementia capable home and community based services.6Again, we anticipate focusing on that and we've heard the recommendations around lead7state agencies for that kind of effort and that was incorporated into our fiscal 13 funding7opportunity announcements and we anticipate something similar for that going forward in72014.7In terms of more detail than that, we're still in the planning phases and so we will be able7to update you with more specifics at the next meeting.7In terms of things we have done outside of the grant world, there has been collaboration7between NIA and CDC, national institutes on aging, centers for disease control and the7administration for community living.7Around educating the aging network, the public health network and the legal services network.7Around a wide variety of issues that relate to dementia capabilities.7So for example with the legal services network we did a number of webinars around planning7for people who might end up for example the protective services system, many of those7folks have dementia or cognitive impairment.7We educated the aging and legal network about those special considerations.7So we anticipate, and we met the objectives and milestones that were planned for this7past year and we anticipate doing that going forward I did want to take a little bit of7time to talk about other milestones met recently in terms of major reports.7So there was last week in the gerontology an issue devoted to culture change in nursing7hopes.7A big part is residence centered or person centered planning an approach to caring for7residents that involve things like consistent staff assignments and resident choice over7various aspects of their lives such as when they choose their meals.7Given that the roughly half of the folks in nursing homes have some dementia or cognitive7impairment, this is a big focus on a large vulnerable population.7And there are copies available at the registration table if you haven't already picked them up.7There was as part of the national plan, there was a request for research on care coordination,7and ASPE will release a study ha summarizes that research, basically the conclusion is7that more evidence is needed on these models.7As Shari mentioned, there are a number of innovative demonstration projects coming out7of CMMic that will address and move the research forward and hopefully lead to translations7that will be important in the future.7ASPE also recently completed a study of managed long term services and supports.7The case studieses that were done basically did not find major disruptions in the providers7that are delivering these services to vulnerable people and we can make a briefing available7to this advisory council if people are interested on more details of the results of that study.7Another thing that Dave actually mentioned was that CMS issued final regulations on implementing7home an community based services with a opinion-centered approach.7We can -- a opinion-centered approach and we can arrange a briefing if you like.7There's a lot of major progress in terms of meeting the needs of folks with cognitive7impairment and dementia as well a others that are receiving home and community based services.7So I don't know if you want me -- if we want to get questions now about these or go on7to the presentation about research recruitment.7What would you like to do?7>> Let's go ahead.7Nina, you can do that, we'll get you a microphone.7>> This is another example of a collaboration across agencies.7From that Rima will be talking about.7Recruiting people into dementia research.7She has slides, go on to the podium.7That's fine.7Thank you, I (inaudible) (off mic)7>> Can you hear me now?7>> I'm Nina silverberg, national institute on aging.7I would like to thank the committee for allowing me to present on behalf of the team working7on this project recruiting older adults into research.7I'm working with the CDC, I'm from the national institute on aging and working with administration7for community living.7I know we have -- we're short on time so I'll rush a little bit.7So the project is aiming to engage older adults including those of diverse ethnic and racial7background to volunteer for participation in clinical research and we specifically clinical7research not clinical trials because we're including biomarker research, maybe survey7research, any research related to Alzheimer's disease, we're trying to improve recruitment.7And all studies in general have few older adults so we're starting this project focusing7on Alzheimer's research.7The goal for this project is to use aging services of the administration for community7living network and the public health networks of the centers for disease control.7As trusted sources of information that already have reach in these communities.7At a local level.7Obviously the overall goal is to help accelerate scientific discovery.7This project is serving parts of the national plan, I won't go through these details T slides7are available.7And also the healthy brain initiative that the CDC is taking the lead on, I believe.7So the project is really focused on making this an easy simple call to action using existing7registry platforms.7I'll show row those in a minute.7We're engaging trusted messengers as I said involving aging services and public health7networks with specifically diverse oler adults and caregivers.7We're trying to deliver a simple persuasive message.7Then we planning to measure impact.7So here are the services from the aging services and public health networks.7We're connecting these with the research Alzheimer's disease senors and other academic centers7conducting Alzheimer's research.7These are the registries that we're working with, we have connected them with each other7to the extent they weren't already, research match is an NIH funded through the CTSA program,7Alzheimer's prevention registry and Alzheimer's association trial match registries.7We have convened a thought leaders meeting in December bringing together all these different7groups, public health research, voluntary health organizations the registries, state7government, Federal Government, those of us opt team.7Aging services.7We have input from all these different groups, all in one place.7We have already developed the simple call to action and into mention that this project7is not complete but we made the conscious decision to bring it to the committee at this7point where we have a draft plan, it's already developed but it's draft.7So we'll be happy to share it, we're already sharing it with the communities that attended7our thought leaders meeting.7And we would love to have input from council on what we're planning to do to help increase7recruitment.7In the recent months we have been busy, we as I mention held a thought leaders meeting,7we got a little behind due to the government shutdown but caught back up.7We have some sites but this is also not in stope for pilot testing materials.8We're bringing together various materials.8We're in the process of gathering feedback and we intend to finalize the plan an implement8it in the very near future.8So I think this is the last slide, just to share we are planning to continue this strong8relationship we have developed across agencies to build on the momentum from the collaborations.8This project and its related work that has been done already which Jane mentioned have8won two HHS level awards, HHS innovates and HHS ignites.8Out's tied in of course with this Napa council and brain health initiative and I think I8have already mentioned the rest of that.8The team is listed here, led by Amy Rodriguez, Jennifer Watson, Andy (inaudible) is opt phone8and Kate Gordon hunter and Jane Tilly at arcCL.8So thank you.8>> Thank you, Nina.8>> Happy to take questions.8>> How are you going to know whether this is successful?8>> The primary metric, the goal is to get more people into research.8Since we're using the registries, the main goal is to get people to sign up at the registries,8we'll see increases because we focused on local areas.8We should be able to tell whether people are joining because of our efforts and we compare8to areas we haven't started doing the pilot testing.8>> So one of the -- like the Alzheimer's prevention registry trial, get a large number of people8who sign up show interest with the website but actual funneling into not only clinical8trials but clinical research studies.8Q. That's a little harder to measure.8We have done some back and forth on that.8There are issues with asking people where they found out and that I have thing so best8is if there's uncreased number of people in registries and we hope that leads to increased8research.8We'll see how the numbers go.8>> This is a great effort.8I have got two -- one question and one comment.8How did the resource senors for minority aging research play into your plan for outreach8to join these registries?8And then I gets I would express a hope that the outcome or the metric can be better refined8because I know that it's a challenge for some of these registries right now that people8are signing up and getting disappointed.8That people don't contact them or they're not eligible.8I think that would be ashame because the efforts to get people signed ups all these people8would be waiting and then getting disappointed, that wouldn't be the best thing.8So I'm sure you have all talked about that.8>> We have given that quite a bit of thought and we're conscious of it as we do our planning.8It's in our outreach plans.8Both to deal with specific diverse populations and do focused outreach in those immunities.8We're working with African Americans against Alzheimer's to -- but that's in the developmental8stages so we're not quite ready to share what's happening with that yet but we haven't gotten8all the way through the planning of that.8We had at our meeting our thought leaders meeting involved people from RickMAR and we8have RICMAR representatives on our council from NIA so we hope for feedback from them8as well and we also plan to connect the Alzheimer's center education course with the RICMARS to8help in them sharing the same message that's in the works.8I hope we're able to develop better metrics and we love to get feedback how we might do8that.8From >> Yes.8So the George is brig up that the A-4 trial, the antiamyloid and anti-symptomatic Alzheimer's8trial getting going with recruitment requires 20% of the participants, of the screens the8people who are screened, to be of -- from diverse populations.8>> And I want to comment that that's -- that is a great goal for the people screen but8it has to be passed on to the people admittedded to the trial.8Out's incredibly important that that kind of goal be given the situation with what I8know of ADNE so far, 99% white well educated people, that's who is participating in that8wonderfully informative but limited because of the participation, lack of participation8of does verse people.8>> Absolutely true, so's the attention being paid to the issue and hopefully that will8translate further down the line.8I also want to address your concern about the messages that are getting out I think8that's why we're so focused on things not just clinical trials, it's clinical research8and we want to make sure that people who do sign up do participate in some way and some8things related to Alzheimer's research so we're very conscious of that and we're trying8to make sure that that message is conveyed in our materials that when they're signing8up for the registries that doesn't mean you're going to get a drug that will cure Alzheimer's.8It means that hopefully you're in the list of people willing to participate and that8then you can contribute in some way.8>> Thank you very much.8Great presentation and I would echo JEN's comments.8Speaking from the public health immunity and as a state official in contact on a daily8basis with folks in both public health and aging, in the absence of targeted resources8to states to support this kind of activity, having this exercise happen has been a tremendous8step forward for folks in state public health agencies to feel engaged and to try to answer8that question what's the appropriate role for the State lead entity or what's the appropriate8role for state public health and state aging agencies, with the absence of significant8resourceses to address Alzheimer's disease, and addressing health disparities has historically8something that we have had as one of our primary focal points.8So this was a very logical step in the right direction.8And I would applaud the team because they have done a great job at making sure folks8stay engaged in this process.8>> Thank you.8Thanks very much, Jane and Nina.8Appreciate that.8Now I think as you gleened from the agenda, a major task for today is the discussion of8the recommendations for the 2014 plan.8we Rearranged the agenda a bit because we want public input after the recommendations8are presented to everybody.8Public input then this afternoon after hearing that we'll have the final discussion and we'll8vote on the recommendations.8So your fearless leader let us slip a half hour behind but nevertheless some time in8the afternoon to make up so this is an important part of the meeting.8So I don't want to cut this short.8So let's turn then to the -- question?8I thought there was something on the phone.8We'll turn now to the presentation of the recommendations and we'll go through the three9subcomittee reports.9All these are in your folder and obviously open for a good bit of discussion.9So let me start with JEN and the research committee.

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